{"state":"TX","name":"Texas","verified":"2026-10-14","records":[{"id":"D1-A-01","facts":[{"k":"statutory definition of practice of pharmacy","v":"Tex. Occ. Code 551.003(33) defines it as: (A) providing an act or service necessary to provide pharmaceutical care; (B) interpreting or evaluating a prescription drug order or medication order; (C) participating in drug or device selection as authorized by law, and participating in drug administration, drug regimen review, or drug or drug-related research; (D) providing patient counseling; (E) being responsible for dispensing a prescription drug order or distributing a medication order, compounding or labeling a drug or device (other than manufacturer/repackager/distributor labeling of a nonprescription or commercially packaged prescription drug or device), properly and safely storing a drug or device, or maintaining proper records for a drug or device; (F) performing for a patient a specific act of drug therapy management delegated to a pharmacist by a written protocol from a Texas-licensed physician; or (G) administering an immunization or vaccination under a physician's written protocol.","c":"Tex. Occ. Code 551.003(33)","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"license required to practice","v":"A person may not practice pharmacy without a Texas pharmacist license; may not impersonate a pharmacist or use 'Registered Pharmacist'/'R.Ph.' without one; and may not dispense or distribute prescription drugs unless a pharmacist or otherwise authorized by the Pharmacy Act.","c":"Tex. Occ. Code 558.001","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"acts reserved to a pharmacist (Class A list)","v":"22 TAC 291.32(c)(2) reserves these to a pharmacist, and 291.32(d)(2)(A) bars technicians and trainees from them: (1) receiving oral prescription drug orders for controlled substances and reducing them to writing; (2) interpreting prescription drug orders; (3) selecting drug products; (4) performing the final check of the dispensed prescription before delivery; (5) communicating to the patient or agent information the pharmacist deems significant (counseling); (6) communicating on request information about drugs dispensed to the patient; (7) assuring a reasonable effort is made to obtain, record and maintain patient medication records; (8) interpreting patient medication records and performing drug regimen reviews; (9) performing a specific act of drug therapy management under a physician's written protocol; (10) verifying receipt of controlled substances listed on invoices by initialling and dating; (11) transferring or receiving transfer of original prescription information for a controlled substance.","c":"22 TAC 291.32(c)(2)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"exclusive dispensing authority","v":"Notwithstanding any other law, a pharmacist has the exclusive authority to determine whether or not to dispense a drug.","c":"Tex. Occ. Code 551.006","st":"statute","ed":"2017-09-01","df":"no federal analogue"},{"k":"who is outside the Act","v":"The Pharmacy Act does not apply to, among others, a practitioner who supplies his or her own patient with a drug as state/federal law allows and does not run a retail prescription pharmacy; a college of pharmacy faculty pharmacist acting only for the college; a person procuring drugs for lawful research, teaching or testing and not resale; certain home and community support services agencies; and a low-THC cannabis dispensing organization under HSC Chapter 487.","c":"Tex. Occ. Code 551.004","st":"statute","ed":"2015-06-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D1-A-02","facts":[{"k":"no independent prescribing authority","v":"Texas gives pharmacists no independent prescriptive authority. Pharmacist clinical authority is delegated authority: it exists only through a written protocol from a Texas-licensed physician under Tex. Occ. Code 554.005 and Chapter 157 of the Medical Practice Act, implemented at 22 TAC 295.13.","c":"22 TAC 295.13(c)(1)","st":"regulation","ed":null,"df":"true"},{"k":"limited delegated authority to SIGN a prescription for dangerous drugs","v":"A physician may delegate to a pharmacist the authority to sign a prescription drug order for dangerous drugs (non-controlled) only if the delegation follows the physician's diagnosis, initial patient assessment and drug therapy order, AND the pharmacist practices in a federally qualified health center, hospital, hospital-based clinic, or academic health care institution whose bylaws and medical staff policy permit it. The pharmacist must notify the board before signing any such prescription, file the protocol, file updates within 10 days of change, and put his or her own and the delegating physician's name, address and phone number on each prescription.","c":"22 TAC 295.13(c)(2)(B), (c)(3)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"no authority for controlled substances","v":"The delegated signing authority reaches dangerous drugs only. Nothing in 295.13 authorizes a pharmacist to sign or issue a prescription for a controlled substance.","c":"22 TAC 295.13(c)(2)(B)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"vaccines: Texas requires a physician protocol, which the PREP Act preempts in part","v":"Texas permits a pharmacist to administer immunizations only under a physician's written protocol (22 TAC 295.15(e)(1)); Texas grants no independent authority to order a vaccine. For covid-19 and seasonal influenza vaccines and authorized covid-19 therapeutics, the PREP Act declaration amendment makes a state-licensed pharmacist a 'qualified person' who may order and administer them through 2029-12-31 and expressly preempts contrary state law, so the Texas written-protocol requirement is unenforceable as to those products for the life of the declaration.","c":"22 TAC 295.15(e)(1); PREP Act declaration, 89 FR (2024-12-11)","st":"regulation","ed":null,"df":"true"},{"k":"federal-employee exception","v":"Pharmacists employed by VA, IHS and PHS prescribe under federal agency scope; Texas law does not reach that practice. The Pharmacy Act's internship rules expressly contemplate federal government pharmacies as a separate category.","c":"Tex. Occ. Code 551.004","st":"statute","ed":"2015-06-01","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"high"},{"id":"D1-A-03","facts":[{"k":"no pharmacist authority to initiate hormonal contraception","v":"Texas law does not address this. Texas has no statute or board rule authorizing a pharmacist to initiate, prescribe or furnish hormonal contraception, and no statewide standing order or protocol for it. A pharmacist could do so only through an individual physician's written protocol for drug therapy management under 22 TAC 295.13, which requires a prior physician diagnosis, initial patient assessment and drug therapy order, and so is not self-initiation.","c":"22 TAC 295.13(c)(2)(A)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"age limits / training requirements","v":"Texas law does not address this. - no age threshold or training standard exists because the underlying authority does not exist.","c":"22 TAC Chapter 295","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"high"},{"id":"D1-A-04","facts":[{"k":"mechanism: valid prescription, including one issued by standing order","v":"A pharmacist may dispense an opioid antagonist under a valid prescription, including a prescription issued by a standing order. It is not independent pharmacist authority and not a self-executing statewide protocol in the pharmacy rules; it operates through a prescriber's standing order.","c":"22 TAC 295.14(c)(1)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"who may receive it","v":"A person at risk of experiencing an opioid-related drug overdose, or a family member, friend or other person in a position to assist such a person.","c":"22 TAC 295.14(c)(1)(A)-(B)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"legitimacy and immunity","v":"A prescription dispensed under the rule is deemed dispensed for a legitimate medical purpose in the usual course of professional practice. A pharmacist acting in good faith and with reasonable care who dispenses OR declines to dispense an opioid antagonist is immune from criminal and civil liability and from professional discipline, both for the decision and for any outcome of the eventual administration.","c":"22 TAC 295.14(c)(2)-(3)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"underlying statutory authority","v":"The rule implements the opioid antagonist provisions of the Texas Dangerous Drug Act, Health and Safety Code Chapter 483.","c":"22 TAC 295.14(a)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-A-05","facts":[{"k":"no test-and-treat authority","v":"Texas law does not address this. Texas has no statute or board rule authorizing pharmacist testing and treatment for strep, influenza, covid-19 or any other condition. A pharmacist may order drug-therapy-related laboratory tests only as a delegated act inside a physician's written protocol, after the physician's diagnosis and initial patient assessment.","c":"22 TAC 295.13(b)(4)(C), (c)(2)(A)","st":"silent","ed":null,"df":"true"},{"k":"CLIA status","v":"Texas law does not address this. The word CLIA does not appear anywhere in the Texas Pharmacy Act or the TSBP rules; Texas imposes no CLIA-waiver condition because it confers no testing authority to condition.","c":"22 TAC Part 15","st":"silent","ed":null,"df":"true"},{"k":"training requirements","v":"Texas law does not address this. - no training standard exists for an authority Texas has not granted. The only point-of-care adjacent training standards in Texas rules are the immunization course under 22 TAC 295.15(c) and the drug therapy management CE under 22 TAC 295.13(d).","c":"22 TAC 295.15(c); 22 TAC 295.13(d)","st":"silent","ed":null,"df":"true"}],"ver":"2026-10-14","pc":null,"vol":"high"},{"id":"D1-A-06","facts":[{"k":"tobacco cessation","v":"Texas law does not address this. No Texas statute or board rule authorizes a pharmacist to prescribe or furnish tobacco cessation products.","c":"22 TAC Part 15","st":"silent","ed":null,"df":"no federal analogue"},{"k":"PrEP / PEP","v":"Texas law does not address this. No Texas statute or board rule authorizes a pharmacist to initiate or furnish HIV pre-exposure or post-exposure prophylaxis.","c":"22 TAC Part 15","st":"silent","ed":null,"df":"no federal analogue"},{"k":"only available route","v":"Either could in principle be done only as a delegated act under an individual physician's written protocol following the physician's diagnosis and initial assessment, which is not furnishing authority.","c":"22 TAC 295.13(c)(2)(A)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"high"},{"id":"D1-A-07","facts":[{"k":"permitted - but called drug therapy management under written protocol","v":"Texas does not use the term 'collaborative practice agreement'. The equivalent is drug therapy management delegated by a physician to a pharmacist through a written protocol, authorized by Tex. Occ. Code 554.005 and Chapter 157 of the Medical Practice Act and governed by 22 TAC 295.13.","c":"22 TAC 295.13(a)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"prescriber types - PHYSICIANS ONLY","v":"Only a physician may delegate. The rule speaks exclusively of 'a physician licensed in this state'; advanced practice registered nurses, physician assistants, dentists, podiatrists and optometrists cannot enter into these protocols with a pharmacist.","c":"22 TAC 295.13(c)(1); 22 TAC 291.32(c)(2)(I)","st":"regulation","ed":null,"df":"true"},{"k":"patients covered","v":"Patients with whom the delegating physician has established and maintains a physician-patient relationship, and whom the physician has informed that drug therapy will be managed by a pharmacist under written protocol. A standard protocol may be used, or the physician may write a protocol for an individual patient; deviations from a standard protocol must be recorded by the physician.","c":"22 TAC 295.13(e)(2), (b)(6)(B)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"required contents of the written protocol","v":"At a minimum: (i) a statement identifying the individual physician responsible for the delegation; (ii) a statement identifying the individual pharmacist authorized to dispense and to engage in drug therapy management; (iii) a statement of the types of drug therapy management decisions the pharmacist may make, including the ailments or diseases, the drugs and the types of management authorized, plus a specific statement of the procedures, decision criteria or plan to follow; (iv) a statement of the activities the pharmacist must follow, including the documentation method and a feedback plan to the physician; and (v) a statement describing the mechanisms and time schedule for reporting to the physician monitoring the pharmacist.","c":"22 TAC 295.13(b)(6)(A)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"scope of acts that may be delegated","v":"Collecting and reviewing patient drug use histories; ordering or performing routine drug-therapy-related patient assessment procedures including temperature, pulse and respiration; ordering drug-therapy-related laboratory tests; implementing or modifying drug therapy following the physician's diagnosis, initial assessment and drug therapy order as detailed in the protocol; and any other drug-therapy-related act delegated by the physician. It does NOT include selecting drug products the physician did not prescribe unless named in the protocol or in the physician's record of deviation.","c":"22 TAC 295.13(b)(4)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"pharmacist training required","v":"Initially, a statement (producible to the board within 24 hours of request) that within the last year the pharmacist completed at least six hours of ACPE-approved drug-therapy CE, or was already engaged in drug therapy management under prior law. Thereafter, six hours of ACPE-approved drug-therapy CE annually, which may count toward license renewal hours.","c":"22 TAC 295.13(d)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"physician supervision conditions","v":"Supervision is adequate only if the physician formulates or approves the protocol and any patient-specific deviations and reviews them at least annually; has and maintains a physician-patient relationship and informs the patient; is geographically located so as to be able to be physically present daily to provide medical care and supervision; receives periodic status reports on the schedule the protocol sets; is available through direct telecommunication for consultation; and determines that the pharmacist establishes and maintains a pharmacist-patient relationship.","c":"22 TAC 295.13(e)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"recordkeeping","v":"Records required by the section must be kept and available for inspection for at least two years. Interventions must be documented within a reasonable time, in the patient medication record, the medical chart or a separate log. Where the delegation includes implementing or modifying drug therapy, the pharmacist must keep a copy of the protocol until at least the seventh anniversary of its expiration date.","c":"22 TAC 295.13(f)(1)(A), (f)(2)(B); 22 TAC 295.13(c)(2)(A)(ii)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-A-08","facts":[{"k":"no general filing or board approval requirement","v":"A drug therapy management written protocol is NOT generally filed with or approved by the board. It is maintained by the pharmacist and produced on inspection.","c":"22 TAC 295.13(f)(2)(A)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"exception - board notification when the pharmacist may sign prescriptions","v":"A pharmacist delegated authority to sign a prescription for a dangerous drug must notify the board on a board-provided application before signing any such prescription, submit a copy of the written protocol at initial notification, and submit an updated copy within 10 days of any change to the protocol.","c":"22 TAC 295.13(c)(3)(A)-(C)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"public posting","v":"The board must post on its website the name and license number of each pharmacist who has notified it of delegated signing authority, and the name and address of the delegating physician.","c":"22 TAC 295.13(c)(4)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"expiration and review","v":"The rule sets no fixed expiration term. Written protocols, including standard protocols, any patient-specific deviations and any individual patient protocol, must be reviewed by the physician and pharmacist AT least annually and revised if necessary, and the review must be documented in the pharmacist's records.","c":"22 TAC 295.13(f)(2)(D); 22 TAC 295.13(e)(1)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-A-09","facts":[{"k":"exclusive authority to decline","v":"Notwithstanding any other law, a pharmacist has the exclusive authority to determine whether or not to dispense a drug. This is a broad, unconditioned statutory grant and is the controlling Texas provision.","c":"Tex. Occ. Code 551.006","st":"statute","ed":"2017-09-01","df":"no federal analogue"},{"k":"affirmative duty NOT to dispense in defined circumstances","v":"A pharmacist must verify a questionable order with the practitioner before dispensing, and must not dispense if the pharmacist knows or should have known the order issued without a valid pre-existing patient-practitioner relationship (as defined by the Texas Medical Board at 22 TAC 190.8) or without a valid prescription drug order - including where the practitioner did not establish a diagnosis through acceptable medical practices, prescribed drugs not necessary for the patient, or prescribed outside the usual course of medical practice.","c":"22 TAC 291.29(a)-(b)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"no conscience clause","v":"Texas law does not address this. Texas pharmacy law contains no conscience or moral-objection clause for pharmacists, and no rule conditioning refusal on moral or religious grounds. Searched the Act and the TSBP rules for 'conscience' and 'refuse to fill' - zero occurrences.","c":"22 TAC Part 15","st":"silent","ed":null,"df":"no federal analogue"},{"k":"DUTY TO TRANSFER - four business hours","v":"An individual may NOT refuse to transfer original prescription information to another individual acting on behalf of a patient who requests it, and the transfer must be completed within four business hours of the request. This is the enforceable referral/transfer backstop in Texas.","c":"22 TAC 291.34(g)(9)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"nonresident (Class E) pharmacies bound too","v":"A pharmacist in a Class E pharmacy may not refuse to transfer, subject to the law of the state where the pharmacy is located.","c":"22 TAC 291.105","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"no general duty to refer","v":"Texas law does not address this. Beyond the transfer duty, no Texas rule requires a pharmacist who declines to dispense to refer the patient to another pharmacy or pharmacist.","c":"22 TAC Part 15","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-B-01","facts":[{"k":"hour requirement is set by reference to ACPE, not by a Texas number","v":"Texas does not state its own numeric internship hour total. The board requires 'the number of hours of internship required by ACPE for licensure'. Do not quote a fixed Texas figure.","c":"22 TAC 283.4(b)(1)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"how hours may be earned","v":"Through a board-approved student internship program; a board-approved extended-internship program; graduation from a college/school of pharmacy (credited at the number the college obtains and reports); or internship hours approved and certified to the board by another state board of pharmacy.","c":"22 TAC 283.4(b)(1)(A)-(D)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"weekly cap","v":"A pharmacist-intern may be credited no more than 50 hours per week of internship experience.","c":"22 TAC 283.4(b)(2)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"shelf life of hours","v":"Internship hours may be used for licensure for no longer than three years from the date the internship is completed.","c":"22 TAC 283.4(b)(3)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"out-of-state hours","v":"Accepted, but only if approved and certified to the Texas board by another state board of pharmacy.","c":"22 TAC 283.4(b)(1)(D)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"hours before graduation","v":"Student internship hours are earned concurrent with college attendance (including spring, between-semester and whole-semester breaks where the student attended the immediately preceding semester and is scheduled for the immediately following one), in board-licensed pharmacies, federal government pharmacies or a board-approved program, under a pharmacist preceptor or healthcare professional preceptor.","c":"22 TAC 283.4(c)(1)(B)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"cap on healthcare-professional-preceptor hours","v":"No more than 600 of the required hours may be obtained under a healthcare professional preceptor, except when the pharmacist-intern is working in a federal government pharmacy.","c":"22 TAC 283.4(c)(3)(B)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"no substitution into the school program","v":"None of the internship hours acquired outside a school-based program may be substituted for any of the hours required in a college/school of pharmacy internship program.","c":"22 TAC 283.4(c)(1)(C)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D1-B-02","facts":[{"k":"examinations required","v":"Two: the naplex and the Texas Pharmacy Jurisprudence Examination. Both are required for licensure by examination.","c":"22 TAC 283.7","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"NAPLEX passing standard","v":"A minimum scaled score of 75.","c":"22 TAC 283.7(4)(A)","st":"regulation","ed":null,"df":"false"},{"k":"jurisprudence exam passing standard","v":"A minimum grade of 75.","c":"22 TAC 283.7(5)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"retake limit - five total administrations each","v":"On failing either exam the applicant may retake it four additional times, for a total of five administrations of that exam.","c":"22 TAC 283.11(a)(1)-(2)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"remediation before subsequent retakes","v":"Before any subsequent retake the applicant must complete course work in subject areas recommended by the board, submit documentation of successful completion, and re-comply with 22 TAC 283.7. Course work means one or more standard courses or self-paced work offered in a college of pharmacy's academic program.","c":"22 TAC 283.11(a)(1)(A)-(C), (c)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"failing both","v":"If the applicant fails both, he or she must retake the examinations until a passing grade is achieved on one of them, with the retakes governed by the same five-administration and remediation rules.","c":"22 TAC 283.11(a)(3)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"retake limit on reciprocity","v":"A reciprocity applicant who fails the Texas Pharmacy Jurisprudence Examination gets the same four additional attempts, five total, with the same remediation precondition.","c":"22 TAC 283.11(b)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"shelf life of a passing score","v":"A passing grade may be used for licensure for two years from the date of passing.","c":"22 TAC 283.7(6)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"jurisprudence exam before graduation","v":"An applicant who has completed the three didactic years (P1-P3) may take the Texas Pharmacy Jurisprudence Examination a maximum of ONE time prior to graduation.","c":"22 TAC 283.7(3)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"student-intern status lost on repeated failure","v":"A student internship expires if the student-intern fails more than once either the naplex or the Texas Pharmacy Jurisprudence Examination, or fails to take either within six calendar months after graduation.","c":"22 TAC 283.4(c)(2)(A)(ii)-(iii)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D1-B-03","facts":[{"k":"cycle - biennial","v":"The board requires biennial renewal of all pharmacist licenses. The statute permits one or two years as the board determines; the board has set two.","c":"22 TAC 295.5(a); Tex. Occ. Code 559.002","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"renewal date - assigned expiration month, not a statewide fixed date","v":"A license expires on the last DAY OF THE assigned expiration month. There is no single statewide renewal date. The assigned month is tied to the licensee's birth month.","c":"22 TAC 295.7(1)-(2)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"initial period is prorated","v":"New licenses are assigned an expiration date and the initial fee is prorated. The initial license period runs from eighteen to thirty months depending on the licensee's birth month.","c":"22 TAC 295.5(b)(2); 22 TAC 295.8(b)(12)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"late renewal ladder","v":"Expired 90 days or less: renew at 1.5x the renewal fee. Expired more than 90 days but less than one year: 2x the renewal fee. Expired one year or more: the license may not be renewed; the person must apply for a new license.","c":"Tex. Occ. Code 559.003(b)-(d); 22 TAC 295.7(3)","st":"statute","ed":"2017-09-01","df":"no federal analogue"},{"k":"bar on renewal where another state has acted","v":"A person may not renew a Texas pharmacist license while holding a pharmacist license in another state that has been suspended, revoked, canceled or subjected to an action prohibiting practice there.","c":"Tex. Occ. Code 559.003(e)","st":"statute","ed":"2017-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D1-B-04","facts":[{"k":"total hours per cycle","v":"30 contact hours (3.0 CEUs) of approved continuing education obtained during the previous license period, i.e. per two-year renewal.","c":"22 TAC 295.8(a)(1), (d)(1)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"law-specific carve-out","v":"At least ONE contact hour (0.1 CEU) of the 30 must relate to Texas pharmacy laws or rules.","c":"22 TAC 295.8(d)(1)(A)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"opioid / controlled substance carve-out - one-time, not per cycle","v":"Not later than the first anniversary of becoming licensed, a pharmacist must complete at least TWO contact hours (0.2 CEU) related to approved procedures of prescribing and monitoring controlled substances under HSC 481.07635. This is a one-time new-licensee requirement, not a recurring per-cycle carve-out.","c":"22 TAC 295.8(d)(1)(B)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"human trafficking prevention course","v":"A pharmacist must complete the human trafficking prevention course required by Tex. Occ. Code 116.002.","c":"22 TAC 295.8(d)(1)(D); Tex. Occ. Code 116.002","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"live-hours requirement","v":"None. Texas sets no minimum number of live (as opposed to home study / enduring materials) hours for pharmacists. The rule defines both 'live programs' and 'enduring materials (home study)' but imposes no live minimum.","c":"22 TAC 295.8(b)(11), (b)(14)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"alternative ways to satisfy the requirement","v":"Completing the 30 hours; or completing, during the preceding license period, one credit hour (15 contact hours) for each year of the license period as part of an ACPE-accredited professional degree program; or taking and passing the naplex during the preceding license period as a Texas-licensed pharmacist (not the naplex used for initial licensure).","c":"22 TAC 295.8(c)(1)-(3)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"specialty add-on hours","v":"Pharmacists must additionally report any specialty requirements applicable to them - preceptor, sterile compounding, immunization, drug therapy management. Examples: 3 hours every 2 years to maintain immunization competency (22 TAC 295.15(c)(2)(B)); 6 hours of drug-therapy CE annually for drug therapy management (22 TAC 295.13(d)(2), which MAY be applied toward the 30); 3 hours of preceptor training per renewal period to continue preceptor certification (22 TAC 283.6(a)(2)(B)(ii)).","c":"22 TAC 295.8(d)(1)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"initial-period exemption","v":"Pharmacists are exempt from the 30-hour requirement during their initial license period, except for the controlled-substance course and the human trafficking course, which must still be completed in their stated time periods.","c":"22 TAC 295.8(d)(4)(A)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"mandatory electronic reporting","v":"Proof of completion of all CE must be reported to the board through the board's continuing education tracking system (CPE Monitor); no renewal certificate issues until it is.","c":"22 TAC 295.8(g); Tex. Occ. Code 112.103","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-B-05","facts":[{"k":"retention period - three years","v":"Pharmacists must maintain certificates of completion of approved CE for three years from the date of reporting the contact hours or course completion on a license renewal application. Hard copy or electronic format is acceptable.","c":"22 TAC 295.8(f)(1)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"how audits run","v":"The board audits using its continuing education tracking system. On written request the pharmacist must provide documentation of proof for all contact hours and course completions reported during the specified license period(s).","c":"22 TAC 295.8(f)(2)(A)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"consequence of failing to produce records","v":"Failure to provide all requested records within the specified time period constitutes prima facie evidence of failure to keep and maintain records and subjects the pharmacist to disciplinary action.","c":"22 TAC 295.8(f)(2)(A)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"consequence of unsupported hours","v":"Hours without documentation showing completion during the specified license period are disallowed, and a pharmacist who received credit for disallowed hours is subject to disciplinary action. Submitting false or fraudulent records is separately a basis for discipline.","c":"22 TAC 295.8(f)(2)(B)-(C)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"failure to report at renewal","v":"The license is not renewed and no renewal certificate issues until the CE is completed and reported; practicing without a current renewal certificate carries all the penalties of practicing without a license, including delinquent fees under Tex. Occ. Code 559.003.","c":"22 TAC 295.8(d)(2)(A)-(B)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"technician CE records","v":"Pharmacy technicians have a parallel record-retention duty under 22 TAC 297.8(b)(5).","c":"22 TAC 297.8(b)(5)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D1-B-06","facts":[{"k":"reciprocity available","v":"Yes. Texas grants licensure by reciprocity under 22 TAC 283.8, using the Texas and NABP applications.","c":"22 TAC 283.8(a)(3)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"Texas jurisprudence exam required","v":"Yes. A reciprocity applicant must pass the Texas Pharmacy Jurisprudence Examination with a minimum grade of 75; the passing grade is usable for reciprocity for two years.","c":"22 TAC 283.8(a)(5)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"no practice-hour prerequisite","v":"Texas law does not address this. - 22 TAC 283.8 imposes no minimum number of practice hours or years of experience for reciprocity.","c":"22 TAC 283.8","st":"silent","ed":null,"df":"no federal analogue"},{"k":"original licensure by examination required","v":"The applicant must present proof of initial licensing BY examination, and proof that the current license and every other license granted by any other state has not been suspended, revoked, canceled, surrendered or otherwise restricted for any reason.","c":"22 TAC 283.8(a)(4)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"NAPLEX requirement by licensure date","v":"An applicant originally licensed after January 1, 1978 who holds a professional pharmacy degree must show he or she passed the naplex or an equivalent examination based on criteria no less stringent than those in force in Texas.","c":"22 TAC 283.8(b)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"foreign pharmacy graduates","v":"Must provide written documentation of full fpgec certification and of passing the naplex or an equivalent examination.","c":"22 TAC 283.8(c)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"mutuality condition","v":"An applicant is NOT eligible for reciprocity unless the state in which he or she is currently or was initially licensed also grants reciprocal licensing to pharmacists licensed by examination in Texas, under like circumstances and conditions.","c":"22 TAC 283.8(d)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"military fast track","v":"Separate provisions exist for military service members, veterans and spouses.","c":"22 TAC 283.12","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D1-B-07","facts":[{"k":"registration, not licensure","v":"Texas registers pharmacy technicians and pharmacy technician trainees with the board; it does not license them. A person must register before beginning work in a Texas pharmacy in either role, and a person not registered may not be employed as or perform the duties of a technician or trainee.","c":"Tex. Occ. Code 568.002(a); 22 TAC 297.3(a)(1)","st":"statute","ed":"2013-06-14","df":"no federal analogue"},{"k":"national certification IS mandatory for technicians","v":"To register as a pharmacy technician an applicant must have taken and passed a board-approved pharmacy technician certification examination and hold a current certification certificate, OR have been granted a board exemption under 22 TAC 297.7.","c":"22 TAC 297.3(c)(1)(B)","st":"regulation","ed":null,"df":"true"},{"k":"trainees are not certified","v":"A pharmacy technician trainee need not be certified. A person may register as a trainee only once, the registration may not be renewed, and it expires two years from registration or on issuance of technician registration, whichever is earlier.","c":"22 TAC 297.3(b), (b)(3)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"education requirement","v":"High school or equivalent diploma (e.g. GED), or working toward one for no more than two years.","c":"22 TAC 297.3(b)(1)(A), (c)(1)(A)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"fingerprinting / criminal history","v":"Both technicians and trainees must meet all requirements for the board to access criminal history record information, including submitting fingerprints and paying the associated costs.","c":"22 TAC 297.3(b)(1)(C), (c)(1)(D)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"exemptions from certification","v":"Two narrow classes are exempt from the certification requirement: long-term exempt technicians, who as of 1 September 2001 had been continuously employed as a pharmacy technician in Texas for at least ten years and received a board exemption; and rural county exempt technicians working in a county with a population of 50,000 or less, by petition.","c":"22 TAC 297.7(b)-(c); Tex. Occ. Code 568.002(b)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"registration cycle","v":"Biennial. Initial registration $88 and renewal $85 for a two-year registration; trainee registration $55 for two years. Registration expires on the last day of the assigned expiration month.","c":"22 TAC 297.4(a)-(b); 22 TAC 297.3(d)(2)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"identification","v":"Technicians must wear a tag or badge bearing their name identifying them as a pharmacy technician, or as a certified pharmacy technician if they maintain current ptcb or other board-approved certification; trainees must be badged as trainees.","c":"22 TAC 291.32(e)(1)-(2)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-B-08","facts":[{"k":"Class A (community) - baseline ratio 1:6","v":"The ratio of ON-site pharmacists to pharmacy technicians AND pharmacy technician trainees may be 1:6, provided the pharmacist is on-site and a maximum of three of the six are trainees.","c":"22 TAC 291.32(d)(3)(A)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"Class A - trainee sub-cap 1:3","v":"The ratio of pharmacists to pharmacy technician trainees may not exceed 1:3, inside the 1:6 overall cap.","c":"22 TAC 291.32(d)(3)(A)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"Class A central fill carve-out - no ratio","v":"The 1:6 ratio does not apply to a central fill pharmacy (as defined in 22 TAC 291.125) that has no patient-facing contact, meaning no direct interaction between a pharmacy employee and a patient or patient's agent.","c":"22 TAC 291.32(d)(3)(B)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"Class A restricted-formulary pharmacies - 1:5","v":"A Class A pharmacy may operate at 1:5 if it dispenses no more than 20 different prescription drugs and does not produce sterile preparations including intravenous or intramuscular drugs on-site, and if at least four of the five are registered technicians rather than trainees, and the pharmacy has written policies limiting those technicians and trainees to one process at a time.","c":"22 TAC 291.32(d)(3)(C); Tex. Occ. Code 568.006","st":"regulation","ed":"2013-06-14","df":"no federal analogue"},{"k":"Class B (nuclear) - 1:6 with a different internal split","v":"The ratio may be 1:6 provided at least three of the six are pharmacy technicians trained in the applicable duties; the ratio of authorized nuclear pharmacists to pharmacy technician trainees may not exceed 1:3.","c":"22 TAC 291.53","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"Class C (institutional) - NO numeric ratio","v":"Texas sets no technician-to-pharmacist ratio for institutional pharmacies. Class C personnel are controlled instead by bed-count-based supervision rules (facilities with 101 beds or more require physically present pharmacist supervision for the listed functions; 100 beds or fewer permit electronic supervision for a subset).","c":"22 TAC 291.73(e)(2)(A)-(B)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"Class D (clinic) - NO numeric ratio","v":"No technician-to-pharmacist ratio is stated for clinic pharmacies.","c":"22 TAC 291.92","st":"silent","ed":null,"df":"no federal analogue"},{"k":"Class E (nonresident) - NO numeric ratio in the Texas rule","v":"No technician-to-pharmacist ratio is stated for nonresident pharmacies in 22 TAC 291.103.","c":"22 TAC 291.103","st":"silent","ed":null,"df":"no federal analogue"},{"k":"effect of certification status on the ratio","v":"Certification status changes the ratio in Texas, but indirectly: the caps are written in terms of registered technicians versus trainees, and trainees are the constrained category. In Class A the trainee sub-cap is 1:3 inside the 1:6, and the 1:5 restricted-formulary option requires at least four of the five to be registered technicians. Since registration as a technician itself requires national certification (22 TAC 297.3(c)(1)(B)), the practical effect is that certified staff raise the usable ratio.","c":"22 TAC 291.32(d)(3)(A), (C)(ii)(I)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"pharmacist-interns excluded from the count","v":"A pharmacist-intern functioning as a technician is NOT counted as a pharmacy technician in the ratio.","c":"22 TAC 283.5(b)(5)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-B-09","facts":[{"k":"EXPRESSLY PERMITTED - technicians and trainees alike","v":"Nonjudgmental technical duties associated with preparing and distributing prescription drugs: (1) initiating and receiving refill authorization requests; (2) entering prescription data into a data processing system; (3) taking a stock bottle from the shelf for a prescription; (4) preparing and packaging prescription drug orders (counting tablets/capsules, measuring liquids, placing them in the container); (5) affixing prescription and auxiliary labels to the container; (6) reconstituting medications; (7) prepackaging and labeling prepackaged drugs; (8) loading bulk unlabeled drugs into an automated dispensing system, a pharmacist verifying proper loading before use; (9) loading pharmacist- or manufacturer-verified prepackaged containers into an automated dispensing system; (10) compounding non-sterile prescription drug orders; (11) compounding bulk non-sterile preparations.","c":"22 TAC 291.32(d)(2)(C)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"EXPRESSLY PERMITTED - registered technicians only, not trainees","v":"(12) receiving oral prescription drug orders for dangerous drugs and reducing them to writing; (13) transferring or receiving a transfer of original prescription information for a dangerous drug on behalf of a patient; (14) contacting a prescriber for information regarding an existing prescription for a dangerous drug.","c":"22 TAC 291.32(d)(2)(D)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"EXPRESSLY PROHIBITED","v":"Technicians and trainees may not perform any duty reserved to a pharmacist: (1) receiving oral prescription drug orders for controlled substances and reducing them to writing; (2) interpreting prescription drug orders; (3) selecting drug products; (4) performing the final check of the dispensed prescription before delivery; (5) counseling - communicating to the patient or agent information the pharmacist deems significant; (6) communicating on request information about drugs dispensed to the patient; (7) assuring a reasonable effort is made to obtain, record and maintain patient medication records; (8) interpreting patient medication records and performing drug regimen reviews; (9) performing a specific act of drug therapy management under a physician's written protocol; (10) verifying receipt of invoiced controlled substances by initialling and dating; (11) transferring or receiving a transfer of original prescription information for a controlled substance.","c":"22 TAC 291.32(d)(2)(A); 22 TAC 291.32(c)(2)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"the general gate on delegation","v":"A pharmacist may delegate any nonjudgmental technical duty associated with the preparation and distribution of prescription drugs provided a pharmacist verifies the accuracy of all acts, tasks and functions performed (unless 22 TAC 291.33 provides otherwise), the technician or trainee is under the direct supervision of and responsible to a pharmacist, and only properly trained staff access an automated pharmacy dispensing system.","c":"22 TAC 291.32(d)(2)(B)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"training precondition","v":"All technicians and trainees must meet the training requirements of 22 TAC 297.6; those compounding non-sterile preparations must additionally meet 22 TAC 291.131 training.","c":"22 TAC 291.32(d)(1)(A)-(B)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-B-10","facts":[{"k":"permitted - Class C with an ongoing clinical pharmacy program","v":"Yes. A Class C (institutional) pharmacy with an ongoing clinical pharmacy program may allow a pharmacy technician to verify the accuracy of specified duties performed by another pharmacy technician.","c":"Tex. Occ. Code 568.008(b); 22 TAC 291.73(e)(2)(C)","st":"statute","ed":"2009-06-19","df":"no federal analogue"},{"k":"which duties may be tech-checked","v":"Only three: filling medication carts; distributing routine orders for stock supplies to patient care areas; and accessing and restocking automated medication supply systems after proper training and demonstrated knowledge of the written operating policies and procedures.","c":"22 TAC 291.73(e)(2)(C)(ii)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"who may check","v":"A registered pharmacy technician, not a pharmacy technician trainee, who meets the training requirements of 22 TAC 297.6 plus specific training on the verification procedures, the required documentation, and which duties may be checked by another technician.","c":"22 TAC 291.73(e)(2)(C)(i), (e)(1)(B)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"standing conditions","v":"The patient's orders must have been previously reviewed and approved by a pharmacist, and a pharmacist must be on duty in the facility at all times the pharmacy is open for pharmacy services.","c":"22 TAC 291.73(e)(2)(C)(iii)-(iv)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"board notification and PIC policies","v":"The pharmacist-in-charge of the clinical pharmacy program must adopt policies and procedures for the verification process, and the hospital must notify the board before implementing it.","c":"Tex. Occ. Code 568.008(c)-(d)","st":"statute","ed":"2009-06-19","df":"no federal analogue"},{"k":"separate rural hospital regime - not tech-check-tech","v":"A rural hospital may let a registered technician perform listed duties when NO pharmacist is on duty, but the check is performed by a nurse or practitioner at the hospital, or by a pharmacist through electronic supervision - not by another technician. Conditions: registered technician (not trainee), trained, a pharmacist immediately accessible by phone/paging/e-mail at all times, and adequate staffing.","c":"22 TAC 291.73(e)(2)(D); Tex. Occ. Code 562.1011","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"not available in community pharmacy","v":"Texas law does not address this. No tech-check-tech provision exists for community pharmacy; the final check remains a pharmacist-only duty under 22 TAC 291.32(c)(2)(D).","c":"22 TAC 291.32(c)(2)(D)","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-B-11","facts":[{"k":"called-in prescription - yes for dangerous drugs, never for controlled substances","v":"A registered pharmacy technician MAY receive an oral prescription drug order for a dangerous drug and reduce it to writing. Receiving an oral order for a controlled substance is reserved to a pharmacist.","c":"22 TAC 291.32(d)(2)(D)(i); 22 TAC 291.32(c)(2)(A)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"trainees may not take called-in orders at all","v":"The authority to receive oral orders for dangerous drugs is given to pharmacy technicians only; pharmacy technician trainees are excluded from the 291.32(d)(2)(D) list.","c":"22 TAC 291.32(d)(2)(D)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"transfer - yes for dangerous drugs, never for controlled substances","v":"A registered pharmacy technician MAY transfer or receive a transfer of original prescription information for a dangerous drug on behalf of a patient. Transferring or receiving a transfer for a controlled substance is reserved to a pharmacist.","c":"22 TAC 291.32(d)(2)(D)(ii); 22 TAC 291.32(c)(2)(K)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"electronic transfer between pharmacies","v":"An electronic transfer between pharmacies may be initiated by a pharmacist intern, a pharmacy technician or a pharmacy technician trainee acting under the direct supervision of a pharmacist.","c":"22 TAC 291.34(g)(8)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"counseling - prohibited","v":"No. Communicating to the patient or the patient's agent information about the prescription drug or device that the pharmacist deems significant is a duty only a pharmacist may perform, and technicians and trainees are expressly barred from it.","c":"22 TAC 291.32(c)(2)(E); 22 TAC 291.32(d)(2)(A)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"contacting a prescriber","v":"A registered pharmacy technician may contact a prescriber for information regarding an existing prescription for a dangerous drug.","c":"22 TAC 291.32(d)(2)(D)(iii)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-B-12","facts":[{"k":"preceptor-to-intern ratio is 1:1","v":"A preceptor may supervise only ONE pharmacist-intern at any given time.","c":"22 TAC 283.6(b)(1)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"exception - Texas college/school programs have no ratio","v":"There is NO ratio requirement for preceptors supervising student-interns as part of a Texas college/school of pharmacy program.","c":"22 TAC 283.6(b)(2)(B)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"supervision level for school-program interns","v":"Direct supervision when the student-intern is engaged in functions associated with the preparation and delivery of prescription or medication drug orders; general supervision for functions not so associated.","c":"22 TAC 283.6(b)(2)(A)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"intern may do what a pharmacist does, under supervision","v":"An intern has the same dispensing-process responsibilities described for a pharmacist - drug regimen review, verification of accurate data entry, packaging, preparation, compounding, transferring, labeling and the final check - but must perform them under the supervision of a pharmacist.","c":"22 TAC 291.32(c)(1)(F)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"intern may work as a technician without registering as one","v":"When not under a pharmacist preceptor's supervision, a pharmacist-intern may function as a pharmacy technician and perform all technician duties without registering as a technician, provided the intern is registered with the board as a pharmacist-intern, is under the direct supervision of a pharmacist, has completed the pharmacy's on-site technician training program, has completed 22 TAC 291.133 training if compounding sterile preparations, and is NOT counted in the pharmacist-to-technician ratio.","c":"22 TAC 283.5(b)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"what an intern may NOT do","v":"Present or identify himself or herself as a pharmacist; or sign or initial any document required to be signed or initialled by a pharmacist unless a preceptor cosigns it.","c":"22 TAC 283.5(c)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"intern reverts to technician status when the pharmacist steps out","v":"During the times a pharmacist is absent from the prescription department, a pharmacist-intern is considered a registered pharmacy technician and may perform only technician duties.","c":"22 TAC 291.33(b)(3)(A)(vi)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"preceptor eligibility","v":"A pharmacist preceptor must hold a current, non-inactive Texas license, have at least one year of experience as a licensed pharmacist (or six months of residency training if the resident is completing a residency), complete three hours of ACPE-approved preceptor training within the previous two years for initial certification (three hours within the current renewal period to continue), and be certified by the board.","c":"22 TAC 283.6(a)(2)-(3)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D1-B-13","facts":[{"k":"statutory baseline by pharmacy class","v":"A Class A or Class B pharmacy must be under the continuous ON-site supervision of a pharmacist during the time the pharmacy is open for pharmacy services. A Class C pharmacy in an institution with more than 100 beds has the same continuous on-site requirement; a Class C pharmacy in an institution with 100 beds or fewer must instead have the services of a pharmacist on a part-time or consulting basis as the board specifies.","c":"Tex. Occ. Code 562.101(b)-(d)","st":"statute","ed":null,"df":"no federal analogue"},{"k":"technicians work under DIRECT supervision","v":"Pharmacy technicians and trainees must be under the direct supervision of and responsible to a pharmacist; pharmacists are solely responsible for that direct supervision and for delegating duties, and each pharmacist is responsible for any delegated act performed under his or her supervision.","c":"22 TAC 291.32(d)(2)(B)(ii); 22 TAC 291.32(c)(1)(C)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"data entry - three permitted supervision modes","v":"For technicians and trainees entering prescription data, a pharmacist must supervise by one of: (i) physically present supervision, verifying each prescription at the time of data entry; (ii) electronic supervision, where the pharmacist can immediately communicate directly with the technician, has immediate access to the original documents (imaging acceptable if the original can be reviewed when needed), and verifies accuracy before release to the system; or (iii) electronic verification of data entry.","c":"22 TAC 291.32(c)(1)(D)(i)-(iii)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"remote electronic verification across pharmacies","v":"Electronic verification may be performed by a Texas-licensed pharmacist, or by a pharmacist employed by a Class E pharmacy that either has the same owner as the Class A pharmacy or has a written contract with it setting out services, responsibilities and accountabilities. The pharmacy must establish controls to protect confidential records and keep permanent records of electronically verified prescriptions for two years.","c":"22 TAC 291.32(c)(1)(D)(iii)(II)-(IV)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"Class C supervision is bed-count driven","v":"In facilities with 101 beds or more, the listed technician functions must be performed under physically present pharmacist supervision. In facilities with 100 beds or fewer, a defined subset may be performed under electronic OR physically present supervision, while prepacking, bulk compounding, loading automated devices and medium/high-risk sterile compounding still require physical presence.","c":"22 TAC 291.73(e)(2)(A)-(B)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"immediate availability during a short absence","v":"Where the pharmacist leaves the prescription department briefly, the standard is that the pharmacist remains ON-site at the licensed location and is immediately available.","c":"22 TAC 291.33(b)(3)(A)(i)(II)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"automated pharmacy systems - electronic supervision allowed","v":"An automated pharmacy system must be under the continuous supervision of a pharmacist, but the pharmacist need not be physically present at the system's site and may supervise electronically.","c":"Tex. Occ. Code 562.109(c)","st":"statute","ed":"2001-05-11","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-B-14","facts":[{"k":"PIC required","v":"Each Class A pharmacy must have one pharmacist-in-charge, employed on a full-time basis.","c":"22 TAC 291.32(a)(1)(A)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"general rule - one pharmacy only","v":"The pharmacist-in-charge may be PIC for only one such pharmacy.","c":"22 TAC 291.32(a)(1)(A)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"exception 1 - non-simultaneous hours","v":"A PIC may serve more than one Class A pharmacy if the additional Class A pharmacies are NOT open to provide pharmacy services simultaneously.","c":"22 TAC 291.32(a)(1)(A)(i)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"exception 2 - emergency","v":"During an emergency, a PIC may serve up to TWO Class A pharmacies open simultaneously, if the PIC works at least 10 hours per week in each pharmacy, for no more than 30 consecutive days.","c":"22 TAC 291.32(a)(1)(A)(ii)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"cross-class bar","v":"The PIC of a Class A pharmacy may NOT serve as the PIC of a Class B pharmacy, or of a Class C pharmacy with 101 beds or more.","c":"22 TAC 291.32(a)(1)(C)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"eligibility - Texas license and inventory duty","v":"The PIC must comply with the inventory requirements of 22 TAC 291.17, and on taking the role must attest that an inventory was conducted by the departing and incoming PICs and that he or she has read and understands the laws and rules relating to that class of pharmacy. Operating a Class E or Class E-S pharmacy without a Texas-licensed PIC is a separately penalised violation.","c":"22 TAC 291.32(a)(1)(B); 22 TAC 291.3(e)(2)(D)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"consultant pharmacist may be the PIC in Class C","v":"In an institutional pharmacy, the consultant pharmacist may be the pharmacist-in-charge.","c":"22 TAC 291.73(c)(1)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"losing the PIC can close the pharmacy","v":"A pharmacy that temporarily closes for loss of a pharmacist-in-charge must notify the board in writing on a board form.","c":"22 TAC 291.3(k)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-B-15","facts":[{"k":"PIC's enumerated duties (Class A)","v":"Responsibility for the practice of pharmacy at that pharmacy, including at a minimum: (A) educating and training pharmacy technicians and trainees; (B) supervising a system to assure appropriate procurement of prescription drugs, devices and other products dispensed; (C) disposing of and distributing drugs; (D) storing all materials including drugs, chemicals and biologicals; (E) maintaining records of all transactions necessary for accurate control over and accountability for all pharmaceutical materials; (F) supervising a system to assure effective controls against theft or diversion of prescription drugs and the records for them; (G) adhering to policies and procedures for maintaining records in a data processing system; (H) legally operating the pharmacy, including meeting all inspection and other requirements of state and federal law; and (I) where an automated pharmacy dispensing system is used, consulting with the owner on operating policies, inspecting medications in the system at least monthly for expiration date, misbranding, physical integrity, security and accountability, controlling personnel access, ensuring staff are trained, and ensuring accurate stocking and an accountability record.","c":"22 TAC 291.32(a)(2)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"relationship to the owner","v":"The owner holds responsibility for all administrative and operational functions; the PIC may advise the owner on administrative or operational concerns. A non-pharmacist owner must consult the PIC or another Texas-licensed pharmacist.","c":"22 TAC 291.32(a)(2), (b)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"notification deadline on PIC change - 10 days","v":"The incoming pharmacist-in-charge is responsible for notifying the board within 10 days, in writing on a board-provided form, that a change of PIC has occurred.","c":"22 TAC 291.3(e)(2)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"statutory basis for the 10 days","v":"A pharmacy shall report in writing to the board not later than the 10th day after the date of a change of the person designated as the pharmacist-in-charge.","c":"Tex. Occ. Code 562.106(a)(3)","st":"statute","ed":null,"df":"no federal analogue"},{"k":"contents of the PIC-change notice","v":"Name and license number of the departing PIC; name and license number of the incoming PIC; the date the incoming PIC became PIC; and a signed statement by the incoming PIC attesting that an inventory under 22 TAC 291.17 was conducted by the departing and incoming PICs (with an explanation if not taken by both), and that the incoming PIC has read and understands the laws and rules for that class of pharmacy.","c":"22 TAC 291.3(e)(2)(A)-(D)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"related 10-day notification - change of pharmacist employment","v":"When a change in pharmacist employment occurs the pharmacist must report it in writing to the board within 10 days, and is responsible for having his or her name removed from the former pharmacy's license and added to the new one.","c":"22 TAC 291.3(e)(1); 22 TAC 295.2(a)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"contrast - immediate notifications","v":"Theft or significant loss of a controlled substance or a dangerous drug must be reported in writing to the board immediately on discovery, as must discovery of a forged prescription.","c":"22 TAC 291.3(f)(1)-(2)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-B-16","facts":[{"k":"no individual self-reporting deadline for arrest or conviction","v":"Texas law does not address this. Texas imposes no affirmative duty on an individual pharmacist to report an arrest, charge or conviction to the board within a stated period between renewals. Criminal history is captured instead through mandatory fingerprinting and criminal history record access at application and renewal, and through disclosure on the renewal application.","c":"22 TAC 283.7(1)(B); 22 TAC 295.7","st":"silent","ed":null,"df":"no federal analogue"},{"k":"conviction is a ground for discipline regardless","v":"The board may discipline a pharmacist who has been convicted of, or placed on deferred adjudication community supervision or deferred disposition (or the federal equivalent) for, a misdemeanor involving moral turpitude, a misdemeanor under HSC Chapter 481 or 483 or the federal Controlled Substances Act, or any felony.","c":"Tex. Occ. Code 565.001(a)(6)","st":"statute","ed":null,"df":"no federal analogue"},{"k":"pre-application criminal history determination available","v":"A person holding or seeking a license or technician registration, or planning to take a required examination, who has reason to believe he or she may be ineligible due to a conviction or deferred adjudication, may request a board determination of eligibility.","c":"22 TAC 281.31","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"out-of-state discipline - pharmacy-level duty, 10 days","v":"A pharmacy must report in writing to the board not later than the 10th day after a final order against the pharmacy license holder by the regulatory or licensing agency of the state where the pharmacy is located (if located in another state), or after a final order against the pharmacist designated as its PIC by that state's agency.","c":"22 TAC 291.3(j); Tex. Occ. Code 562.106(a)(7)-(8)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"out-of-state discipline blocks renewal","v":"A person may not renew a Texas pharmacist license if he or she holds a pharmacist license in another state that has been suspended, revoked, canceled or subjected to an action prohibiting practice there.","c":"Tex. Occ. Code 559.003(e)","st":"statute","ed":"2017-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-B-17","facts":[{"k":"no mandated meal or rest break","v":"Texas law does not address this. Texas pharmacy law does not require that a pharmacist be given a meal or rest break, and sets no break duration or frequency.","c":"22 TAC Part 15","st":"silent","ed":null,"df":"no federal analogue"},{"k":"the pharmacy MAY remain open during a single pharmacist's break","v":"Yes, and this is expressly regulated. If a pharmacy is staffed by only one pharmacist, the pharmacist may leave the prescription department for short periods without closing it and without removing technicians and other personnel, provided: at least one pharmacy technician remains in the prescription department; the pharmacist remains ON-site at the licensed location and is immediately available; the pharmacist reasonably believes security will be maintained (and must close the department and clear it if in his or her professional judgment it should close); and a notice is posted stating that the pharmacist is on a break and the time of return, and that technicians may begin processing orders but nothing may be delivered until the pharmacist verifies accuracy.","c":"22 TAC 291.33(b)(3)(A)(i)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"what technicians may do during the break","v":"Only technicians who have completed the pharmacy's training program may act, and only on: initiating and receiving refill authorization requests; entering prescription data; taking a stock bottle from the shelf; preparing and packaging orders; affixing labels; prepackaging and labeling prepackaged drugs; receiving oral orders for dangerous drugs and reducing them to writing; transferring or receiving a transfer of original prescription information for dangerous drugs; and contacting a prescriber about an existing dangerous drug prescription.","c":"22 TAC 291.33(b)(3)(A)(ii)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"duties on the pharmacist's return","v":"The pharmacist must conduct a drug regimen review under 22 TAC 291.33(c)(2) and verify the accuracy of all acts, tasks and functions performed by the technicians before any prescription is delivered to the patient or the patient's agent.","c":"22 TAC 291.33(b)(3)(A)(iii)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"staggering where more than one pharmacist is on duty","v":"In pharmacies with two or more pharmacists on duty, the pharmacists shall stagger their breaks and meal periods so that the prescription department is not left without a pharmacist on duty.","c":"22 TAC 291.33(b)(3)(A)(vii)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"intern status during the break","v":"A pharmacist-intern is treated as a registered pharmacy technician during the pharmacist's absence and may perform only technician duties.","c":"22 TAC 291.33(b)(3)(A)(vi)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D1-B-18","facts":[{"k":"technician CE - 20 contact hours per renewal period","v":"All pharmacy technicians must complete and report 20 contact hours of approved CE obtained during the previous renewal period to renew.","c":"22 TAC 297.8(b)(2)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"technician in-service cap","v":"No more than 5 of the 20 contact hours may be earned at the technician's workplace through in-service education and training under the direct supervision of the pharmacist(s).","c":"22 TAC 297.8(b)(2)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"technician law carve-out","v":"At least ONE of the 20 contact hours must relate to Texas pharmacy laws or rules.","c":"22 TAC 297.8(b)(4)(A)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"technician human trafficking course","v":"A pharmacy technician must complete the human trafficking prevention course required by Tex. Occ. Code 116.002.","c":"22 TAC 297.8(b)(4)(C)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"trainees exempt","v":"Pharmacy technician trainees are not required to complete continuing education.","c":"22 TAC 297.8(a)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"technician initial period exemption and alternatives","v":"Technicians are exempt from CE during their initial registration period. The 20 hours may alternatively be satisfied by one credit hour for each year of the renewal period in pharmacy-related college courses, or by taking and passing a board-approved technician certification examination during the preceding renewal period.","c":"22 TAC 297.8(b)(1), (b)(3)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"PIC - no separate CE requirement","v":"Texas law does not address this. Texas imposes no continuing education requirement on a pharmacist-in-charge over and above the general 30-hour pharmacist requirement. The specialty add-ons named in the CE rule are preceptor, sterile compounding, immunization and drug therapy management - the PIC role is not among them.","c":"22 TAC 295.8(d)(1)","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D1-C-01","facts":[{"k":"regulator is NOT the pharmacy board","v":"Wholesale drug distributors are licensed by the Texas Department of State Health Services under the Texas Food, Drug, and Cosmetic Act, not by the Texas State Board of Pharmacy.","c":"Tex. Health & Safety Code 431.402","st":"statute","ed":null,"df":"no federal analogue"},{"k":"prescription drug wholesale distribution license","v":"A person may not engage in wholesale distribution of prescription drugs in Texas without a wholesale drug distribution license under HSC ch. 431, subch. N, for each place of business. The license expires on the second anniversary of issuance.","c":"Tex. Health & Safety Code 431.402(a)-(b)","st":"statute","ed":null,"df":"no federal analogue"},{"k":"nonprescription drug wholesale distribution license","v":"A separate license is required to engage in wholesale distribution of nonprescription drugs, under HSC ch. 431, subch. I or subch. N; it also expires on the second anniversary of issuance.","c":"Tex. Health & Safety Code 431.202(a), (c)","st":"statute","ed":null,"df":"no federal analogue"},{"k":"supporting licensing machinery","v":"Subchapter N sets out the application, mandatory pre-license inspection, qualifications, reporting of operations in other jurisdictions, criminal history record information, fees, renewal, change of location and minimum restrictions on transactions.","c":"Tex. Health & Safety Code 431.404, 431.4045, 431.405, 431.406, 431.407, 431.409, 431.4095, 431.410, 431.411","st":"statute","ed":null,"df":"no federal analogue"},{"k":"third-party logistics providers","v":"Texas law does not address this. As a separate Texas license category. 'Third-party logistics provider' appears in HSC ch. 431 only inside the definitions of 'drop shipment' and the normal distribution chain, not as a licensed class. Texas appears to rely on the federal DSCSA 3PL licensing regime rather than layering its own.","c":"Tex. Health & Safety Code 431.401","st":"silent","ed":null,"df":"true"},{"k":"pharmacies exempt for certain compounded transfers","v":"A Class A pharmacy need not register or be licensed under HSC ch. 431 to distribute compounded pharmaceutical products to a Class C pharmacy, and a Class C pharmacy need not do so to distribute compounded or prepackaged products it has prepared to other commonly owned Class C pharmacies.","c":"Tex. Occ. Code 562.154","st":"statute","ed":"2005-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-C-02","facts":[{"k":"there is no Texas 5% rule for pharmacy-to-pharmacy transfer of ordinary drugs","v":"Texas law does not address this. Texas has no percentage cap on a pharmacy selling or transferring dangerous (non-controlled) drugs to another pharmacy. The question's warning is well founded: the NABP Model Act 5% figure is not adopted as a general Texas pharmacy-to-pharmacy limit.","c":"22 TAC Part 15","st":"silent","ed":null,"df":"no federal analogue"},{"k":"the 5.0% figure that DOES exist is a controlled-substance registration rule","v":"A pharmacy may distribute controlled substances to a practitioner, another pharmacy or other registrant without being registered as a distributor only if the total number of dosage units so distributed does not exceed 5.0% of all controlled substances dispensed AND distributed by the pharmacy during the 12-month registration period. If it exceeds 5.0% at any time, the pharmacy must obtain an additional registration to distribute.","c":"22 TAC 291.34(h)(2)","st":"regulation","ed":null,"df":"false"},{"k":"condition on the recipient","v":"The registrant receiving the controlled substance must be registered under the Controlled Substances Act to dispense that controlled substance.","c":"22 TAC 291.34(h)(1)","st":"regulation","ed":null,"df":"false"},{"k":"records and DEA 222 for Schedule II","v":"For Schedule III, IV or V distributions a record must show the actual date of distribution; the name, strength and quantity distributed; and the name, address and DEA registration number of both the distributing pharmacy and the recipient. For Schedule II the pharmacy must comply with 21 CFR 1305: the recipient issues Copies 1 and 2 of DEA Form 222 to the distributing pharmacy, which completes the supplier section, keeps Copy 1 for two years and forwards Copy 2 to the DEA Divisional Office.","c":"22 TAC 291.34(h)(3)-(4)","st":"regulation","ed":null,"df":"false"},{"k":"compounded product transfers are separately exempted","v":"A Class A pharmacy may distribute compounded products to a Class C pharmacy, and a Class C pharmacy to commonly owned Class C pharmacies, without HSC ch. 431 wholesale licensing.","c":"Tex. Occ. Code 562.154; 22 TAC 291.131(f)(1)(B)-(C)","st":"statute","ed":"2005-09-01","df":"no federal analogue"},{"k":"otherwise wholesale licensing applies","v":"Transfers outside those exemptions constitute wholesale distribution and require a DSHS wholesale drug distribution license.","c":"Tex. Health & Safety Code 431.402(a)","st":"statute","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-C-03","facts":[{"k":"written recall procedure required","v":"The pharmacist-in-charge must develop and implement a written procedure for proper management of drug recalls by the manufacturer.","c":"22 TAC 291.7(a)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"patient notification - conditional, not absolute","v":"The written procedure must include, where appropriate, contacting patients to whom the recalled drug products have been dispensed. Texas does not impose a flat, unconditional duty to notify every patient on every Class I recall; it requires the procedure to provide for it where appropriate.","c":"22 TAC 291.7(a)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"24-hour removal and quarantine","v":"The PIC must reasonably ensure that a recalled drug is removed from inventory NO more than 24 hours after receipt of the recall notice, and quarantined until proper disposal or destruction.","c":"22 TAC 291.7(b)(1)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"unlot-numbered stock is deemed included","v":"If a drug subject to recall is held by the pharmacy in a container without a lot number, the PIC must consider that drug included in the recall.","c":"22 TAC 291.7(b)(2)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"no Class I-specific tier","v":"Texas law does not address this. 22 TAC 291.7 does not distinguish Class I, II and III recalls; the same duties apply to a manufacturer recall regardless of class.","c":"22 TAC 291.7","st":"silent","ed":null,"df":"true"},{"k":"compounding pharmacies - additional duties","v":"A pharmacy that compounds must have written recall procedures and must immediately initiate a recall of any preparation it compounded where there is confirmed or probable harm; a mandatory recall must be notified to the board. A pharmacy compounding sterile preparations must notify the board immediately of adverse effects potentially attributable to its compounded sterile preparation, and not later than 24 hours after it issues a recall for one.","c":"22 TAC 291.131(g); Tex. Occ. Code 562.156(b)","st":"regulation","ed":"2013-09-01","df":"no federal analogue"},{"k":"returned-drug bar","v":"Drugs subject to a mandatory state or federal recall, or a voluntary recall by a seller or manufacturer, may not be returned to a pharmacy under the unused-drug return provisions.","c":"22 TAC 291.8(b)(3)(A)(ii); Tex. Occ. Code 562.1085(a)(2)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-C-04","facts":[{"k":"general prohibition on return and restock","v":"A pharmacist may not accept an unused prescription or drug, in whole or in part, for resale or re-dispensing to any person after it has been originally dispensed or sold - except as provided in 22 TAC 291.8(b), HSC ch. 431 subch. M, or HSC ch. 442.","c":"22 TAC 291.8(a)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"exception - returns from health care facilities and penal institutions only","v":"A consultant pharmacist for a health care facility, or a licensed health care professional responsible for drug administration in a penal institution, may return certain unused drugs to the pharmacy they were purchased from. Drugs may NOT be returned by individual retail patients.","c":"Tex. Occ. Code 562.1085(a); 22 TAC 291.8(b)(3)","st":"statute","ed":"2007-06-15","df":"no federal analogue"},{"k":"no controlled substances","v":"Controlled substances as defined by HSC ch. 481 are excluded from the return program.","c":"Tex. Occ. Code 562.1085(a)","st":"statute","ed":"2007-06-15","df":"no federal analogue"},{"k":"packaging conditions","v":"The drug must be FDA-approved and either sealed in unopened tamper-evident packaging and individually or unit-dose packaged; oral or parenteral medication in sealed FDA-approved single-dose containers; topical or inhalant drugs in sealed FDA-approved unit-of-use containers; or parenteral medication in sealed FDA-approved multiple-dose containers from which no doses have been withdrawn. Tamper-evident packaging need not be the manufacturer's original packaging unless federal law requires it.","c":"Tex. Occ. Code 562.1085(a)(1), (f)","st":"statute","ed":"2007-06-15","df":"no federal analogue"},{"k":"four absolute exclusions","v":"A facility or penal institution may not return a drug that has been compounded; appears on inspection to be adulterated; requires refrigeration; or has less than 120 days until the expiration date or end of shelf life. Drugs subject to a mandatory or voluntary recall are also excluded, as are drugs that have been in the physical possession of the person for whom they were prescribed.","c":"Tex. Occ. Code 562.1085(a)(2), (b); 22 TAC 291.8(b)(3)(A)(iii)","st":"statute","ed":"2007-06-15","df":"no federal analogue"},{"k":"pharmacy duties on accepting a return","v":"A pharmacist must examine the drug to ensure product integrity; the pharmacy must reimburse or credit the entity that paid, including the state Medicaid program, and keep a record of the credit; only after issuing credit may the pharmacy restock and re-dispense.","c":"Tex. Occ. Code 562.1085(b)-(d); 22 TAC 291.8(b)(4)","st":"statute","ed":"2007-06-15","df":"no federal analogue"},{"k":"inventory and HHSC copy","v":"The consultant pharmacist or licensed health care professional must ensure an inventory of the returned drugs is completed, listing facility name and address, the responsible professional's name and license number, date of return, date dispensed, the pharmacy's unique prescription identification number, dispensing pharmacy name, drug name, strength and quantity, and a signature. A copy goes to the pharmacy with the drugs AND to the Health and Human Services Commission.","c":"22 TAC 291.8(b)(3)(C)-(D)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"participation is voluntary","v":"Nothing in the rule requires a consultant pharmacist, health care facility, penal institution or pharmacy to participate in the return of unused drugs.","c":"22 TAC 291.8(b)(1)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"liability shield","v":"A pharmacy returning unused drugs and a manufacturer accepting them, and their employees, are not liable for harm from accepting, dispensing or administering drugs returned in strict compliance, unless the harm is caused by wilful or wanton negligence, conscious indifference or reckless disregard for the safety of others, or intentional conduct. The shield does not apply where harm results from failure to comply fully.","c":"Tex. Occ. Code 562.1086","st":"statute","ed":"2003-09-01","df":"no federal analogue"},{"k":"separate donation program exists","v":"Texas operates a prescription drug donation program under Health and Safety Code Chapter 442; the pharmacy rules implement redistribution of donated prepackaged prescription drugs by participating providers, including labeling with the provider's lot number and beyond use date and prescribed recordkeeping.","c":"22 TAC 291.33(c)(9); Tex. Health & Safety Code 442.0515","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-C-05","facts":[{"k":"dispensed product BUD - one year or manufacturer expiry, whichever is earlier","v":"If a drug is dispensed in a container other than the manufacturer's original container, the label must state the beyond-use date. Unless the manufacturer specifies otherwise, the beyond-use date is ONE year from the date the drug is dispensed OR the manufacturer's expiration date, whichever IS earlier.","c":"22 TAC 291.33(c)(7)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"where the BUD may appear","v":"On the prescription label or on a flag label attached to the bottle.","c":"22 TAC 291.33(c)(7)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"narrow exemption","v":"A beyond-use date is not required on the label of a prescription dispensed to a person at the time of release from prison or jail if the prescription is for not more than a 10-day supply.","c":"22 TAC 291.33(c)(7)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"same rule for nonresident (Class E) pharmacies","v":"The identical one-year-or-manufacturer-expiry BUD rule applies to Class E pharmacy labeling.","c":"22 TAC 291.104(e)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"prepackaged (repackaged) stock - label must bear a BUD but no numeric limit is set","v":"Drugs may be prepackaged for internal distribution only by a pharmacist, or by technicians or trainees under a pharmacist's direction and direct supervision. The prepackaged unit label must show the brand name and strength (or generic name, strength and manufacturer/distributor), the facility's lot number, the facility'S beyond USE date, and the quantity if more than one. The rule does NOT impose a numeric maximum - the facility assigns the BUD.","c":"22 TAC 291.33(g)(1)-(2)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"prepackaging records and quarantine","v":"Records must show drug name, strength and dosage form; facility lot number; manufacturer or distributor; manufacturer's lot number; manufacturer's expiration date; quantity per prepackaged unit; number of units; date packaged; the prepacker's name, initials or electronic signature; and the responsible pharmacist's signature. Stock packages, repackaged units and control records must be quarantined together until checked and released by the pharmacist.","c":"22 TAC 291.33(g)(3)-(4)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"compounded non-sterile preparations use USP <795>","v":"The beyond-use date for a compounded non-sterile preparation is determined as outlined in Chapter 795 of the USP/NF, defined as the current edition, with the rule setting maximum BUDs by preparation category and requiring a shorter BUD where stability data or component expiry demands it.","c":"22 TAC 291.131(d)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"compounded sterile preparations use the rule's own standards plus USP <797>","v":"Sterile compounding BUDs are governed by 22 TAC 291.133, which sets its own standards and in places refers to Chapter 797 of the USP/NF.","c":"22 TAC 291.133","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-C-06","facts":[{"k":"Texas has its own Food, Drug, and Cosmetic Act","v":"Yes. Health and Safety Code Chapter 431 may be cited as the Texas Food, Drug, and Cosmetic Act. It is separate from the federal FD&C Act and is administered by the Department of State Health Services.","c":"Tex. Health & Safety Code 431.001","st":"statute","ed":null,"df":"true"},{"k":"adulterated drug or device","v":"A drug or device is deemed adulterated if it consists in whole or part of any filthy, putrid or decomposed substance; if it has been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health; or if the methods, facilities or controls used for its manufacture, processing, packing or holding do not conform to and are not operated in conformity with current good manufacturing practice to assure the drug meets the chapter's safety requirements and has the identity and strength, and meets the quality and purity characteristics, it purports or is represented to possess. Further grounds continue through the section.","c":"Tex. Health & Safety Code 431.111","st":"statute","ed":null,"df":"false"},{"k":"misbranded drug or device","v":"A drug or device is deemed misbranded if its labeling is false or misleading in any particular; if its labeling or packaging fails to conform with Section 431.181; or if, in package form, it fails to bear a label containing the name and place of business of the manufacturer, packer or distributor and an accurate statement of the quantity of contents by weight, measure or numerical count, subject to reasonable variations. Further grounds continue through the section.","c":"Tex. Health & Safety Code 431.112","st":"statute","ed":null,"df":"false"},{"k":"misleading labeling or advertising","v":"A separate general provision governs when an article is misbranded because of misleading labeling or advertising.","c":"Tex. Health & Safety Code 431.003","st":"statute","ed":null,"df":"no federal analogue"},{"k":"adulterated / misbranded food and cosmetics","v":"Parallel definitions exist for food (431.081, 431.082) and cosmetics (431.141, 431.142).","c":"Tex. Health & Safety Code 431.081, 431.082, 431.141, 431.142","st":"statute","ed":null,"df":"false"},{"k":"relevance inside pharmacy practice","v":"Adulteration has direct pharmacy consequences: a drug that appears on inspection to be adulterated may not be returned under the unused-drug program, and the PIC must inspect automated system stock monthly for misbranding among other things.","c":"22 TAC 291.8(b)(3)(B)(ii); 22 TAC 291.32(a)(2)(I)(ii)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D1-C-07","facts":[{"k":"no Texas suspect/counterfeit product rule for pharmacies","v":"Texas law does not address this. Neither the Texas Pharmacy Act nor the TSBP rules contain a suspect-product or counterfeit-product quarantine and notification provision for pharmacies. Texas has not layered a state notification recipient on top of the federal duty.","c":"22 TAC Part 15","st":"silent","ed":null,"df":"true"},{"k":"federal duty stands alone","v":"A Texas pharmacy's suspect and illegitimate product obligations - quarantine, investigation, notification to FDA and trading partners within 24 hours - arise under DSCSA, FD&C Act 582(c)(4), 21 USC 360eee-1, not under Texas law.","c":"FD&C Act 582(c)(4); 21 USC 360eee-1","st":"silent","ed":null,"df":"true"},{"k":"nearest Texas analogues","v":"Texas supplies adjacent but distinct duties: immediate written board notification on discovery of a forged prescription or of theft or significant loss of a controlled substance or dangerous drug; 24-hour removal and quarantine of recalled stock; and, for pharmacies compounding sterile preparations, immediate board notification of adverse effects and board notification within 24 hours of issuing a recall.","c":"22 TAC 291.3(f)-(g); 22 TAC 291.7(b)(1); Tex. Occ. Code 562.156(b)","st":"regulation","ed":"2013-09-01","df":"no federal analogue"},{"k":"state supply-chain hook is at the wholesaler level","v":"Texas's DSCSA-adjacent requirements sit in the wholesale distributor licensing regime administered by DSHS, including minimum restrictions on transactions, rather than in pharmacy rules.","c":"Tex. Health & Safety Code 431.411","st":"statute","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-C-08","facts":[{"k":"Texas has an enacted importation statute","v":"Yes. The Wholesale Prescription Drug Importation Act added Chapter 444 to the Health and Safety Code, directing the Health and Human Services Commission to establish a wholesale prescription drug importation program to make lower-cost drugs available to Texas consumers.","c":"Tex. Health & Safety Code 444.002(a)","st":"statute","ed":"2023-09-01","df":"no federal analogue"},{"k":"enacting legislation and effective date","v":"H.B. 25, 88th Legislature, Regular Session (2023). Passed the House 12 April 2023 (144-1) and the Senate 22 May 2023 (31-0). The Act takes effect September 1, 2023.","c":"Acts 2023, 88th Leg., R.S. (H.B. 25), Sec. 5","st":"statute","ed":"2023-09-01","df":"no federal analogue"},{"k":"administering agency","v":"The Texas Health and Human Services Commission, not the Board of Pharmacy and not DSHS.","c":"Tex. Health & Safety Code 444.001(2), 444.002","st":"statute","ed":"2023-09-01","df":"no federal analogue"},{"k":"source and supply chain","v":"HHSC contracts with one or more prescription drug wholesalers - persons licensed as wholesale distributors under HSC ch. 431 subch. N that contract with the state - and with Canadian suppliers, meaning manufacturers, wholesale distributors or pharmacies appropriately licensed under Canadian federal or provincial law.","c":"Tex. Health & Safety Code 444.001(1), (3), 444.002(b)(1)","st":"statute","ed":"2023-09-01","df":"no federal analogue"},{"k":"eligible drugs","v":"A drug may be imported only if it meets FDA standards for safety, effectiveness, misbranding and adulteration; does not violate federal patent law through its importation; is expected to generate cost savings; and is NOT a controlled substance, a biological product, an infused drug, an intravenously injected drug, a drug inhaled during surgery, or a parenteral drug.","c":"Tex. Health & Safety Code 444.003","st":"statute","ed":"2023-09-01","df":"no federal analogue"},{"k":"federal compliance condition","v":"The commission must ensure the program meets the requirements of 21 USC 384 (FD&C Act 804) and must ensure the program and its contracted wholesalers comply with the tracking, tracing, verification and identification requirements of 21 USC 360eee-1.","c":"Tex. Health & Safety Code 444.002(b)(6), (c)","st":"statute","ed":"2023-09-01","df":"false"},{"k":"in-state-only restriction","v":"The commission must prohibit the distribution, dispensing or sale of drugs imported under the chapter outside the boundaries of Texas.","c":"Tex. Health & Safety Code 444.002(b)(7)","st":"statute","ed":"2023-09-01","df":"no federal analogue"},{"k":"implementation expressly contingent on federal authorization","v":"The Act provides that if a state agency determines a waiver or authorization from a federal agency is necessary to implement a provision, the agency shall request it and MAY delay implementing that provision until it is granted. A Section 804 importation program requires FDA authorization, so the statute is enacted but its operation depends on federal action.","c":"Acts 2023, 88th Leg., R.S. (H.B. 25), Sec. 4","st":"statute","ed":"2023-09-01","df":"no federal analogue"},{"k":"reporting obligations","v":"HHSC must report annually to the governor and legislature by December 1 on drugs and Canadian suppliers included, the number of participating issuers, providers and pharmacies, prescriptions dispensed, estimated cost savings, and audit implementation. The executive commissioner must develop audit procedures by rule, and HHSC with the attorney general must monitor anticompetitive activity.","c":"Tex. Health & Safety Code 444.004, 444.006, 444.007","st":"statute","ed":"2023-09-01","df":"no federal analogue"},{"k":"current operational status (SETTLED)","v":"Enacted BUT NOT operational. HHSC's Wholesale Prescription Drug Importation Program annual report for 2025 states there are no new implementation activities to report for fiscal year 2025, attributing this to the need for funding before operations can begin. No Section 804 proposal has been submitted to or authorized by FDA for Texas. The report notes the program could be transferred to the Texas Pharmaceutical Initiative Board. For exam purposes: Texas HAS an importation statute; it imports no drugs.","c":"Tex. Health & Safety Code ch. 444; HHSC Wholesale Prescription Drug Importation Program Annual Report 2025","st":"board policy","ed":"2023-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":"Program dormant pending funding; may transfer to the Texas Pharmaceutical Initiative Board. Re-check each legislative session.","vol":"high"},{"id":"D1-C-09","facts":[{"k":"general prohibition","v":"Unless otherwise specified, a pharmacy may NOT sell, purchase, trade or possess prescription drug samples.","c":"22 TAC 291.16","st":"regulation","ed":null,"df":"true"},{"k":"the single narrow exception - all four conditions required","v":"A pharmacy may hold samples only if it meets ALL of: (1) the pharmacy is owned by a charitable organization described in the Internal Revenue Code of 1986, or by a city, state or county government; (2) the pharmacy is part of a health care entity that provides health care primarily to indigent or low income patients at no or reduced cost; (3) the samples are for dispensing or provision at NO charge to patients of that health care entity; and (4) the samples are possessed in compliance with the federal Prescription Drug Marketing Act of 1987.","c":"22 TAC 291.16(1)-(4)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"relationship to federal law","v":"Pdma (21 USC 353(c)-(d)) governs sample distribution; Texas independently bars pharmacy possession, so a transaction lawful under pdma can still violate Texas law unless the four conditions are met.","c":"22 TAC 291.16; 21 USC 353(c)-(d)","st":"regulation","ed":null,"df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D1-D-01","facts":[{"k":"USP <795> - incorporated functionally, current edition, no fixed revision","v":"Adopted in substance, but not by a dated incorporation. A pharmacy compounding non-sterile preparations must maintain a current copy of Chapter 795 of the USP/NF, and the beyond-use date of a compounded non-sterile preparation is determined as outlined in Chapter 795. 'USP/NF' is defined as THE current edition, so the reference floats rather than freezing at a revision. revision: current edition, undated. effective date: none stated in the rule.","c":"22 TAC 291.131(b)(14); 22 TAC 291.131(c); 22 TAC 291.131(d)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"USP <797> - referenced, not wholesale adopted; Texas writes its own sterile standards","v":"Partially adopted. 22 TAC 291.133 sets out Texas's own detailed sterile compounding standards - ISO class environments, air exchange, personnel, testing, beyond-use dating - rather than adopting Chapter 797 as the operative standard. Chapter 797 appears in three limited roles: defining 'immediate use' (a preparation NOT prepared according to USP 797 standards); as a required library holding; and as the reference for determining certain beyond-use dates. 'USP/NF' is again defined as the current edition. revision: current edition, undated. effective date: none stated.","c":"22 TAC 291.133(b)(29); 22 TAC 291.133(b)(54); 22 TAC 291.133(c)(7)(C)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"USP <800> - NOT adopted as a mandatory standard","v":"NOT adopted. Chapter 800 appears in the Texas rules only as an example in the library requirement - a pharmacy must hold 'any additional USP/NF chapters applicable to the practice of the pharmacy (e.g., USP Chapter 800, Hazardous Drugs--Handling in Healthcare Settings...)'. Texas instead imposes its own hazardous drug handling provisions. revision: none specified. effective date: none - never adopted as a standard.","c":"22 TAC 291.133(c)(7)(D)","st":"regulation","ed":null,"df":"true"},{"k":"confirmation that USP <800>'s framework is absent","v":"The USP <800> 'assessment of risk' concept does not appear anywhere in the TSBP rules - zero occurrences on full-text search - confirming Texas has not imported the chapter's compliance architecture.","c":"22 TAC Part 15","st":"silent","ed":null,"df":"true"},{"k":"other USP chapters named","v":"The sterile compounding library must contain the USP/NF containing Chapter 71 (Sterility Tests), Chapter 85 (Bacterial Endotoxins Test), Chapter 795, Chapter 797 and Chapter 1163 (Quality Assurance in Pharmaceutical Compounding), plus any additional applicable chapters such as 800 and 823.","c":"22 TAC 291.133(c)(7)(C)-(D)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"USP/NF for storage temperatures generally","v":"Across pharmacy classes, drugs must be stored at the proper temperature as defined in the USP/NF and 22 TAC 291.15.","c":"22 TAC 291.15","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"high"},{"id":"D1-D-02","facts":[{"k":"regulator","v":"The Texas State Board of Pharmacy. It licenses and registers pharmacists, pharmacy technicians and pharmacies, establishes regulations for pharmacy practice, and disciplines licensees and registrants.","c":"Tex. Occ. Code 551.003(2); Tex. Occ. Code 554.051","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"independent of the health department","v":"Yes. TSBP is a standalone state agency, separate from the Department of State Health Services and from the Health and Human Services Commission. The split shows in practice: TSBP regulates pharmacies and pharmacists, DSHS licenses wholesale drug distributors under HSC ch. 431, and HHSC administers the drug importation program under HSC ch. 444.","c":"Tex. Occ. Code 554.051; Tex. Health & Safety Code 431.402; Tex. Health & Safety Code 444.002","st":"statute","ed":null,"df":"no federal analogue"},{"k":"rulemaking authority","v":"The board shall adopt rules consistent with the Pharmacy Act for its administration and enforcement, and may adopt rules to administer enumerated controlled substance prescription sections of HSC ch. 481. It may also make rules about the operation of an in-state licensed pharmacy applicable to an out-of-state pharmacy it licenses where necessary to protect public health and welfare.","c":"Tex. Occ. Code 554.051(a), (a-1), (b)","st":"statute","ed":null,"df":"no federal analogue"},{"k":"subject to Sunset review - abolition date 2033","v":"The board is subject to the Texas Sunset Act, Chapter 325, Government Code. Unless continued in existence as that chapter provides, the board is abolished and the Pharmacy Act expires september 1, 2033.","c":"Tex. Occ. Code 551.005","st":"statute","ed":null,"df":"no federal analogue"},{"k":"location","v":"George H. W. Bush State Office Building, 1801 Congress Avenue, Suite 13.100, Austin, TX 78701-1319.","c":"pharmacy.texas.gov (agency contact page)","st":"board policy","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":"Sunset review: the Pharmacy Act expires 2033-09-01 unless continued. Not imminent, but the date is a hard expiry that any dated content should compute rather than assume.","vol":"low"},{"id":"D1-E-01","facts":[{"k":"statutory definition of compounding","v":"The preparation, mixing, assembling, packaging or labeling of a drug or device: (A) as the result of a practitioner's prescription drug order based on the practitioner-patient-pharmacist relationship in the course of professional practice; (B) for administration to a patient by a practitioner as the result of a practitioner's initiative based on that relationship; (C) IN anticipation of a prescription drug order based on a routine, regularly observed prescribing pattern; or (D) for or as an incident to research, teaching or chemical analysis and not for selling or dispensing, except as allowed under Tex. Occ. Code 562.154 or Chapter 563.","c":"Tex. Occ. Code 551.003(9)","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"the statutory line between compounding and manufacturing","v":"Texas draws it in its Food, Drug, and Cosmetic Act: 'Manufacture' means the process of preparing, propagating, compounding, processing, packaging, repackaging, labeling, testing or quality control of a drug or drug product, BUT does NOT include compounding that is done within the practice of pharmacy. Compounding within pharmacy practice is therefore carved out of manufacturing by definition.","c":"Tex. Health & Safety Code 431.002","st":"statute","ed":null,"df":"no federal analogue"},{"k":"the rule's parallel definition","v":"22 TAC 291.131 repeats the four-limb compounding definition for non-sterile compounding, with the same anticipation limb and the same research/teaching carve-out referencing Tex. Occ. Code 562.154 and Chapter 563.","c":"22 TAC 291.131(b)(5)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"anticipatory compounding IS allowed","v":"Yes. Non-sterile drug preparations may be compounded in licensed pharmacies in anticipation of future prescription drug or medication orders based on routine, regularly observed prescribing patterns.","c":"22 TAC 291.131(d)(1)(A)(ii)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"conditions on anticipatory compounding","v":"It must be based on a history of receiving valid prescriptions issued within an established pharmacist/patient/prescriber relationship, and the pharmacist must judge the quantity prepared to be stable for the anticipated shelf time. That professional judgment must rest on the beyond-use-date criteria in the rule, and documentation of the criteria used to determine stability for the anticipated shelf time must be maintained and available for inspection.","c":"22 TAC 291.131(d)(1)(B)(i)-(iii)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"no batch-size percentage cap","v":"Texas law does not address this. Texas sets no numeric or percentage limit on anticipatory batch size. The limit is qualitative - prescribing history plus demonstrated stability for the anticipated shelf time.","c":"22 TAC 291.131(d)(1)(B)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"third permitted basis - office use","v":"Non-sterile preparations may also be compounded in reasonable quantities for office use by a practitioner and for use by a veterinarian.","c":"22 TAC 291.131(d)(1)(A)(iii)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-E-02","facts":[{"k":"separate license IS required - and it is a license, not an endorsement","v":"A pharmacy may not compound and dispense a sterile preparation unless the pharmacy holds a license as required by board rule.","c":"Tex. Occ. Code 562.156(a)","st":"statute","ed":"2013-09-01","df":"true"},{"k":"the sterile license classes","v":"Texas creates class-specific sterile designations: Class A-S (community pharmacies compounding sterile preparations), Class C-S (institutional) and Class E-S (nonresident).","c":"22 TAC 291.36; 22 TAC 291.77; 22 TAC 291.106","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"classification reverts on relocation","v":"When a Class A-S, C-S or E-S pharmacy changes location, the pharmacy's classification reverts to Class A, C or E respectively - the sterile designation does not travel with the move automatically.","c":"22 TAC 291.3(d)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"governing operational rule","v":"22 TAC 291.133 sets the substantive requirements for all pharmacies compounding sterile preparations, covering personnel, training, environment, equipment, process, testing, labeling, records and recalls.","c":"22 TAC 291.133","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"facility and environmental requirements","v":"Compounding facilities must be physically designed and environmentally controlled to minimize airborne contamination reaching critical sites, with adequate hepa-filtered airflow and defined air exchange requirements for cleanroom suites, and an ISO Class 5 primary engineering control for exposure of critical sites. Containment primary engineering controls - containment ventilated enclosures, biological safety cabinets, compounding aseptic containment isolators - are defined for hazardous preparations.","c":"22 TAC 291.133(c)(8); 22 TAC 291.133(b)(40); 22 TAC 291.131(b)(6)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"hazardous drug cabinet requirement","v":"For hazardous sterile compounded preparations the biological safety cabinet must be a Class II or III cabinet, with a limited exemption for pharmacies preparing a low volume of hazardous drugs.","c":"22 TAC 291.133(c)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"training requirements","v":"Pharmacists, technicians, trainees and pharmacist-interns engaged in sterile compounding must meet the training requirements specified in 22 TAC 291.133. In Class C, technicians compounding medium- and high-risk sterile preparations must be supervised by a pharmacist who has also completed that training and who conducts in-process and final checks.","c":"22 TAC 291.133; 22 TAC 291.73(e)(2)(B)(i)(IV); 22 TAC 283.4(a)(2)(G)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"required reference library","v":"A reference text on injectable drug preparations; a specialty reference text appropriate to the scope of services (e.g. a hazardous drug preparation text if hazardous drugs are prepared); the USP/NF containing USP Chapters 71, 85, 795, 797 and 1163; and any additional applicable USP/NF chapters.","c":"22 TAC 291.133(c)(7)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"adverse event and recall reporting","v":"A pharmacy compounding sterile preparations must notify the board immediately of any adverse effects reported to it or known to be potentially attributable to a sterile preparation it compounded, and not later than 24 hours after it issues a recall.","c":"Tex. Occ. Code 562.156(b)","st":"statute","ed":"2013-09-01","df":"no federal analogue"},{"k":"immediate-use carve-out","v":"An 'immediate use' sterile preparation is defined as one NOT prepared according to USP 797 standards, i.e. outside the normal sterile compounding framework, and is treated separately.","c":"22 TAC 291.133(b)(29)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"documentation","v":"Master Formulation Records and Compounding Records are required documentation of the compounding process; records of office-use distribution must be kept at least two years, maintained separately from prescription records, and supplied to the board within 72 hours on request.","c":"22 TAC 291.133(f); 22 TAC 291.131(c), (f)(3)(A)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"high"},{"id":"D1-E-03","facts":[{"k":"office use compounding is EXPRESSLY PERMITTED","v":"A pharmacy may dispense and deliver a reasonable quantity of a compounded drug to a practitioner for office use by the practitioner. Texas is squarely in the permitting camp.","c":"Tex. Occ. Code 562.152","st":"statute","ed":"2005-09-01","df":"true"},{"k":"statutory conditions","v":"To do so the pharmacy must verify the source of the raw materials; comply with applicable USP guidelines including testing requirements and with HIPAA; comply with all applicable competency and accrediting standards as determined by the board; and comply with board rules including rules on practitioner reporting of adverse events and recall procedures.","c":"Tex. Occ. Code 562.153","st":"statute","ed":"2005-09-01","df":"no federal analogue"},{"k":"definition of reasonable quantity","v":"An amount that does not exceed what the practitioner anticipates may be used in the practitioner's office or facility before the drug's beyond use date; is reasonable considering the intended use and the nature of the practitioner's practice; and, for any practitioner and all practitioners as a whole, is not greater than an amount the pharmacy can compound in compliance with identity, strength, quality and purity standards consistent with USP guidelines and accreditation practices.","c":"22 TAC 291.131(b)(10)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"written agreement required","v":"A pharmacy providing compounded preparations to practitioners for office use, or to another pharmacy, must enter a written agreement that addresses acceptable standards of practice and states the preparations may only be administered to the patient and may not be dispensed to the patient or sold to any other person or entity; states that the practitioner or receiving pharmacy should log the lot number and beyond-use date of preparations administered; and describes the scope of services including the process for a patient to report an adverse reaction or complaint and for the pharmacy to recall batches.","c":"22 TAC 291.131(f)(2)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"recordkeeping and the 72-hour production rule","v":"Records of orders and distribution for office use must be kept at least two years, maintained separately from records of products dispensed on prescription, and supplied to the board or its representative within 72 hours of request.","c":"22 TAC 291.131(f)(3)(A)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"labeling","v":"Preparations distributed for office use must bear the statement 'For Institutional or Office Use Only--Not for Resale'.","c":"22 TAC 291.131(f)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"sterile office use has its own parallel provision","v":"Office use compounding and distribution of sterile compounded preparations is separately provided for.","c":"22 TAC 291.133(f)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"distribution to Class C pharmacies and veterinarians","v":"The same subsection covers distribution of compounded preparations to Class C pharmacies and to veterinarians, and confirms that a Class A pharmacy need not be licensed under HSC ch. 431 to distribute non-sterile compounded preparations to a Class C pharmacy, nor a Class C pharmacy to commonly owned Class C pharmacies.","c":"22 TAC 291.131(f)(1)(B)-(C); Tex. Occ. Code 562.154","st":"regulation","ed":"2005-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-E-04","facts":[{"k":"no USP <800> adoption - Texas writes its own hazardous drug rules","v":"Texas has not adopted USP Chapter 800 as a mandatory standard; it appears only as an example of 'additional USP/NF chapters applicable to the practice of the pharmacy' in the sterile compounding library requirement. The operative handling requirements are Texas's own.","c":"22 TAC 291.133(c)(7)(D)","st":"regulation","ed":null,"df":"true"},{"k":"no assessment of risk requirement","v":"Texas law does not address this. The USP <800> 'assessment of risk' concept does not exist in Texas pharmacy rules - zero occurrences on full-text search of the TSBP master rules file. Texas imposes no AoR documentation duty and offers no AoR-based alternative containment strategy.","c":"22 TAC Part 15","st":"silent","ed":null,"df":"true"},{"k":"preparation and storage conditions","v":"Hazardous drugs must be prepared only under conditions that protect personnel during preparation and storage, and must be stored separately from other inventory in a manner that prevents contamination and personnel exposure.","c":"22 TAC 291.133(c)(6)(F)(i)-(ii)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"PPE - and the breadth of when it is required","v":"All personnel involved in compounding hazardous drugs must wear appropriate protective apparel - such as gowns, face masks, eye protection, hair covers, shoe covers or dedicated shoes - and appropriate gloving AT ALL times when handling hazardous drugs, including receiving, distribution, stocking, inventorying, preparation for administration, and disposal. The duty is not confined to the compounding step.","c":"22 TAC 291.133(c)(6)(F)(iii)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"containment technique","v":"Appropriate safety and containment techniques for compounding hazardous drugs must be used IN conjunction with the aseptic techniques required for preparing sterile preparations.","c":"22 TAC 291.133(c)(6)(F)(iv)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"engineering controls","v":"For hazardous sterile compounded preparations the biological safety cabinet must be a Class II or III cabinet; pharmacies preparing a LOW volume of hazardous drugs are not required to comply with that requirement. Containment primary engineering control is defined to include containment ventilated enclosures, biological safety cabinets and compounding aseptic containment isolators. Where volatile hazardous drugs are prepared, exhaust air from the isolator is addressed.","c":"22 TAC 291.133(c); 22 TAC 291.131(b)(6)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"waste disposal","v":"Disposal of hazardous waste must comply with all applicable local, state and federal requirements, and the pharmacy must have a system to dispose of hazardous waste appropriately.","c":"22 TAC 291.133(c)(6)(F)(v)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"dispensing and labeling","v":"Prepared doses of hazardous drugs must be dispensed, labeled with proper precautions inside and outside, and distributed in a manner that minimizes patient contact with hazardous agents; hazardous drug warning labels are required where appropriate.","c":"22 TAC 291.133(c)(6)(F)(vi)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"policies and training","v":"Handling of hazardous drugs, if applicable, must be addressed in the pharmacy's written policies and procedures, and a specialty reference text on the preparation of hazardous drugs is a required library holding for a pharmacy that prepares them.","c":"22 TAC 291.133(c)(7)(B)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"radiopharmaceuticals excluded","v":"Radiopharmaceuticals are not considered hazardous drugs for these purposes.","c":"22 TAC 291.133(b)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"high"},{"id":"D1-E-05","facts":[{"k":"no state outsourcing facility registration","v":"Texas law does not address this. Neither the Texas Pharmacy Act, the TSBP rules, nor the Texas Food, Drug, and Cosmetic Act creates an 'outsourcing facility' license, registration or class. The term does not appear in any of them. Texas has not built a post-dqsa state 503B regime.","c":"22 TAC Part 15; Tex. Health & Safety Code ch. 431","st":"silent","ed":null,"df":"true"},{"k":"how such a facility would be licensed in Texas instead","v":"A 503B outsourcing facility operating in or shipping into Texas would fall under the generally applicable DSHS regimes - drug manufacturer licensing or wholesale drug distribution licensing under HSC ch. 431 - rather than a bespoke category. A pharmacy that compounds remains licensed by TSBP in its A-S, C-S or E-S class.","c":"Tex. Health & Safety Code 431.402; Tex. Occ. Code 562.156(a)","st":"statute","ed":"2013-09-01","df":"no federal analogue"},{"k":"no compounding volume reporting requirement","v":"Texas law does not address this. Texas imposes no duty on a pharmacy to report its compounding volume to the board. The board-facing compounding reports Texas does require are event-driven, not volumetric.","c":"22 TAC Part 15","st":"silent","ed":null,"df":"true"},{"k":"what IS reportable - event-driven, sterile only","v":"A pharmacy that compounds a sterile preparation must notify the board immediately of any adverse effects reported to it or known to be potentially attributable to a sterile preparation it compounded, and not later than 24 hours after it issues a recall for one. A compounding pharmacy must also notify the board if it institutes a mandatory recall.","c":"Tex. Occ. Code 562.156(b); 22 TAC 291.131(g)","st":"statute","ed":"2013-09-01","df":"no federal analogue"},{"k":"records produced on demand, not filed","v":"Office-use compounding and distribution records must be kept at least two years and supplied to the board within 72 hours of request - an inspection-on-demand model rather than periodic reporting.","c":"22 TAC 291.131(f)(3)(A)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-F-01","facts":[{"k":"pharmacy-specific closed list of permitted disclosures","v":"Texas pharmacy rules make confidential records privileged and releasable only to: the patient or the patient's agent; a practitioner or another pharmacist where in the pharmacist's professional judgment release is necessary to protect the patient's health and well-being; the board or a person or state or federal agency authorized by law to receive the record; a law enforcement agency investigating a suspected violation of HSC ch. 481 or 483 or the federal Controlled Substances Act; a person employed by a state agency that licenses a practitioner, performing official duties; or an insurance carrier or other third party payor authorized by the patient. This is narrower than HIPAA's broad treatment-payment-operations permissions.","c":"22 TAC 291.27(b)","st":"regulation","ed":null,"df":"true"},{"k":"security and policy duties","v":"A pharmacist must provide adequate security of prescription drug orders, medication orders and patient medication records to prevent indiscriminate or unauthorized access, and a pharmacy must have written policies and procedures prohibiting unauthorized disclosure. Where information passes through a data communication device, the device operator may not access or maintain confidential health information unless specifically authorized by the rule.","c":"22 TAC 291.27(a), (c)","st":"regulation","ed":null,"df":"true"},{"k":"statutory confidentiality","v":"The Pharmacy Act separately protects confidential records, and 'confidential record' is defined as a health-related record containing individually identifying information maintained by a pharmacy or pharmacist.","c":"Tex. Occ. Code 562.102; Tex. Occ. Code 551.003(10)","st":"statute","ed":"1999-09-01","df":"true"},{"k":"Texas Medical Records Privacy Act applies on top","v":"Health and Safety Code Chapter 181 applies to pharmacies as covered entities and is broader than HIPAA in its reach. Protected health information is expressly not public.","c":"Tex. Health & Safety Code 181.006; Tex. Health & Safety Code 181.001","st":"statute","ed":null,"df":"true"},{"k":"STRICTER THAN HIPAA - separate authorization for electronic disclosure","v":"A covered entity must give notice to an individual whose PHI is subject to electronic disclosure, by posting in its place of business, on its website, or where such individuals are likely to see it. And, subject to stated exceptions, a covered entity may NOT electronically disclose an individual's PHI to any person without a separate authorization from the individual or the individual's legally authorized representative. HIPAA requires no such separate authorization for ordinary treatment or payment disclosures.","c":"Tex. Health & Safety Code 181.154(a)-(b)","st":"statute","ed":null,"df":"true"},{"k":"STRICTER THAN HIPAA - sale of PHI and marketing","v":"Texas separately prohibits the sale of protected health information subject to exceptions, and regulates marketing uses of information and reidentified information.","c":"Tex. Health & Safety Code 181.153; 181.152; 181.151","st":"statute","ed":null,"df":"true"},{"k":"STRICTER THAN HIPAA - mandatory workforce training with a deadline","v":"Each covered entity must train employees on state and federal law concerning PHI as necessary for their duties, and an employee must complete that training NOT later than THE 90TH DAY after hire, with retraining within a reasonable period after a material change in the law. HIPAA requires training but sets no 90-day clock.","c":"Tex. Health & Safety Code 181.101(a)-(c)","st":"statute","ed":null,"df":"true"},{"k":"STRICTER THAN HIPAA - 15 business day electronic record access","v":"If a health care provider uses an EHR system capable of fulfilling the request, it must provide the requested electronic health record in electronic form not later than the 15TH business DAY after a written request, unless the person agrees to another form. HIPAA allows 30 days.","c":"Tex. Health & Safety Code 181.102(a)","st":"statute","ed":null,"df":"true"},{"k":"pharmacy record access deadline is tighter still","v":"A pharmacy must respond to a request for confidential records no later than fifteen days after receipt, and must respond to an expedited request in a medical emergency within 24 hours if records are held at the pharmacy or 72 hours if stored off-site.","c":"22 TAC 291.28(c)(1), (c)(3)","st":"regulation","ed":null,"df":"true"},{"k":"heightened categories - HIV, mental health, substance use, reproductive health","v":"Texas law does not address this. Within pharmacy law. Neither 22 TAC 291.27 nor the Pharmacy Act creates category-specific heightened protections for HIV status, mental health, substance use disorder, minors or reproductive health. Those protections exist in Texas law outside the pharmacy chapters and in federal law (42 CFR Part 2 for substance use disorder records), and 22 TAC 295.13(g)(1) directs pharmacists to comply with HIPAA, HSC ch. 181, Insurance Code ch. 28B and any other federal or state confidentiality provisions.","c":"22 TAC 295.13(g)(1)","st":"silent","ed":null,"df":"true"},{"k":"physician-patient privilege preserved","v":"Nothing in the drug therapy management rule affects or alters the confidentiality of physician-patient communication under the Medical Practice Act, Chapter 159.","c":"22 TAC 295.13(g)(2)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-F-02","facts":[{"k":"no pharmacy rule on non-custodial parent access","v":"Texas law does not address this. Texas pharmacy law does not address whether a non-custodial parent may access a minor's medication record. 22 TAC 291.27(b)(1) permits release to 'the patient or the patient's agent' and 22 TAC 291.28(a) requires compliance with the request of 'a patient or a patient's agent', without defining agency for a minor or distinguishing custodial from non-custodial parents.","c":"22 TAC 291.27(b)(1); 22 TAC 291.28(a)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"fallback to general law","v":"A pharmacy must comply with all relevant state and federal laws regarding release of confidential records to third party requestors, which routes the question to HIPAA's personal representative rules (45 CFR 164.502(g)) and to the Texas Family Code rather than to pharmacy law.","c":"22 TAC 291.28(a)","st":"regulation","ed":null,"df":"true"},{"k":"no age at which a minor controls the pharmacy record","v":"Texas law does not address this. Texas pharmacy law sets no age of control over one's own medication record. The only age-related thresholds in the pharmacy rules concern vaccination - physician referral required for patients under 14, with influenza vaccination permitted for patients over 7 without an established physician-patient relationship.","c":"22 TAC 295.15(e)(2)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"one adjacent express provision - PMP access","v":"In the controlled substance / prescription monitoring context, Texas expressly provides for a request by a patient, the patient's parent or legal guardian IF THE patient IS A minor, or the patient's legal guardian, supported by a copy of the patient's birth certificate or the order of guardianship. This is PMP record access, not pharmacy medication record access.","c":"22 TAC 315.14","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D1-F-03","facts":[{"k":"governing statute","v":"Texas Business and Commerce Code Chapter 521, Subchapter B. A pharmacy conducting business in Texas is a 'person' subject to it; the duty is separate from and additional to HIPAA's breach notification rule.","c":"Tex. Bus. & Com. Code 521.053","st":"statute","ed":null,"df":"true"},{"k":"what triggers the duty","v":"A breach of system security, meaning unauthorized acquisition of computerized data that compromises the security, confidentiality or integrity of sensitive personal information maintained by a person - including encrypted data where the person accessing it holds the decryption key. Good faith acquisition by an employee or agent for the person's purposes is not a breach unless the information is then used or disclosed in an unauthorized manner.","c":"Tex. Bus. & Com. Code 521.053(a)","st":"statute","ed":null,"df":"true"},{"k":"DEADLINE - 60 days","v":"A person who conducts business in Texas and owns or licenses computerized data including sensitive personal information must disclose the breach to any individual whose sensitive personal information was, or is reasonably believed to have been, acquired by an unauthorized person, without unreasonable delay and in each case NOT later than THE 60TH DAY after the date the person determines the breach occurred.","c":"Tex. Bus. & Com. Code 521.053(b)","st":"statute","ed":null,"df":"true"},{"k":"permitted delay","v":"Notification may be delayed as provided by Subsection (d) (law enforcement) or as necessary to determine the scope of the breach and restore the reasonable integrity of the data system.","c":"Tex. Bus. & Com. Code 521.053(b)","st":"statute","ed":null,"df":"false"},{"k":"out-of-state residents","v":"Where the affected individual resides in a state that requires notice, a conforming-notice provision applies.","c":"Tex. Bus. & Com. Code 521.053(b-1)","st":"statute","ed":null,"df":"no federal analogue"},{"k":"how it compares with HIPAA","v":"Stricter on the clock: HIPAA allows notification without unreasonable delay and in no case later than 60 days after discovery of the breach, while Texas runs 60 days from the date the person determines the breach occurred, and Texas reaches sensitive personal information generally, not only protected health information. Both duties apply to a pharmacy independently.","c":"Tex. Bus. & Com. Code 521.053(b); 45 CFR 164.404","st":"statute","ed":null,"df":"true"},{"k":"no separate pharmacy board breach rule","v":"Texas law does not address this. The TSBP rules impose no independent data breach notification duty. The nearest pharmacy-specific duty is the pharmacist-in-charge's obligation to report to the board in writing any significant loss of information from the pharmacy's data processing system.","c":"22 TAC 291.34(e); 22 TAC 291.3(i)","st":"silent","ed":null,"df":"true"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-A-01","facts":[{"k":"Texas-licensed prescribers of dangerous (legend) drugs","v":"A 'practitioner' who may prescribe dangerous drugs is a person licensed by the Texas Medical Board, the State Board of Dental Examiners, the Texas Optometry Board, or the State Board of Veterinary Medical Examiners to prescribe and administer dangerous drugs, or licensed by the Texas Department of Licensing and Regulation to prescribe and administer dangerous drugs in podiatry.","c":"Tex. Health & Safety Code 483.001(12)(A)","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"APRNs and physician assistants","v":"An APRN or PA is a practitioner for dangerous-drug purposes only to the extent a physician has delegated prescribing or ordering authority under Occupations Code 157.0511, 157.0512 or 157.054.","c":"Tex. Health & Safety Code 483.001(12)(D)","st":"statute","ed":"2013-11-01","df":"no federal analogue"},{"k":"Drug-category limits by prescriber type","v":"Authority is bounded by the licensing act: veterinarians prescribe for animals only; podiatrists only within podiatry; optometrists only as therapeutic optometrists (license number plus 'T') or optometric glaucoma specialists ('TG'). TSBP's quick-reference chart requires the T or TG designation to appear with the license number on the prescription.","c":"Tex. Health & Safety Code 483.001(12)(A); TSBP, Quick Reference: Prescriptions Which May be Dispensed in Texas","st":"board policy","ed":null,"df":"no federal analogue"},{"k":"Pharmacists under drug therapy management","v":"A Texas pharmacist practicing drug therapy management under a physician's written protocol may issue a dangerous-drug prescription electronically, in writing or by fax, but only when practicing at a federally qualified health center, hospital, hospital-based clinic or academic institution, and the delegating physician's information must appear. The pharmacist may communicate a new prescription orally only as the delegating physician's designated agent.","c":"TSBP, Quick Reference: Prescriptions Which May be Dispensed in Texas (implementing 22 TAC 295.13)","st":"board policy","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-A-02","facts":[{"k":"Physicians, dentists, podiatrists, veterinarians","v":"May prescribe Schedules II-V, subject to DEA registration.","c":"Tex. Health & Safety Code 481.074(g), (h), (i)","st":"statute","ed":"2019-09-01","df":"false"},{"k":"APRN / PA - Schedules III-V","v":"A physician may delegate prescribing of Schedule III, IV and V controlled substances to an APRN or PA. The prescription, including all refills, may not exceed a 90-day supply; any refill must be authorized only after consultation with the delegating physician and that consultation noted in the chart.","c":"Tex. Occ. Code 157.0511(b)","st":"statute","ed":"2013-11-01","df":"true"},{"k":"APRN / PA - Schedule II (narrow)","v":"Schedule II may be delegated only (1) in a hospital facility-based practice under medical-staff-approved policies, for a patient admitted with an intended stay of 24 hours or more or receiving emergency department services, or (2) in the plan of care for a hospice patient with a written certification of terminal illness. TSBP adds that the in-hospital prescriptions must be filled at the in-hospital pharmacy.","c":"Tex. Occ. Code 157.0511(b-1); TSBP, Quick Reference: Prescriptions Which May be Dispensed in Texas","st":"statute","ed":"2013-11-01","df":"true"},{"k":"APRN / PA - patients under two years","v":"A controlled substance prescription for a child under two must be issued only after consultation with the delegating physician, documented in the patient's chart.","c":"Tex. Occ. Code 157.0511(b)","st":"statute","ed":"2013-11-01","df":"true"},{"k":"APRN / PA - prescription form","v":"An APRN or PA may use only official prescription forms showing the mid-level's name, address, telephone number and DEA number plus the delegating physician's name and DEA number.","c":"22 TAC 315.3(e)","st":"regulation","ed":"2021-06-09","df":"true"},{"k":"Therapeutic optometrists (T) and optometric glaucoma specialists (TG)","v":"May prescribe Schedule III-V controlled substances limited to a single three-day supply with no refills; no Schedule II authority.","c":"TSBP, Quick Reference: Prescriptions Which May be Dispensed in Texas","st":"board policy","ed":null,"df":"true"},{"k":"Pharmacists under drug therapy management","v":"No controlled substance authority in any schedule.","c":"TSBP, Quick Reference: Prescriptions Which May be Dispensed in Texas","st":"board policy","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-A-03","facts":[{"k":"Out-of-state prescriber, dangerous drugs","v":"Yes. 'Practitioner' expressly includes a person licensed by another state in a health field in which Texas law permits a licensee to prescribe dangerous drugs, so a Texas pharmacist may fill the prescription.","c":"Tex. Health & Safety Code 483.001(12)(B)","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"Out-of-state prescriber, Schedules III-V","v":"A Texas pharmacy may fill a Schedule III, IV or V prescription issued by an out-of-state practitioner if that practitioner is authorized by the other state to prescribe the substance. No board plan is needed.","c":"22 TAC 315.9(b)","st":"regulation","ed":"2024-03-07","df":"false"},{"k":"Out-of-state prescriber, Schedule II","v":"Yes, but only if ALL of these apply: the out-of-state practitioner is authorized by that state to prescribe it; the pharmacy has a plan approved by TSBP and kept on file permitting the activity; the pharmacy processes and reports the prescription as that approved plan requires; AND, under the statute, a share of the pharmacy's business involves the dispensing and delivery or mailing of controlled substances. That last condition is in the statute, not the rule, and means the authority is not open to every Texas pharmacy. Out-of-state NPs and PAs may not prescribe any controlled substance for dispensing in Texas.","c":"22 TAC 315.9(a); Tex. Health & Safety Code 481.075(m), (m)(1)","st":"regulation","ed":"2024-03-07","df":"true"},{"k":"Out-of-state nurse practitioner or physician assistant","v":"May prescribe dangerous drugs for dispensing in Texas, but may NOT prescribe controlled substances in any schedule for dispensing in Texas.","c":"TSBP, Quick Reference: Prescriptions Which May be Dispensed in Texas","st":"board policy","ed":null,"df":"true"},{"k":"Substitution on out-of-state orders","v":"The Texas dispensing-directive rules do not apply to out-of-state orders; a pharmacist may not substitute unless the prescriber authorized it on the order, the pharmacist obtains and notes verbal or written authorization, or the pharmacist keeps on file (updated annually) written documentation from the other state's board that substitution is permitted unless prohibited.","c":"22 TAC 309.3(c)(5)","st":"regulation","ed":"2020-12-10","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-A-04","facts":[{"k":"Canadian or Mexican prescriber, dangerous drugs","v":"Permitted. 'Practitioner' expressly includes a person licensed in Canada or Mexico in a health field in which Texas law permits a licensee to prescribe dangerous drugs.","c":"Tex. Health & Safety Code 483.001(12)(C)","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"Form of transmission","v":"Written only. TSBP's chart permits a written prescription bearing a manual signature or an electronic replica of the signature on secured paper; electronic, faxed and oral prescriptions from Canadian or Mexican prescribers may not be dispensed, and only refills authorized on the original written prescription may be dispensed (those refills may be transferred).","c":"TSBP, Quick Reference: Prescriptions Which May be Dispensed in Texas","st":"board policy","ed":null,"df":"no federal analogue"},{"k":"Faxed prescriptions prohibited by rule","v":"A pharmacist may not dispense a faxed prescription for a dangerous drug or a controlled substance issued by a practitioner licensed in Canada or Mexico unless that practitioner is also licensed in Texas.","c":"22 TAC 291.34(b)(5)(C)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"},{"k":"Controlled substances","v":"Not permitted in any schedule from a Canadian or Mexican prescriber.","c":"TSBP, Quick Reference: Prescriptions Which May be Dispensed in Texas","st":"board policy","ed":null,"df":"true"},{"k":"Substitution","v":"The dispensing-directive format rules do not apply to dangerous-drug orders from Mexico or Canada; substitution follows the out-of-state pathway in 309.3(c)(5).","c":"22 TAC 309.3(b)(3), (c)(5)","st":"regulation","ed":"2020-12-10","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-A-05","facts":[{"k":"Refill window for a dangerous (legend) drug prescription","v":"A prescription for a dangerous drug or a nonprescription drug may not be refilled more than one year after the date the prescription was originally issued. After that, new prescriber authorization is required for any further quantity.","c":"22 TAC 291.34(b)(8)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Window for the INITIAL fill","v":"Texas law does not address this. Texas sets no express outer limit on how long after issuance a legend-drug prescription may be filled for the first time; the one-year rule is written as a limit on refilling. Searched Tex. Occ. Code 562.007 (Refills), 22 TAC 291.34(b)(8) and 22 TAC 291.33(c); none states an initial-fill expiry.","c":"22 TAC 291.34(b)(8); Tex. Occ. Code 562.007","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-A-06","facts":[{"k":"Schedule II - fill window","v":"A Schedule II prescription must be dispensed within 30 days of the date it was issued. Where a practitioner issues multiple same-day Schedule II prescriptions for sequential filling, the 30 days run from the earliest date on which a pharmacy may dispense that prescription. (This period was 21 days before the June 9, 2021 amendment.)","c":"22 TAC 315.3(a)(4)","st":"regulation","ed":"2021-06-09","df":"true"},{"k":"Schedule II - refills","v":"No refills. The statute states Schedule II prescriptions may not be refilled.","c":"Tex. Health & Safety Code 481.074(d)","st":"statute","ed":"2019-09-01","df":"false"},{"k":"Schedule III and IV","v":"May not be filled or refilled more than six months after the date issued, and may not be refilled more than five times, unless renewed by the practitioner.","c":"Tex. Health & Safety Code 481.074(g); 22 TAC 315.3(b)(2)","st":"statute","ed":"2019-09-01","df":"false"},{"k":"Schedule V","v":"Texas applies the same six-month / five-refill ceiling to Schedule V prescriptions, including the low-concentration codeine and dihydrocodeine preparations.","c":"Tex. Health & Safety Code 481.074(h), (i)","st":"statute","ed":"2019-09-01","df":"true"},{"k":"Schedule II - LTCF / hospice exception","v":"A Schedule II prescription partially filled for an ltcf patient or a documented terminally ill hospice patient is valid for 60 days after issue unless discontinued sooner.","c":"Tex. Health & Safety Code 481.074(f)","st":"statute","ed":"2019-09-01","df":"false"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-A-07","facts":[{"k":"Controlled substance prescription - required elements","v":"Quantity (in numerals on an electronic prescription, or as transcribed by the receiving pharmacist for an oral/telephone order); date of issue; for a multiple Schedule II set, the earliest date a pharmacy may fill it; patient name, address and date of birth or age (for an animal, species plus owner's name and address); drug name and strength; directions for use; the intended use unless the practitioner determines disclosure is not in the patient's best interest; and the practitioner's name, address, DEA number and telephone number at the usual place of business.","c":"Tex. Health & Safety Code 481.074(k)","st":"statute","ed":"2019-09-01","df":"true"},{"k":"Dangerous drug prescription - required elements","v":"Date issued; patient name and address; species if for an animal; drug name and quantity; directions for use; intended use unless the practitioner determines disclosure is not in the patient's best interest; practitioner's name, address and telephone number at the usual place of business, legibly printed or stamped; and, if signed by a licensed midwife, registered nurse or physician assistant, that person's name, address and telephone number legibly printed or stamped.","c":"Tex. Health & Safety Code 483.001(13)","st":"statute","ed":"2019-09-01","df":"true"},{"k":"What the pharmacy must additionally record","v":"On the pharmacy's own record: the unique prescription identification number, the dispensing pharmacist's initials or identification code, the initials or code of any technician who entered the prescription, the quantity or date if either differs from the prescription, and the brand or manufacturer dispensed if a substitution was made.","c":"22 TAC 291.34(b)(7)(B)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Elements beyond the federal baseline","v":"Patient date OF birth OR AGE and the intended USE / diagnosis are required on Texas controlled substance prescriptions; patient address and intended use are required on dangerous drug prescriptions. Federal law requires none of age/DOB or intended use. There is no state-required diagnosis code.","c":"Tex. Health & Safety Code 481.074(k)(3), (k)(6); 483.001(13)(B), (13)(F)","st":"statute","ed":"2019-09-01","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-A-08","facts":[{"k":"Scope of the Texas e-prescribing mandate","v":"Mandatory for controlled substances only. A controlled substance may not be dispensed or administered except on an electronic prescription meeting Sec. 481.075, other than in a board-defined emergency or under the exceptions in 481.075(j) or (m) or 481.0755. There is no Texas mandate for non-controlled prescriptions.","c":"Tex. Health & Safety Code 481.074(b)","st":"statute","ed":"2021-01-01","df":"true"},{"k":"Commencement date","v":"The requirement bites on prescriptions issued on or after January 1, 2021; prescriptions issued before that date are expressly excepted.","c":"Tex. Health & Safety Code 481.0755(a)(11); 22 TAC 315.3(c)(2)","st":"statute","ed":"2021-01-01","df":"true"},{"k":"Exemptions","v":"Veterinarian-issued; temporary technological or electronic failure making e-prescribing unavailable; prescription to be dispensed by a pharmacy outside Texas; prescriber and dispenser in the same location or under the same license; required elements not supported by the current national e-prescribing data standard; FDA requires information e-prescribing cannot capture; non-patient-specific prescriptions under standing order, approved drug therapy protocol, collaborative drug management or comprehensive medication management, during a public health emergency or otherwise permitted; research protocol; prescriber holds a waiver under Sec. 481.0756; prescriber reasonably determines the patient could not obtain the drug in a timely manner and delay would adversely affect the patient.","c":"Tex. Health & Safety Code 481.0755(a)(1)-(10)","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"Waiver mechanics","v":"A prescriber may apply to the licensing agency for a waiver on grounds of economic hardship (case by case), technological limitations beyond the prescriber's control, or other exceptional circumstances. A waiver lasts one year and the prescriber may reapply no earlier than 30 days before expiration if the circumstances continue.","c":"22 TAC 315.3(c)(3); Tex. Health & Safety Code 481.0756","st":"regulation","ed":"2021-06-09","df":"no federal analogue"},{"k":"Pharmacist verification duty","v":"None. A dispensing pharmacist who receives a non-electronic controlled substance prescription is not required to verify that the prescription qualifies for an exception, and may dispense on an otherwise valid written, oral or telephonic prescription that meets the subchapter's requirements.","c":"Tex. Health & Safety Code 481.0755(b)","st":"statute","ed":"2019-09-01","df":"false"},{"k":"Form of an exempt prescription","v":"Outside an emergency an exempt controlled substance prescription must be written; a written Schedule II prescription must be on the TSBP official prescription form and bear the prescriber's and the dispensing pharmacist's signatures; a written non-Schedule II prescription needs the Sec. 481.074(k) information and the prescriber's signature.","c":"Tex. Health & Safety Code 481.0755(c)-(e)","st":"statute","ed":"2019-09-01","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"high"},{"id":"D2-A-09","facts":[{"k":"Dangerous drugs by fax","v":"A pharmacist may dispense a prescription for a dangerous drug transmitted by facsimile.","c":"22 TAC 291.34(b)(5)(A)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"},{"k":"Schedules III-V by fax","v":"Permitted only if the practitioner manually signed the prescription. A system that electronically replicates the signature does not satisfy the rule.","c":"22 TAC 291.34(b)(5)(B)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Schedule II by fax","v":"A written Schedule II prescription must be on the official prescription form; TSBP's chart permits a faxed copy of the official form only in the three federal situations (narcotic for home infusion/IV pain therapy, ltcf patient, hospice patient) under 21 CFR 1306.11(e), (f), (g).","c":"22 TAC 291.34(b)(2)(E); TSBP, Quick Reference: Prescriptions Which May be Dispensed in Texas","st":"board policy","ed":null,"df":"false"},{"k":"Canada / Mexico","v":"A faxed dangerous-drug or controlled-substance prescription from a practitioner licensed in Canada or Mexico may not be dispensed unless that practitioner is also licensed in Texas.","c":"22 TAC 291.34(b)(5)(C)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"},{"k":"What makes the fax the original","v":"Texas does not declare the fax to be the original by rule. The record must bear a statement showing it was faxed (for example 'Faxed to') and, where a designated agent transmitted it, the agent's name. For Schedules III-V the manually signed faxed copy functions as the written prescription.","c":"22 TAC 291.34(b)(7)(A)(ix)","st":"regulation","ed":"2022-03-15","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-A-10","facts":[{"k":"State-issued serialised form - Schedule II","v":"Yes. A written Schedule II prescription, regardless of quantity, must be issued on the Texas official prescription form, or as a compliant electronic prescription. This includes an emergency Schedule II prescription.","c":"22 TAC 315.3(a)(1), (a)(2)","st":"regulation","ed":"2021-06-09","df":"true"},{"k":"Sole source of the form","v":"The Texas State Board of Pharmacy is the sole source of official prescription forms. Only practitioners registered with DEA to prescribe Schedule II may order them; institutional practitioners and APRNs/PAs with delegated authority may order under stated conditions, and an APRN's or PA's forms become void and must be returned if the delegation is withdrawn.","c":"22 TAC 315.2(a)-(d)","st":"regulation","ed":"2019-06-20","df":"true"},{"k":"Return of unused forms","v":"Unused official prescription forms must be returned within 30 days after a DEA number or license is denied, suspended, cancelled, surrendered or revoked. One Schedule II prescription per form; a form may be dated or signed only on the date of issue.","c":"Tex. Health & Safety Code 481.0755(f)-(n)","st":"statute","ed":"2019-09-01","df":"true"},{"k":"Schedules III-V forms","v":"No official state form. A practitioner may use prescription forms obtained through individual sources or an electronic prescription; the form must carry the DEA registration number and meet the Controlled Substances Act requirements. No tamper-resistant or security specification is imposed by this rule.","c":"22 TAC 315.12(a), (b)","st":"regulation","ed":"2019-03-12","df":"true"},{"k":"General tamper-resistant blank requirement","v":"Texas law does not address this. No Texas statute or TSBP rule imposes a general tamper-resistant or security-paper requirement for dangerous-drug or Schedule III-V prescription blanks. Looked at 22 TAC 315.2, 315.12, 315.13 and 291.34(b); the only security-paper reference located is in TSBP's quick-reference chart for Canadian/Mexican written prescriptions.","c":"22 TAC 315.12","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-A-11","facts":[{"k":"Texas list of permitted / prohibited Schedule II changes","v":"Texas law does not address this. Texas has no rule or statute enumerating which elements of a Schedule II prescription a pharmacist may change and which may never be changed. Searched 22 TAC 315.8 (titled 'Pharmacy Responsibility - Modification of Prescription'), 22 TAC 315.3, 22 TAC 291.34(b), Tex. Health & Safety Code 481.074 and 481.075, and the TSBP practice-resources and news pages.","c":"22 TAC 315.8","st":"silent","ed":null,"df":"true"},{"k":"What Texas does require - documentation","v":"Where a prescription is modified, the pharmacy must document the date the change or addition was authorized, the information authorized to be added or changed, the name of the prescribing practitioner who gave the authorization, and the pharmacist's initials or identification code. The rule presupposes prescriber authorization for any modification.","c":"22 TAC 315.8","st":"regulation","ed":"2016-03-10","df":"true"},{"k":"TSBP's published position","v":"TSBP has republished DEA's interim measure: a pharmacist may make changes to a Schedule II prescription where permitted by state regulations or policy, after oral consultation with the prescriber, pending new DEA regulations. TSBP cites no Texas list of its own.","c":"TSBP, 'DEA Information for Pharmacists - Changes To Schedule II Prescriptions' (August 2022)","st":"board policy","ed":"2022-08-01","df":"false"},{"k":"Adding a drug","v":"A changed original prescription is invalid and any additional drug requires a new prescription with a new prescription number; a dispensing error may never cause an original prescription or a data-system record to be destroyed or deleted.","c":"22 TAC 291.34(b)(6)(D), (b)(9)","st":"regulation","ed":"2022-03-15","df":"true"}],"ver":"2026-10-14","pc":"DEA has said it is drafting regulations to replace the 2022 interim measure; Texas would then need to decide whether to adopt a list. Nothing proposed by TSBP as of 2026-10-14.","vol":"high"},{"id":"D2-A-12","facts":[{"k":"Controlled substances","v":"No independent clarification authority. 22 TAC 315.8 requires the pharmacy to record the name of the prescribing practitioner who authorized the addition or change, which means a missing or corrected element on a controlled substance prescription must be authorized by the prescriber.","c":"22 TAC 315.8","st":"regulation","ed":"2016-03-10","df":"true"},{"k":"Patient address on a dangerous drug prescription","v":"The pharmacy's original prescription record may omit the patient's address for a dangerous drug if the address is readily retrievable elsewhere in the pharmacy.","c":"22 TAC 291.34(b)(7)(A)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Adding or correcting strength or dosage form without contacting the prescriber","v":"Texas law does not address this. No Texas statute or TSBP rule authorizes a pharmacist to add or correct a missing drug strength or dosage form on his or her own judgment. Searched 22 TAC 291.34(b)(6)-(b)(9), 22 TAC 291.33(c), 22 TAC 315.8 and Tex. Occ. Code ch. 562.","c":"22 TAC 291.34(b)(6)-(b)(9)","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-A-13","facts":[{"k":"General emergency refill authority","v":"A pharmacist may exercise professional judgment and refill a prescription for a prescription drug other than a Schedule II controlled substance without the prescriber's authorization.","c":"Tex. Occ. Code 562.054(a)","st":"statute","ed":"2007-09-01","df":"no federal analogue"},{"k":"Day supply","v":"No more than a 72-hour supply.","c":"Tex. Occ. Code 562.054(a)(3); Tex. Health & Safety Code 481.074(l)(3)","st":"statute","ed":"2007-09-01","df":"no federal analogue"},{"k":"Conditions","v":"All must be met: failure to refill might interrupt the patient's therapeutic regimen or cause patient suffering; either a natural or manmade disaster prevents the pharmacist from contacting the practitioner, or the pharmacist cannot reach the practitioner after reasonable effort; the patient or the patient's agent is told at dispensing that the refill was made without authorization and that authorization is required for future refills; and the practitioner is informed of the emergency refill at the earliest reasonable time.","c":"Tex. Occ. Code 562.054(a)(1)-(5)","st":"statute","ed":"2007-09-01","df":"no federal analogue"},{"k":"Excluded drug classes","v":"Schedule II controlled substances are excluded. Schedules III, IV and V are expressly within the authority.","c":"Tex. Occ. Code 562.054(a); Tex. Health & Safety Code 481.074(l)","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"Insulin","v":"An emergency refill of insulin may be dispensed in a quantity up to a 30-day supply.","c":"22 TAC 291.34(b)(8)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"},{"k":"Schedules III-V - notify the prescriber","v":"If an emergency refill of a Schedule III, IV or V drug is dispensed, the pharmacy must inform the prescribing practitioner.","c":"22 TAC 315.7(c)","st":"regulation","ed":"2016-03-10","df":"no federal analogue"},{"k":"How often","v":"Texas law does not address this. Texas sets no limit on how frequently the emergency-refill authority may be used for the same patient or drug. Searched Tex. Occ. Code 562.054, Tex. Health & Safety Code 481.074(l) and 22 TAC 291.34(b)(8).","c":"Tex. Occ. Code 562.054","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-A-14","facts":[{"k":"Disaster emergency supply","v":"During a natural or manmade disaster a pharmacist may dispense up to a 30-DAY supply of a prescription drug other than a Schedule II controlled substance without the prescriber's authorization.","c":"Tex. Occ. Code 562.054(b); Tex. Health & Safety Code 481.074(l-1)","st":"statute","ed":"2007-09-01","df":"no federal analogue"},{"k":"Trigger conditions","v":"All four: failure to refill might interrupt the therapeutic regimen or cause patient suffering; the disaster prevents the pharmacist from contacting the practitioner; the Governor has declared a state of disaster under Chapter 418, Government Code; and the Board, acting through its executive director, has notified Texas pharmacies that a 30-day supply may be dispensed.","c":"Tex. Occ. Code 562.054(b)(1)-(4)","st":"statute","ed":"2007-09-01","df":"no federal analogue"},{"k":"Prescriber liability","v":"A prescriber is not liable for any act or omission of a pharmacist in dispensing under the disaster provision.","c":"Tex. Occ. Code 562.054(c); Tex. Health & Safety Code 481.074(l-2)","st":"statute","ed":"2007-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-A-15","facts":[{"k":"Follow-up deadline and FORM","v":"Within seven days after authorizing an emergency oral or telephone controlled substance prescription, the prescriber must have an electronic prescription delivered to the dispensing pharmacy. Texas therefore matches the federal seven-day clock but requires an electronic rather than a written follow-up.","c":"Tex. Health & Safety Code 481.074(c)","st":"statute","ed":"2019-09-01","df":"true"},{"k":"Pharmacist's annotation duty","v":"On receipt the pharmacist must annotate the prescription record with the original authorization and the date of that authorization.","c":"Tex. Health & Safety Code 481.074(c)","st":"statute","ed":"2019-09-01","df":"true"},{"k":"Pharmacy recordkeeping on an emergency Schedule II","v":"The oral or telephone prescription must be promptly reduced to writing with the information required for an official prescription; the pharmacy must keep that written record, note the emergency nature of the prescription, attach the original official prescription to it upon receipt from the practitioner, and retain both in the pharmacy records for two years from the date dispensed.","c":"22 TAC 315.7(a), (b), (d)","st":"regulation","ed":"2016-03-10","df":"true"},{"k":"What the pharmacist must do if it never arrives","v":"Texas law does not address this. Neither Tex. Health & Safety Code 481.074(c) nor 22 TAC 315.7 imposes a duty to notify the board, DPS or the nearest DEA office if the follow-up prescription is not delivered; 315.7(b)(3) only requires attachment 'upon receipt'. The federal duty under 21 CFR 1306.11(d)(4) to notify the nearest DEA office continues to apply independently.","c":"22 TAC 315.7(b)","st":"silent","ed":null,"df":"true"},{"k":"Who may transmit the emergency oral order","v":"In a board-defined emergency a practitioner described in Sec. 481.002(39)(A) may designate an agent in writing to telephone in the prescription; a different agent requires a new written designation, the practitioner must give a copy to a pharmacist on request, and the practitioner is personally responsible for the agent's actions.","c":"Tex. Health & Safety Code 481.074(b-1), (b-2)","st":"statute","ed":"2019-09-01","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-A-16","facts":[{"k":"Numeric refill cap for legend drugs","v":"None. Refills may be dispensed only as authorized by the prescriber; if the prescription shows no refills or all authorized refills have been used, the pharmacy must obtain the prescriber's authorization before dispensing more.","c":"22 TAC 291.34(b)(8)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"Time limit","v":"A prescription for a dangerous drug or a nonprescription drug may not be refilled more than ONE year after the date the prescription was originally issued.","c":"22 TAC 291.34(b)(8)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Refills follow the original instruction","v":"A properly authorized refill must be dispensed in accordance with the original dispensing instruction unless the prescriber or the prescriber's agent indicates otherwise.","c":"Tex. Occ. Code 562.007","st":"statute","ed":"2011-09-01","df":"no federal analogue"},{"k":"Accelerated refills","v":"A pharmacy may dispense up to a 90-day supply of a dangerous drug by accelerating authorized refills, subject to stated conditions; psychotropic drugs used to treat a mental or psychiatric condition are excluded.","c":"22 TAC 291.34(b)(10)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"},{"k":"Auto-refill programs","v":"An auto-refill program may not be used for Schedule II or Schedule III drugs; the patient must opt in and may withdraw at any time.","c":"22 TAC 291.34(b)(8)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-A-17","facts":[{"k":"Schedule V - Texas adds a numeric cap","v":"Texas applies a six-month / five-refill ceiling to Schedule III through V prescriptions. Federal law imposes NO numeric refill limit on Schedule V, so this is a genuine Texas addition. Note the two statutory subsections often cited for this are narrower than the rule: 481.074(h) reaches Schedule III-V only for prescriptions from a 481.002(39)(C) practitioner, and 481.074(i) reaches only Schedule V preparations with 200 mg or less of codeine or 100 mg or less of dihydrocodeine per 100 mL or 100 g. The general ceiling is in the board rule.","c":"22 TAC 315.3(b)(2)","st":"statute","ed":"2026-09-01","df":"true"},{"k":"Opioids for acute pain - zero refills","v":"A practitioner may not authorize ANY refill of an opioid prescribed for acute pain, in any schedule.","c":"Tex. Health & Safety Code 481.07636(b)(2); 22 TAC 315.3(f)(1)","st":"statute","ed":"2019-09-01","df":"true"},{"k":"APRN / PA controlled substance prescriptions","v":"The total supply including refills may not exceed 90 days, and each refill must be authorized only after consultation with the delegating physician, documented in the chart - a practical reduction below the federal five-refill allowance.","c":"Tex. Occ. Code 157.0511(b)","st":"statute","ed":"2013-11-01","df":"true"},{"k":"Therapeutic optometrist / optometric glaucoma specialist","v":"Schedule III-V prescriptions are limited to a single three-day supply with no refills.","c":"TSBP, Quick Reference: Prescriptions Which May be Dispensed in Texas","st":"board policy","ed":null,"df":"true"},{"k":"Nonprescription Schedule V containing codeine or dihydrocodeine","v":"May not be distributed without a prescription drug order in Texas, removing the federal OTC Schedule V pathway for those products.","c":"22 TAC 291.33(f)(3)","st":"regulation","ed":"2024-12-30","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-A-18","facts":[{"k":"Initial opioid day supply limit","v":"For the treatment of acute pain a practitioner may not issue an opioid prescription in an amount that exceeds a 10-day supply, and may not authorize a refill.","c":"Tex. Health & Safety Code 481.07636(b); 22 TAC 315.3(f)(1)","st":"statute","ed":"2019-09-01","df":"true"},{"k":"Definition of acute pain","v":"The normal, predicted physiological response to a stimulus such as trauma, disease or operative procedure; acute pain is time limited.","c":"Tex. Health & Safety Code 481.07636(a)","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"Exclusions built into the definition","v":"Acute pain does NOT include chronic pain, pain being treated as part of cancer care, pain being treated as part of hospice or other end-of-life care, or pain being treated as part of palliative care. Those prescriptions are outside the limit entirely.","c":"Tex. Health & Safety Code 481.07636(a)","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"Substance use disorder exemption","v":"The limit does not apply to an FDA-approved opioid prescribed to treat substance addiction when the practitioner issues it for that purpose.","c":"Tex. Health & Safety Code 481.07636(c); 22 TAC 315.3(f)(2)","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"Minors","v":"No separate rule. The statute draws no distinction between adults and minors; the same 10-day limit and the same exclusions apply.","c":"Tex. Health & Safety Code 481.07636","st":"silent","ed":null,"df":"no federal analogue"},{"k":"Effect on the dispenser","v":"A dispenser is not subject to criminal, civil or administrative penalties for dispensing, or for refusing to dispense, under a prescription that exceeds the limit.","c":"Tex. Health & Safety Code 481.07636(d); 22 TAC 315.3(f)(3)","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"Interaction with multiple Schedule II prescriptions","v":"The 10-day acute-pain limit overrides the 90-day multiple-prescription allowance for opioids used to treat acute pain.","c":"22 TAC 315.3(a)(3), (f)","st":"regulation","ed":"2021-06-09","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-A-19","facts":[{"k":"MME threshold triggering a pharmacist duty","v":"Texas law does not address this. No Texas statute or TSBP rule defines a morphine milligram equivalent threshold that triggers any pharmacist duty. Looked at Tex. Health & Safety Code 481.07636 (opioid limits), 481.0764 and 481.0765 (PMP duties), 22 TAC 315.3 and 315.15, and searched TSBP guidance and newsletters. Texas regulates acute-pain opioids by DAY supply (10 days), not by MME.","c":"Tex. Health & Safety Code 481.07636; 22 TAC 315.15","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-A-20","facts":[{"k":"State registration or special authority to dispense buprenorphine for OUD","v":"Texas law does not address this. No Texas statute or TSBP rule imposing a state registration, quantity limit or special dispensing condition for buprenorphine used to treat opioid use disorder was located. Searched 22 TAC ch. 291 and ch. 315, Tex. Health & Safety Code ch. 481 (including 481.074, 481.07636, 481.0764) and TSBP practice resources.","c":"22 TAC ch. 315","st":"silent","ed":null,"df":"no federal analogue"},{"k":"What does apply","v":"Buprenorphine is a Schedule III controlled substance, so the ordinary Texas rules apply: electronic prescribing mandate (481.074(b)), six-month / five-refill ceiling (481.074(g)), and the mandatory PMP check before dispensing an opioid (481.0764(a); 22 TAC 315.15(a)).","c":"Tex. Health & Safety Code 481.074(b), (g); 481.0764(a); 22 TAC 315.15(a)","st":"statute","ed":"2021-01-01","df":"true"},{"k":"Acute-pain limit does not reach it","v":"The 10-day acute-pain opioid limit does not apply to an FDA-approved opioid prescribed to treat substance addiction.","c":"Tex. Health & Safety Code 481.07636(c)","st":"statute","ed":"2019-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"high"},{"id":"D2-A-21","facts":[{"k":"Who may issue a medication order","v":"Drugs may be administered to a patient of an institutional facility only on the order of a practitioner. No change in the order may be made without practitioner approval, except where the practitioner has authorized pharmacist product interchange under the facility's formulary provisions.","c":"22 TAC 291.74(f)(5); 291.74(f)(2)(C)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"Source document for distribution","v":"Drugs may be distributed only from the original written order or a direct copy of the practitioner's medication order.","c":"22 TAC 291.74(f)(5)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"Who may receive a verbal or telephone order","v":"A pharmacist. Reducing verbal medication orders to writing, manually or electronically, and receiving and evaluating drug orders are assigned to pharmacists.","c":"22 TAC 291.73(d)(2)(B)","st":"regulation","ed":"2022-12-06","df":"no federal analogue"},{"k":"Technicians and trainees may not take oral orders","v":"A pharmacy technician or pharmacy technician trainee may not receive oral medication orders.","c":"22 TAC 291.74(f)(5); 22 TAC 291.73(e)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"Pharmacist review before the first dose","v":"Where a pharmacist is on duty, the drug regimen review must be prospective - done before the drug is distributed or administered - except for an emergency order. Any question about an order must be resolved with the prescriber and the discussion documented.","c":"22 TAC 291.74(g)(1)(B)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"Automated supply systems","v":"When a pharmacist is on duty a pharmacist must approve each original or new medication order before the drug is withdrawn from an automated medication supply system, except for an emergency order.","c":"22 TAC 291.74(j)(2)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-A-22","facts":[{"k":"Who may obtain drugs when no pharmacist is on duty","v":"Only a designated licensed nurse or a practitioner may remove drugs from the pharmacy, and only in quantities sufficient for the patient's immediate therapeutic needs. The withdrawal must be recorded; the original written order or a direct copy may serve as the record if it contains the required information.","c":"22 TAC 291.74(e)(1)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"Retrospective verification - facility with a FULL-TIME pharmacist","v":"A pharmacist must verify the withdrawal and complete the drug regimen review within 72 hours.","c":"22 TAC 291.74(e)(1)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"Retrospective verification - facility with a PART-TIME or CONSULTANT pharmacist","v":"The pharmacist must verify withdrawals within seven days. The drug regimen review is due within seven days if the average daily inpatient census is ten or fewer, or within 96 hours if the census exceeds ten. The census is calculated annually from the Medicare Cost Report, averaged over three years.","c":"22 TAC 291.74(e)(1)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"Floor stock","v":"Floor-stock drugs must remain in original or prepackaged containers; a licensed nurse or practitioner removes them and a pharmacist must verify the withdrawal within seven days.","c":"22 TAC 291.74(e)(1)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"Automated systems with no pharmacist on duty","v":"Pharmacist approval of the order is retrospective: within 72 hours at a facility with a full-time pharmacist, or within seven days at a facility with a part-time or consultant pharmacist.","c":"22 TAC 291.74(j)(2)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"After-hours security","v":"The pharmacy must be enclosed and lockable to prevent unauthorized access; only individuals the pharmacist-in-charge authorizes may enter; Schedule II substances and other drugs needing extra security must be in locked storage.","c":"22 TAC 291.74(b)(2)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"Emergency room and radiology","v":"When no pharmacist is on duty these departments may supply only listed drugs in prepackaged quantities under a system supervised by the pharmacist-in-charge or a designated pharmacist; records must be verified at least every seven days.","c":"22 TAC 291.74(h)(2), (i)(2)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"Remote review","v":"Drug regimen review for a Class A pharmacy may be performed remotely by a Texas-licensed pharmacist employee with privacy controls, or by a Class E pharmacist under a written agreement.","c":"22 TAC 291.33(c)(2)(A)","st":"regulation","ed":"2024-12-30","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-A-23","facts":[{"k":"Multiple Schedule II prescriptions permitted","v":"Yes. A practitioner may issue multiple prescriptions authorizing a patient to receive a total of up to a 90-DAY supply of a Schedule II controlled substance.","c":"Tex. Health & Safety Code 481.074(d-1); 22 TAC 315.3(a)(3)","st":"statute","ed":"2019-09-01","df":"false"},{"k":"Conditions","v":"Each prescription must be issued for a legitimate medical purpose in the usual course of practice; the practitioner must conclude that the arrangement does not create an undue risk of diversion or abuse; and issuance must comply with other state and federal law.","c":"Tex. Health & Safety Code 481.074(d-1)","st":"statute","ed":"2019-09-01","df":"false"},{"k":"Earliest-fill-date notation","v":"Each prescription must state the earliest date on which a pharmacy may fill it. The board rule clarifies that the notation is required on each prescription except the first, where that one is intended to be filled immediately. The earliest fill date is also an element required on the face of the prescription.","c":"22 TAC 315.3(a)(3); Tex. Health & Safety Code 481.074(k)(2-a); 481.075(e)(1)(G)","st":"regulation","ed":"2021-06-09","df":"true"},{"k":"Texas-added dispensing window","v":"Each prescription in the set must still be dispensed within 30 days, measured from the earliest date on which a pharmacy may dispense it. Federal law imposes no such window.","c":"22 TAC 315.3(a)(4)","st":"regulation","ed":"2021-06-09","df":"true"},{"k":"Opioid acute-pain override","v":"The 90-day multiple-prescription allowance is subject to the 10-day acute-pain opioid limit, which prevails for opioids prescribed for acute pain.","c":"22 TAC 315.3(a)(3), (f)","st":"regulation","ed":"2021-06-09","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-A-24","facts":[{"k":"Who may prescribe for animals","v":"A person licensed by the State Board of Veterinary Medical Examiners to prescribe and administer dangerous drugs is a 'practitioner'. Veterinarians licensed in another state, or in Canada or Mexico, also fall within the definition on the same terms as other out-of-state and foreign practitioners.","c":"Tex. Health & Safety Code 483.001(12)(A)(i), (12)(B), (12)(C)","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"Prescription content for an animal","v":"The prescription must state the species of the animal; for a controlled substance it must give the species plus the owner's name and address in place of patient name, address and date of birth.","c":"Tex. Health & Safety Code 483.001(13)(C); 481.074(k)(3)","st":"statute","ed":"2019-09-01","df":"true"},{"k":"Animal-patient labeling","v":"The dispensing container label must show the species of the animal and the owner's name in place of the patient's name, together with the other required label elements.","c":"Tex. Occ. Code 562.006(b)(4); 22 TAC 291.33(c)(7)(A); Tex. Health & Safety Code 483.042(a)(1)","st":"statute","ed":"2015-09-01","df":"true"},{"k":"Food-production animals","v":"Labeling requirements do not apply to a dangerous drug for food-production animals in an agricultural operation if federal requirements are met and a licensed veterinarian has issued a written medical directive or treatment guideline.","c":"Tex. Health & Safety Code 483.042(f)","st":"statute","ed":"2001-09-01","df":"true"},{"k":"Sale to a veterinarian for office use","v":"The general delivery-and-labeling offense does not apply to delivery of a dangerous drug to persons listed in Sec. 483.041(c) for use in the usual course of business or practice or in the performance of official duties, which is the pathway for supplying a practitioner's office stock.","c":"Tex. Health & Safety Code 483.042(b) (referring to 483.041(c))","st":"statute","ed":"2001-09-01","df":"no federal analogue"},{"k":"Veterinarians and the e-prescribing mandate","v":"Exempt - a prescription issued by a veterinarian need not be issued electronically.","c":"Tex. Health & Safety Code 481.0755(a)(1)","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"Veterinarians and the PMP","v":"Veterinarians are excluded from the mandatory PMP check, and the pharmacist's own mandatory check does not apply where the prescriber is a veterinarian. A veterinarian may access PMP data only for prescriptions dispensed for an owner's animals and may not consider the owner's personal prescription history.","c":"Tex. Health & Safety Code 481.0764(a), (c); 22 TAC 315.15(b)","st":"statute","ed":"2020-03-01","df":"no federal analogue"},{"k":"Jurisdiction","v":"The prescriber is regulated by the State Board of Veterinary Medical Examiners; the pharmacy and the pharmacist remain under TSBP, and the drugs under the Dangerous Drug Act and the Texas Controlled Substances Act.","c":"Tex. Health & Safety Code 483.001(12)(A)(i)","st":"statute","ed":"2019-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-01","facts":[{"k":"Statutory label elements","v":"Identification of the actual drug or biological product dispensed, by brand name, or if none, by generic or biological product name plus strength and the name of the manufacturer or distributor; the pharmacy's name, address and telephone number; the date dispensed; the prescribing practitioner's name; the patient's name (or the animal's species and the owner's name); directions for use; the quantity dispensed; a beyond-use date if the drug is in a container other than the manufacturer's original; and any other information the board requires by rule.","c":"Tex. Occ. Code 562.006(a), (b)","st":"statute","ed":"2015-09-01","df":"true"},{"k":"Board-rule label elements (Class A)","v":"Adds the prescription identification number, the dispensing pharmacist's initials or identification code, ancillary instructions and warnings, the federal transfer-caution statement for Schedule II-IV drugs, the substitution statement where applicable, the drug name and strength, a beyond-use date for a non-original container (one year from dispensing or the manufacturer's expiration date, whichever is earlier), and the statement 'Do not flush unused medications or pour down a sink or drain' on the label or in the accompanying information.","c":"22 TAC 291.33(c)(7)(A)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Substitution statement","v":"If a different drug or biological product is dispensed than the one prescribed, the container must bear 'Substituted for brand prescribed' or 'Substituted for [brand name]'.","c":"Tex. Occ. Code 562.006(e); 22 TAC 291.33(c)(7)(A)","st":"statute","ed":"2015-09-01","df":"true"},{"k":"Medication disposal statement","v":"The statement 'Do not flush unused medications or pour down a sink or drain' must appear either on the dispensing container label or in the written information required by Sec. 562.0061.","c":"Tex. Occ. Code 562.0062","st":"statute","ed":"2009-09-01","df":"true"},{"k":"Elements exceeding federal requirements","v":"Federal law (21 CFR 201.100) requires only the dispenser's name and address, serial number, date, prescriber name, patient name and directions. Texas adds: pharmacy telephone number, quantity dispensed, drug name and strength, the dispensing pharmacist's initials or identification code, a beyond-use date, ancillary warnings, the substitution statement and the do-not-flush statement.","c":"Tex. Occ. Code 562.006; 22 TAC 291.33(c)(7)(A)","st":"statute","ed":"2015-09-01","df":"true"},{"k":"Release from prison or jail","v":"The Sec. 562.006(b) label elements do not apply to a prescription given to a person on release from prison or jail if it is for no more than a 10-day supply.","c":"Tex. Occ. Code 562.006(d)","st":"statute","ed":"2015-09-01","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-02","facts":[{"k":"Drug's physical description on an outpatient label","v":"Not required. Neither Tex. Occ. Code 562.006 nor 22 TAC 291.33(c)(7)(A) requires a physical description on an ordinary dispensing label.","c":"Tex. Occ. Code 562.006; 22 TAC 291.33(c)(7)(A)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"Physical description on a patient med-pak","v":"Required. A customised patient medication package label must give the name, strength, physical description or identification, and total quantity of each drug product in the package.","c":"22 TAC 291.33(h)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Prescriber's telephone number","v":"Not required on the label - only the prescriber's name. The prescriber's telephone number is required on the face of the prescription, not the container.","c":"Tex. Occ. Code 562.006(b)(3); Tex. Health & Safety Code 483.001(13)(G); 481.074(k)(7)","st":"statute","ed":"2015-09-01","df":"true"},{"k":"Pharmacist's initials","v":"Required. The dispensing pharmacist's initials or identification code must appear on the label.","c":"22 TAC 291.33(c)(7)(A)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Purpose-of-use statement on the label","v":"Not required on the label. The 'intended use' is required on the prescription unless the practitioner determines disclosure is not in the patient's best interest.","c":"Tex. Health & Safety Code 483.001(13)(F); 481.074(k)(6)","st":"statute","ed":"2019-09-01","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-03","facts":[{"k":"Readability standard","v":"The board must adopt rules requiring prescription labels to use plain language and a font size that consumers can easily read.","c":"Tex. Occ. Code 562.006(f)","st":"statute","ed":"2015-09-01","df":"true"},{"k":"Type-size rule","v":"If the label uses type smaller than ten-point Times Roman, the pharmacy must supply written information with the prescription. Written information reinforcing counseling must itself be in plain language and in a font no smaller than ten-point Times Roman.","c":"22 TAC 291.33(c)(7)(B); 291.33(c)(1)(B)(v)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Spanish-language contact information","v":"For a prescription delivered to a patient's residence or another location, the written information that accompanies it must include bilingual (English and Spanish) language telling the patient how to contact a pharmacist.","c":"22 TAC 291.33(c)(1)(F)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Large-print, Braille or full multilingual labels on request","v":"Texas law does not address this. No Texas statute or TSBP rule requires a pharmacy to provide a large-print, Braille, audio or translated label on patient request. Searched Tex. Occ. Code 562.006 and 562.0061 and 22 TAC 291.33(c)(1) and (c)(7). The only accessibility-adjacent provisions located are the ten-point type rule, the bilingual contact-information requirement for delivered prescriptions, and the narrow allowance for reusing an audio-labeled container.","c":"22 TAC 291.33(c)(7)","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-B-04","facts":[{"k":"Institutional / inpatient labeling","v":"The Dangerous Drug Act labeling requirements do not apply to drugs dispensed for institutionalised patients; the board must adopt rules for labeling those drugs. Institutional pharmacies are also exempt from the Tex. Occ. Code 562.006 labeling and 562.009 patient-notification requirements for drugs distributed under medication orders.","c":"Tex. Health & Safety Code 483.042(e); 22 TAC 309.4(d)","st":"statute","ed":"2015-12-06","df":"true"},{"k":"Outpatient label exemption for institutionalised patients","v":"22 TAC 291.33(c)(7)(D) exempts certain institutionalised patients from the Class A outpatient label requirements where stated conditions are met.","c":"22 TAC 291.33(c)(7)(D)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Unit-dose / prepackaged labeling","v":"Prepackaging may be done by a pharmacist or by personnel under a pharmacist's supervision, and the prepackaged label and associated records must meet the rule's requirements.","c":"22 TAC 291.33(g)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Patient med-pak label","v":"Must show the patient's name; a unique identifier for the med-pak and a separate unique identifier for each prescription in it; name, strength, physical description or identification and total quantity of each drug; directions for use and cautionary statements for each product; an alcohol warning if applicable; storage instructions; the prescriber's name for each product; pharmacy name, address and telephone number; the dispensing pharmacist's initials or identification code (may be omitted if recorded in the data system); a beyond-use date; and the do-not-flush statement. If intact containers can be removed, each must be separately labeled with its drug product.","c":"22 TAC 291.33(h)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Long-term care and home-infusion specific labeling","v":"Texas law does not address this. As a distinct label list. Texas regulates these through the Class C institutional rules, the med-pak rule and the compounding rules rather than a separate LTC or home-infusion label provision. 22 TAC 291.133 (sterile compounding) was not read.","c":"22 TAC 291.74; 22 TAC 291.33(h)","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-B-05","facts":[{"k":"Controlled substance transfer caution","v":"The label of a Schedule II, III or IV drug must bear the federal transfer-caution statement.","c":"22 TAC 291.33(c)(7)(A)","st":"regulation","ed":"2024-12-30","df":"false"},{"k":"Medication disposal statement - exact wording","v":"'Do not flush unused medications or pour down a sink or drain' - on the label or in the accompanying written information.","c":"Tex. Occ. Code 562.0062; 22 TAC 291.33(c)(7)(A)","st":"statute","ed":"2009-09-01","df":"true"},{"k":"Schedule II safe-disposal notice","v":"A person dispensing a Schedule II controlled substance must give the patient written notice on safe disposal, listing locations where Schedule II drugs may be disposed of or directing the patient to a board-specified searchable website. The notice may be electronic if the patient requests it and the request is documented. No notice is required if the drug is dispensed at a location authorized to take back and regularly accepting such drugs, or if the dispenser provides at no cost, at the time of dispensing, a mail-in disposal pouch or a means to render unused drugs unusable or unretrievable.","c":"Tex. Health & Safety Code 481.075(n), (o); 22 TAC 315.3(a)(5)","st":"statute","ed":"2021-06-09","df":"true"},{"k":"Opioid-specific warning label wording","v":"Texas law does not address this. No Texas statute or rule prescribes opioid-specific warning-label wording (for example a risk-of-addiction or respiratory-depression caution). Searched Tex. Occ. Code 562.006, 562.0062, 22 TAC 291.33(c)(7) and 22 TAC 315.3. The only opioid-specific written communication Texas requires is the Schedule II safe-disposal notice.","c":"22 TAC 291.33(c)(7)(A)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"Ancillary warnings generally","v":"The label must bear ancillary instructions and warnings; the rule does not prescribe their wording.","c":"22 TAC 291.33(c)(7)(A)","st":"regulation","ed":"2024-12-30","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-B-06","facts":[{"k":"Written prescription - the only valid method","v":"The prescriber prohibits substitution by handwriting 'brand necessary' or 'brand medically necessary' across the face of the prescription. Handwriting is the only valid method.","c":"22 TAC 309.3(c)(2)(A), (c)(2)(D)","st":"regulation","ed":"2020-12-10","df":"no federal analogue"},{"k":"What does NOT work","v":"The directive may not be preprinted, rubber-stamped or otherwise reproduced on the form. Two-line forms, check boxes and other 'substitution instructions' notations do not prohibit substitution, so the pharmacist may substitute.","c":"22 TAC 309.3(c)(2)(C), (c)(2)(D)","st":"regulation","ed":"2020-12-10","df":"no federal analogue"},{"k":"Prescription form reminder statement","v":"A written Texas prescription may use a single-signature-line form bearing a reminder statement beginning 'A generically equivalent drug product may be dispensed unless...' and ending with the prescriber handwriting 'Brand Necessary' or 'Brand Medically Necessary'. A pharmacist may still dispense an order not on that form.","c":"22 TAC 309.3(b)(1), (b)(2)","st":"regulation","ed":"2020-12-10","df":"no federal analogue"},{"k":"Oral prescriptions","v":"The prescriber or agent must use the 'brand necessary' wording and the substitution instructions must be noted on the file copy. If brand necessity is not clearly indicated, the pharmacist may substitute.","c":"22 TAC 309.3(c)(3)(A), (c)(3)(B)","st":"regulation","ed":"2020-12-10","df":"no federal analogue"},{"k":"Electronic prescriptions","v":"The prescriber must clearly indicate substitution instructions in the electronic order; if brand necessity is not clearly indicated the pharmacist may substitute. The statute requires the board to exempt electronically transmitted prescriptions from the handwriting-based dispensing directive.","c":"22 TAC 309.3(c)(4); Tex. Occ. Code 562.015(b)","st":"regulation","ed":"2020-12-10","df":"no federal analogue"},{"k":"Medicaid oral prescriptions","v":"For a Medicaid-reimbursed oral order the prescriber must orally state that the brand is medically necessary and must mail or fax a compliant written prescription to the pharmacy within 30 days.","c":"22 TAC 309.3(c)(3)(C)","st":"regulation","ed":"2020-12-10","df":"true"},{"k":"Multiple orders on one form","v":"If one form carries several orders, the prescriber must clearly indicate which ones the directive covers; if not, the pharmacist may substitute on all of them.","c":"22 TAC 309.3(b)(4)","st":"regulation","ed":"2020-12-10","df":"no federal analogue"},{"k":"Brand with no generic available","v":"Where no generic exists the pharmacist must dispense the brand; when a generic or interchangeable biological later becomes available the pharmacist may substitute unless the prescriber specified on the initial prescription that the brand is medically necessary. Overriding a prohibition requires verbal or written prescriber authorization, noted on the original order, with patient notification under 309.4.","c":"22 TAC 309.3(c)(1)(A), (c)(1)(B)","st":"regulation","ed":"2020-12-10","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-07","facts":[{"k":"Patient may refuse","v":"Yes. A pharmacist may dispense a generically equivalent drug or interchangeable biological product only if the patient does not refuse the substitution.","c":"22 TAC 309.3(a)(2)","st":"regulation","ed":"2020-12-10","df":"no federal analogue"},{"k":"Duty to offer the choice","v":"Before delivering the prescription the pharmacist, personally or through an agent or employee, must tell the patient or the patient's agent that a less expensive equivalent is available for the brand prescribed, and must ask the patient or agent to choose between the equivalent and the brand prescribed.","c":"Tex. Occ. Code 562.009(a)(1), (a)(2); 22 TAC 309.4(a)(1)","st":"statute","ed":"2015-09-01","df":"true"},{"k":"Copayment rule","v":"If the drug's price is lower than the patient's copayment, the pharmacist must offer the patient the option of paying that lower price instead of the copayment.","c":"22 TAC 309.4(a)(2)","st":"regulation","ed":"2015-12-06","df":"true"},{"k":"Exceptions to the notification duty","v":"Does not apply to a refill where the pharmacy already complied for the same patient or agent, or where the prescriber or the prescriber's agent tells the pharmacy that the prescriber informed the patient of the cheaper option and the patient chose one of them.","c":"Tex. Occ. Code 562.009(b); 22 TAC 309.4(b)","st":"statute","ed":"2015-09-01","df":"true"},{"k":"Mail order","v":"A mail-order pharmacy complies by including clear and conspicuous language on the patient's order form stating that a less expensive equivalent may be available and allowing the patient to indicate a choice. If the patient indicates no choice, the pharmacy may dispense the generically equivalent product.","c":"Tex. Occ. Code 562.009(c), (d); 22 TAC 309.4(c)","st":"statute","ed":"2015-09-01","df":"true"},{"k":"Public payer - Medicaid","v":"For a Medicaid-reimbursed oral prescription the prescriber must orally state brand medical necessity and send a compliant written prescription within 30 days, consistent with 42 CFR 447.331. For Medicaid-reimbursed electronic prescriptions the prescriber must comply with state and federal law.","c":"22 TAC 309.3(c)(3)(C), (c)(4)(C)","st":"regulation","ed":"2020-12-10","df":"true"},{"k":"Institutional pharmacies","v":"Exempt from the Sec. 562.006 labeling and Sec. 562.009 patient-notification requirements for drugs distributed under medication orders.","c":"22 TAC 309.4(d)","st":"regulation","ed":"2015-12-06","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-08","facts":[{"k":"Savings must reach the patient","v":"Yes, structurally. A pharmacist may select a generically equivalent drug or interchangeable biological product only if it costs the patient less than the prescribed drug.","c":"Tex. Occ. Code 562.011(a); 22 TAC 309.3(a)(1)","st":"statute","ed":"2015-09-01","df":"true"},{"k":"Cap on the professional fee","v":"A pharmacist may not charge a professional fee for the substituted product that is higher than the fee the pharmacist customarily charges for dispensing the prescribed brand-name product.","c":"Tex. Occ. Code 562.011(b)","st":"statute","ed":"2015-09-01","df":"true"},{"k":"Copayment option","v":"Where the drug price is lower than the patient's copayment the pharmacist must offer the patient the lower price.","c":"22 TAC 309.4(a)(2)","st":"regulation","ed":"2015-12-06","df":"true"},{"k":"How the amount is determined","v":"Texas law does not address this. Texas sets no formula, percentage or method for calculating the savings to be passed through; the rule is simply that the substituted product must cost the patient less and the professional fee may not exceed the customary brand fee.","c":"Tex. Occ. Code 562.011","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-09","facts":[{"k":"Interchangeable biologicals may be substituted","v":"Yes. A pharmacist may dispense an interchangeable biological product on the same footing as a generically equivalent drug, subject to the same three conditions: it costs the patient less, the patient does not refuse, and the prescriber has not issued a compliant dispensing directive.","c":"Tex. Occ. Code 562.008; 22 TAC 309.3(a); 22 TAC 291.33(c)(3)","st":"statute","ed":"2015-09-01","df":"no federal analogue"},{"k":"Prescriber notification deadline","v":"Within three business days after dispensing a biological product, the dispensing pharmacist or the pharmacist's designee must communicate to the prescriber the specific product dispensed, identified by name and by manufacturer or national drug code number.","c":"Tex. Occ. Code 562.0051(a)","st":"statute","ed":"2019-05-07","df":"no federal analogue"},{"k":"Permitted methods","v":"By entry in an interoperable electronic medical records system, electronic prescribing technology, a pharmacy benefit management system or a pharmacy record that the pharmacist reasonably concludes the prescriber can access electronically (the record may include claims-payment information); otherwise by fax, telephone, electronic transmission or other prevailing means.","c":"Tex. Occ. Code 562.0051(b)","st":"statute","ed":"2019-05-07","df":"no federal analogue"},{"k":"Exceptions to the notification duty","v":"No communication is required if there is no FDA-approved interchangeable biological product for the prescribed product, or if the prescription is a refill unchanged from the product dispensed on the first fill.","c":"Tex. Occ. Code 562.0051(a)","st":"statute","ed":"2019-05-07","df":"no federal analogue"},{"k":"Board list","v":"The board maintains a list of approved interchangeable biological products.","c":"Tex. Occ. Code 562.016","st":"statute","ed":"2015-09-01","df":"no federal analogue"},{"k":"Label statement","v":"The substitution statement 'Substituted for brand prescribed' or 'Substituted for [brand name]' applies to biological products as it does to drugs.","c":"Tex. Occ. Code 562.006(e)","st":"statute","ed":"2015-09-01","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-B-10","facts":[{"k":"Therapeutic interchange outside an institution","v":"Not permitted unilaterally. A switch to a drug with a similar therapeutic response may not be made without prior approval of the prescribing practitioner. Generic substitution is expressly excluded from this paragraph.","c":"22 TAC 291.33(c)(5)","st":"regulation","ed":"2024-12-30","df":"no federal analogue"},{"k":"Patient notification on interchange","v":"The patient must be notified before or upon delivery, with a description of the change, the reason for it, a contact, and instructions for returning the product.","c":"22 TAC 291.33(c)(5)","st":"regulation","ed":"2024-12-30","df":"no federal analogue"},{"k":"Dosage form substitution","v":"Permitted under Tex. Occ. Code 562.012 only if the patient consents, the substituted product contains the identical amount of active ingredient, it is not an enteric-coated or time-release product, and the change does not alter desired clinical outcomes. Substituting a pharmacist-compounded product requires prior contact with and permission from the practitioner.","c":"Tex. Occ. Code 562.012; 22 TAC 291.33(c)(4)","st":"statute","ed":"2024-12-30","df":"no federal analogue"},{"k":"Institutional authority","v":"Inside a Class C institutional pharmacy, product interchange may be made without separate practitioner approval where the practitioner has authorized it under the facility's formulary provisions.","c":"22 TAC 291.74(f)(2)(C), (f)(5)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"Drug therapy management","v":"A pharmacist may manage drug therapy, including modifications, only as delegated by a physician under a written protocol.","c":"22 TAC 291.33(c)(2)(B); 22 TAC 295.13","st":"regulation","ed":"2024-12-30","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-11","facts":[{"k":"Record of the product actually dispensed","v":"When a substitution is made the pharmacy must record the brand name or the name of the manufacturer of the product dispensed.","c":"22 TAC 291.34(b)(7)(B)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Record of prescriber authorization to override a directive","v":"Where the prescriber has prohibited substitution and later authorizes it verbally or in writing, the pharmacist must note that authorization on the original prescription order.","c":"22 TAC 309.3(c)(1)(B)","st":"regulation","ed":"2020-12-10","df":"no federal analogue"},{"k":"Out-of-state board documentation","v":"A pharmacist relying on written documentation from another state's board that substitution is permitted must note on the original order that the documentation is on file, and the documentation must be updated yearly.","c":"22 TAC 309.3(c)(5)(B)(ii)","st":"regulation","ed":"2020-12-10","df":"no federal analogue"},{"k":"Record of therapeutic interchange notification","v":"Documentation of the patient notification required on a therapeutic interchange is itself required.","c":"22 TAC 291.33(c)(5)","st":"regulation","ed":"2024-12-30","df":"no federal analogue"},{"k":"Retention period","v":"Prescription records, including substitution entries, must remain legible and be kept for TWO years from the date of filling or the date of the last refill, and be produced on site or within 72 hours of a board agent's request.","c":"22 TAC 291.34(a)(1)(A), (b)(6)(C), (a)(1)(B)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Dedicated substitution records rule (SETTLED)","v":"22 TAC 309.6 is substantive and adds a duty not captured elsewhere. On dispensing a generically equivalent drug or interchangeable biological product, the pharmacy must note on the original prescription or in the data processing system: (1) any substitution instructions given orally by the practitioner or the practitioner's agent, OR A notation that NO substitution instructions were given \u2014 an affirmative record of the negative, which is the most testable part; and (2) the name and strength of the product actually dispensed, either the brand name and strength, or the generic/interchangeable name, strength and manufacturer or distributor (an abbreviation suffices if it identifies them). On a refill with a product from a different manufacturer or distributor, the same information must be recorded again for that refill. Patient medication records may carry it. The NDC may be added at the pharmacist's discretion but does NOT satisfy these requirements.","c":"22 TAC 309.6(a)-(d)","st":"regulation","ed":"2026-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-12","facts":[{"k":"Who must be counseled","v":"ALL patients, not Medicaid patients only. The pharmacist must counsel new and existing patients.","c":"22 TAC 291.33(c)(1)(B)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"New prescriptions","v":"Counseling is required with each NEW prescription drug order. A prescription is 'new' if the same drug has not been dispensed to that patient in the same dosage and strength within the previous year.","c":"22 TAC 291.33(c)(1)(B)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Refills","v":"Counseling is required on any prescription, including a refill, at the request of the patient or the patient's agent. Routine counseling on every refill is not separately mandated.","c":"22 TAC 291.33(c)(1)(B)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Relationship to the OBRA floor","v":"Texas exceeds the OBRA '90 Medicaid floor in two ways: it reaches all patients regardless of payer, and it imposes a duty to counsel rather than merely a duty to offer counseling.","c":"22 TAC 291.33(c)(1)(B), (c)(1)(C)","st":"regulation","ed":"2024-12-30","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-13","facts":[{"k":"Only a pharmacist may counsel","v":"Only a pharmacist may verbally provide drug information to a patient or a patient's agent. Counseling may not be delegated to a pharmacy technician.","c":"22 TAC 291.33(c)(1)(C)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"No screening by non-pharmacists","v":"Non-pharmacist staff and the pharmacy's computer system may not screen or otherwise limit the patient's interaction with a pharmacist.","c":"22 TAC 291.33(c)(1)(C)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Pharmacist must be present for pharmacy delivery","v":"A prescription may not be delivered to a patient at the pharmacy unless a pharmacist is present, subject to the temporary-absence provisions.","c":"22 TAC 291.33(c)(1)(E), (b)(3)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Delegation of the OFFER","v":"Not applicable in the Texas model. Because Texas requires counseling rather than an offer, and reserves verbal drug information to pharmacists, there is no delegable 'offer to counsel' step.","c":"22 TAC 291.33(c)(1)(B), (c)(1)(C)","st":"regulation","ed":"2024-12-30","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-14","facts":[{"k":"Documenting that counseling occurred","v":"The counseling pharmacist's initials or identification code must be recorded - on the hard-copy prescription, in the data processing system, in an electronic logbook, or in a hard-copy log.","c":"22 TAC 291.33(c)(1)(B)(iv)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Documenting refusal","v":"Nothing requires a pharmacist to counsel where the patient or the patient's agent refuses; in that case the pharmacist must document the refusal.","c":"22 TAC 291.33(c)(1)(D)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Form of documentation","v":"Four permitted forms for the counseling record: on the hard-copy prescription, in the data processing system, in an electronic logbook, or in a hard-copy log. The rule does not prescribe a form for the refusal record beyond requiring documentation.","c":"22 TAC 291.33(c)(1)(B)(iv), (c)(1)(D)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Retention","v":"Two years, as with other required pharmacy records, produced on site or within 72 hours of a board agent's request.","c":"22 TAC 291.34(a)(1)(A), (a)(1)(B)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Documenting a request for hard-copy written information","v":"Until February 28, 2026 the pharmacy had to document a patient's request for a hard copy of the written information. Effective March 1, 2026 that documentation requirement is removed and the written information may be provided electronically unless a hard copy is requested.","c":"22 TAC 291.33(c)(1) (amended, Texas Register Feb. 20, 2026 adoption)","st":"regulation","ed":"2026-03-01","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"high"},{"id":"D2-B-15","facts":[{"k":"Content element 1","v":"Name and description of the drug or device","c":"22 TAC 291.33(c)(1)(A)(i)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Content element 2","v":"Dosage form, dosage, route of administration and duration of therapy","c":"22 TAC 291.33(c)(1)(A)(ii)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Content element 3","v":"Special directions and precautions for preparation, administration and use","c":"22 TAC 291.33(c)(1)(A)(iii)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Content element 4","v":"Common severe side effects, adverse effects, interactions and contraindications, including how to avoid them and what to do if they occur","c":"22 TAC 291.33(c)(1)(A)(iv)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Content element 5","v":"Techniques for self-monitoring of drug therapy","c":"22 TAC 291.33(c)(1)(A)(v)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Content element 6","v":"Proper storage","c":"22 TAC 291.33(c)(1)(A)(vi)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Content element 7","v":"Refill information","c":"22 TAC 291.33(c)(1)(A)(vii)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Content element 8","v":"Action to take in the event of a missed dose","c":"22 TAC 291.33(c)(1)(A)(viii)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"List is illustrative","v":"The rule requires the pharmacist to communicate information the pharmacist deems significant 'such as' these eight items; professional judgment governs which apply.","c":"22 TAC 291.33(c)(1)(A)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"May written material substitute","v":"No. Counseling must be oral unless the patient or the patient's agent is not at the pharmacy or a specific communication barrier prevents oral communication. Written information must accompany, not replace, the counseling; from March 1, 2026 that written information may be supplied electronically unless the patient requests a hard copy.","c":"22 TAC 291.33(c)(1)(B), (c)(1)(B)(v) (as amended eff. 2026-03-01)","st":"regulation","ed":"2026-03-01","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"high"},{"id":"D2-B-16","facts":[{"k":"Delivery at the pharmacy","v":"A prescription may not be delivered to a patient at the pharmacy unless a pharmacist is present, subject to the temporary-absence provisions - which governs drive-through and will-call handoffs.","c":"22 TAC 291.33(c)(1)(E), (b)(3)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Mailed or delivered prescriptions","v":"Where a prescription is delivered to the patient's residence or another location, written information must accompany it, it must include bilingual (English and Spanish) language telling the patient how to contact a pharmacist, and the shipping must be temperature-appropriate.","c":"22 TAC 291.33(c)(1)(F)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Oral counseling when the patient is absent","v":"The oral-counseling requirement is relaxed where the patient or the patient's agent is not at the pharmacy, or where a specific communication barrier prevents oral communication.","c":"22 TAC 291.33(c)(1)(B)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Electronic written information","v":"Effective March 1, 2026 the written information that reinforces counseling may be provided electronically, for example by email, unless the patient or the patient's agent requests a hard copy; the pharmacy no longer has to document that request.","c":"22 TAC 291.33(c)(1) (amended, Texas Register Feb. 20, 2026 adoption); parallel amendment to 22 TAC 291.104 for Class E non-resident pharmacies","st":"regulation","ed":"2026-03-01","df":"true"},{"k":"Non-resident (Class E) pharmacies","v":"The same counseling-information rules apply to Class E non-resident pharmacies serving Texas patients, amended in parallel effective March 1, 2026.","c":"22 TAC 291.104","st":"regulation","ed":"2026-03-01","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"high"},{"id":"D2-B-17","facts":[{"k":"Counseling area required","v":"Yes. A Class A pharmacy serving the general public must have an area suitable for confidential patient counseling.","c":"22 TAC 291.33(b)(1)(C)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Specifications","v":"The area must be easily accessible to both patient and pharmacist, must not be accessible to prescription drugs by patients, and must be designed to maintain the confidentiality and privacy of the pharmacist-patient communication.","c":"22 TAC 291.33(b)(1)(C)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Factors the board weighs","v":"Proximity to the checkout or cash register, the amount of foot traffic in the vicinity, whether walls or other barriers separate the area from the rest of the pharmacy, and evidence that persons other than the pharmacist and patient have overheard confidential communications.","c":"22 TAC 291.33(b)(1)(C)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Minimum size, signage or placement","v":"Texas law does not address this. The rule prescribes no minimum dimensions, no required signage and no mandated location; suitability is judged against the listed factors.","c":"22 TAC 291.33(b)(1)(C)","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-18","facts":[{"k":"Prospective DUR required","v":"Yes. Before or at the time of dispensing a prescription drug order the pharmacist must review the patient's medication record.","c":"22 TAC 291.33(c)(2)(A)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Screening elements","v":"Known allergies; rational therapy contraindications; reasonable dose and route of administration; reasonable directions for use; duplication of therapy; drug-drug interactions; drug-food interactions; drug-disease interactions; adverse drug reactions; and proper utilization, including over- or under-utilization.","c":"22 TAC 291.33(c)(2)(A)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Duty on finding a problem","v":"The pharmacist must take appropriate steps to resolve the problem, including consultation with the prescribing practitioner; questions must be resolved before dispensing.","c":"22 TAC 291.33(c)(2)(A)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Documentation","v":"Consultations must be documented with the date, the name of the person who relayed the prescriber's instructions, the relevant details, and the pharmacist's initials or identification code. The review itself is documented through the dispensing record and the pharmacist's identification.","c":"22 TAC 291.33(c)(2)(C)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Remote review","v":"The review may be performed remotely by a Texas-licensed pharmacist employee with privacy controls in place, or by a Class E pharmacist under a written agreement.","c":"22 TAC 291.33(c)(2)(A)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Institutional setting","v":"In a Class C pharmacy the review is prospective when a pharmacist is on duty, except for an emergency order, and retrospective within the stated windows when no pharmacist is on duty.","c":"22 TAC 291.74(g)(1)(B); 291.74(e)(1)","st":"regulation","ed":"2024-03-07","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-19","facts":[{"k":"Patient records required","v":"A patient medication record system must be maintained for patients to whom prescription drug orders are dispensed.","c":"22 TAC 291.34(c)(1)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Required contents","v":"The pharmacist-in-charge must ensure a reasonable effort is made to obtain and record at least: full name, address and telephone number; age or date of birth and gender; known allergies, drug reactions, idiosyncrasies, chronic conditions and other drugs currently taken that are relevant to drug regimen review; the pharmacist's relevant comments; and a two-year list of all new and refill prescriptions dispensed, showing date, drug name, strength, quantity, prescriber, prescription number and dispensing pharmacist.","c":"22 TAC 291.34(c)(3)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Retrieval","v":"The system must allow immediate retrieval of the previous 12 months of information needed for prospective drug regimen review.","c":"22 TAC 291.34(c)(2)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Patient may decline","v":"Yes. If a patient or the patient's agent refuses to provide the necessary information, the pharmacist is not required to obtain, record or maintain information beyond the prescription order information.","c":"22 TAC 291.34(c)(5)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Retention and modification","v":"Records are kept two years, the previous 12 months online in a data system; any modification of a profile must be documented.","c":"22 TAC 291.34(c)(4)","st":"regulation","ed":"2022-03-15","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-20","facts":[{"k":"What Texas provides","v":"Partial filling of a Schedule II prescription is permitted 'under applicable federal law'. Texas adopts the federal rules by reference and adds no state clock, quantity rule or documentation requirement of its own for patient- or prescriber-requested partial fills.","c":"Tex. Health & Safety Code 481.074(e)","st":"statute","ed":"2019-09-01","df":"false"},{"k":"Interaction with the Texas 30-day fill window","v":"The separate Texas rule that a Schedule II prescription must be dispensed within 30 days of issuance continues to apply, so in Texas the practical outer limit for completing a partial fill at the patient's or prescriber's request is the shorter of the federal 30-days-from-writing clock and the state 30-day dispensing window.","c":"22 TAC 315.3(a)(4)","st":"regulation","ed":"2021-06-09","df":"true"},{"k":"State prohibition","v":"None. No Texas statute or rule prohibits or restricts partial filling at the patient's or prescriber's request beyond the federal framework.","c":"Tex. Health & Safety Code 481.074(e)","st":"silent","ed":null,"df":"false"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-21","facts":[{"k":"Who qualifies","v":"A Schedule II prescription for a patient in a long-term care facility, or for a patient with a medical diagnosis documenting a terminal illness who is receiving hospice care, may be partially filled, including in individual dosage units.","c":"Tex. Health & Safety Code 481.074(f)","st":"statute","ed":"2019-09-01","df":"false"},{"k":"Doubt about terminal illness","v":"If there is any question whether the patient is terminally ill, the pharmacist must contact the practitioner before making the partial fill.","c":"Tex. Health & Safety Code 481.074(f)","st":"statute","ed":"2019-09-01","df":"false"},{"k":"Mandatory record notation","v":"The record must be annotated 'terminally ill hospice patient' or 'ltcf patient'. Dispensing without that notation is a violation of the chapter.","c":"Tex. Health & Safety Code 481.074(f)","st":"statute","ed":"2019-09-01","df":"true"},{"k":"Record of each partial fill","v":"Each partial fill must record the date, the quantity dispensed, the quantity remaining, and the identity of the dispensing pharmacist. Before each subsequent partial fill the pharmacist must confirm that it is necessary. The total of the partial fills may not exceed the total quantity prescribed.","c":"Tex. Health & Safety Code 481.074(f)","st":"statute","ed":"2019-09-01","df":"false"},{"k":"Expiry","v":"Such a prescription expires 60 days after the date of issue unless discontinued sooner.","c":"Tex. Health & Safety Code 481.074(f)","st":"statute","ed":"2019-09-01","df":"false"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-22","facts":[{"k":"Defined early-refill threshold","v":"Texas law does not address this. No Texas statute or TSBP rule sets a percentage-of-days-supply threshold (for example 75 percent or 90 percent) governing when a controlled substance may be refilled early, nor any documentation requirement tied to such a threshold. Searched 22 TAC 291.34(b)(8) and (b)(10), 22 TAC 315.3, 22 TAC 315.15 and Tex. Health & Safety Code 481.074.","c":"22 TAC 291.34(b)(8)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"What constrains early refilling instead","v":"The five-refill / six-month ceiling for Schedules III-V, the prohibition on auto-refill for Schedules II and III, the mandatory PMP check before dispensing an opioid, benzodiazepine, barbiturate or carisoprodol, and the pharmacist's duty not to dispense where the prescription was issued without a valid patient-practitioner relationship.","c":"Tex. Health & Safety Code 481.074(g), (a)(2); 22 TAC 291.34(b)(8); 22 TAC 315.15(a)","st":"statute","ed":"2020-03-01","df":"true"},{"k":"Accelerated refills are dangerous drugs only","v":"The accelerated-refill provision allowing up to a 90-day supply applies to dangerous drugs, not controlled substances, and excludes psychotropic drugs used to treat a mental or psychiatric condition.","c":"22 TAC 291.34(b)(10)","st":"regulation","ed":"2022-03-15","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-B-23","facts":[{"k":"Schedules III-V refill transfer","v":"Original prescription information for a Schedule III, IV or V controlled substance may be transferred for the purpose of refill dispensing ONE time only.","c":"22 TAC 291.34(g)(1)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"Shared real-time database exception","v":"Pharmacies that electronically share a real-time online database may transfer up to the maximum number of refills permitted by law and by the prescriber's authorization.","c":"22 TAC 291.34(g)(1)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"Dangerous drugs","v":"Transfers are permitted without a fixed numeric cap, up to the number of refills originally authorized.","c":"22 TAC 291.34(g)(1)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"},{"k":"Schedule II transfer, including an electronic prescription","v":"NOT permitted in Texas. 22 TAC 291.34(g) authorizes transfer only of Schedule III-V refill information and of dangerous-drug prescriptions; it contains no authorization to transfer a Schedule II prescription, and no Texas rule implements the 2023 federal initial-fill transfer provision. Because 21 CFR 1306.08(e) permits a one-time transfer of an electronic controlled substance prescription only where state law permits, the federal allowance does not operate in Texas.","c":"22 TAC 291.34(g)(1); 21 CFR 1306.08(e)","st":"silent","ed":null,"df":"true"},{"k":"Anti-re-transfer control","v":"A controlled substance prescription must have a mechanism in the pharmacy system that prohibits re-transfer or refilling after a prior transfer.","c":"22 TAC 291.34(g)(8)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Downtime","v":"Electronic prescriptions may not be transferred by non-electronic means during system downtime except after consulting and obtaining authorization from the prescriber; a hard copy may be provided for information only and the prescription may be read by telephone.","c":"22 TAC 291.34(g)(8)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Pharmacy may not refuse","v":"A pharmacy may not refuse a transfer request made by a person acting on the patient's behalf and must complete the transfer within four business hours of the request.","c":"22 TAC 291.34(g)","st":"regulation","ed":"2022-03-15","df":"true"}],"ver":"2026-10-14","pc":"No TSBP rulemaking implementing 21 CFR 1306.08(e)-(h) was located in the May 2025 rule memo, the December 26 2025 proposed rules or the February 20 2026 adopted rules. If TSBP later amends 291.34(g), this answer changes.","vol":"high"},{"id":"D2-B-24","facts":[{"k":"Controlled substances","v":"The transfer must be communicated directly between two licensed people: pharmacist or pharmacist-intern to pharmacist or pharmacist-intern. A pharmacy technician may not transfer or receive a controlled substance prescription.","c":"22 TAC 291.34(g)(3)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Dangerous drugs","v":"A pharmacist, pharmacist-intern or pharmacy technician may transfer to a pharmacist, pharmacist-intern or pharmacy technician.","c":"22 TAC 291.34(g)(3)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"},{"k":"Electronic transfers","v":"A pharmacist-intern, pharmacy technician or pharmacy technician trainee may initiate an electronic transfer under the direct supervision of a pharmacist.","c":"22 TAC 291.34(g)(8)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Method and confirmation","v":"Transfers are communicated orally by telephone or by facsimile. Both parties must confirm the information, either by faxing the hard copy or by having the receiver repeat the verbal information back for the sender to verify.","c":"22 TAC 291.34(g)(3), (g)(7)","st":"regulation","ed":"2022-03-15","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-B-25","facts":[{"k":"Transferring pharmacy","v":"Write 'void' on the face of the invalidated prescription, or void it in the data system; record the receiving pharmacy's name and address, and its DEA registration number for a controlled substance; the name of the individual receiving the information; the date of the transfer; and the name of the individual transferring it.","c":"22 TAC 291.34(g)(5)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Transferring pharmacy - electronic transfers","v":"Must additionally include the date of the original dispensing, the number of refills remaining, and for controlled substances the dates and locations of prior refills, together with the transferring pharmacy's details.","c":"22 TAC 291.34(g)(5)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Receiving pharmacy","v":"Write 'transfer' on the face of the transferred prescription or flag it in the record; record all required prescription information; the original date of issue and the original prescription number; the original number of refills authorized; the date of the original dispensing; the number of refills remaining; for controlled substances the dates and locations of prior refills; and the name and address of the transferring pharmacy and the name of the individual transferring the information.","c":"22 TAC 291.34(g)(6)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Receiving pharmacy - electronic transfers","v":"A new electronic record is created that includes the name of the receiving pharmacist.","c":"22 TAC 291.34(g)(6)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Where the records live and for how long","v":"Both the original and the transferred prescription records must be maintained for two years from the date of the last refill.","c":"22 TAC 291.34(g)(4)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Compounded prescriptions","v":"A transferred compounded prescription must include the full formula; if the formula is patented or protected the pharmacy must at least provide the quantity or strength of each active ingredient.","c":"22 TAC 291.34(g)(10)","st":"regulation","ed":"2022-03-15","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-26","facts":[{"k":"Shared database permitted","v":"Yes. Pharmacies that share the same prescription records may transfer prescriptions electronically provided the original is voided and the required information is stored.","c":"22 TAC 291.34(g)(8)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"Effect on the one-transfer limit","v":"Pharmacies electronically sharing a real-time online database may transfer Schedule III-V prescriptions up to the maximum number of refills permitted by law and by the prescriber's authorization, rather than once only.","c":"22 TAC 291.34(g)(1)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"Pharmacies not under common ownership","v":"Pharmacies not under common ownership must sign an access agreement with the owner, chief executive officer or designee of the database before sharing records.","c":"22 TAC 291.34(g)(8)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"Bulk transfers","v":"Bulk electronic transfer of prescription records between two pharmacies is permitted if both keep the required records and the transferring pharmacy notifies the patient or the patient's agent, giving the receiving pharmacy's telephone number.","c":"22 TAC 291.34(g)(11)","st":"regulation","ed":"2022-03-15","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-27","facts":[{"k":"Mandatory PMP query","v":"Yes. A pharmacist must consult the Texas Prescription Monitoring Program before dispensing an outpatient prescription for an opioid, benzodiazepine, barbiturate or carisoprodol.","c":"22 TAC 315.15(a); Tex. Health & Safety Code 481.0764(a)","st":"regulation","ed":"2020-03-01","df":"true"},{"k":"Who is responsible","v":"The dispensing pharmacist, unless the pharmacy has recorded another pharmacist in its data processing system as responsible for the PMP review.","c":"22 TAC 315.15(a)","st":"regulation","ed":"2020-03-01","df":"true"},{"k":"Other controlled substances","v":"Discretionary. An authorized person MAY access PMP information before prescribing or dispensing any other controlled substance.","c":"Tex. Health & Safety Code 481.0764(b)","st":"statute","ed":"2019-09-01","df":"true"},{"k":"Exceptions","v":"The duty does not apply where the prescriber is a veterinarian; where the prescription record clearly notes a diagnosis of cancer or sickle cell disease or that the patient is receiving hospice care; or where the pharmacist cannot access the PMP despite a documented good-faith effort.","c":"22 TAC 315.15(b); Tex. Health & Safety Code 481.0765(a)-(c)","st":"regulation","ed":"2020-03-01","df":"true"},{"k":"Integrated systems","v":"Reviewing a pharmacy management system that integrates PMP data satisfies the review requirement.","c":"22 TAC 315.15(c)","st":"regulation","ed":"2021-03-14","df":"true"},{"k":"Enforcement","v":"A violation of the mandatory-access duty is grounds for disciplinary action by the agency that licensed, certified or registered the violator.","c":"Tex. Health & Safety Code 481.0764(d)","st":"statute","ed":"2019-09-01","df":"true"},{"k":"Mandatory registration for pharmacists","v":"Texas law does not address this. No Texas statute or TSBP rule expressly requires a pharmacist to register with the PMP; the duty found in law is a duty to check, and access authority flows from Tex. Health & Safety Code 481.076(a)(5). Searched 22 TAC 315.15, Tex. Health & Safety Code 481.076, 481.0764 and 481.0765.","c":"22 TAC 315.15","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"high"},{"id":"D2-B-28","facts":[{"k":"Reporting deadline","v":"By the next business DAY after the prescription is completely filled, the dispensing pharmacist must send the required information to the board electronically or in another board-approved form.","c":"Tex. Health & Safety Code 481.074(q); 481.075(i)(3); 22 TAC 315.6(a)","st":"statute","ed":"2019-09-01","df":"true"},{"k":"Which drugs are reportable","v":"Controlled substances, Schedules II through V. The data elements are those marked required in the board's Data Submission Guide for Dispensers.","c":"22 TAC 315.6(a); Tex. Health & Safety Code 481.076(a)","st":"regulation","ed":"2023-03-07","df":"true"},{"k":"Drugs beyond controlled substances","v":"Texas law does not address this. No Texas statute or rule requires reporting of non-controlled drugs (for example gabapentin or naloxone) to the PMP. Searched 22 TAC 315.6 and Tex. Health & Safety Code 481.074(q), 481.075(i) and 481.076.","c":"22 TAC 315.6","st":"silent","ed":null,"df":"no federal analogue"},{"k":"Corrections","v":"On discovering an error, omission or inaccuracy in data already submitted, the pharmacy must electronically correct the record within seven business days of discovery.","c":"22 TAC 315.6(b)","st":"regulation","ed":"2023-03-07","df":"true"},{"k":"Zero reports","v":"A pharmacy that dispenses no controlled substances must electronically submit a zero report every seven days. The statute separately requires a report where no controlled substance prescriptions are dispensed for seven consecutive days, unless a waiver or permission to delay has been obtained.","c":"22 TAC 315.6(c); Tex. Health & Safety Code 481.075(i)(4)","st":"regulation","ed":"2023-03-07","df":"true"},{"k":"Waiver","v":"A non-dispensing pharmacy may request a waiver of the zero-report requirement on the board's form; the waiver ends once the pharmacy begins dispensing.","c":"22 TAC 315.6(d)","st":"regulation","ed":"2023-03-07","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-B-29","facts":[{"k":"Who may access","v":"Pharmacists, pharmacist-interns and pharmacy technicians acting at the direction of a pharmacist; prescribers (physicians, dentists, veterinarians, podiatrists, optometrists, advanced practice nurses and certain physician assistants) and their employees or agents acting at their direction; regulatory agencies investigating a specific licensee or monitoring prescribing or dispensing patterns; board employees; law enforcement and prosecutors with a warrant, subpoena or court order; medical examiners conducting an investigation; other states under an interoperability agreement; CMS-certified health care facilities; and patients or their parent or guardian as to their own record.","c":"Tex. Health & Safety Code 481.076(a)(1)-(9)","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"Delegation to a technician","v":"Yes. A pharmacy technician may access PMP information when acting at the direction of a pharmacist and as authorized under Tex. Health & Safety Code 481.076.","c":"22 TAC 315.15(d); Tex. Health & Safety Code 481.076(a)(5)","st":"regulation","ed":"2021-03-14","df":"no federal analogue"},{"k":"Individual credentials","v":"Each authorized user must use their own assigned login and may not use another person's.","c":"22 TAC 315.15(d)","st":"regulation","ed":"2021-03-14","df":"no federal analogue"},{"k":"Consequence of misuse","v":"Unauthorized access is a violation of the Texas Controlled Substances Act, the Texas Pharmacy Act and board rules. Submitted information remains confidential even where access is permitted.","c":"22 TAC 315.15(d); Tex. Health & Safety Code 481.076(i)","st":"regulation","ed":"2021-03-14","df":"no federal analogue"},{"k":"Specific penalty amounts or criminal grades","v":"Texas law does not address this. Tex. Health & Safety Code 481.0768 (administrative penalty) and 481.0769 (offense relating to prescription information) exist but their text was not retrieved, so no penalty figure or offense grade is stated here.","c":"Tex. Health & Safety Code 481.0768; 481.0769","st":"silent","ed":null,"df":"no federal analogue"},{"k":"Record retention / data purge","v":"Patient identities must be deleted no later than 36 months after entry unless needed for an ongoing investigation.","c":"Tex. Health & Safety Code 481.076(e)","st":"statute","ed":"2019-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-B-30","facts":[{"k":"Affirmative duty to report a red flag","v":"Texas law does not address this. No Texas statute or TSBP rule requires a pharmacist to report a suspicious PMP finding to the board, to law enforcement or to the prescriber. Searched Tex. Health & Safety Code 481.0764, 481.0765, 481.076 and 22 TAC 315.15; none creates a reporting duty.","c":"22 TAC 315.15","st":"silent","ed":null,"df":"no federal analogue"},{"k":"What the pharmacist must do instead","v":"The corresponding-responsibility prohibitions bite: a pharmacist may not dispense a controlled substance except under a valid prescription issued in the course of professional practice, may not dispense where the pharmacist knows or should have known the prescription was issued without a valid patient-practitioner relationship, and may not fill a prescription not prepared or issued as the chapter requires.","c":"Tex. Health & Safety Code 481.074(a)(1)-(3)","st":"statute","ed":"2019-09-01","df":"false"},{"k":"Drug regimen review obligation","v":"A PMP finding bearing on over-utilization or duplication of therapy engages the prospective drug regimen review duty, under which the pharmacist must take appropriate steps to resolve the problem, including consulting the prescriber, and must resolve questions before dispensing.","c":"22 TAC 291.33(c)(2)(A)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Board guidance","v":"TSBP publishes guidance on corresponding responsibility and on recognizing nontherapeutic dispensing among its practice resources; the documents themselves were not retrieved and no reporting duty is asserted here on their basis.","c":"TSBP Practice Resources \u2014 corresponding responsibility and recognizing nontherapeutic dispensing","st":"board policy","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-B-31","facts":[{"k":"Daily limit","v":"A business may not sell more than 3.6 grams of ephedrine, pseudoephedrine, norpseudoephedrine or a combination of these to a purchaser in a single calendar day. Matches the federal CMEA retail daily limit.","c":"Tex. Health & Safety Code 486.014(b)","st":"statute","ed":"2011-09-01","df":"false"},{"k":"30-day limit","v":"No more than 9 grams of those substances, alone or in combination, to a purchaser in any 30-day period. Matches the federal CMEA retail 30-day limit.","c":"Tex. Health & Safety Code 486.014(b)","st":"statute","ed":"2011-09-01","df":"false"},{"k":"Identification - Texas adds a minimum age","v":"Before completing an over-the-counter sale the business must check a photographic identification showing the purchaser is at least 16 years OF AGE. Federal CMEA requires photo identification but sets no purchaser age floor, so this is a Texas addition.","c":"Tex. Health & Safety Code 486.014(a)","st":"statute","ed":"2011-09-01","df":"true"},{"k":"Logging and real-time transmission","v":"The purchaser must sign for the purchase, the business must record the required sale details, and the record must be transmitted as required by Sec. 486.0141 (the real-time electronic sales-tracking system). Texas therefore requires electronic transmission, not merely a retained paper logbook.","c":"Tex. Health & Safety Code 486.014(a); 486.0141","st":"statute","ed":"2011-09-01","df":"true"},{"k":"Is a prescription required","v":"No. These products remain available over the counter in Texas subject to the limits above.","c":"Tex. Health & Safety Code 486.014","st":"statute","ed":"2011-09-01","df":"false"},{"k":"Mail-order 30-day limit","v":"Texas Chapter 486 governs over-the-counter sales and does not state a separate mail-order figure; the federal 7.5 g per 30 days mail-order limit in 21 CFR 1314.100 continues to apply.","c":"Tex. Health & Safety Code 486.014; 21 CFR 1314.100","st":"silent","ed":null,"df":"false"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-32","facts":[{"k":"Nonprescription Schedule V - pharmacist only","v":"Only a pharmacist may distribute a nonprescription Schedule V controlled substance. A non-pharmacist employee may not do so even under a pharmacist's supervision, though a non-pharmacist may complete the cash or credit transaction and the delivery after the pharmacist has discharged the professional and legal responsibilities.","c":"22 TAC 291.33(f)(3)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Codeine and dihydrocodeine excluded","v":"Schedule V products containing codeine, dihydrocodeine or their salts may NOT be distributed without a prescription drug order in Texas.","c":"22 TAC 291.33(f)(3)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Product strength limit","v":"Only products containing no more than 15 milligrams of opium per 29.5729 mL or per 28.35 grams qualify for nonprescription distribution.","c":"22 TAC 291.33(f)(3)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Quantity limit","v":"No more than 240 mL (eight fluid ounces), or no more than 48 solid dosage units, of any opium-containing substance may be sold to the same purchaser in any 48-hour period without a prescription.","c":"22 TAC 291.33(f)(3)","st":"regulation","ed":"2024-12-30","df":"false"},{"k":"Purchaser age and identification","v":"The purchaser must be at least 18 years old, and the pharmacist must require suitable identification, including proof of age where appropriate, from any purchaser not known to the pharmacist.","c":"22 TAC 291.33(f)(3)","st":"regulation","ed":"2024-12-30","df":"false"},{"k":"Record","v":"A bound record book must show the purchaser's true name and current address, the name and quantity of the controlled substance, the date of each purchase, and the signature or written initials of the distributing pharmacist.","c":"22 TAC 291.33(f)(3)","st":"regulation","ed":"2024-12-30","df":"false"},{"k":"Ephedrine / pseudoephedrine","v":"Behind-the-counter by statute, with the 3.6 g daily and 9 g 30-day limits, photo identification showing age 16 or older, purchaser signature and electronic transmission of the record.","c":"Tex. Health & Safety Code 486.014","st":"statute","ed":"2011-09-01","df":"true"},{"k":"Any other state-specific BTC class","v":"Texas law does not address this. No further Texas behind-the-counter or pharmacist-only drug class was located beyond nonprescription Schedule V and the ephedrine group. Searched 22 TAC 291.33(f), Tex. Health & Safety Code ch. 483 and ch. 486.","c":"22 TAC 291.33(f)","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-33","facts":[{"k":"Prescription required to sell a syringe","v":"No. No Texas statute or TSBP rule requires a prescription for the sale of a hypodermic syringe or needle. Searched Tex. Health & Safety Code ch. 481 and ch. 483 and 22 TAC ch. 291.","c":"Tex. Health & Safety Code ch. 481; 22 TAC ch. 291","st":"silent","ed":null,"df":"no federal analogue"},{"k":"Quantity limit or logging duty","v":"Texas law does not address this. No Texas quantity cap, purchaser identification requirement or sales log for syringes was located.","c":"Tex. Health & Safety Code ch. 481","st":"silent","ed":null,"df":"no federal analogue"},{"k":"The operative constraint - drug paraphernalia","v":"A person commits an offense by delivering, or possessing with intent to deliver, drug paraphernalia knowing that the recipient intends to use it to plant, propagate, manufacture, store, conceal or introduce a controlled substance into the human body in violation of the chapter. The offense requires that knowledge, so an ordinary pharmacy sale for a lawful medical purpose is not caught. Delivery under subsection (b) is a Class A misdemeanor; delivery by an adult to a person under 18 who is at least three years younger is a state jail felony.","c":"Tex. Health & Safety Code 481.125(b), (c)","st":"statute","ed":"2021-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-B-34","facts":[{"k":"General rule","v":"No. A pharmacist may not accept an unused prescription or drug, in whole or in part, for resale or redispensing after it has been dispensed or sold, except as provided in 22 TAC 291.8(b), Tex. Health & Safety Code ch. 431 subch. M, and Tex. Health & Safety Code ch. 442.","c":"22 TAC 291.8(a)","st":"regulation","ed":"2023-12-04","df":"true"},{"k":"The only return pathway","v":"Returns are permitted only from a health care facility regulated under Tex. Health & Safety Code ch. 242, or from a penal institution, and only back to the pharmacy that dispensed them, under Tex. Occ. Code 562.1085. A pharmacy may therefore not take in and repackage another pharmacy's dispensed prescription.","c":"22 TAC 291.8(b); Tex. Occ. Code 562.1085","st":"regulation","ed":"2023-12-04","df":"true"},{"k":"Who may return and what qualifies","v":"A consultant pharmacist, or a licensed health care professional in a penal institution, may return non-controlled drugs purchased from that pharmacy. The drug must be FDA-approved, sealed in appropriate unopened tamper-evident, unit-dose, single-dose, unit-of-use or unopened multiple-dose parenteral packaging, not subject to recall, and never in the patient's possession.","c":"22 TAC 291.8(b)","st":"regulation","ed":"2023-12-04","df":"true"},{"k":"Excluded drugs","v":"Compounded drugs, drugs that appear adulterated, drugs requiring refrigeration, and drugs with fewer than 120 days until expiration or end of shelf life.","c":"22 TAC 291.8(b)","st":"regulation","ed":"2023-12-04","df":"true"},{"k":"Receiving pharmacy duties","v":"A pharmacist must examine the returned drugs for integrity; the pharmacy must credit or reimburse the payer, including Texas Medicaid, and keep records of each credit; only after issuing credit may the pharmacy restock and redispense.","c":"22 TAC 291.8(b)","st":"regulation","ed":"2023-12-04","df":"true"},{"k":"Undelivered prescriptions","v":"A prescription that was filled but never delivered to the patient may be returned to stock; the pharmacist must evaluate quality and safety, the item must not be mixed into the manufacturer's container, the expiration date becomes the lesser of one year from dispensing or the manufacturer's date, and labels must be removed to protect patient information.","c":"22 TAC 291.33(c)(8)","st":"regulation","ed":"2024-12-30","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-35","facts":[{"k":"Default requirement","v":"A drug dispensed under a prescription drug order must be dispensed in a child-resistant container.","c":"22 TAC 291.33(c)(6)(A)","st":"regulation","ed":"2024-12-30","df":"false"},{"k":"Patient or practitioner waiver","v":"A non-child-resistant container may be used where the patient OR THE practitioner requests that the prescription not be dispensed in a child-resistant container. Either may make the request; the rule does not restrict the practitioner's request to a single prescription.","c":"22 TAC 291.33(c)(6)(A)(i)","st":"regulation","ed":"2024-12-30","df":"false"},{"k":"PPPA exemption","v":"A non-child-resistant container may also be used where the product is exempted from the requirements of the Poison Prevention Packaging Act of 1970.","c":"22 TAC 291.33(c)(6)(A)(ii)","st":"regulation","ed":"2024-12-30","df":"false"},{"k":"Must the request be in writing","v":"Texas law does not address this. The Texas rule does not require the patient's or the practitioner's request to be in writing and prescribes no documentation form. Searched 22 TAC 291.33(c)(6) and 291.34(b).","c":"22 TAC 291.33(c)(6)(A)","st":"silent","ed":null,"df":"true"},{"k":"Blanket or standing patient waiver","v":"Texas law does not address this. The rule neither expressly authorizes nor expressly prohibits a standing or blanket patient waiver; it speaks only of a request. Federal law (16 CFR 1700.14 and the pppa) permits a blanket patient request, and nothing in the Texas rule displaces that.","c":"22 TAC 291.33(c)(6)(A)(i)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"Reuse of containers","v":"Containers and closures may not be reused, with a narrow exception for audio-labeled containers.","c":"22 TAC 291.33(c)(6)","st":"regulation","ed":"2024-12-30","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-B-36","facts":[{"k":"Authority to prepare adherence packaging","v":"A pharmacist may provide a customised patient medication package (patient med-pak) in lieu of dispensing two or more prescribed drug products in separate containers.","c":"22 TAC 291.33(h)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Consent","v":"The pharmacist must have the consent of the patient, the patient's caregiver, or the prescriber.","c":"22 TAC 291.33(h)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Package standards","v":"Each container within the med-pak must be non-reclosable or must show evidence of having been opened, unless stricter packaging requirements apply. A patient package insert must accompany the med-pak where any product requires one, or a single overall educational insert may be provided.","c":"22 TAC 291.33(h)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Records","v":"Each med-pak record must show the patient's name and address; the unique identifiers for the med-pak and for each prescription; the manufacturer or distributor and lot number for each product; information sufficient to recreate an identical med-pak; the preparation date and the assigned beyond-use date; any special labeling instructions; and the preparing pharmacist's initials or identification code.","c":"22 TAC 291.33(h)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Prepackaging generally","v":"Prepackaging may be performed by a pharmacist or by personnel under a pharmacist's supervision, subject to the rule's label and record requirements.","c":"22 TAC 291.33(g)","st":"regulation","ed":"2024-12-30","df":"true"},{"k":"Long-term care patients","v":"A pharmacy may prepare a med-pak for an LTC patient using the same consent, labeling and record rules; it may not, however, take in and repackage a prescription already dispensed by a different pharmacy.","c":"22 TAC 291.33(h); 22 TAC 291.8(a)","st":"regulation","ed":"2024-12-30","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D2-C-01","facts":[{"k":"Basis of authority","v":"Protocol, not independent and not prescription-by-prescription. A pharmacist may administer immunizations or vaccinations only under a physician'S written protocol meeting board standards; the authority may not be delegated.","c":"Tex. Occ. Code 554.004; 22 TAC 295.15(d), (e)(4)","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"Which vaccines","v":"No statewide list. The written protocol itself must identify the immunizations or vaccinations the pharmacist may administer, so the permitted set is protocol-specific.","c":"22 TAC 295.15(b)(13)(A)(iv)","st":"regulation","ed":"2016-01-01","df":"no federal analogue"},{"k":"Influenza vaccine - minimum age","v":"Over seven years of age. A pharmacist may administer influenza vaccine to a patient over seven years of age without an established physician-patient relationship between the delegating physician and that patient.","c":"22 TAC 295.15(d)(2), (e)(2)","st":"regulation","ed":"2016-01-01","df":"no federal analogue"},{"k":"All other protocol vaccines - minimum age","v":"Age fourteen and above without referral. A patient under 14 may be vaccinated only on referral from a physician who has an established physician-patient relationship with that patient.","c":"22 TAC 295.15(e)(2)","st":"regulation","ed":"2016-01-01","df":"no federal analogue"},{"k":"Absolute minimum age","v":"Texas law does not address this. The rule sets no floor below which a pharmacist may not vaccinate at all; below 14 (and below 7 for influenza) the constraint is the physician-referral requirement rather than a prohibition.","c":"22 TAC 295.15(e)(2)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"COVID-19 vaccine - added consent requirement","v":"Before administering a covid-19 vaccine a health care provider must obtain written informed consent (from a parent, guardian or conservator for a minor or a person lacking capacity), acknowledging receipt of a standardized DSHS information sheet covering benefits and risks including side effects, the vaccine's expedited development, whether long-term studies have been done, whether manufacturers may be held civilly liable for vaccine injuries, and VAERS with reporting instructions. Violation is grounds for discipline by the provider's licensing authority.","c":"Tex. Health & Safety Code 161.0086 (added by Acts 2025, 89th Leg., H.B. 4535)","st":"statute","ed":"2025-09-01","df":"true"},{"k":"Place of administration","v":"A pharmacist may not administer medication, including a vaccine, at a patient's residence, except at a licensed nursing home or hospital.","c":"Tex. Occ. Code 554.004","st":"statute","ed":"1999-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":"H.B. 3540 (89th Leg., 2025) would have amended Tex. Occ. Code 554.004; its enactment was NOT confirmed and it does not appear in TSBP's August 2025 list of enacted bills affecting pharmacy. Treat 554.004 as unamended but re-verify.","vol":"high"},{"id":"D2-C-02","facts":[{"k":"Initial training course","v":"Completion of an ACPE-approved course that is evidence-based, includes study material, hands-on training and testing with a passing score, and meets current CDC training guidelines.","c":"22 TAC 295.15(c)","st":"regulation","ed":"2016-01-01","df":"no federal analogue"},{"k":"Minimum hours","v":"A minimum of 20 hours of instruction and experiential training.","c":"22 TAC 295.15(c)","st":"regulation","ed":"2016-01-01","df":"no federal analogue"},{"k":"Required course content","v":"Immunology; vaccine-preventable diseases; immunization schedules; vaccine storage; informed consent; administration techniques; and identification, response to, documentation of and reporting of adverse events.","c":"22 TAC 295.15(c)","st":"regulation","ed":"2016-01-01","df":"no federal analogue"},{"k":"CPR requirement","v":"Current American Heart Association Basic Cardiac Life Support for Health-Care Providers certification, or an equivalent.","c":"22 TAC 295.15(c)","st":"regulation","ed":"2016-01-01","df":"no federal analogue"},{"k":"Continuing education","v":"Three hours every two years on disease states, drugs and the administration of immunizations or vaccinations.","c":"22 TAC 295.15(c)","st":"regulation","ed":"2016-01-01","df":"no federal analogue"},{"k":"Documentation","v":"The pharmacist must keep documentation of the initial course, the continuing education and the BCLS certification.","c":"22 TAC 295.15(c)","st":"regulation","ed":"2016-01-01","df":"no federal analogue"},{"k":"Physician supervision standard","v":"Supervision is adequate where the delegating physician formulates or approves the protocol and reviews it periodically, has the required relationship with patients under 14, is geographically accessible, receives periodic patient status reports, and is available by direct telecommunication.","c":"22 TAC 295.15(d)","st":"regulation","ed":"2016-01-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-C-03","facts":[{"k":"State registry reporting - patients under 18","v":"Mandatory. A health care provider who administers an immunization to an individual younger than 18 must submit the immunization data elements to the Department of State Health Services, which maintains the Texas immunization registry (ImmTrac2), in the format the department prescribes.","c":"Tex. Health & Safety Code 161.007(d)","st":"statute","ed":"2015-09-01","df":"no federal analogue"},{"k":"State registry reporting - patients 18 and over","v":"Permissive, not mandatory. A provider or payor may, but is not required to, submit the data.","c":"Tex. Health & Safety Code 161.007(c), (d)","st":"statute","ed":"2015-09-01","df":"no federal analogue"},{"k":"Consent","v":"For a person under 18, a parent, managing conservator or guardian gives a one-time consent that must reach the department before the individual's 18th birthday; information may remain until age 26 unless consent is withdrawn or renewed after 18. For a person 18 or older, the individual must consent, and the consent remains valid until withdrawn. The department must verify consent before including reported information and may not retain identifiable information where consent cannot be verified.","c":"Tex. Health & Safety Code 161.007(a-1), (a-2), (c), (d), (e)","st":"statute","ed":"2015-09-01","df":"no federal analogue"},{"k":"Reporting deadline","v":"Texas law does not address this. Tex. Health & Safety Code 161.007 sets no number of days within which the submission must be made. A DSHS registry rule in 25 TAC may set one; it was not located or read.","c":"Tex. Health & Safety Code 161.007","st":"silent","ed":null,"df":"no federal analogue"},{"k":"Separate physician-notification deadlines (board rule)","v":"Distinct from the registry: the immunizing pharmacist must notify the physician who issued the written protocol within 24 hours, and the patient's primary care physician within 14 days. Records must be kept at least two years.","c":"22 TAC 295.15(g)(1), (h)(1)(A)","st":"regulation","ed":"2016-01-01","df":"no federal analogue"},{"k":"Liability protection","v":"Persons who submit data in good faith, and department employees, are not liable for civil damages; registry information is confidential and may be disclosed only with written or electronic consent, subject to listed exceptions.","c":"Tex. Health & Safety Code 161.007(i), (j)","st":"statute","ed":"2015-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D2-C-04","facts":[{"k":"May a technician or intern administer vaccines","v":"No. The authority of a pharmacist to administer immunizations or vaccinations may not be delegated, and the statute likewise provides that the authority to administer medication may not be delegated.","c":"22 TAC 295.15(e)(4); Tex. Occ. Code 554.004","st":"regulation","ed":"2016-01-01","df":"true"},{"k":"Supervision arrangements for non-pharmacists","v":"Texas law does not address this. Because delegation is prohibited, Texas prescribes no supervision framework for technician or intern administration. Searched 22 TAC 295.15, Tex. Occ. Code 554.004, and 22 TAC ch. 297 by title.","c":"22 TAC 295.15(e)(4)","st":"silent","ed":null,"df":"true"},{"k":"Federal PREP Act overlay (SETTLED \u2014 overrides the Texas rule)","v":"Texas prohibits delegation under 22 TAC 295.15(e)(4), but the PREP Act declaration amendment of 11 December 2024 makes pharmacy interns and qualified pharmacy technicians 'qualified persons' who may administer: ACIP-recommended childhood vaccines to ages 3-18; seasonal influenza vaccine to ages 19 and older; and FDA-authorized or licensed covid-19 vaccines to ages 3 and older. Conditions: the intern or technician must be licensed or registered by the state board and act under a supervising pharmacist who is readily and immediately available; must complete an ACPE-approved practical training program covering hands-on injection technique, indications and contraindications, and recognition and treatment of emergency reactions; and must hold current basic CPR certification. Coverage runs through 31 December 2029. The declaration states that any state law prohibiting a qualified person from administering these countermeasures IS preempted. So the Texas non-delegation rule is unenforceable for these products while the declaration stands.","c":"PREP Act declaration amendment, 89 FR (11 December 2024), Sections V(d) and XII(iii)-(iv)","st":"statute","ed":"2024-12-11","df":"true"}],"ver":"2026-10-14","pc":"PREP Act coverage for these vaccines expires 31 December 2029 unless extended. Texas has not amended 295.15 to match.","vol":"high"},{"id":"D2-C-05","facts":[{"k":"General authority to administer non-vaccine medication","v":"A pharmacist may administer medication other than an immunization only under board-set conditions ensuring that no licensed health care provider authorized to administer the medication is reasonably available, that failure to administer might cause a significant delay or interruption of a critical phase of drug therapy, that the pharmacist has the required skill, education and certification, and that the patient's responsible provider is notified within a reasonable time.","c":"Tex. Occ. Code 554.004","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"Place limitation","v":"A pharmacist may not administer medication at a patient's residence, except at a licensed nursing home or hospital, and the authority may not be delegated.","c":"Tex. Occ. Code 554.004","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"Epinephrine","v":"A pharmacist may administer epinephrine by auto-injector to a patient in an emergency. The authority may not be delegated; the epinephrine must be in the lawful possession of the pharmacist or the pharmacy, which is responsible for drug accountability and administration records. The pharmacist may not be paid for the administration but may seek reimbursement for the auto-injector's cost, and is protected from civil liability for good-faith acts absent wilful or wanton negligence.","c":"22 TAC 295.16; Tex. Occ. Code 562.057","st":"regulation","ed":"2016-12-19","df":"no federal analogue"},{"k":"Routes","v":"'Administer' is defined to include applying a prescription drug directly to a person's body, including by injection. Beyond injection the rules do not enumerate permitted routes.","c":"22 TAC 295.16","st":"regulation","ed":"2016-12-19","df":"no federal analogue"},{"k":"Long-acting injectables","v":"Texas law does not address this. No Texas statute or TSBP rule creating a specific authority for pharmacists to administer long-acting injectable antipsychotics or similar agents was located. Such administration would have to fit within Tex. Occ. Code 554.004's narrow conditions or a physician's written protocol under 22 TAC 295.13. Searched Tex. Occ. Code 554.004 and 562.057 and 22 TAC 295.13 through 295.16 by title.","c":"Tex. Occ. Code 554.004","st":"silent","ed":null,"df":"no federal analogue"},{"k":"Opioid antagonists","v":"22 TAC 295.14 is titled 'Dispensing of Opioid Antagonist by Pharmacist'. It governs dispensing rather than administration; its text was not read.","c":"22 TAC 295.14","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"high"},{"id":"D2-C-06","facts":[{"k":"Protocol must cover reactions","v":"The physician's written protocol must include procedures to follow in the case of reactions following administration, and the pharmacist may carry drugs listed in the protocol to treat adverse reactions.","c":"22 TAC 295.15(b)(13)(A)(v), (f)(3)","st":"regulation","ed":"2016-01-01","df":"no federal analogue"},{"k":"Notification after immunization","v":"The pharmacist must notify the physician who issued the written protocol within 24 hours and the patient's primary care physician within 14 days of administering an immunization or vaccination.","c":"22 TAC 295.15(g)(1)","st":"regulation","ed":"2016-01-01","df":"no federal analogue"},{"k":"Epinephrine administration - immediate steps and report","v":"Immediately after administering epinephrine the pharmacist must ensure 911 is called and that emergency personnel evaluate the patient for possible transfer to the nearest emergency department. The pharmacist must report the use to the patient's primary care physician as soon as practical and no later than 72 hours, giving the patient's name, the patient's age if under 8, the auto-injector's name and manufacturer, the date of administration, the name and title of the person who administered it, and the pharmacy's name, address and telephone number.","c":"22 TAC 295.16","st":"regulation","ed":"2016-12-19","df":"no federal analogue"},{"k":"Record retention","v":"Immunization records must be kept at least two years; epinephrine notifications must be kept at least two years and made available to TSBP and authorized law enforcement or regulatory agencies for inspection and copying.","c":"22 TAC 295.15(h)(1)(A); 22 TAC 295.16","st":"regulation","ed":"2016-12-19","df":"no federal analogue"},{"k":"Reporting adverse events to TSBP or a state agency","v":"Texas law does not address this. No Texas statute or TSBP rule requires a pharmacist to report a vaccine or drug adverse event to the board or to a state agency. Searched 22 TAC 295.15 and 295.16 and Tex. Occ. Code 554.004. Training must cover adverse-event documentation and reporting, but the reporting pathway is the federal one.","c":"22 TAC 295.15(c)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"Federal pathways alongside","v":"VAERS reporting for vaccines and MedWatch for drugs remain the operative reporting systems; the Texas covid-19 consent statute requires the DSHS information sheet to explain VAERS and how to report.","c":"Tex. Health & Safety Code 161.0086","st":"statute","ed":"2025-09-01","df":"false"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D3-A-01","facts":[{"k":"total members","v":"The Texas State Board of Pharmacy has 11 members.","c":"Tex. Occ. Code 552.001(a)","st":"statute","ed":"2013-09-01","df":"no federal analogue"},{"k":"pharmacist members","v":"Seven members must be licensed pharmacists. The board must include pharmacists practicing in Class A (community) and Class C (institutional) pharmacies.","c":"Tex. Occ. Code 552.001(a); Tex. Occ. Code 552.002(a)","st":"statute","ed":"2013-09-01","df":"no federal analogue"},{"k":"public members","v":"Three members are public (consumer) members. A public member is ineligible if the person or spouse holds a health care license, has specified business ties to a regulated entity, owns more than 10% of such an entity, or substantially uses board goods, services or funds.","c":"Tex. Occ. Code 552.001(a); Tex. Occ. Code 552.003","st":"statute","ed":"2013-09-01","df":"no federal analogue"},{"k":"pharmacy technician member (Texas-specific)","v":"One member must be a licensed/registered pharmacy technician. A dedicated technician seat is unusual among state boards.","c":"Tex. Occ. Code 552.001(a)","st":"statute","ed":"2013-09-01","df":"no federal analogue"},{"k":"appointing authority","v":"The governor appoints all members with the advice and consent of the Senate. The governor also designates the board president, who serves at the governor's pleasure.","c":"Tex. Occ. Code 552.001(a); Tex. Occ. Code 552.007(a)","st":"statute","ed":"2013-09-01","df":"no federal analogue"},{"k":"term length","v":"Staggered six-year terms. A member may not serve more than two consecutive full terms. The governor fills vacancies for the unexpired term.","c":"Tex. Occ. Code 552.005","st":"statute","ed":"2013-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D3-A-02","facts":[{"k":"rulemaking","v":"The board shall adopt rules consistent with Subtitle J to administer and enforce it, and shall set minimum standards for professional responsibility in the conduct of a pharmacy. It may also adopt rules administering listed Health and Safety Code controlled substance provisions (481.074-481.0769), and may apply an in-state pharmacy operating rule to a board-licensed out-of-state pharmacy when needed to protect Texans' health and welfare.","c":"Tex. Occ. Code 554.051(a), (a-1), (b), (d)","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"general administration and enforcement","v":"The board must administer and enforce the subtitle and its rules and other pharmacy laws, cooperate with state and federal agencies, maintain an office of permanent records, and preserve a record of its proceedings.","c":"Tex. Occ. Code 554.001(a)","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"inspection","v":"The board may inspect a facility licensed under the subtitle to determine compliance. Inspection scope covers drug storage and security, equipment, compounding components and labeling, sanitation, required records, and (only in a specific complaint investigation) financial records.","c":"Tex. Occ. Code 554.001(c)(2); Tex. Occ. Code 556.051","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"subpoena","v":"The board or an officer of the board may issue subpoenas ad testificandum and duces tecum to compel witness attendance and production of books, records and documents, administer oaths, and take testimony on matters within its jurisdiction. A person named in a subpoena may serve it.","c":"Tex. Occ. Code 565.058","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"emergency/temporary suspension","v":"A three-member disciplinary panel appointed by the board president must temporarily suspend or restrict a license if a majority finds the holder's continued practice is a continuing threat to the public welfare. It may act without notice or hearing if a hearing to decide whether to continue the action is already set within 14 days.","c":"Tex. Occ. Code 565.059","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"administrative penalty","v":"The board may impose an administrative penalty of up to $5,000 per violation, with each day a violation continues counting as a separate violation. The board must adopt a penalty schedule by rule.","c":"Tex. Occ. Code 566.002; 22 TAC 281.65","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"fee authority","v":"The board sets fees by rule and may issue duplicate licenses and renewal certificates for a fee.","c":"Tex. Occ. Code 554.006; Tex. Occ. Code 554.001(c)(1)","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"injunction and cease-and-desist","v":"The board may seek injunctive relief and may issue a cease and desist order.","c":"Tex. Occ. Code 566.051; Tex. Occ. Code 566.052","st":"statute","ed":"1999-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D3-A-03","facts":[{"k":"inspection scope","v":"The board or its representative may enter and inspect a facility to check drug storage and security, equipment, compounding components and labeling, sanitation and required records. Financial records may be inspected only in connection with a specific complaint investigation and only as to records related to that complaint.","c":"Tex. Occ. Code 556.051","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"notice before entry","v":"Texas does NOT expressly authorize unannounced inspection. Before entering, the board representative must state the purpose of the inspection and show the owner, pharmacist or agent in charge appropriate credentials and written notice of authority. Where a warrant supports the inspection, the warrant serves as that written notice.","c":"Tex. Occ. Code 556.052","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"what may be produced, copied and taken","v":"Unless a warrant provides otherwise, the representative may copy required records, inspect within reasonable limits, and inventory and take samples of drugs and components. Compounded-product test results are generally confidential, though the board may recall a product and release results where patient safety is at risk. Financial, sales (other than shipment) and pricing data obtained on inspection are not public information.","c":"Tex. Occ. Code 556.053; Tex. Occ. Code 556.054","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"warrantless entry","v":"No warrant is needed to inspect records under an administrative subpoena, or to enter and inspect where the owner, pharmacist or agent in charge consents, where there is imminent danger to public health and safety, where a conveyance is involved and obtaining a warrant is impracticable, or in an emergency such as a natural disaster. Otherwise a district judge may issue a warrant on sworn probable cause; it must be served during normal business hours and executed and returned within 10 days.","c":"Tex. Occ. Code 556.101; Tex. Occ. Code 556.103; Tex. Occ. Code 556.104; Tex. Occ. Code 556.105","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"refusing entry","v":"A pharmacy may not simply refuse. Refusing entry for an authorized inspection, where the pharmacist knew or should have known the inspection was authorized, is a statutory ground for discipline and is defined as unprofessional conduct by rule.","c":"Tex. Occ. Code 565.001(a)(11); 22 TAC 281.7(a)(7)","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"pharmacist records outside a pharmacy","v":"A pharmacist must provide records of practice occurring outside a pharmacy when the board requests them, within the time set by board rule.","c":"Tex. Occ. Code 556.057","st":"statute","ed":null,"df":"no federal analogue"},{"k":"after an inspection finds violations","v":"A board agent may issue a written warning notice listing the specific violations and allowing a reasonable time to comply, or may recommend action where previously cited violations continue or the violations are serious enough that a warning would not serve the public interest. The board treats a reasonable time as no less than 10 days before filing a complaint, except where imminent danger justifies an injunction.","c":"22 TAC 291.19; 22 TAC 291.18; Tex. Occ. Code 556.055","st":"regulation","ed":"2020-06-18","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D3-A-04","facts":[{"k":"statutory grounds for discipline (pharmacist)","v":"The board may discipline an applicant for or holder of a current or expired pharmacist license for, among other things: violating the subtitle or a board rule; unprofessional conduct; gross immorality; an incapacity preventing safe practice; fraud, deceit or misrepresentation; conviction or deferred adjudication for a moral-turpitude misdemeanor, a drug-law misdemeanor, or any felony; intemperate use of alcohol or drugs endangering a patient; failing to keep complete and accurate records of controlled substance or dangerous drug purchases and disposals; violating drug laws; aiding unlicensed practice; refusing an authorized inspection; negligence in practice; dispensing outside the usual course of professional practice; discipline by another board; violating a board order including a confidential Chapter 564 order; failing to supervise or inappropriately delegating to a technician; and being responsible for a drug audit shortage.","c":"Tex. Occ. Code 565.001(a)","st":"statute","ed":"2013-06-14","df":"no federal analogue"},{"k":"unprofessional conduct, top practice-triggerable grounds","v":"22 TAC 281.7(a) defines unprofessional conduct. The twelve most likely to be triggered in daily practice are: (1) dispensing under a forged, altered or fraudulent prescription - 281.7(a)(1); (2) dispensing under an order not issued for a legitimate medical purpose or in the usual course of practice, including grossly excessive quantities, dosages or durations - 281.7(a)(2); (3) refusing or failing to keep, maintain or furnish required records, notices or information - 281.7(a)(6); (4) refusing entry for an authorized inspection - 281.7(a)(7); (5) failing to maintain effective controls against diversion or loss of controlled substances or dangerous drugs or their records (PIC, owner, partner or managing officer) - 281.7(a)(23); (6) dispensing a prescription drug outside the usual course of professional practice - 281.7(a)(20); (7) dispensing controlled substances or dangerous drugs inconsistently with public health or welfare - 281.7(a)(12); (8) failing to practice consistently with public health and welfare - 281.7(a)(13); (9) refilling a 'prn' prescription more than one year after issuance - 281.7(a)(14); (10) providing false or fraudulent information on a required application, notification or document - 281.7(a)(21); (11) failing to correct issues identified in a warning notice within the time specified - 281.7(a)(24); (12) failing to respond to or produce records for a continuing education audit within the specified time - 281.7(a)(29). The full list runs to 30 items in 281.7(a), with gross immorality defined in 281.7(b) and fraud/deceit/misrepresentation in 281.7(c).","c":"22 TAC 281.7","st":"regulation","ed":"2020-03-05","df":"no federal analogue"},{"k":"grounds for discipline (pharmacy license)","v":"Separate grounds apply to a pharmacy, including failing to maintain effective controls against diversion shown by inadequate security or procedures, employing or allowing drug access by a person whose license or registration was revoked, cancelled, retired, surrendered, denied or suspended, trafficking in samples or in export-only/hospital-purchased/charity-donated drugs, handling misbranded or expired drugs, prior discipline of the owner or managing officer, a non-resident pharmacy failing to reimburse inspection expenses, abusive behavior toward board staff, and waiving or discounting a copayment for a compounded drug without documented hardship or a good-faith collection effort.","c":"Tex. Occ. Code 565.002; 22 TAC 281.8","st":"regulation","ed":"2016-09-11","df":"no federal analogue"},{"k":"sanctions available","v":"The board may suspend, revoke, restrict, refuse to issue or renew, place on probation with conditions and a probation fee, reprimand, retire the license, impose an administrative penalty under Chapter 566, or impose more than one of these.","c":"Tex. Occ. Code 565.051; 22 TAC 281.61","st":"statute","ed":"2005-09-01","df":"no federal analogue"},{"k":"administrative penalty amounts","v":"Maximum $5,000 per violation, each day a separate violation. The board's published schedule includes up to $5,000 for dispensing under a forged/unauthorized prescription or grossly excessive quantities; $2,500 for aiding unlicensed practice; $1,000-$2,500 for unlawful PMP access; $1,000 for failing to counsel, failing to perform drug regimen review, improper technician supervision, or failing to keep an annual inventory; $500 for failing to identify the dispensing pharmacist, violating a board order or impaired-pharmacist contract, practicing on a delinquent license, or failing to check the PMP before dispensing certain controlled drugs; and $100 per CE credit hour not produced on audit. Pharmacy amounts run to $5,000, with $3,000 for allowing unregistered technician work and $2,500 for failing to keep an annual inventory.","c":"Tex. Occ. Code 566.002; 22 TAC 281.65","st":"regulation","ed":"2020-09-09","df":"no federal analogue"},{"k":"aggravating and mitigating factors","v":"Sanctions are set using enumerated aggravating and mitigating factors and, for criminal offenses, separate consideration and sanction rules.","c":"22 TAC 281.62; 22 TAC 281.63; 22 TAC 281.64","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D3-A-05","facts":[{"k":"complaint filing","v":"A complaint may be filed in writing or on a board complaint form submitted by mail, other delivery or the Internet. The board must keep the form on its website and at its office. The form asks for the complainant's contact details, the subject's details, the incident date, a description of any drugs involved and a description of the incident. The board must adopt rules establishing methods of notifying consumers how to direct complaints to it.","c":"22 TAC 281.21; Tex. Occ. Code 555.002; Tex. Occ. Code 555.003","st":"regulation","ed":"2001-12-19","df":"no federal analogue"},{"k":"seven-year lookback limit","v":"The board may not consider or act on a complaint about a violation alleged to have occurred more than seven years before the board received the complaint.","c":"Tex. Occ. Code 555.007","st":"statute","ed":null,"df":"no federal analogue"},{"k":"investigation and disposition duties","v":"The board must adopt policies to assess complaint seriousness, prevent complaints being closed without appropriate consideration, and notify the complainant of the action taken; must give the complainant a chance to explain the allegations; must dispose of a complaint in a timely manner; and must establish a schedule for each phase of the investigation or disposition within its control. Staff may dismiss a complaint where investigation shows no violation or no jurisdiction, with dismissals reported at each public meeting. No fixed number of days is set in statute.","c":"Tex. Occ. Code 555.007; Tex. Occ. Code 555.006","st":"statute","ed":null,"df":"no federal analogue"},{"k":"ten-day wait after an inspection","v":"Where a complaint arises from an inspection warning notice, the board treats a reasonable time to comply as no less than 10 days from the inspection before a complaint may be filed, unless imminent danger to public health and safety justifies seeking an injunction immediately.","c":"22 TAC 291.18; Tex. Occ. Code 556.055","st":"regulation","ed":"2007-09-18","df":"no federal analogue"},{"k":"informal disposition","v":"Informal proceedings and informal disposition of a contested case are provided for by statute and rule.","c":"Tex. Occ. Code 565.056; 22 TAC 281.22","st":"statute","ed":null,"df":"no federal analogue"},{"k":"contested case hearing","v":"A disciplinary action on a Subchapter A ground is governed by the Administrative Procedure Act, Gov't Code ch. 2001, and the board's rules of practice and procedure. Chapter 564 impaired-pharmacist and peer review matters are excluded. Pleadings and notice, burden of proof, default on failure to attend, the proposal for decision and the record of hearing are addressed by rule.","c":"Tex. Occ. Code 565.061(a); 22 TAC 281.30; 22 TAC 281.31; 22 TAC 281.32; 22 TAC 281.33; 22 TAC 281.34","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"burden of proof","v":"The burden of proof in a contested case is addressed by both statute and rule.","c":"Tex. Occ. Code 565.062; 22 TAC 281.31","st":"statute","ed":null,"df":"no federal analogue"},{"k":"temporary suspension deadlines","v":"A three-member disciplinary panel may hold a hearing after the 10th day following notice to the license holder. Where the panel acts without notice, a panel hearing must be scheduled no later than the 14th day after the action. The board must initiate disciplinary action within 90 days of the suspension or restriction and soah must hold the contested case hearing; if it does not occur within the required time the license is automatically reinstated.","c":"Tex. Occ. Code 565.059","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"appeal","v":"Judicial review of a final board decision is available and is governed by Gov't Code ch. 2001.","c":"Tex. Occ. Code 565.061(b)","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"reinstatement","v":"A person whose license was revoked or restricted may petition for reinstatement or removal of the restriction; a revoked license may be reinstated no earlier than 12 months after revocation, on completion of board-set requirements.","c":"Tex. Occ. Code 565.101; Tex. Occ. Code 565.102; Tex. Occ. Code 565.103; 22 TAC 281.61; 22 TAC 281.66","st":"statute","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D3-A-06","facts":[{"k":"program exists","v":"Yes. The board is authorized to operate a program to aid impaired pharmacists and pharmacy students.","c":"Tex. Occ. Code 564.051","st":"statute","ed":null,"df":"no federal analogue"},{"k":"funding","v":"Funded by a surcharge of up to $10 for each 12 months of a license period added to a license or renewal fee, plus accepted federal, state, other public or private funds. Money goes to general revenue and may be used only to administer the program, including the initial evaluation and referral of an impaired pharmacist or student by a qualified health professional and related administrative costs. It may NOT pay for treatment or rehabilitation after that initial evaluation and referral.","c":"Tex. Occ. Code 564.051","st":"statute","ed":null,"df":"no federal analogue"},{"k":"confidentiality","v":"Yes, and broadly. Information about a report, including the identity of the person or entity making it, is confidential. Reports, interviews, statements, memoranda, evaluations and communications about a potentially impaired pharmacist or student are confidential, as is the identity of a program participant (except as 564.003 allows) and records of how the board, its agents or a pharmaceutical organization committee operate as to such a person. These are not public information under Gov't Code ch. 552 and are not subject to disclosure, subpoena or discovery, except for a board member or authorized agent involved in disciplining an applicant or license holder.","c":"Tex. Occ. Code 564.002; Tex. Occ. Code 564.003","st":"statute","ed":"2011-06-17","df":"no federal analogue"},{"k":"immunity and records","v":"Immunity is provided for reporting, and the chapter governs the record of a report and examination of a report.","c":"Tex. Occ. Code 564.004; Tex. Occ. Code 564.005; Tex. Occ. Code 564.006","st":"statute","ed":null,"df":"no federal analogue"},{"k":"does it substitute for discipline","v":"Not as a stated substitution. Chapter 564 operates alongside discipline rather than replacing it: violating a board order including a confidential order or contract issued under Chapter 564 is itself a statutory ground for discipline, and violating an impaired-pharmacist program contract carries a $500 administrative penalty under the board's schedule. The board may hold a disciplinary hearing in executive session for a pharmacist or student impaired by chemical abuse or mental or physical illness, and 565.061 excludes Chapter 564 matters from the ordinary contested-case track. A separate remedial plan mechanism exists for non-serious matters.","c":"Tex. Occ. Code 565.001(a)(17); 22 TAC 281.65; Tex. Occ. Code 552.011; Tex. Occ. Code 565.061(a); Tex. Occ. Code 565.060; 22 TAC 281.68","st":"statute","ed":null,"df":"no federal analogue"},{"k":"pharmacy peer review committee","v":"Separately from the impairment program, Texas provides for a pharmacy peer review committee. Its proceedings and records are confidential and communications to it are privileged, subject to a relevance exception for anticompetitive and 42 U.S.C. 1983 actions. Material may be shared with other peer review committees, state and federal agencies, accreditation bodies and licensing boards without waiver. A pharmacist facing censure, suspension, restriction, limitation, revocation or denial must receive a written copy of the recommendation and final decision with its basis. Reports the board receives are investigative files, confidential, and released only as 565.055 allows.","c":"Tex. Occ. Code 564.101; Tex. Occ. Code 564.102; Tex. Occ. Code 564.103; Tex. Occ. Code 564.104; Tex. Occ. Code 564.105; Tex. Occ. Code 564.106","st":"statute","ed":"2001-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D3-A-07","facts":[{"k":"civil penalty","v":"A person who violates the subtitle's license requirements is liable to the state for a civil penalty of up to $1,000 for each day the violation continues. A person the board finds to have unlawfully practiced pharmacy or unlawfully operated a pharmacy is subject to this penalty.","c":"Tex. Occ. Code 566.101","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"who collects the civil penalty","v":"The attorney general, or a district, county or city attorney, may collect it; venue is governed by statute.","c":"Tex. Occ. Code 566.102; Tex. Occ. Code 566.103; Tex. Occ. Code 566.104","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"criminal penalty","v":"Criminal offenses include violating the subtitle or a rule about unlawfully practicing pharmacy or unlawfully operating a pharmacy; knowingly violating the licensing requirements or 558.001, 558.002 or 560.002; and violating 560.001 (pharmacy license required) or 560.003 (prohibited advertising of a pharmacy). For the knowing-violation and pharmacy-license offenses each day is a separate offense. Each offense is a Class A misdemeanor.","c":"Tex. Occ. Code 566.151","st":"statute","ed":null,"df":"no federal analogue"},{"k":"administrative penalty","v":"Up to $5,000 per violation, each day a separate violation, set against enumerated factors (seriousness and hazard, economic harm, violation history, deterrence, corrective efforts, and what justice requires), with a penalty schedule adopted by rule.","c":"Tex. Occ. Code 566.002; 22 TAC 281.65","st":"statute","ed":"2005-09-01","df":"no federal analogue"},{"k":"pharmacy license required","v":"A person may not operate a pharmacy in Texas unless it is licensed by the board; an out-of-state pharmacy may not ship, mail or deliver prescription drugs or devices into Texas unless licensed or exempt.","c":"Tex. Occ. Code 560.001","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"other enforcement","v":"The board may seek injunctive relief and may issue a cease and desist order.","c":"Tex. Occ. Code 566.051; Tex. Occ. Code 566.052","st":"statute","ed":"1999-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D3-A-08","facts":[{"k":"published position on newsletter authority","v":"Texas law does not address this. The board has published no statement I could locate on whether its newsletter, policy statements, declaratory rulings or FAQs are binding, advisory or enforceable as rule.","c":"n/a","st":"silent","ed":null,"df":"no federal analogue"},{"k":"what the board does say about the newsletter","v":"The only published characterization is purposive, not legal. The board states the newsletter 'is published in an attempt to keep pharmacists, pharmacy owners, pharmacy technicians, and the public informed about law and rule changes, news, and other updates relating to the practice of pharmacy in Texas.' It makes no claim that the newsletter is official or binding and does not disclaim it either.","c":"Texas State Board of Pharmacy, Newsletter page, pharmacy.texas.gov/newsletter","st":"newsletter","ed":null,"df":"no federal analogue"},{"k":"board guidance documents carry no cited authority","v":"The board's own compliance guidance can and does omit legal citations. Its 'Reporting Theft and Loss' guidance document tells pharmacies what to file and where to send it but cites no statute or rule as its authority, which is itself evidence the board does not present guidance as rule.","c":"Texas State Board of Pharmacy, Reporting Theft and Loss guidance, pharmacy.texas.gov/files_pdf/rule-book/reporting-theft-and-loss.pdf","st":"board policy","ed":null,"df":"no federal analogue"},{"k":"what IS enforceable","v":"Discipline runs off the Pharmacy Act and the board's adopted rules: the statutory grounds in 565.001/565.002 reach a violation of 'this subtitle or a rule adopted under this subtitle', and the board's rulemaking duty under 554.051 is the mechanism by which a board position becomes enforceable. Nothing in the disciplinary grounds reaches a newsletter item as such.","c":"Tex. Occ. Code 565.001(a)(1); Tex. Occ. Code 554.051(a)","st":"statute","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D3-A-09","facts":[{"k":"expiration","v":"A pharmacist license expires on the last day of its assigned expiration month. To renew before expiration the board must receive the completed application and renewal fee on or before that day.","c":"22 TAC 295.7(1); 22 TAC 295.7(2)","st":"regulation","ed":"2006-03-06","df":"no federal analogue"},{"k":"grace period and late fees","v":"There is no separate grace period; there is a tiered late-renewal fee. Expired 90 days or less: renew by paying 1.5 times the standard renewal fee. Expired more than 90 days but less than one year: 2 times the standard renewal fee.","c":"22 TAC 295.7(3); 22 TAC 295.5","st":"regulation","ed":"2006-03-06","df":"no federal analogue"},{"k":"one year or more","v":"Renewal is no longer available. The person must apply for a new license under the rule governing application for a pharmacist license that has expired.","c":"22 TAC 295.7(3); 22 TAC 283.10","st":"regulation","ed":"2006-03-06","df":"no federal analogue"},{"k":"practice during lapse","v":"Prohibited. A person shall not practice pharmacy with an expired license. Practicing with a delinquent license carries a $500 administrative penalty under the board's schedule, and the board may discipline the holder of an expired license.","c":"22 TAC 295.7(3); 22 TAC 281.65; Tex. Occ. Code 565.001(a)","st":"regulation","ed":"2020-09-09","df":"no federal analogue"},{"k":"inactive status","v":"An inactive license status is separately provided for by rule.","c":"22 TAC 295.9","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D3-A-10","facts":[{"k":"published statement on state vs federal conflict","v":"Texas law does not address this. I located no current board publication stating how to apply state versus federal law when the two conflict.","c":"n/a","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D3-B-01","facts":[{"k":"who sets the schedules","v":"The Commissioner of the Department of State Health Services establishes and modifies Texas Schedules I through V. A reference to a schedule means the latest version the commissioner established or changed and published in the Texas Register on or after January 1, 1998.","c":"Tex. Health & Safety Code 481.032","st":"statute","ed":"2001-09-01","df":"true"},{"k":"relationship to federal scheduling","v":"Texas does NOT adopt federal scheduling automatically. On notice of a federal designation, rescheduling or deletion the commissioner shall make the same change after a 30-day period that begins the day after Federal Register publication, unless the commissioner objects within that period. If the commissioner objects, reasons are published, interested parties are heard, and a final decision is published; control of the substance is stayed from publication of the objection until the decision. Federal-conformity changes are exempt from the otherwise required Austin hearing.","c":"Tex. Health & Safety Code 481.034(g); Tex. Health & Safety Code 481.034(b)","st":"statute","ed":null,"df":"true"},{"k":"independent state scheduling","v":"The commissioner may add, delete or reschedule on state findings, with executive commissioner approval and an Austin hearing, weighing eight enumerated factors including abuse potential, dependence liability, public health risk, and whether the substance is an analogue or precursor. The commissioner may not re-add a substance the legislature deleted, delete one the legislature added, or reschedule one the legislature placed. Notice of action goes to the director and licensing agencies within 10 days.","c":"Tex. Health & Safety Code 481.034(a), (c), (d), (e), (h); Tex. Health & Safety Code 481.035","st":"statute","ed":null,"df":"true"},{"k":"publication and effective date","v":"The commissioner files a certified copy of each schedule with the secretary of state, who publishes it in the Texas Register no later than the fifth working day after the commissioner acts. Each published schedule shows changes since last publication. A scheduling action may take effect not earlier than the 21st day after Texas Register publication, except in an emergency requiring earlier action to avoid an imminent hazard to public safety.","c":"Tex. Health & Safety Code 481.036","st":"statute","ed":null,"df":"true"},{"k":"current Texas-only divergence: THC and marihuana extract definitions","v":"Texas's own modified Schedule I definitions of 'tetrahydrocannabinols' (item 31) and 'marihuana extract' (item 58) were reinstated by DSHS notice published 10 July 2026 at 51 TexReg 4597, effective 31 July 2026, after the Supreme Court of Texas reversed the temporary injunction in Sky Marketing Corp. v. Texas DSHS (opinion 1 May 2026, mandate 5 June 2026) that had forced their removal. The Texas definitions reach tetrahydrocannabinols beyond delta-9-THC, including synthetic equivalents, derivatives and isomers, and cannabinoid-containing extracts, with hemp exceptions. This is the live Texas-vs-federal scheduling divergence as of today.","c":"Texas Register 51 TexReg 4597 (10 July 2026), DSHS notice reinstating modifications to the 2021 Schedules of Controlled Substances; Tex. Health & Safety Code 481.032","st":"regulation","ed":"2026-07-31","df":"true"},{"k":"full list of Texas-only scheduled substances","v":"Texas law does not address this. As an exhaustive list. I could not enumerate every Texas entry that lacks a federal counterpart.","c":"n/a","st":"silent","ed":null,"df":"true"}],"ver":"2026-10-14","pc":"DSHS schedules are republished annually and amended by order through the year; re-verify against the next annual republication before this content ships.","vol":"high"},{"id":"D3-B-02","facts":[{"k":"separate state CSR required","v":"No. Texas requires only federal DEA registration. A person may not manufacture, distribute, prescribe, possess, analyze or dispense a controlled substance in Texas without a DEA registration or a DEA exemption, and a DEA registrant may engage in those activities within the scope of that registration.","c":"Tex. Health & Safety Code 481.061(a), (b)","st":"statute","ed":"2016-09-01","df":"false"},{"k":"the former Texas registration was repealed","v":"Texas formerly ran its own controlled substances registration through the Department of Public Safety. Subsections 481.061(c) and (d), which carried it, were repealed by Acts 2015, 84th Leg., R.S., Ch. 1268 (S.B. 195), Sec. 25(1), effective 1 September 2016. There is no state CSR to obtain or renew.","c":"Tex. Health & Safety Code 481.061(c), (d) (repealed); Acts 2015, 84th Leg., R.S., Ch. 1268 (S.B. 195), Sec. 25(1)","st":"statute","ed":"2016-09-01","df":"false"},{"k":"renewal cycle","v":"Not applicable - there is no state registration. The DEA registration cycle governs.","c":"Tex. Health & Safety Code 481.061(a)","st":"statute","ed":"2016-09-01","df":"false"},{"k":"exemptions","v":"Chapter 481 contains its own exemptions provision at 481.062. Its contents are NOT YET verified and must be read before this answer is published.","c":"Tex. Health & Safety Code 481.062 (unverified)","st":"statute","ed":null,"df":"false"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D3-B-03","facts":[{"k":"frequency","v":"Annual, not biennial. Class A, A-S, C, C-S and F pharmacies must take an inventory of all controlled substances on hand, including expired drugs, every year.","c":"22 TAC 291.17(c)(1)","st":"regulation","ed":"2026-09-01","df":"true"},{"k":"date and window","v":"On 1 May, or on the pharmacy's regular general physical inventory date. The inventory may be taken within four days of that date.","c":"22 TAC 291.17(c)(1)","st":"regulation","ed":"2026-09-01","df":"true"},{"k":"signature and dating (notarization REPEALED)","v":"Each person taking the inventory and the pharmacist-in-charge must note the time, sign and date it. The former requirement that the pharmacist-in-charge's signature be notarized within three business days was repealed in 2025 \u2014 proposed 27 June 2025 (50 TexReg 3719), adopted by the board 5 August 2025 and published 29 August 2025. Older study material still lists a notarization requirement; it is no longer the rule. The repeal also reached 291.17(d)(4) and (e)(2).","c":"22 TAC 291.17(c)(3)","st":"regulation","ed":"2025-08-29","df":"false"},{"k":"filing with anyone","v":"The inventory itself is not filed with the board. It is kept at the pharmacy. However, the pharmacy's renewal application must include an attestation that the annual inventory was conducted, the date it was taken, and the names of the persons who took it - so the fact of the inventory is reported to the board at renewal.","c":"22 TAC 291.17(c)(2); 22 TAC 291.17(a)(3)","st":"regulation","ed":"2026-09-01","df":"true"},{"k":"general inventory requirements","v":"Written, typed or printed (oral recordings promptly transcribed); kept at the pharmacy and available for inspection for two years; filed separately from all other records; listing all controlled substances on hand on the inventory date including expired stock; taken as of opening or closing of business with the record stating which, and the time for a 24-hour pharmacy; exact count or measure for Schedule II; estimated count for Schedules III-V except an exact count for any container holding more than 1,000 tablets or capsules; Schedule II listed separately from III-V; and any perpetual inventory reconciled on the inventory date.","c":"22 TAC 291.17(a)","st":"regulation","ed":"2026-09-01","df":"true"},{"k":"failure to keep an annual inventory","v":"Carries a $1,000 administrative penalty for a pharmacist and $2,500 for a pharmacy under the board's schedule.","c":"22 TAC 281.65","st":"regulation","ed":"2020-09-09","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D3-B-04","facts":[{"k":"initial inventory on opening","v":"A new Class A, A-S, C, C-S or F pharmacy must inventory all controlled substances on the day it opens. A pharmacy opening with no controlled substances must record that fact as its initial inventory. The initial inventory serves until the next 1 May or regular physical inventory date.","c":"22 TAC 291.17(b)","st":"regulation","ed":"2019-06-20","df":"true"},{"k":"change of ownership","v":"An inventory is required on the date ownership changes, covering all controlled substances including expired drugs. It serves as the seller's closing inventory and the buyer's initial inventory. Transfers of Schedule II substances require DEA Form 222. Signature and timing follow the annual-inventory rule (the notarization requirement in that rule was repealed in 2025).","c":"22 TAC 291.17(d)","st":"regulation","ed":"2019-06-20","df":"true"},{"k":"change of pharmacist-in-charge","v":"An inventory is required on the date of the change, covering all controlled substances including expired drugs. It serves as the departing pharmacist's closing inventory and the incoming pharmacist's beginning inventory. If the two cannot inventory together, each conducts a separate inventory. The incoming PIC must notify the board within 10 days.","c":"22 TAC 291.17(g); 22 TAC 291.3(e)(2)","st":"regulation","ed":"2019-06-20","df":"true"},{"k":"closing the pharmacy","v":"A closing inventory is required, and within 10 days of ceasing operation the pharmacist-in-charge must notify the board attesting to the closing inventory, its date, and how the drugs were transferred or disposed of.","c":"22 TAC 291.17(e); 22 TAC 291.5","st":"regulation","ed":"2023-12-04","df":"true"},{"k":"theft or significant loss","v":"Texas's inventory rule does not list theft or loss as an inventory trigger. The related duty is in the notification rule: where a loss from a fire or other disaster cannot be determined, the pharmacy must take a new complete inventory and submit a statement to DEA and to the board that the loss is indeterminable, with the inventory date.","c":"22 TAC 291.3(g)(1)(B)(ii)","st":"regulation","ed":"2023-12-04","df":"true"},{"k":"newly scheduled drug","v":"Texas's inventory rule is silent. The federal requirement to inventory a substance on the effective date of its scheduling applies.","c":"22 TAC 291.17 (silent); 21 CFR 1304.11(d)","st":"silent","ed":null,"df":"false"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D3-B-05","facts":[{"k":"retention period","v":"Two years. Records required under the Class A subchapter must be kept by the pharmacy and be available for at least two years from the date of the record for inspecting and copying by the board and other authorized agencies. Inventories specifically must be kept at the pharmacy and available for inspection for two years. Class C institutional pharmacies have the same two-year general rule.","c":"22 TAC 291.34(a)(1); 22 TAC 291.17(a)(3); 22 TAC 291.75(a)(1)(A)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"must they be kept on site","v":"Yes. Records must be maintained at the licensed location. Only invoices and financial data may be kept at a central location under stated conditions.","c":"22 TAC 291.34(a)(1); 22 TAC 291.34(j)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"72-hour production","v":"Texas adds a hard production deadline federal law does not: the pharmacy must produce requested records within 72 hours of the request. A Class E non-resident pharmacy must be able to provide a prescription record to the board within 72 hours of request.","c":"22 TAC 291.34(a)(1); 22 TAC 291.104(a)(2)(C)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"separation of controlled substance records","v":"Schedule II records must be kept separate from all other pharmacy records. Schedule III-V records must be kept separately or be readily retrievable - asterisked, red-lined or otherwise readily identifiable. The same separation applies in Class C.","c":"22 TAC 291.34(a)(2); 22 TAC 291.34(a)(3); 22 TAC 291.75(a)(2); 22 TAC 291.75(a)(3)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"the seven-year exception","v":"The log tying an initial or identification code to the person who used it is kept at least seven years, not two. See D4-B-01.","c":"22 TAC 291.34(i)(1); 22 TAC 291.75(e)(1)","st":"regulation","ed":"2022-03-15","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D3-B-06","facts":[{"k":"filing system","v":"Three separate files for original prescription drug orders: (i) Schedule II; (ii) Schedules III-V; and (iii) dangerous drugs and nonprescription drugs. Texas specifies the three-file system rather than permitting the federal two-file alternative.","c":"22 TAC 291.34(b)(6)(E)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"required marking","v":"Texas does not require a red 'C'. Where Schedule III-V records are not kept in a separate file, they must be asterisked, red-lined or in some other manner readily identifiable and retrievable from other records.","c":"22 TAC 291.34(b)(3)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"imaging","v":"Original prescriptions other than Schedule II may be stored in a direct imaging system, provided the same three-file separation and numerical order are maintained.","c":"22 TAC 291.34(b)(6)(F)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"legibility and retention of originals","v":"Original prescriptions must be maintained legible for two years from the date of filling or the date of the last refill.","c":"22 TAC 291.34(b)(6)(C)","st":"regulation","ed":"2022-03-15","df":"false"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D3-B-09","facts":[{"k":"to whom","v":"Two recipients. Texas requires written notice to the Texas State Board of Pharmacy IN addition to the federal DEA notification. A pharmacy shall report in writing to the board immediately on discovery the theft or significant loss of any controlled substance.","c":"22 TAC 291.3(f)(1); Tex. Occ. Code 562.106(b)","st":"regulation","ed":"2023-12-04","df":"true"},{"k":"Texas deadline","v":"Immediately on discovery, in writing. The statute requires a pharmacy to immediately report in writing any theft or significant loss of a controlled substance with a list of the substances involved. This is tighter than the federal one-business-day written notice.","c":"Tex. Occ. Code 562.106(b); 22 TAC 291.3(f)(1)","st":"statute","ed":"2015-09-01","df":"true"},{"k":"what is filed with the board","v":"A copy of DEA Form 106, or a list of all controlled substances stolen or lost.","c":"22 TAC 291.3(f)(1)","st":"regulation","ed":"2023-12-04","df":"true"},{"k":"federal duties unchanged","v":"The federal duties still run independently: written notice to the DEA Field Division Office within one business day of discovery, and a complete DEA Form 106 filed through DEA's secure network application within 45 calendar days of discovery.","c":"21 CFR 1301.76(b)","st":"regulation","ed":"2023-07-24","df":"true"},{"k":"board guidance on mechanics","v":"The board's published guidance directs the pharmacy to complete DEA Form 106, send the original and one copy to the DEA divisional office for its location (Dallas, Houston or San Antonio), send one copy to TSBP in Austin, and keep one copy on file for two years. It also singles out all dosage forms containing nalbuphine as reportable. Ambulatory surgical centers must additionally report theft or loss to the Texas Department of State Health Services, Health Facility Licensing and Compliance Division.","c":"Texas State Board of Pharmacy, Reporting Theft and Loss guidance, pharmacy.texas.gov/files_pdf/rule-book/reporting-theft-and-loss.pdf","st":"board policy","ed":null,"df":"true"},{"k":"record retention of the notification","v":"A pharmacy must keep a copy of each required notification for two years and make it available for inspection.","c":"Tex. Occ. Code 562.106(d)","st":"statute","ed":"2015-09-01","df":"true"},{"k":"failure to maintain controls","v":"Failing to maintain effective controls against diversion or loss of controlled substances or dangerous drugs is independently a ground for discipline for the PIC, owner, partner or managing officer, and for the pharmacy.","c":"22 TAC 281.7(a)(23); 22 TAC 281.8(a); Tex. Occ. Code 565.002(a)(9)","st":"regulation","ed":null,"df":"true"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D3-B-10","facts":[{"k":"duty exists for dangerous drugs","v":"YES, and it has no federal analogue. A pharmacy shall report in writing to the board immediately on discovery the theft or significant loss of any dangerous drug - that is, a non-controlled prescription/legend drug.","c":"22 TAC 291.3(f)(2)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"what must be reported","v":"A list of the name and quantity of each dangerous drug stolen or lost.","c":"22 TAC 291.3(f)(2)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"deadline","v":"Immediately on discovery, in writing. Same trigger as for controlled substances.","c":"22 TAC 291.3(f)(2)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"disaster losses of dangerous drugs","v":"Where a fire or other disaster destroys or causes loss of dangerous drugs, the pharmacy must notify the board in writing with a list. Where the loss cannot be determined, the pharmacy takes a new complete inventory and submits a statement to the board that the loss is indeterminable, covering both controlled substances and dangerous drugs.","c":"22 TAC 291.3(g)(1)(B)(i)(II); 22 TAC 291.3(g)(1)(B)(ii)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"form","v":"No form is prescribed by rule. Board guidance directs a letter to the board containing the pharmacy's name, address and TSBP license number; the name and quantity of each drug lost; the circumstances of the loss; and the date of the loss, with a copy kept on file for two years.","c":"Texas State Board of Pharmacy, Reporting Theft and Loss guidance, pharmacy.texas.gov/files_pdf/rule-book/reporting-theft-and-loss.pdf","st":"board policy","ed":null,"df":"no federal analogue"},{"k":"statutory counterpart","v":"Note the asymmetry: the statute's immediate-reporting duty in 562.106(b) is written for controlled substances only. The dangerous-drug duty lives in the board's rule, adopted under the board's general rulemaking authority.","c":"Tex. Occ. Code 562.106(b); 22 TAC 291.3(f)(2); Tex. Occ. Code 554.051(a)","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D3-B-11","facts":[{"k":"stock controlled substances","v":"A pharmacist licensed by the board shall dispose of stock controlled substances owned by a licensed pharmacy, following procedures authorized by the federal and Texas Controlled Substances Acts and the rules adopted under them. The Texas rule itself prescribes no separate procedure - it points to the federal/state CSA framework.","c":"22 TAC 303.2(c); 22 TAC 303.2(a)","st":"regulation","ed":"2015-03-15","df":"false"},{"k":"stock dangerous drugs","v":"A licensed pharmacist may destroy stock dangerous drugs owned by a licensed pharmacy, provided they are rendered unfit for human consumption and disposed of in compliance with applicable state and federal requirements. 'Stock' means dangerous drugs or controlled substances in the original manufacturer's container.","c":"22 TAC 303.2(b); 22 TAC 303.2(a)","st":"regulation","ed":"2015-03-15","df":"no federal analogue"},{"k":"drugs returned to the pharmacy by a patient","v":"A pharmacist may accept and destroy dangerous drugs previously dispensed to a patient and returned by the patient or the patient's agent. Controlled substances may be accepted only as federal DEA rules allow. The drugs must be rendered unfit for human consumption and disposed of under applicable state and federal requirements, and documentation must include the dispensing pharmacy's name and address, the prescription's unique ID number if available, the drug name and strength, and the pharmacist's signature.","c":"22 TAC 303.1(b)","st":"regulation","ed":"2023-03-07","df":"true"},{"k":"drugs dispensed to patients in a facility","v":"A consultant pharmacist in good standing may destroy them under a written agreement with the facility, after an inventory the consultant verifies, with enumerated content and witnessed destruction; or may transfer them to a waste disposal service meeting tceq and EPA rules, with a tamper-evident sealed container signed over by the consultant, secure storage, a transfer record and proof of destruction. Controlled substances, including dangerous drugs comingled with them in a shared container, are handled as DEA rules allow.","c":"22 TAC 303.1(a)(1); 22 TAC 303.1(a)(2)","st":"regulation","ed":"2023-03-07","df":"true"},{"k":"records of disposal","v":"All inventory records and forms for disposed drugs must be kept for two years from the date of transfer, disposal or destruction, available for inspection by an agent of the board, DPS, DEA or any other authorized agent. Facility destruction records are kept at the facility for two years from the destruction date.","c":"22 TAC 303.3; 22 TAC 303.1(a)(3)","st":"regulation","ed":"1984-04-25","df":"true"},{"k":"may a pharmacy act as an authorized collector","v":"Silent but covered by the federal framework. Chapter 303 creates no Texas authorized-collector or take-back registration and imposes no state condition on becoming one. A Texas pharmacy that wishes to act as a collector does so under the DEA take-back rules, and the Texas rule's repeated 'as federal DEA rules allow' formulation is what accommodates it.","c":"22 TAC 303.1(b); 22 TAC 303.2(c); 21 CFR Part 1317","st":"silent","ed":null,"df":"false"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D3-B-12","facts":[{"k":"kiosk placement, access and recordkeeping requirements","v":"Texas law does not address this. Texas has no board rule or statute I could locate setting requirements for a drug take-back kiosk or collection receptacle in a pharmacy - nothing on placement, access control, who may empty it, or kiosk-specific records.","c":"n/a","st":"silent","ed":null,"df":"false"},{"k":"what does govern","v":"A pharmacy operating a collection receptacle does so under the federal DEA take-back framework. The nearest Texas provisions are the disposal rules in Chapter 303 and the two-year record retention for disposal records, neither of which mentions a kiosk.","c":"22 TAC 303.1; 22 TAC 303.2; 22 TAC 303.3; 21 CFR Part 1317","st":"silent","ed":null,"df":"false"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D3-B-13","facts":[{"k":"Class C and C-S institutional pharmacies","v":"Required. A Class C or C-S pharmacy must maintain a perpetual inventory of all Schedule II controlled substances, and must reconcile it on the annual inventory date. The institutional records rule repeats the Schedule II perpetual inventory requirement.","c":"22 TAC 291.17(f)(1)(A); 22 TAC 291.17(f)(1)(B); 22 TAC 291.75(c)(4)(B)","st":"regulation","ed":"2019-06-20","df":"true"},{"k":"Class A community pharmacies","v":"NOT required. Texas does not mandate a perpetual inventory in a community pharmacy. If a pharmacy chooses to maintain one, the rule requires that it be reconciled on the date of the annual inventory. The board's security rule also lists perpetual inventories among optional contents of written security policies.","c":"22 TAC 291.17(a)(11); 22 TAC 291.33(b)(2)(E)","st":"regulation","ed":"2019-06-20","df":"true"},{"k":"institutional inventory location rules","v":"The Class C annual inventory must be kept at the pharmacy and must cover all controlled substances in the pharmacy and in any other department of the institution, with pharmacy stock listed separately and stock in other departments identified by department.","c":"22 TAC 291.17(f)(2)","st":"regulation","ed":"2019-06-20","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D3-B-14","facts":[{"k":"express prohibition","v":"None found in the Pharmacy Act, the board's rules or the Texas Controlled Substances Act. Texas is silent in the sense of having no flat statutory or TSBP-rule ban on a practitioner prescribing or dispensing a controlled substance for themselves or an immediate family member.","c":"n/a","st":"silent","ed":null,"df":"false"},{"k":"the general prohibition that does apply","v":"Silent but covered by a general prohibition. A practitioner may not prescribe, dispense, deliver or administer a controlled substance, or cause one to be administered under the practitioner's direction and supervision, except for a valid medical purpose and IN THE course OF medical practice. Anabolic steroids and human growth hormone carry an express additional limit, and bodybuilding or muscle enhancement in a healthy person is not a valid medical purpose.","c":"Tex. Health & Safety Code 481.071(a), (b), (c)","st":"statute","ed":null,"df":"false"},{"k":"the pharmacist's side of it","v":"A pharmacist may not dispense where the pharmacist knows or should have known the order was not issued within a valid patient-practitioner relationship, as that relationship is defined by the Texas Medical Board rule, or was issued in violation of the practitioner's standard of practice - including where the practitioner made no diagnosis using acceptable methods or prescribed unnecessary drugs. This is the operative constraint a Texas pharmacist is actually tested and disciplined on.","c":"22 TAC 291.29(b); 22 TAC 291.29(b)(2)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"unprofessional conduct backstop","v":"Dispensing under an order not issued for a legitimate medical purpose or in the usual course of professional practice is unprofessional conduct, as is dispensing a prescription drug outside the usual course of professional practice.","c":"22 TAC 281.7(a)(2); 22 TAC 281.7(a)(20)","st":"regulation","ed":"2020-03-05","df":"false"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D3-B-15","facts":[{"k":"corresponding responsibility expressed","v":"Yes, expressly. A pharmacist may not dispense a prescription the pharmacist knows or should know is fraudulent or forged, and must make reasonable efforts to prevent inappropriate dispensing, consistent with a 'corresponding responsibility'.","c":"22 TAC 291.29(f)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"red flags enumerated in rule","v":"YES - nineteen, to be assessed by the totality of the circumstances, which is unusually explicit. They are: substantially identical controlled substance prescriptions for numerous persons; low overall volume with a consistent one-to-one ratio of controlled substances to other drugs; routine prescribing of commonly abused drugs; nonspecific or missing diagnoses or intended use; highest strengths or large quantities; routine addition of dangerous drugs or OTC products; inability to reach the prescriber or get appropriate responses; an unregistered pain clinic prescribing opioids or benzodiazepines; drugs or quantities inconsistent with the prescriber's specialty; PMP data showing multiple prescribers or pharmacies; multiple people at one address with similar prescriptions; consistent cash or cash-equivalent payment; unusual presentation patterns such as shared vehicles or street names; prices significantly higher than nearby pharmacies; orders from multiple suppliers; supplier discontinuation of controlled substance orders; sporadic or zero dispensing volume; abnormal weekday operating hours; and prior TSBP warnings or discipline for controlled substance dispensing.","c":"22 TAC 291.29(f)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"questionnaire-based prescribing factors","v":"A separate list of seven suspicion factors applies where the pharmacist suspects a prescription was based solely on a questionnaire and/or without a documented examination: daily prescription volume; a disproportionate share of controlled-substance patients; how the prescription was authorized or received; distance between prescriber, patient and pharmacy; knowledge that the prescription was questionnaire-based; the pharmacy's association with a site marketing drugs without a valid prescription; and known doctor- or pharmacy-shopping.","c":"22 TAC 291.29(c)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"accuracy and authenticity duty","v":"A pharmacist must use sound professional judgment on the accuracy and authenticity of any prescription drug order, and must verify a questioned order with the practitioner before dispensing.","c":"22 TAC 291.29(a)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"pain management clinic bar","v":"A pharmacist may not dispense an order from a practitioner at a pain management clinic that is not complying with the Texas Medical Board's rules; certification of a clinic does not make its orders automatically valid. Chronic pain prescriptions must be dispensed consistently with TMB guidelines.","c":"22 TAC 291.29(e); 22 TAC 291.29(d)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"telemedicine","v":"Telemedicine and teledentistry prescriptions are held to the same standards as in-person prescriptions and must be issued for a legitimate medical purpose within a practitioner-patient relationship.","c":"22 TAC 291.29(g); Tex. Occ. Code 111.005","st":"regulation","ed":"2022-03-15","df":"false"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D3-B-16","facts":[{"k":"must not dispense","v":"A pharmacist may not dispense a prescription the pharmacist knows or should know is fraudulent or forged, and must make reasonable efforts to prevent inappropriate dispensing.","c":"22 TAC 291.29(f)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"must verify first","v":"Where the pharmacist questions the accuracy or authenticity of an order, the pharmacist must verify it with the practitioner before dispensing.","c":"22 TAC 291.29(a)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"must report to the board","v":"YES, and this is the Texas-specific duty. A pharmacy must report IN writing to the board immediately ON discovery that controlled substances or dangerous drugs were obtained by a forged prescription. The report must include the licensee's name, the dates of the forgery, the names and amounts of the drugs, and copies OF THE forged prescriptions.","c":"22 TAC 291.3(i)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"retention","v":"Because copies of the forged prescriptions go to the board, the originals are retained in the pharmacy's records; a copy of each required notification is kept two years. The rule does not direct the pharmacist to surrender the original to anyone.","c":"22 TAC 291.3(i); Tex. Occ. Code 562.106(d); 22 TAC 291.34(a)(1)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"notify police","v":"No duty found. Neither the notification rule nor the professional responsibility rule requires the pharmacist to notify law enforcement of a forged or suspicious prescription. Forgery offenses are prosecutable under the Controlled Substances Act's fraud provisions, but the reporting duty the board imposes runs to the board.","c":"22 TAC 291.3(i) (silent as to law enforcement)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"discipline if dispensed","v":"Dispensing under a forged, altered or fraudulent prescription is unprofessional conduct and carries an administrative penalty of up to $5,000 for a pharmacist and up to $5,000 for a pharmacy.","c":"22 TAC 281.7(a)(1); 22 TAC 281.65","st":"regulation","ed":"2020-09-09","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D3-B-17","facts":[{"k":"state registration of distributors, manufacturers or researchers","v":"Texas maintains no separate state controlled substance registration for any tier. The state registration subsections were repealed effective 1 September 2016, leaving federal DEA registration as the sole controlled substance registration applicable in Texas, within the scope of which a registrant may manufacture, distribute, analyze, dispense or conduct research.","c":"Tex. Health & Safety Code 481.061(a), (b); Tex. Health & Safety Code 481.061(c), (d) (repealed, Acts 2015, 84th Leg., R.S., Ch. 1268 (S.B. 195), Sec. 25(1))","st":"statute","ed":"2016-09-01","df":"false"},{"k":"does a pharmacy need one to transfer stock","v":"No separate state registration. Texas instead caps the volume: a pharmacy's distribution of controlled substances to other registrants is limited to 5.0% of all controlled substances dispensed and distributed by the pharmacy in a 12-month period, with record requirements. Exceeding the 5% threshold is what pushes a pharmacy into distributor status.","c":"22 TAC 291.34(h)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"Schedule II transfers","v":"Transfers of Schedule II controlled substances on a change of ownership require DEA Form 222, and Class C pharmacies must comply with DEA 222 requirements for Schedule II.","c":"22 TAC 291.17(d)(3); 22 TAC 291.75(e)","st":"regulation","ed":"2019-06-20","df":"false"},{"k":"state addition to the DEA 222 / CSOS scheme","v":"None found. No Texas statute or board rule adds a state filing, copy, or approval to the federal ordering scheme in 21 CFR Part 1305.","c":"21 CFR Part 1305; Texas: no analogue located","st":"silent","ed":null,"df":"false"},{"k":"wholesale drug distributor licensing","v":"Separate from controlled substance registration, Texas licenses wholesale drug distribution through DSHS. A person may not engage in wholesale distribution of nonprescription drugs in Texas without a wholesale drug distribution license from the department; the license expires on the second anniversary of issuance.","c":"Tex. Health & Safety Code 431.202","st":"statute","ed":"2011-09-01","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D3-B-18","facts":[{"k":"Schedule II distribution records","v":"Must show the patient, the prescriber, the drug name, dosage form and strength, the time, date and quantity administered, the individual administering, returns, and waste. Waste must be witnessed and cosigned.","c":"22 TAC 291.75(c)(4)(C)","st":"regulation","ed":"2021-06-09","df":"true"},{"k":"floor stock records, Schedules II-V","v":"Must show the same categories of detail including returns and waste, with waste witnessed and cosigned, and must be kept separate from patient records. A pharmacist must review floor stock records against medication orders at intervals NOT exceeding 30 days.","c":"22 TAC 291.75(c)(5)(A); 22 TAC 291.75(c)(5)(B); 22 TAC 291.75(c)(5)(C)","st":"regulation","ed":"2021-06-09","df":"true"},{"k":"withdrawal records when no pharmacist is on duty","v":"When no pharmacist is on duty, only a designated licensed nurse or practitioner may remove drugs for a bona fide patient, and a record is required at the time of withdrawal. The pharmacist must verify the withdrawals afterwards: within 72 hours where the institution has a full-time pharmacist, or within 7 days where the pharmacist is part-time or a consultant.","c":"22 TAC 291.74(e)(1); 22 TAC 291.74(e)(1)(A)(v); 22 TAC 291.74(e)(1)(B)(iv)","st":"regulation","ed":"2024-03-07","df":"true"},{"k":"floor stock withdrawal detail","v":"Each withdrawal must record the drug name, strength, dosage form, quantity, floor stock location, date and time, and the signature or electronic signature of the person removing it, with pharmacist verification within 7 days. Floor stock may be removed only in the original manufacturer's or a prepackaged container and only by a designated licensed nurse or practitioner.","c":"22 TAC 291.74(e)(2)(A); 22 TAC 291.74(e)(2)(B); 22 TAC 291.74(e)(2)(C); 22 TAC 291.74(e)(2)(D)","st":"regulation","ed":"2024-03-07","df":"true"},{"k":"rural hospital technician floor stock duties","v":"Where a rural hospital uses a pharmacy technician for certain floor stock duties, distribution records must be kept for two years and the pharmacist must verify them within 7 days.","c":"22 TAC 291.74(e)(3); Tex. Occ. Code 562.1011","st":"regulation","ed":"2024-03-07","df":"true"},{"k":"audit trails and other records","v":"The pharmacy must be able to produce distribution and return audit trails. Other required records include invoices bearing the pharmacist's initials and receipt date, credit memos, hard-copy inventories, surrender and destruction reports, a Schedule V nonprescription register, and distribution records to other registrants.","c":"22 TAC 291.75(c)(7); 22 TAC 291.75(d)(3); 22 TAC 291.75(d)(4); 22 TAC 291.75(e)(2); 22 TAC 291.75(e)(7)","st":"regulation","ed":"2021-06-09","df":"true"},{"k":"discrepancy resolution","v":"Texas does not use the phrase 'discrepancy resolution' and prescribes no discrete discrepancy-resolution procedure. The functional equivalents are the mandatory pharmacist review of floor stock records against medication orders at intervals not exceeding 30 days, the 72-hour / 7-day verification of withdrawals, and the Schedule II perpetual inventory reconciled annually. A significant loss of data system information must be reported to the board in writing within 10 days of discovery, and theft or significant loss of controlled substances must be reported to DEA and the board.","c":"22 TAC 291.75(c)(5)(C); 22 TAC 291.75(c)(6)(D); 22 TAC 291.75(e)(8)(A); 22 TAC 291.17(f)(1)(B)","st":"regulation","ed":"2021-06-09","df":"true"},{"k":"proof-of-use sheets","v":"Texas does not use the term 'proof of use'. The Schedule II distribution record in 291.75(c)(4)(C) is the Texas equivalent.","c":"22 TAC 291.75(c)(4)(C)","st":"regulation","ed":"2021-06-09","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D3-B-19","facts":[{"k":"institutional waste must be witnessed and cosigned","v":"In a Class C pharmacy, waste recorded on Schedule II distribution records and on floor stock records for Schedules II-V must be witnessed and cosigned.","c":"22 TAC 291.75(c)(4)(C); 22 TAC 291.75(c)(5)(B)","st":"regulation","ed":"2021-06-09","df":"true"},{"k":"who qualifies as a witness for institutional waste","v":"Texas law does not address this. The institutional records rule requires waste to be 'witnessed and cosigned' but does not define who may serve as the witness. No qualification standard for the cosigner appears in 291.75 or 291.74.","c":"22 TAC 291.75(c)(4)(C); 22 TAC 291.75(c)(5)(B)","st":"silent","ed":null,"df":"true"},{"k":"witnesses for destruction of drugs dispensed to patients in a facility - the enumerated Texas list","v":"Where a consultant pharmacist destroys dangerous drugs dispensed to patients in a health care facility, destruction must be witnessed by ONE of the following: a commissioned peace officer; an agent of the board; an agent of the Health and Human Services Commission authorized by the board; an agent of the Department of State Health Services authorized by the board; OR any TWO of these facility staff - the facility administrator, the director of nursing, the acting director of nursing, or a licensed nurse. This is an express, enumerated witness-qualification list of the kind the question is looking for.","c":"22 TAC 303.1(a)(1)(E)","st":"regulation","ed":"2023-03-07","df":"no federal analogue"},{"k":"documentation of that destruction","v":"The inventory the consultant pharmacist verifies must include the facility name and address, the consultant's name and license number, the destruction date, the dispensing date, the pharmacy's unique prescription number, the dispensing pharmacy's name, the drug name, strength and quantity, the consultant's signature, the witness signatures and the method of destruction. Signatures and method may appear on a cover sheet stating the number of attached pages, with each page initialed by the consultant and the witnesses. Drugs must be rendered unfit for human consumption. Records are kept at the facility for two years.","c":"22 TAC 303.1(a)(1)(B); 22 TAC 303.1(a)(1)(C); 22 TAC 303.1(a)(1)(D); 22 TAC 303.1(a)(3)","st":"regulation","ed":"2023-03-07","df":"no federal analogue"},{"k":"sealing for a waste disposal service","v":"Where a waste disposal service is used, the consultant pharmacist seals the container in the presence of the facility administrator and director of nursing, or another witness from the same enumerated list, applies tamper-resistant tape so reopening breaks it, and signs over the tape. The sealed container stays in a secure area until transferred, with a transfer record and proof of destruction from the service.","c":"22 TAC 303.1(a)(2)(B); 22 TAC 303.1(a)(2)(C); 22 TAC 303.1(a)(2)(D); 22 TAC 303.1(a)(2)(E)","st":"regulation","ed":"2023-03-07","df":"no federal analogue"},{"k":"controlled substance waste specifically","v":"Controlled substances, and dangerous drugs comingled with them in a shared container, are destroyed or transferred as federal DEA rules allow. The enumerated Texas witness list in 303.1(a)(1)(E) is written for dangerous drugs.","c":"22 TAC 303.1(a)(1); 22 TAC 303.1(a)(2); 22 TAC 303.2(c)","st":"regulation","ed":"2023-03-07","df":"false"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D3-B-20","facts":[{"k":"has Texas adopted Subpart P","v":"Texas adopted its own hazardous waste pharmaceutical rules at 30 TAC Chapter 335, Subchapter W, effective 3 February 2022, administered by the Texas Commission on Environmental Quality as the RCRA-authorized state.","c":"30 TAC Chapter 335, Subchapter W; 40 CFR 266 Subpart P","st":"regulation","ed":"2022-02-03","df":"true"},{"k":"sewering prohibition","v":"Tceq imposes a sewering ban at 30 TAC 335.761 applying to hazardous waste pharmaceuticals generated at healthcare facilities and reverse distributors.","c":"30 TAC 335.761","st":"regulation","ed":"2022-02-03","df":"false"},{"k":"non-controlled / non-hazardous pharmaceutical waste","v":"The sewering prohibition does NOT extend to non-hazardous pharmaceutical wastes. tceq's published position is that it discourages sewering of any pharmaceuticals in any setting, but that is guidance, not prohibition.","c":"30 TAC 335.761; Texas Commission on Environmental Quality, Hazardous Waste Pharmaceuticals Management, tceq.texas.gov/permitting/registration/ihw/pharm","st":"board policy","ed":"2022-02-03","df":"true"},{"k":"pharmacy-facing counterpart","v":"Independently of RCRA, Texas requires a disposal statement on the prescription. Written patient information and the container label must include 'Do not flush unused medications or pour down a sink or drain', unless the product is on the FDA flush list.","c":"Tex. Occ. Code 562.0062; 22 TAC 291.33(c)(1)(B); 22 TAC 291.33(c)(7)(A)","st":"statute","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D3-B-21","facts":[{"k":"program","v":"Texas authorizes low-THC cannabis only through the Compassionate Use Program, under which licensed dispensing organizations, not pharmacies, dispense. The program is administered by the Department of Public Safety.","c":"Tex. Health & Safety Code Chapter 487","st":"statute","ed":null,"df":"true"},{"k":"registry verification and recording","v":"Before dispensing, the dispensing organization must verify that the prescription is for a registered patient, that it matches the total amount in the registry, and that it has not been filled before. After dispensing, the organization must record in the compassionate-use registry the form and quantity dispensed and the date and time.","c":"Tex. Health & Safety Code 487.107","st":"statute","ed":null,"df":"true"},{"k":"pharmacist's role","v":"Texas law does not address this. I located no Texas provision requiring, or prohibiting, a pharmacist's involvement in a dispensing organization. Nothing in the Pharmacy Act or the board's rules that I read addresses low-THC cannabis.","c":"n/a","st":"silent","ed":null,"df":"true"},{"k":"reportable to the PDMP","v":"Texas law does not address this. 487.107 directs recording to the compassionate-use registry, which is a separate system from the Texas prescription monitoring program. I found no provision requiring low-THC cannabis to be reported to the PMP.","c":"Tex. Health & Safety Code 487.107 (registry only)","st":"silent","ed":null,"df":"true"},{"k":"scheduling interaction","v":"Separately, Texas's Schedule I definitions of 'tetrahydrocannabinols' and 'marihuana extract' were restored to their Texas-modified form effective 31 July 2026 following Sky Marketing Corp. v. Texas DSHS - see D3-B-01.","c":"Texas Register 51 TexReg 4597 (10 July 2026)","st":"regulation","ed":"2026-07-31","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"high"},{"id":"D3-C-01","facts":[{"k":"theft or significant loss of controlled substances","v":"Report in writing to the board immediately on discovery, with a copy of DEA Form 106 or a list of the substances. Federal DEA notification runs separately.","c":"22 TAC 291.3(f)(1); Tex. Occ. Code 562.106(b)","st":"regulation","ed":"2023-12-04","df":"true"},{"k":"theft or significant loss of dangerous drugs","v":"Report in writing to the board immediately on discovery, with the name and quantity of each drug. No federal analogue.","c":"22 TAC 291.3(f)(2)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"forged prescriptions","v":"Report in writing to the board immediately on discovery that controlled substances or dangerous drugs were obtained by a forged prescription, with the licensee's name, the forgery dates, the drug names and amounts, and copies of the forged prescriptions.","c":"22 TAC 291.3(i)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"disaster, accident or emergency affecting drugs","v":"A pharmacy must immediately report in writing any disaster, accident or emergency that may affect the strength, purity or labeling of a drug, medication, device or other treatment material; the PIC must report the disaster date to the board within 10 days.","c":"Tex. Occ. Code 562.106(c); 22 TAC 291.3(g)(1)(A)","st":"statute","ed":"2015-09-01","df":"no federal analogue"},{"k":"abuse, neglect or exploitation of an elderly or disabled person","v":"A pharmacist is covered. Anyone with cause to believe an elderly person, a person with a disability, or an individual receiving services from a covered provider is being abused, neglected or exploited must report immediately. Reports go to the department (dfps/HHS), or to the state agency that operates, licenses, certifies or registers the facility, or to the Health and Human Services Commission for certain waiver and institutional providers. The duty applies without exception to people whose knowledge comes from their employment or whose professional communications are normally confidential, expressly including medical practitioners. There is no shorter or longer professional deadline - it is immediate for everyone.","c":"Tex. Hum. Res. Code 48.051","st":"statute","ed":null,"df":"no federal analogue"},{"k":"child abuse or neglect (SETTLED \u2014 mandatory)","v":"Mandatory, and a pharmacist is covered. Tex. Fam. Code 261.101(a) requires any person with reasonable cause to believe a child's health or welfare has been adversely affected by abuse or neglect to report immediately. 261.101(b) imposes a shorter, specific duty on a 'professional': the report must be made NOT later than THE 48th hour after the professional first has reasonable cause to believe the child has been or may be abused or neglected. 'Professional' is defined as a state-licensed or state-certified individual, or an employee of a licensed, certified or state-operated facility, who has direct contact with children in the normal course of duties requiring that license \u2014 which reaches a pharmacist with direct patient contact. This duty sits in the Family Code, not the Pharmacy Act, which is why candidates miss it.","c":"Tex. Fam. Code 261.101(a), (b)","st":"statute","ed":null,"df":"no federal analogue"},{"k":"impaired colleague (SETTLED \u2014 permissive, not mandatory)","v":"Permissive. Tex. Occ. Code 564.001 uses 'may' throughout and never 'shall'. (a) any individual or entity with knowledge of conduct that might ground discipline under 565.001(a)(4) or (7) MAY report to the board; (b) a professional-society committee composed mainly of pharmacists, its staff, or a district or local intervenor in an impairment-assistance program MAY report in writing; (c) the board MAY pass information to such a committee. Contrast this with the child-abuse duty above, which is mandatory \u2014 the exam tests the difference.","c":"Tex. Occ. Code 564.001(a)-(c)","st":"statute","ed":"2011-06-17","df":"no federal analogue"},{"k":"out-of-state disciplinary action","v":"A non-resident pharmacy must report in writing not later than the 10th day after a final order against the pharmacy license holder, or against its pharmacist-in-charge, by the licensing agency of the state where the pharmacy is located.","c":"22 TAC 291.3(j); Tex. Occ. Code 562.106(a)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"professional liability claims","v":"A notice of claim letter or a filed complaint seeking damages for pharmaceutical care, and any settlement, must be reported - by the insurer, or by the licensee personally if uninsured or insured by a non-reporting carrier. Initial report within 30 days of receipt; follow-up report within 105 days after disposition.","c":"22 TAC 281.18; Tex. Occ. Code Chapter 569","st":"regulation","ed":"2000-03-29","df":"no federal analogue"},{"k":"pharmacist change of address or employment","v":"A pharmacist must report a change of address or place of employment in writing to the board not later than the 10th day after the change.","c":"Tex. Occ. Code 562.053; 22 TAC 295.1; 22 TAC 295.2","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"suspected diversion at the point of dispensing","v":"There is no separate 'report suspected diversion' filing. The duty is expressed as a refusal-to-dispense duty plus the forged-prescription report: the pharmacist must not dispense where the pharmacist knows or should know the order is fraudulent or forged, assessed against 19 enumerated red flags, and failure to maintain effective controls against diversion is itself a disciplinary ground.","c":"22 TAC 291.29(f); 22 TAC 281.7(a)(23); 22 TAC 281.8(a)","st":"regulation","ed":"2022-03-15","df":"false"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D3-C-02","facts":[{"k":"must a dispensing error be reported to the board","v":"No duty found. Neither the Pharmacy Act nor the board's records rules require a pharmacy or pharmacist to report a dispensing error to the board. The only board-reporting duty in the records rule concerns a significant loss of data processing system information, reported within 10 days of discovery, which is a data-loss duty rather than an error-reporting duty.","c":"22 TAC 291.34(e)(1)(E); 22 TAC 291.34(b)(9) (no reporting duty)","st":"silent","ed":null,"df":"false"},{"k":"must a dispensing error be reported to the patient","v":"No duty found. No Texas statute or board rule I read requires disclosure of a dispensing error to the patient.","c":"22 TAC 291.34(b)(9) (silent as to patient notification)","st":"silent","ed":null,"df":"false"},{"k":"what IS required - records relating to dispensing errors","v":"Texas regulates the evidence rather than the reporting. Where a dispensing error occurs: the original prescription drug order shall not be destroyed and must be maintained under the records rule, and shall not be altered - altering includes placing a label or any other item over any of the information on the order. A prescription record in a data processing system shall not be deleted and must be maintained; it may be changed only in compliance with the system-change provision, which requires the change to be documented and the individual responsible identified; and where the error was incorrect data entry, the record must be either voided or cancelled so the incorrect order cannot be dispensed, or the system must keep an audit trail of changes.","c":"22 TAC 291.34(b)(9)(A)(i); 22 TAC 291.34(b)(9)(A)(ii); 22 TAC 291.34(b)(9)(B)(i); 22 TAC 291.34(b)(9)(B)(ii); 22 TAC 291.34(b)(9)(B)(iii); 22 TAC 291.34(e)(2)(B)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"},{"k":"general continuous quality improvement mandate","v":"None. Texas imposes no general CQI program requirement on pharmacies. This is a notable Texas gap relative to states that mandate CQI.","c":"22 TAC 291.33 and 22 TAC 291.34 (no CQI program requirement)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"CQI where it IS required","v":"A continuous quality improvement program is required only in specific contexts: the policy and procedure manual for centralized prescription drug or medication order processing must include a continuous quality improvement program, reviewed at least annually and documented; and a pharmacy using an automated checking device must maintain continuous quality assurance with testing at least monthly. Class C automated medication supply systems require a written quality assurance program with continuous monitoring and accuracy testing at least every six months.","c":"22 TAC 291.123(d); 22 TAC 291.33(i)(3); 22 TAC 291.74(j)(2)(B)","st":"regulation","ed":"2019-06-20","df":"no federal analogue"},{"k":"is it privileged","v":"There is no CQI privilege as such, because there is no CQI mandate. The available privilege is the pharmacy peer review committee privilege: committee proceedings and records are confidential and communications to it are privileged, generally not subject to subpoena, discovery or admission in civil, judicial or administrative proceedings, with exceptions where a court preliminarily finds relevance to an anticompetitive action or a 42 U.S.C. 1983 action, where disclosure is required or authorized by law, or where the committee waives in writing. Sharing with the affected pharmacist does not waive confidentiality. Reports the board receives are investigative files, confidential, released only as 565.055 allows.","c":"Tex. Occ. Code 564.103; Tex. Occ. Code 564.104; Tex. Occ. Code 564.102","st":"statute","ed":"2001-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D3-C-03","facts":[{"k":"limitations period","v":"Two years. A health care liability claim must be filed within two years of the breach or tort, or of the date the medical or health care treatment that is the subject of the claim, or the related hospitalization, is completed. A claimant under 12 has until the 14th birthday.","c":"Tex. Civ. Prac. & Rem. Code 74.251(a)","st":"statute","ed":null,"df":"no federal analogue"},{"k":"statute of repose","v":"Ten years. A claim must be brought within 10 years of the act or omission giving rise to it; the provision is intended as a statute of repose, so a claim filed after that point is barred regardless of the two-year period.","c":"Tex. Civ. Prac. & Rem. Code 74.251(b)","st":"statute","ed":null,"df":"no federal analogue"},{"k":"noneconomic damages cap","v":"$250,000 per claimant against a physician or health care provider other than a health care institution, regardless of the number of defendants or causes of action, including anyone for whom vicarious liability applies. $250,000 per claimant against a single health care institution. Where more than one health care institution is liable, $250,000 per institution per claimant with an aggregate cap of $500,000 per claimant across all institutions.","c":"Tex. Civ. Prac. & Rem. Code 74.301","st":"statute","ed":null,"df":"no federal analogue"},{"k":"economic damages","v":"The cap in 74.301 is on noneconomic damages. Economic damages are not capped by that section.","c":"Tex. Civ. Prac. & Rem. Code 74.301","st":"statute","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D3-C-04","facts":[{"k":"insurance required to hold a license or permit","v":"No. Nothing in the Pharmacy Act or board rules that I read conditions a pharmacist license, technician registration or pharmacy license on carrying professional liability insurance. The board's rule expressly contemplates uninsured licensees: where a pharmacist, pharmacy technician or pharmacy 'does not carry or is not covered by' professional liability insurance, the reporting duty simply falls on the licensee personally.","c":"22 TAC 281.18","st":"regulation","ed":"2000-03-29","df":"no federal analogue"},{"k":"what is required instead - claims reporting","v":"Insurers or other entities providing pharmacist, pharmacy technician or druggist's professional liability insurance in Texas must report claims to the board; an uninsured licensee, or one insured by a non-admitted carrier or other entity that does not report, reports personally. Reportable are a notice of claim letter or a complaint filed in court seeking damages for providing or failing to provide appropriate pharmaceutical care, plus settlements. Initial report within 30 days of receiving the notice or complaint; follow-up report within 105 days after disposition, with separate reports for each defendant licensee on board forms.","c":"22 TAC 281.18; Tex. Occ. Code Chapter 569","st":"regulation","ed":"2000-03-29","df":"no federal analogue"},{"k":"exclusions from reporting","v":"Product liability, antitrust, improper peer review, civil rights, and premises liability claims without a breach of duty, such as slip-and-fall cases, are not reportable.","c":"22 TAC 281.18","st":"regulation","ed":"2000-03-29","df":"no federal analogue"},{"k":"failing to report is a disciplinary matter","v":"Failing to report malpractice claims carries a $1,000 administrative penalty for a pharmacist and $1,500 for a pharmacy under the board's schedule.","c":"22 TAC 281.65","st":"regulation","ed":"2020-09-09","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D4-A-01","facts":[{"k":"statutory classifications","v":"Each pharmacy license applicant must apply for one or more classifications. Class A: dispensing drugs or devices to the public under a prescription drug order - the community pharmacy license. Class B: dispensing radioactive drugs or devices for administration to an ultimate user - the nuclear pharmacy license. Class C: pharmacies in inpatient facilities such as hospitals, state-operated hospitals, hospice inpatient facilities and ambulatory surgical centers - the institutional pharmacy license. Class D: dispensing a limited type of drug or device under a prescription drug order - the clinic pharmacy license. Class E: out-of-state pharmacies whose primary business is dispensing and delivering prescriptions to patients including Texas patients, processing prescription orders, or performing other board-defined pharmaceutical services - the non-resident pharmacy license.","c":"Tex. Occ. Code 560.051","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"board may create more classes","v":"The board may establish additional classifications and decide which classification a pharmacy is licensed under. A petition process exists for establishing an additional class.","c":"Tex. Occ. Code 560.053; 22 TAC 291.22","st":"statute","ed":null,"df":"no federal analogue"},{"k":"sterile compounding subclasses","v":"Sterile compounding is a separate license designation, not an activity any pharmacy may add: Class A-S for community, Class C-S for institutional, Class E-S for non-resident. A Class A pharmacy is expressly prohibited from compounding sterile preparations; it must hold A-S. Non-sterile compounding is governed separately.","c":"22 TAC 291.36; 22 TAC 291.77; 22 TAC 291.106; 22 TAC 291.33(a)(10); 22 TAC 291.33(a)(9); 22 TAC 291.131; 22 TAC 291.133","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"Class F","v":"Pharmacies located in a freestanding emergency medical care facility, covering facilities licensed by DSHS and those operated by an exempt hospital.","c":"22 TAC 291.151","st":"regulation","ed":"2023-08-27","df":"no federal analogue"},{"k":"Class G","v":"Central prescription drug or medication order processing pharmacy. Any facility established for the primary purpose of processing prescription drug or medication drug orders must hold a Class G license. A Class G pharmacy MAY NOT store bulk drugs and MAY NOT dispense a prescription drug order - processing expressly excludes dispensing.","c":"22 TAC 291.153(a); 22 TAC 291.153(b)(1)","st":"regulation","ed":"2020-12-10","df":"no federal analogue"},{"k":"other activity-specific authorizations","v":"Remote pharmacy services including telepharmacy and emergency medication kits require compliance with 291.121; centralised dispensing and central order processing require compliance with 291.125 and 291.123; an emergency remote pharmacy license and a satellite pharmacy are separately provided for. A Class A licensee operating a Class B nuclear pharmacy need not obtain a second license but must follow the nuclear subchapter.","c":"22 TAC 291.33(a)(11); 22 TAC 291.33(a)(12); 22 TAC 291.127; 22 TAC 291.129; 22 TAC 291.33(a)(8)","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"one license per location, not transferable","v":"Each principal place of business requires its own license and a location may hold only one pharmacy license. A license is not transferable.","c":"Tex. Occ. Code 560.102; Tex. Occ. Code 560.101; 22 TAC 291.33(a)(6)","st":"statute","ed":"1999-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-A-02","facts":[{"k":"license required","v":"Yes. A pharmacy located in another state may not ship, mail or deliver prescription drugs or devices into Texas unless it is licensed by the board or exempt. The Class E pharmacy must register with the board on a pharmacy license application, and each principal place of business needs a separate license.","c":"Tex. Occ. Code 560.001(b); 22 TAC 291.104(a)(1); 22 TAC 291.104(a)(8)","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"isolated transactions exemption","v":"The board MAY grant an exemption from the licensing requirements to an out-of-state pharmacy whose dispensing to Texas residents is limited to isolated transactions.","c":"Tex. Occ. Code 560.004; 22 TAC 291.104(a)(10)","st":"statute","ed":null,"df":"no federal analogue"},{"k":"must the pharmacist-in-charge be Texas-licensed","v":"YES under the board's rule, and this is the heavily tested point. 22 TAC 291.103 requires a Class E pharmacy to designate a pharmacist who, effective 1 September 2016, is licensed AS A pharmacist IN texas to serve as pharmacist-in-charge. The board enforces it: operating a Class E or E-S pharmacy without a Texas-licensed pharmacist-in-charge carries a $1,000 administrative penalty.","c":"22 TAC 291.103; 22 TAC 281.65","st":"regulation","ed":"2016-09-01","df":"no federal analogue"},{"k":"tension with the statute","v":"Read the statute with care. Tex. Occ. Code 562.101 requires a Class E pharmacy to have continuous on-site supervision by a pharmacist and to designate one pharmacist 'licensed by the regulatory agency of the state in which the Class E pharmacy is located' as pharmacist-in-charge. The board's rule adds the Texas licensure requirement on top. Teach the rule's Texas-licensure requirement as the operative standard, but a candidate should know both texts exist.","c":"Tex. Occ. Code 562.101; 22 TAC 291.103","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"must other dispensing pharmacists be Texas-licensed","v":"Texas law does not address this. 291.103 addresses continuous on-site supervision and the pharmacist-in-charge designation; it does not state whether every pharmacist dispensing to a Texas patient must hold a Texas license. No provision resolving this was located \u2014 must be settled before publication.","c":"22 TAC 291.103 (silent)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"initial application conditions","v":"In addition to the general application procedures: evidence of a pharmacy license, registration or permit in the state where located; the names of the owner and pharmacist-in-charge for service of process; ability to provide a prescription record to the board within 72 hours of request; an affidavit by the pharmacist-in-charge that they have read and understand the Class E laws and rules; proof of creditworthiness; and an inspection report issued within two years before the application by the licensing board of the pharmacy's state, or by an alternative inspector substantively equivalent to a board inspection where that board does not inspect.","c":"22 TAC 291.104(a)(2)(A)-(F); Tex. Occ. Code 560.052","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"renewal condition","v":"An inspection report issued within three years before the renewal application.","c":"22 TAC 291.104(a)(3)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"operating conditions","v":"Report ownership changes, managing officer changes and closure within ten days. Where prescriptions are routinely delivered outside the local telephone service area, provide a toll-free line answered during normal business hours to reach a pharmacist, with both local and toll-free numbers on the label statement in English and Spanish. Shipments must maintain drug stability and temperature. Pharmacists must verify questionable orders and counsel patients. Transfer prescription information within four business hours of a request. Electronically report Schedule II-V prescriptions for Texas residents to the board by the next business day. Several duties apply unless compliance would violate the laws of the state where the pharmacy is located.","c":"22 TAC 291.104(a)(4), (a)(6), (a)(7); 22 TAC 291.104(b)(3)(D); 22 TAC 291.104(b)(3)(E); 22 TAC 291.104(b)(1)(B); 22 TAC 291.104(b)(1)(D); 22 TAC 291.104(e); 22 TAC 291.104(f); 22 TAC 291.104(c)(1); Tex. Occ. Code 562.104","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"inspection and discipline reach","v":"The board may inspect a non-resident pharmacy that compounds sterile preparations, and the pharmacy must reimburse the board's inspection expenses including travel; failing to reimburse is a ground for discipline. The board may discipline a non-resident pharmacy and must notify the resident state, and service of process provisions apply.","c":"Tex. Occ. Code 556.0551; 22 TAC 281.8(b)(6); Tex. Occ. Code 565.003; Tex. Occ. Code 565.053; Tex. Occ. Code 565.054","st":"statute","ed":null,"df":"no federal analogue"},{"k":"records retention for Class E","v":"Records must be kept and available for at least two years from the date of the record. A permanent record is required of civil litigation filed by a Texas resident and of complaints about a prescription for a Texas resident lost during delivery.","c":"22 TAC 291.105(a)(1)(A); 22 TAC 291.105(c); Tex. Occ. Code 562.105","st":"regulation","ed":"2013-12-10","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-A-03","facts":[{"k":"change of location","v":"A new pharmacy license application must be filed with the board AT least 30 days before the change; the board issues an amended license and a fee applies. At least 14 days before the change the pharmacist-in-charge must post a sign at the front of the prescription department and at all public entrances showing the move date. The statute independently requires written report at least 30 days before a change of location.","c":"22 TAC 291.3(a)(1)(A); 22 TAC 291.3(a)(1)(B); 22 TAC 291.3(a)(1)(C); 22 TAC 291.3(a)(2); Tex. Occ. Code 562.106(a-1)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"forced relocation","v":"A disaster or emergency that forces a move must be reported to the board immediately, and the PIC must still post the sign as far ahead as circumstances allow.","c":"22 TAC 291.3(a)(3)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"inspection consequences of a move","v":"A Class A-S, C-S or E-S pharmacy reverts to Class A, C or E after a move unless the board inspects the new location first. A Class B pharmacy must be inspected at its new location before becoming operational. Relocating within the same licensed address counts as a change of location for the security grandfather clause in 291.33(b)(2)(B)(i).","c":"22 TAC 291.3(a)(4); 22 TAC 291.3(a)(5); 22 TAC 291.33(b)(2)(B)(i)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"change of name","v":"A new application must be filed within 10 days of the name change; the board issues an amended license and a fee applies.","c":"22 TAC 291.3(b)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"change of ownership","v":"A new application is required, with a sworn disclosure statement and a copy of the purchase contract or mutual agreement, and a fee for a new license. The rule states no filing deadline for the application itself, but the statute requires written report to the board within 10 days after a change of ownership, and the Class A operational rule repeats the 10-day notice. An inventory is required on the date ownership changes.","c":"22 TAC 291.3(d); Tex. Occ. Code 562.106(a); 22 TAC 291.33(a)(2); 22 TAC 291.17(d)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"change of managing officers","v":"The owner must notify the board in writing within 10 days, with the effective date, an updated sworn disclosure statement, and for all managing officers the name and title, home address and phone number, date of birth, a copy of a social security card or other board-approved document, and a copy of a driver's license, state ID or passport. Managing officers are the top four executive officers including the officer in charge of pharmacy operations, who are jointly responsible for the pharmacy's legal operation.","c":"22 TAC 291.3(c)(1); 22 TAC 291.3(c)(2); 22 TAC 291.4","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"change of pharmacist-in-charge","v":"The incoming PIC must notify the board in writing within 10 days on a board form, giving the departing and incoming PICs' names and license numbers, the date the incoming PIC took over, and a signed statement that an inventory was conducted by both PICs, or an explanation if not, and that the incoming PIC has read and understands the laws and rules for this class of pharmacy. The statute also requires report within 10 days of a change of pharmacist-in-charge.","c":"22 TAC 291.3(e)(2); Tex. Occ. Code 562.106(a); 22 TAC 291.17(g)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"temporary closing for loss of PIC","v":"A pharmacy that temporarily closes because it lost its pharmacist-in-charge must notify the board on a board form NOT later than THE next business DAY after the PIC's departure.","c":"22 TAC 291.3(k); 22 TAC 291.5","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"change of telephone number","v":"NOT required. No notification duty to the board for a change of pharmacy telephone number appears in 291.3 or in 562.106. The only telephone references are consumer-facing - the board's number in the complaint notice, and the pharmacy's number on its website and public profile.","c":"22 TAC 291.3 (silent); Tex. Occ. Code 562.106 (silent)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"retention of notifications","v":"A pharmacy must keep a copy of each required notification for two years and make it available for inspection.","c":"Tex. Occ. Code 562.106(d)","st":"statute","ed":"2015-09-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-A-04","facts":[{"k":"advance notice and public sign","v":"At least 14 days before closing, a pharmacy that dispenses prescriptions must post a closing notice sign in the prescription department and at all public entrances, giving the closing date and the name, address and telephone number of the pharmacy acquiring the records.","c":"22 TAC 291.5","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"advance notice to DEA","v":"The pharmacist-in-charge must notify DEA of any controlled substances to be transferred to another registrant.","c":"22 TAC 291.5; 21 CFR 1301.52(d)","st":"regulation","ed":"2023-12-04","df":"false"},{"k":"on the closing day - inventory","v":"Take an inventory under the inventory rule. It is the closing inventory.","c":"22 TAC 291.5; 22 TAC 291.17(e)","st":"regulation","ed":"2023-12-04","df":"true"},{"k":"on the closing day - drugs","v":"Remove all prescription drugs by returning them to the manufacturer or supplier, transferring them to a person or pharmacy legally entitled to possess them, or destroying them under the stock disposal rule.","c":"22 TAC 291.5; 22 TAC 303.2","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"on the closing day - records","v":"If the pharmacy dispenses prescriptions, transfer prescription order files, refill information and patient medication records to a licensed pharmacy.","c":"22 TAC 291.5","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"on the closing day - signage","v":"Remove pharmacy signs, or notify the landlord or owner that continued use of the word 'pharmacy' or misleading graphics is unlawful.","c":"22 TAC 291.5; Tex. Occ. Code 560.002; Tex. Occ. Code 560.003","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"within 10 days after closing","v":"The pharmacist-in-charge must send the board written notice giving the actual closing date, the pharmacy license, an attestation that the inventory was completed and how the drugs were transferred or disposed of, and the name and address of the pharmacy that received the records. A pharmacy registered for controlled substances must also notify the appropriate DEA divisional office, returning its DEA registration certificate and all unused DEA 222 order forms marked void.","c":"22 TAC 291.5; 22 TAC 291.17(e)(1); Tex. Occ. Code 562.106(a)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"effect on the license","v":"The license cannot be renewed once the board is notified of closure. A new license may be applied for under the license application rule.","c":"22 TAC 291.5; 22 TAC 291.1","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"sudden or emergency closure","v":"Where a fire, natural disaster, eviction or bankruptcy prevents 14 days' notice, the pharmacy must comply with the notice requirements as far in advance as circumstances allow. A pharmacy closed by a disaster may not remain closed more than 90 days.","c":"22 TAC 291.5; 22 TAC 291.3(g)(1)(E); 22 TAC 291.11","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"temporary closure for lack of a PIC","v":"A pharmacy may close temporarily for lack of a pharmacist-in-charge for up to 30 days. During that time access to the prescription department is allowed only when a pharmacist is present and the board must be notified by the next business day. The pharmacy must then either reopen within 48 hours under a newly reported pharmacist-in-charge, or comply with the standard closing notice requirements.","c":"22 TAC 291.5; 22 TAC 291.3(k)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"who is responsible","v":"If the pharmacist-in-charge is unavailable, the owner is responsible for compliance. Ceasing to operate for 30 days or longer is itself a defined ground relating to the license.","c":"22 TAC 291.5; 22 TAC 291.11(a)(2); Tex. Occ. Code 565.002(a)(7); Tex. Occ. Code 565.0591","st":"regulation","ed":"2023-12-04","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-A-05","facts":[{"k":"may a non-pharmacist own a pharmacy","v":"Yes. Texas imposes no requirement that a pharmacy owner be a pharmacist. The qualifications provision requires only a license fee, a sworn application including notice that a surety bond may be required and proof that no applicable pharmacy or pharmacist license held by the applicant was restricted, suspended, revoked or surrendered, a statement of ownership and location with pharmacist and PIC license numbers, and a sworn disclosure statement. Nothing conditions ownership on licensure as a pharmacist.","c":"Tex. Occ. Code 560.052(b)","st":"statute","ed":null,"df":"no federal analogue"},{"k":"sworn disclosure statement","v":"Owners and managing officers must be disclosed on a sworn disclosure statement, unless the pharmacy is publicly traded, wholly owned by a retail grocery chain, or applying for a Class B or C license.","c":"Tex. Occ. Code 560.0521; 22 TAC 291.4; 22 TAC 291.3(c)","st":"statute","ed":null,"df":"no federal analogue"},{"k":"owner accountability","v":"Ownership carries disciplinary exposure rather than a licensure bar. A pharmacist who is a sole proprietor, individual owner, partner in ownership, or managing officer of an owning entity shares equal responsibility with the pharmacist-in-charge for maintaining effective controls against diversion or loss. Prior board discipline of the owner or managing officer is itself a ground for discipline against the pharmacy license. A surety bond may be required.","c":"22 TAC 281.7(a)(23)(B)-(D); 22 TAC 281.8(b)(5); Tex. Occ. Code 565.0551; 22 TAC 281.70","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"restriction on prescriber ownership or self-referral","v":"Texas law does not address this. I located no Texas pharmacy-law provision restricting a prescriber from owning a pharmacy or addressing self-referral of prescriptions to a prescriber-owned pharmacy.","c":"Tex. Occ. Code 560.052 (silent); Tex. Occ. Code Chapter 560 (silent)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"related prohibition on fee splitting","v":"Texas does prohibit the adjacent conduct: sharing, or offering to share, with a practitioner compensation received from an individual receiving pharmacy services is unprofessional conduct, and a separate rule governs sharing money received for a prescription.","c":"22 TAC 281.7(a)(16); 22 TAC 295.4; Tex. Occ. Code 562.011","st":"regulation","ed":"2020-03-05","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D4-A-06","facts":[{"k":"may a prescriber dispense from their own office","v":"Yes, for dangerous drugs, and without a pharmacy license. The Dangerous Drug Act's delivery offense does not apply to delivery by a practitioner in the course of practice, or by a registered nurse or physician assistant acting under the delegation rules in Occupations Code Chapter 157, provided the labeling condition is met.","c":"Tex. Health & Safety Code 483.042(a)(2); Tex. Occ. Code Chapter 157","st":"statute","ed":null,"df":"true"},{"k":"labeling required on office-dispensed drugs","v":"The label on the drug's direct container must show the prescribing practitioner's name and address, plus the nurse's or physician assistant's name and address if applicable; the date the drug is delivered; the patient's name, and the animal's species if for an animal; and the drug's name, strength and directions for use.","c":"Tex. Health & Safety Code 483.042(a)(2)","st":"statute","ed":null,"df":"no federal analogue"},{"k":"penalty for dispensing outside the exemption","v":"Violating the delivery provision is a state jail felony.","c":"Tex. Health & Safety Code 483.042","st":"statute","ed":null,"df":"no federal analogue"},{"k":"possession in the course of practice","v":"A practitioner may possess dangerous drugs in the usual course of business or practice; so may a pharmacy licensed by the board, a hospital obtaining drugs for lawful administration by a practitioner, licensed manufacturers and wholesalers, and others listed.","c":"Tex. Health & Safety Code 483.041(c)","st":"statute","ed":null,"df":"no federal analogue"},{"k":"must the prescriber register with the board of pharmacy","v":"Texas law does not address this. I located no requirement that a practitioner dispensing from their own office register with, or obtain a permit from, the Texas State Board of Pharmacy. The pharmacy licensing requirement attaches to operating a pharmacy, and the only exemption provision in Chapter 560 that I read concerns out-of-state isolated transactions, not office dispensing.","c":"Tex. Occ. Code 560.001(a); Tex. Occ. Code 560.004","st":"silent","ed":null,"df":"true"},{"k":"the Class D route","v":"Where a clinic dispenses a limited type of drug or device under a prescription drug order, the appropriate vehicle is a Class D clinic pharmacy license.","c":"Tex. Occ. Code 560.051; 22 TAC 291.91; 22 TAC 291.92; 22 TAC 291.93; 22 TAC 291.94","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"controlled substances dispensed by a practitioner","v":"Governed by the practitioner's DEA registration and by the requirement that a practitioner may not prescribe, dispense, deliver or administer a controlled substance except for a valid medical purpose and in the course of medical practice. Texas requires no separate state controlled substance registration.","c":"Tex. Health & Safety Code 481.071(a); Tex. Health & Safety Code 481.061(a)","st":"statute","ed":"2016-09-01","df":"false"},{"k":"quantity limits","v":"Texas law does not address this. No quantity limit on practitioner office dispensing appears in 483.042 or in the Chapter 560 provisions I read.","c":"Tex. Health & Safety Code 483.042 (silent as to quantity)","st":"silent","ed":null,"df":"true"},{"k":"recordkeeping limits","v":"Texas law does not address this. 483.042 imposes a labeling condition but states no recordkeeping requirement, and none was located elsewhere. A practitioner dispensing controlled substances remains subject to federal DEA recordkeeping.","c":"Tex. Health & Safety Code 483.042 (silent as to records); 21 CFR 1304.03","st":"silent","ed":null,"df":"true"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-B-01","facts":[{"k":"original prescription drug orders","v":"Two years from the date of filling or the date of the last refill. Must be maintained legible. Must not be destroyed or altered, including after a dispensing error.","c":"22 TAC 291.34(b)(6)(C); 22 TAC 291.34(b)(9)(A)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"refill records and dispensing records in a data processing system","v":"Two years. The system must be able to produce a drug usage audit trail for the preceding two years. Data purged during a system change is kept two years from the original entry date. Original and transferred prescription orders are kept two years from the last refill.","c":"22 TAC 291.34(e)(1)(C)(ii); 22 TAC 291.34(e)(1)(D)(iii); 22 TAC 291.34(g)(4)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"purchase invoices and credit memos from suppliers","v":"Two years under the general records rule. Supplier invoices and credit memos are expressly listed among the 'other records' a pharmacy must maintain, and the general rule requires records to be kept and available for at least two years from the date of the record. Class C invoices must bear the pharmacist's initials and the date of receipt.","c":"22 TAC 291.34(i); 22 TAC 291.34(a)(1); 22 TAC 291.75(d)(3)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"patient medication records / patient profiles","v":"Two years. A data processing system must additionally retain the previous 12 months of profile data online, and the profile must list prescriptions dispensed during the last two years.","c":"22 TAC 291.34(c)(4); 22 TAC 291.34(c)(3)(G)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"},{"k":"CQI records","v":"No such record type exists in Texas. Texas imposes no general continuous quality improvement program requirement, so there is no CQI record and no retention period for one. Where a CQI program is required - in the central processing policy and procedure manual - the manual must be available for inspection and reviewed at least annually, but no separate retention period is stated.","c":"22 TAC 291.123(d); 22 TAC 291.33 and 291.34 (no CQI record type)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"controlled substance records","v":"Two years, kept at the pharmacy. Schedule II records separate from all other records; Schedule III-V separate or asterisked, red-lined or otherwise readily identifiable. Inventories kept at the pharmacy, filed separately from all other records, available for inspection two years.","c":"22 TAC 291.34(a)(1); 22 TAC 291.34(a)(2); 22 TAC 291.34(a)(3); 22 TAC 291.17(a)(3); 22 TAC 291.17(a)(4)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"STATE-ONLY: log of initials or identification codes","v":"Seven years. A pharmacy using a data processing system must maintain a log of the initials or identification codes identifying each pharmacist, pharmacy technician and pharmacy technician trainee involved in dispensing. Each code must be unique, and the log must be maintained at least seven years from the date of the transaction. This is the Texas record type with no federal analogue, and it is three and a half times the two-year period that applies to almost everything else. The institutional pharmacy rule imposes the identical seven-year requirement.","c":"22 TAC 291.34(i)(1); 22 TAC 291.75(e)(1)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"},{"k":"STATE-ONLY: permanent record of civil litigation and lost-delivery complaints","v":"Permanent, with no end date. A pharmacy must maintain a permanent record of civil lawsuits filed against the pharmacy by a Texas resident, and of complaints about a prescription for a Texas resident that was lost during delivery. The Class E records rule repeats this. A second Texas-only record type with no federal counterpart and the only one with no expiry.","c":"Tex. Occ. Code 562.105; 22 TAC 291.105(c)","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"daily printout or sign-off log book","v":"The daily hard-copy printout must be produced within 72 hours of dispensing and kept in a separate file; where the alternative daily log book is used it is kept two years after the dispensing date.","c":"22 TAC 291.34(e)(2)(D); 22 TAC 291.34(e)(2)(F)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"},{"k":"delivery records","v":"Two years. Records of when drugs were sent and delivered, and of patient complaints about compromised deliveries, must be kept two years. Complaints may be documented in the patient profile. Where prescriptions are delivered by an agent during a pharmacist's temporary absence, a delivery record is kept with the date, prescription number, patient name, phone number and signature.","c":"22 TAC 291.12(d)(4); 22 TAC 291.33(b)(3)(A)(iv); 22 TAC 291.33(b)(3)(B)(v)","st":"regulation","ed":"2024-06-10","df":"no federal analogue"},{"k":"drug destruction and disposal records","v":"Two years from the date of transfer, disposal or destruction, available for inspection by an agent of the board, DPS, DEA or any other authorized agent. Consultant pharmacist facility destruction records are kept at the facility two years from the destruction date.","c":"22 TAC 303.3; 22 TAC 303.1(a)(3)","st":"regulation","ed":"1984-04-25","df":"no federal analogue"},{"k":"board notifications","v":"Two years. A pharmacy must keep a copy of each required notification, including reports under 562.053, and make it available for inspection. Copies of all inventories, reports and notifications arising from a fire or other disaster are also kept two years.","c":"Tex. Occ. Code 562.106(d); 22 TAC 291.3(g)(1)(G)","st":"statute","ed":"2015-09-01","df":"no federal analogue"},{"k":"prescriber consultation records","v":"Documented with the date, the name of the person relaying instructions, relevant details and the pharmacist's initials or identification code; retained under the general two-year rule.","c":"22 TAC 291.33(c)(2)(C); 22 TAC 291.34(l); 22 TAC 291.34(a)(1)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"prepackaging and med-pak records","v":"Prepackaging records must show the drug details, manufacturer and lot information, expiration, package quantity and count, packaging date, and signatures of the preparer and responsible pharmacist. Customized patient medication package records must include design specifications sufficient to recreate the med-pak. Retained under the general two-year rule.","c":"22 TAC 291.33(g)(3); 22 TAC 291.33(h)(6); 22 TAC 291.34(a)(1)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"on-site requirement and central records","v":"Records must be maintained at the licensed location. Only invoices and financial data may be kept at a central location, under stated conditions. Records must be produced within 72 hours of a request. Only the licensed pharmacy may own and maintain prescription drug records.","c":"22 TAC 291.34(a)(1); 22 TAC 291.34(j); 22 TAC 291.34(k)","st":"regulation","ed":"2022-03-15","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-B-02","facts":[{"k":"may records be electronic only","v":"Yes. An electronic data processing system may be used to maintain required records provided the system contains all the required information and the pharmacy can produce a hard copy. A pharmacy must use either the manual recordkeeping system or the data processing system, not both.","c":"22 TAC 291.34(a); 22 TAC 291.34(e); 22 TAC 291.34(f)","st":"regulation","ed":"2022-03-15","df":"false"},{"k":"must they be retrievable on site","v":"Yes. Records must be maintained at the licensed location and be available there for inspecting and copying by the board and other authorized agencies. Only invoices and financial data may be kept at a central location under stated conditions. Only the licensed pharmacy may own and maintain prescription drug records.","c":"22 TAC 291.34(a)(1); 22 TAC 291.34(j); 22 TAC 291.34(k)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"within what time","v":"72 hours. The pharmacy must produce requested records within 72 hours of the request. A Class E non-resident pharmacy must be able to provide a prescription record to the board within 72 hours of a request, and must transfer prescription information within four business hours of a request.","c":"22 TAC 291.34(a)(1); 22 TAC 291.104(a)(2)(C); 22 TAC 291.104(e)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"backup and audit trail","v":"The data processing system must maintain backups, produce a drug usage audit trail for the preceding two years, and retain data purged during a system change for two years from the original entry date.","c":"22 TAC 291.34(e)(1)(C)(ii); 22 TAC 291.34(e)(1)(D)(iii)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"remote access to the database","v":"An individual pharmacist, pharmacy technician or trainee licensed or registered in Texas may remotely access the pharmacy's electronic database from outside the pharmacy to process orders, provided the pharmacy establishes controls protecting the privacy and security of confidential records. Written prescription orders may not be received at, or kept at, a remote location.","c":"22 TAC 291.123(a)(2); 22 TAC 291.153(a)(2)","st":"regulation","ed":"2019-06-20","df":"true"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D4-B-03","facts":[{"k":"downtime procedure required","v":"Yes. The data processing system subsection expressly covers downtime procedures, and a pharmacy must maintain an auxiliary recordkeeping procedure for use during downtime.","c":"22 TAC 291.34(e)(1)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"reporting a significant loss of information","v":"A significant loss of information from the data processing system must be reported to the board IN writing within 10 days of discovery. The institutional pharmacy rule imposes the same 10-day written reporting duty.","c":"22 TAC 291.34(e)(1)(E); 22 TAC 291.75(c)(6)(D)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"},{"k":"data retained through a system change","v":"Data purged from the system during a change must be retained for two years from the date of original entry.","c":"22 TAC 291.34(e)(1)(D)(iii); 22 TAC 291.75(c)(6)(C)(iii)","st":"regulation","ed":"2022-03-15","df":"true"},{"k":"manual printout fallback","v":"Where there is no printer on site, a certified printout must be obtained within 72 hours. The daily printout itself must be produced within 72 hours of dispensing.","c":"22 TAC 291.34(e)(2)(F); 22 TAC 291.34(e)(2)(D)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"},{"k":"automated system downtime","v":"A pharmacy using an automated pharmacy dispensing system must have a written disaster or downtime recovery plan, including maintenance and testing of the plan. A Class C pharmacy using an automated medication supply system must have a written recovery plan and must notify THE board if downtime exceeds two days of operation or significantly limits services. A pharmacy using an automated pharmacy system at a remote site must have a written recovery plan for downtime.","c":"22 TAC 291.33(i)(2)(E); 22 TAC 291.74(j)(2)(E)(iv); 22 TAC 291.121(a)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"reconciliation after downtime","v":"No general reconciliation procedure is prescribed by rule beyond the duty to maintain the required records through the outage, the 10-day significant-loss report, and the ordinary verification duties.","c":"22 TAC 291.34(e)(1) (no express reconciliation procedure)","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-B-04","facts":[{"k":"daily printout required","v":"Yes. A pharmacy using a data processing system must produce a daily hard-copy printout of all original prescription drug orders dispensed and refilled, containing specified fields.","c":"22 TAC 291.34(e)(2)(C)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"},{"k":"when","v":"The printout must be produced within 72 hours of the dispensing and must be maintained in a separate file at the pharmacy.","c":"22 TAC 291.34(e)(2)(D)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"},{"k":"who signs","v":"Each pharmacist who dispensed or refilled a prescription drug order must verify that the data indicated is correct and must then sign AND date the printout within seven days. The signature must be in the same manner as the pharmacist would sign a check or legal document - initials are not sufficient.","c":"22 TAC 291.34(e)(2)(E)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"},{"k":"log book alternative","v":"In place of the printout, the pharmacy may maintain a bound log book or separate file in which each pharmacist involved in dispensing signs a statement each day attesting that the information entered that day was reviewed and is correct. An electronic signature is permitted. The log book is maintained for two years after the date of dispensing. Where no printer is on site, a certified printout must be obtained within 72 hours.","c":"22 TAC 291.34(e)(2)(F)","st":"regulation","ed":"2022-03-15","df":"no federal analogue"},{"k":"institutional equivalent","v":"Class C pharmacies must be able to produce distribution and return audit trails, with a two-year electronic audit trail retention option.","c":"22 TAC 291.75(c)(7); 22 TAC 291.75(c)(7)(D)","st":"regulation","ed":"2021-06-09","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D4-B-05","facts":[{"k":"permitted - community (Class A)","v":"Yes. A Class A pharmacy may use automated counting devices, automated pharmacy dispensing systems, and an automated checking device.","c":"22 TAC 291.33(i)(1); 22 TAC 291.33(i)(2); 22 TAC 291.33(i)(3)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"permitted - institutional (Class C)","v":"Yes. A Class C pharmacy may use an automated medication supply system under pharmacist-in-charge supervision, with pre-use accuracy testing and results available to the board on request, and the system available for board inspection.","c":"22 TAC 291.74(j)(2)(A)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"permitted - remote sites","v":"A Class A or Class C pharmacy may dispense through an automated pharmacy system at a remote site such as a jail or prison, or a health care facility regulated under listed Health and Safety Code chapters including 242 and 252, where drugs are administered by a licensed health care professional at the facility. A pharmacist at the provider pharmacy must release the initial dose and conduct a drug regimen review before release. Continuous supervision is required but the pharmacist need not be physically present if supervision is electronic.","c":"22 TAC 291.121(a); Tex. Occ. Code 562.109","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"who stocks","v":"Class A automated counting devices: only a pharmacist, or a pharmacy technician under the direct supervision of a pharmacist, may load bulk drugs. Class A automated pharmacy dispensing systems: stocking may be done by a pharmacist, or by a technician or trainee under supervision. Class C automated medication supply systems: stocking and retrieval access is limited to licensed health care professionals, pharmacy technicians or trainees under pharmacist supervision, with access assigned and changed by the pharmacist-in-charge.","c":"22 TAC 291.33(i)(1)(B); 22 TAC 291.33(i)(2)(B); 22 TAC 291.74(j)(2)(C)(i)(III); 22 TAC 291.32(a)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"who checks","v":"Class A: a pharmacist must check every prescription before delivery, unless either a pharmacist checks the final product after the system completes it, or a defined set of checks is performed including pharmacist verification of stocking and data entry plus electronic verification of label placement - that second path requires a fully automated process, detailed staff records, and accuracy testing monthly rather than every 12 months. An automated checking device may perform the final check only where a pharmacist either checks the final product or verifies the order and is responsible for the device's final check; a technician may NOT override device errors, and a pharmacist must review and correct them. Class C: pharmacist review of new orders before withdrawal, or retrospectively within 72 hours for a full-time pharmacist or 7 days for a part-time or consultant pharmacist.","c":"22 TAC 291.33(i)(2)(F); 22 TAC 291.33(i)(3); 22 TAC 291.74(j)(2)(C)(i)(II)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"accuracy auditing intervals","v":"Class A automated pharmacy dispensing system: continuous monitoring, accuracy tested at least every 12 months and after any upgrade or change, with documentation - but monthly if the alternative final-check pathway is used. Class A automated checking device: tested at least monthly, with continuous quality assurance. Class A automated counting devices: calibrated and accuracy-verified routinely, documented. Class C automated medication supply system: written quality assurance program with continuous monitoring and accuracy testing at least every six months plus after any upgrade or change, reduced to monthly where a pharmacist performs the final check. Remote site automated pharmacy system: tested at least every six months and after any upgrade or change.","c":"22 TAC 291.33(i)(2)(C); 22 TAC 291.33(i)(2)(F); 22 TAC 291.33(i)(3); 22 TAC 291.33(i)(1)(A); 22 TAC 291.74(j)(2)(B); 22 TAC 291.74(j)(3)(B)(iv); 22 TAC 291.121(a)","st":"regulation","ed":"2026-03-01","df":"true"},{"k":"required written policies","v":"Class A: written policies covering pharmacist review before each prescription is transmitted, restricted system access, pharmacist verification of stocking before filling, an accountability record for all stocking and removal, prospective drug regimen review, and preventive maintenance, reviewed at least annually, plus a written disaster or downtime recovery plan that is maintained and tested. Class C: written policies reviewed at least annually and a written recovery plan, with board notification if downtime exceeds two days of operation.","c":"22 TAC 291.33(i)(2)(D); 22 TAC 291.33(i)(2)(E); 22 TAC 291.74(j)(2)(C)(ii); 22 TAC 291.74(j)(2)(E)(iv)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"loading records","v":"Automated counting device loading records must show the drug details, manufacturer, lot, expiration, loading date and the signatures of the person loading and the responsible pharmacist, and the device may not be used until a pharmacist verifies the loading and signs the record. Container labels must show the brand name and strength, or the generic name, strength and manufacturer.","c":"22 TAC 291.33(i)(1)(D); 22 TAC 291.33(i)(1)(E); 22 TAC 291.33(i)(1)(C)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"PIC duties for automated systems","v":"Where the pharmacy uses an automated dispensing system the pharmacist-in-charge must consult on its policies, inspect ITS medications AT least monthly, assign or change personnel access, ensure staff training, and maintain stocking and accountability records.","c":"22 TAC 291.32(a)","st":"regulation","ed":"2025-05-28","df":"no federal analogue"},{"k":"automated dispensing and delivery systems for patient pickup","v":"A separate category: systems that dispense and deliver prescriptions to patients at remote delivery sites. Patients must be counseled by a Texas-licensed pharmacist through audio or video and must have the option to use the system. Such a system may be used to pick up previously verified prescriptions while the pharmacist is off site.","c":"22 TAC 291.121(d); 22 TAC 291.33(b)(3)(B)(iii)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-B-06","facts":[{"k":"remote processing permitted","v":"Yes. Centralized prescription drug or medication order processing is permitted. Processing must occur at a facility licensed as a Class A, Class C or Class E pharmacy, or at a Class G central processing pharmacy.","c":"22 TAC 291.123(a)(2); 22 TAC 291.153(a)","st":"regulation","ed":"2019-06-20","df":"no federal analogue"},{"k":"from home","v":"Yes. An individual pharmacist, pharmacy technician or technician trainee licensed OR registered IN texas may remotely access the pharmacy's electronic database from outside the pharmacy to process orders, provided the pharmacy establishes controls protecting the privacy and security of confidential records. Working from a pharmacist's home falls within this exception. Written prescription drug orders may not be received at, or maintained at, the remote location.","c":"22 TAC 291.123(a)(2); 22 TAC 291.153(a)(2)","st":"regulation","ed":"2019-06-20","df":"no federal analogue"},{"k":"from another state","v":"NOT expressly addressed. The rule conditions remote access on the individual holding a Texas license or registration; it does not say whether the individual may be physically located outside Texas. Texas licensure of the individual is the stated requirement.","c":"22 TAC 291.123(a)(2)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"what processing covers","v":"Receiving, interpreting or clarifying orders; entering and transferring order data; performing drug regimen review; obtaining refill and substitution authorizations; verifying data entry; interpreting clinical data for prior authorization; performing therapeutic interventions; and providing drug information about a patient's prescription. Processing expressly excludes dispensing.","c":"22 TAC 291.153(b)(1)","st":"regulation","ed":"2020-12-10","df":"no federal analogue"},{"k":"Class G license","v":"Any facility established for the primary purpose of processing prescription drug or medication drug orders must hold a Class G pharmacy license. It registers with the board, needs a separate license for each principal place of business, and pays issuance and renewal fees. A Class G pharmacy may NOT store bulk drugs and may NOT dispense a prescription drug order.","c":"22 TAC 291.153(a); 22 TAC 291.153(b)(1)","st":"regulation","ed":"2020-12-10","df":"no federal analogue"},{"k":"outsourcing conditions","v":"A pharmacy may outsource processing to another Class A, C or E pharmacy only where the two share the same owner, or have a written contract, and they share a common electronic file or technology giving access to the information needed for non-dispensing functions. The contract must outline the services, each pharmacy's responsibilities and accountabilities, and compliance with federal and state law. The processing pharmacy must also follow the rules for its own class, including which duties require a pharmacist and technician supervision requirements.","c":"22 TAC 291.123(b); 22 TAC 291.123(c)","st":"regulation","ed":"2019-06-20","df":"no federal analogue"},{"k":"policy and procedure manual","v":"Each pharmacy involved must maintain the relevant portions and make them available for inspection. The manual must outline each pharmacy's responsibilities; list the name, address, telephone numbers and all license or registration numbers of each pharmacy involved; and include policies for protecting patient information confidentiality and integrity, tracking the identity and activity of staff performing processing, legal compliance, a continuous quality improvement program, and an annual documented review.","c":"22 TAC 291.123(d)","st":"regulation","ed":"2019-06-20","df":"no federal analogue"},{"k":"patient notice","v":"Before outsourcing, the pharmacy must notify patients that processing may be outsourced and name the other pharmacy; where processing may be done by any pharmacy in a commonly owned network, patients must be told that instead. A one-time written notice or a sign in the pharmacy suffices. Hospitals and nursing homes are exempt.","c":"22 TAC 291.123(c)","st":"regulation","ed":"2019-06-20","df":"no federal analogue"},{"k":"records","v":"Records must identify, for each prescription drug or medication order, the name, initials or identification code of each pharmacist, technician or trainee who performed a processing function. Records may be kept separately by each pharmacy and pharmacist, or in a common electronic file, provided the system can print a list of the functions each pharmacy and pharmacist performed.","c":"22 TAC 291.123(e)","st":"regulation","ed":"2019-06-20","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-B-07","facts":[{"k":"telepharmacy permitted","v":"Yes. A Class A pharmacy may provide telepharmacy services at a remote health care site or a remote dispensing site. A Class C pharmacy may serve only a health care facility.","c":"22 TAC 291.121(c)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"eligible sites","v":"Remote health care sites include rural health clinics, health centers, and facilities in federally designated medically underserved areas or health professional shortage areas, among others. A remote dispensing site is a location licensed as a telepharmacy. A provider pharmacy may operate at no more than TWO remote dispensing sites.","c":"22 TAC 291.121(c)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"distance and proximity limits","v":"A remote health care site may not operate if a Class A or Class C pharmacy dispensing to outpatients is in the same 'community', defined as the census tract within a Metropolitan Statistical Area, or the area within 10 miles of the site if outside an MSA; federally qualified health centers are excepted. A remote dispensing site may not operate if a Class A pharmacy is within 22 road miles. An existing site may continue operating if a competing pharmacy opens later.","c":"22 TAC 291.121(c)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"supervision","v":"Each supervising pharmacist may oversee NO more than TWO remote sites open at the same time. The site must be under continuous electronic supervision by a pharmacist at the provider pharmacy whenever it is open; the pharmacist need not be physically present.","c":"22 TAC 291.121(c)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"camera and technology requirements","v":"Electronic supervision uses audio AND video, still image capture, and store-and-forward technology. Counseling and the final check may be performed electronically; the final check is a visual check using electronic methods.","c":"22 TAC 291.121(c)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"who may be on site and what they may do","v":"Pharmacists employed by the provider pharmacy, pharmacy technicians, and, at remote health care sites, licensed health care providers. Individuals must be designated in writing by the pharmacist-in-charge and complete documented training. only a pharmacist at the provider pharmacy may receive oral orders for controlled substances, verify entries, select products, conduct drug regimen review, authorize label printing, perform the final check, and counsel patients; a remote-site technician may receive oral orders for dangerous drugs only. A remote dispensing site must have an on-site pharmacy technician under continuous pharmacist supervision, with a technician-to-pharmacist ratio not exceeding three TO ONE. Remote dispensing site technicians need one year of retail pharmacy experience within the prior three years plus telepharmacy training, and may not compound.","c":"22 TAC 291.121(c)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"Schedule II bar and on-site visits","v":"A remote dispensing site may NOT dispense Schedule II controlled substances. A pharmacist must make at least monthly on-site visits to a remote dispensing site and must be physically present for services requiring it, such as immunizations.","c":"22 TAC 291.121(c)","st":"regulation","ed":"2023-12-04","df":"true"},{"k":"licensing and registration","v":"An application is filed with the board and must be resubmitted every two years with the provider pharmacy's license renewal, with a fee. The board issues a license for each remote site, which must be displayed there. Closure or discontinuance must be reported to the board within ten days. Testing is required before startup and at least every six months.","c":"22 TAC 291.121(c); 22 TAC 291.6(e)(3); Tex. Occ. Code 562.110","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"volume trigger to full licensure","v":"If a remote dispensing site averages more than 125 prescriptions PER DAY open in a calendar year, it must apply for a Class A pharmacy license.","c":"22 TAC 291.121(c)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-B-08","facts":[{"k":"dedicated cybersecurity or access-control rule","v":"Texas law does not address this. Texas has no pharmacy-specific cybersecurity rule - nothing on encryption, authentication standards, breach notification to the board, penetration testing or vendor security.","c":"n/a","st":"silent","ed":null,"df":"no federal analogue"},{"k":"the general access-control and security provisions that do exist","v":"Silent but partly covered by general provisions. A pharmacy outsourcing order processing must establish controls protecting the privacy and security of confidential records, and its policy manual must include policies for protecting patient information confidentiality and integrity and for tracking the identity and activity of staff who perform processing. An automated pharmacy dispensing system must have written policies restricting system access. Identification codes must be unique to each individual and logged for seven years. Data processing system backups and audit trails are required, and a significant loss of system information must be reported to the board in writing within 10 days. Confidentiality of records and access to confidential records are separately regulated.","c":"22 TAC 291.123(a)(2); 22 TAC 291.123(d); 22 TAC 291.33(i)(2)(D); 22 TAC 291.34(i)(1); 22 TAC 291.34(e)(1); 22 TAC 291.34(e)(1)(E); 22 TAC 291.27; 22 TAC 291.28; Tex. Occ. Code 562.102; Tex. Occ. Code 562.052","st":"regulation","ed":"2022-03-15","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-B-09","facts":[{"k":"central fill permitted","v":"Yes. A Class A or Class C pharmacy may outsource the dispensing of prescription drug orders to a central fill pharmacy where both share the same owner, or where they have a written contract and can access the information needed to dispense or process the order. A Class E pharmacy may do so unless that would violate the pharmacy or drug laws of the state where it is located.","c":"22 TAC 291.125(c)(1)(A); 22 TAC 291.125(c)(1)(B)","st":"regulation","ed":"2022-08-24","df":"true"},{"k":"must the central site hold a separate permit","v":"Not a separate permit class. The central fill pharmacy must hold one of the listed pharmacy classes - Class A, A-S, C, C-S, E or E-S. A nonresident central fill pharmacy need NOT be licensed as Class E where it does not ship, mail or deliver drugs directly to patients in Texas.","c":"22 TAC 291.125(b)(1); 22 TAC 291.125(e)","st":"regulation","ed":"2022-08-24","df":"true"},{"k":"whose name and address appear on the label","v":"The name and address of the outsourcing pharmacy go on the label, along with a unique identifier for the central fill pharmacy - its DEA registration number, or, if it has none, its Texas license number. The label must also indicate that the central fill pharmacy dispensed the prescription.","c":"22 TAC 291.125(c)(3)","st":"regulation","ed":"2022-08-24","df":"true"},{"k":"which pharmacy owns the dispensing record","v":"Both keep records, and each must be able to produce an audit trail of all prescriptions it dispensed. The outsourcing pharmacy records the dates the request was sent and the dispensed prescription received, the delivery method, the name of the person accepting delivery, and the central fill pharmacy's name, address, license number and unique identifier. The central fill pharmacy records the shipping date, the name and address of the recipient, the delivery method, and the outsourcing pharmacy's name, address and license number.","c":"22 TAC 291.125(d)(2); 22 TAC 291.125(d)(3); 22 TAC 291.125(d)(4)","st":"regulation","ed":"2022-08-24","df":"true"},{"k":"patient notice","v":"Before outsourcing, the pharmacy must tell patients their prescription may be outsourced and give the central fill pharmacy's name; for a pharmacy in a commonly owned network, the notice says any network pharmacy may fill it. A one-time written notice or a sign in the pharmacy suffices. Facilities that administer drugs to patients, such as hospitals and nursing homes, are exempt.","c":"22 TAC 291.125(c)(2)(A)(i); 22 TAC 291.125(c)(2)(B)","st":"regulation","ed":"2022-08-24","df":"no federal analogue"},{"k":"direct-to-patient delivery from the central fill site","v":"Where a NON-controlled prescription goes directly from the central fill pharmacy to the patient, the container or a separate sheet must carry, in English and Spanish, a statement that written information has been provided, with the pharmacy's local and toll-free numbers. controlled substance prescriptions may NOT be delivered directly to patients by the central fill pharmacy.","c":"22 TAC 291.125(c)(2)(A)(ii)","st":"regulation","ed":"2022-08-24","df":"true"},{"k":"distinction from central processing","v":"Central fill is dispensing. Central processing is a different activity that expressly excludes dispensing and, where it is a facility's primary purpose, requires a Class G license under which the pharmacy may not store bulk drugs or dispense.","c":"22 TAC 291.123; 22 TAC 291.153(a); 22 TAC 291.153(b)(1)","st":"regulation","ed":"2020-12-10","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-C-01","facts":[{"k":"equipment and supplies","v":"A Class A pharmacy must have: a data processing system with a printer or comparable equipment; a refrigerator; an adequate supply of child-resistant, light-resistant and tight containers, including glass where applicable; prescription, poison and other applicable labels; equipment necessary to prepare prescription drug orders; and metric-apothecary weight and measure conversion charts.","c":"22 TAC 291.33(d)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"references (library)","v":"Texas still has a required reference list. A Class A pharmacy must have current copies of the Texas Pharmacy Act and board rules, the Texas Dangerous Drug Act and rules, the Texas Controlled Substances Act and rules, and the federal Controlled Substances Act and rules, or an official publication describing them. It must have at least one current reference in each of these categories: patient drug information leaflets available to patients; a general drug reference giving interaction severity and recommended action; and, if dispensing veterinary prescriptions, a veterinary drug reference. It must also have basic antidote information and the telephone number of the nearest Regional Poison Control Center.","c":"22 TAC 291.33(e)(1); 22 TAC 291.33(e)(2); 22 TAC 291.33(e)(3); Tex. Occ. Code 554.015","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"physical space and environment","v":"The pharmacy must be kept orderly and clean with required equipment clean and in good working order; have a sink with hot and cold running water, exclusive of restroom facilities, available to all pharmacy personnel and kept sanitary; have proper lighting and ventilation; maintain temperatures suitable for drug storage with a refrigerator in the appropriate range; exclude animals including birds and reptiles from the pharmacy and adjacent areas under its control, excepting aquarium fish, service animals and animals in a separate health-inspected sales area; and provide a designated flammable materials storage area meeting local and state fire laws. A pharmacy serving the public must have a confidential patient counseling area that is readily accessible to both patients and pharmacists, not in a drug storage area, and designed to maintain privacy; the board may weigh proximity to checkout, foot traffic, physical barriers and evidence of overheard conversations.","c":"22 TAC 291.33(b)(1)(A); 22 TAC 291.33(b)(1)(B); 22 TAC 291.33(b)(1)(C); 22 TAC 291.33(b)(1)(D); 22 TAC 291.33(b)(1)(E); 22 TAC 291.33(b)(1)(F); 22 TAC 291.33(b)(1)(G)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"balance registration","v":"A pharmacy balance is separately subject to registration and inspection.","c":"22 TAC 291.10","st":"regulation","ed":null,"df":"no federal analogue"},{"k":"no pharmacy in a residence","v":"No person may operate a pharmacy in a personal residence.","c":"22 TAC 291.11(c)","st":"regulation","ed":"2021-06-09","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-C-02","facts":[{"k":"may the store stay open","v":"Yes. The rule expressly contemplates the rest of the facility being open to the public while the prescription department is closed.","c":"22 TAC 291.33(b)(2)(B)(i)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"basic securing duty","v":"When no pharmacist is on site, the prescription department must be locked by key, combination or other mechanical or electronic means so as to prohibit access by unauthorized individuals, except as the designated-access and temporary-absence provisions allow.","c":"22 TAC 291.33(b)(2)(B)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"securing standard when the rest of the facility is open","v":"The prescription department must be physically or electronically secured. Examples given include floor-to-ceiling walls; barriers at least nine feet SIX inches high; monitored motion detectors; pull-down sliders; or comparable systems.","c":"22 TAC 291.33(b)(2)(B)(i)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"grandfather clause","v":"Pharmacies licensed before 1 june 2009 are exempt from the enclosure standard unless they change location, which includes relocating within the licensed address. A change of ownership alone does NOT remove the exemption.","c":"22 TAC 291.33(b)(2)(B)(i)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"alarm requirement","v":"At a minimum the pharmacy must install a basic alarm system with off-site monitoring and perimeter and motion sensors. Video surveillance is optional, not required.","c":"22 TAC 291.33(b)(2)(B)(iii)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"who is responsible","v":"The pharmacist on duty is responsible for the security of the prescription department, including provisions for effective control against theft or diversion of prescription drugs and records. Written security policies are required.","c":"22 TAC 291.33(b)(2)(A); 22 TAC 291.33(b)(2)(E); 22 TAC 291.32(b)(2)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"institutional equivalent","v":"A Class C pharmacy must be enclosed and lockable, and only individuals authorized by the pharmacist-in-charge may enter.","c":"22 TAC 291.74(b)(2)(A)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-C-03","facts":[{"k":"must hours be posted","v":"Texas law does not address this. Texas has no rule requiring a pharmacy to post its hours of operation. 22 TAC 291.11, 'Operation of a Pharmacy', contains only subsections (a) through (c) - definitions of failing to engage in and ceasing to engage in the business, a definition of 'operating the pharmacy', and the prohibition on operating in a personal residence. None addresses hours.","c":"22 TAC 291.11 (silent)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"must the board be notified of a change in hours","v":"Texas law does not address this. No notification duty for a change of hours appears in 22 TAC 291.3, which is the required-notifications rule, or in Tex. Occ. Code 562.106, which is the statutory notification provision. Neither mentions hours.","c":"22 TAC 291.3 (silent); Tex. Occ. Code 562.106 (silent)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"signs that ARE required","v":"Texas requires posted signs in two situations, neither of which is routine hours: at least 14 days before a change of location, a sign at the front of the prescription department and at all public entrances showing the move date; and at least 14 days before closing, a sign in the prescription department and at all public entrances giving the closing date and the acquiring pharmacy's name, address and telephone number. A temporary-absence notice must also be posted giving the pharmacist's return time.","c":"22 TAC 291.3(a)(2); 22 TAC 291.5; 22 TAC 291.33(b)(3)(A)(i)(IV)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"related operating-continuity duties","v":"Ceasing to operate for 30 days or longer is 'ceased to engage in the business'; failing to begin operating within six months of license issuance is 'failure to engage in the business'. A pharmacy closed by a disaster may not stay closed more than 90 days. Failing to operate per 291.11 carries a $3,000 administrative penalty for a pharmacy, and a pharmacy license may be revoked for failure to operate.","c":"22 TAC 291.11(a)(1); 22 TAC 291.11(a)(2); 22 TAC 291.3(g)(1)(E); 22 TAC 281.65; Tex. Occ. Code 565.0591; Tex. Occ. Code 565.002(a)(7)","st":"regulation","ed":"2021-06-09","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D4-C-04","facts":[{"k":"pharmacy license must be displayed","v":"Yes. A pharmacy must display the license under which it operates in full public view.","c":"Tex. Occ. Code 562.103(a)","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"pharmacist-in-charge license must be displayed","v":"Yes, in a Class A or Class C pharmacy that serves the public: that person's license must be displayed in public view.","c":"Tex. Occ. Code 562.103(b)(2)","st":"statute","ed":"1999-09-01","df":"no federal analogue"},{"k":"other staff - proof kept, not displayed","v":"The pharmacy must keep proof that each pharmacist, pharmacist-intern, pharmacy technician and pharmacy technician trainee holds the appropriate license or registration, and must make that proof available to the public on request. Display is NOT required for these credentials. Separately, all pharmacy personnel must wear an identification tag or badge showing their name and role.","c":"Tex. Occ. Code 562.103(c); 22 TAC 291.32(e)","st":"statute","ed":"2025-05-28","df":"no federal analogue"},{"k":"remote site licenses","v":"The board issues a license for each telepharmacy remote site, which must be displayed at that site.","c":"22 TAC 291.121(c)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"original or copy","v":"Texas law does not address this. Neither 562.103 nor the rules I read specify whether the displayed license must be the original or may be a copy.","c":"Tex. Occ. Code 562.103 (silent)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"may a home address be obscured","v":"Texas law does not address this. No provision addresses obscuring or redacting a home address on a displayed license.","c":"Tex. Occ. Code 562.103 (silent)","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D4-C-05","facts":[{"k":"complaint notice to consumers","v":"Required. A pharmacy must notify consumers how to file complaints with the board, by a posted sign, an electronic display, or a written notice provided with each prescription. Facilities where drugs are administered by staff, such as nursing homes, are exempt. The statute requires the board to establish notice methods, which may include a prominently displayed sign at the place of business, an electronic messaging system in a board-specified font, notice on registration forms, applications or written service contracts, or notice on a bill for service, and requires any statutory health-professional toll-free complaint number to be listed alongside the board's number.","c":"22 TAC 291.3(h)(1)(A); Tex. Occ. Code 555.002","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"website notice","v":"A pharmacy with a generally accessible website must post ownership information, complaint contacts, and pharmacy and license details on its home page and on its sales pages. A site verified by NABP as compliant is treated as meeting this. The board maintains public pharmacy profiles updated at initial licensing and renewal.","c":"22 TAC 291.3(h)(1)(B); 22 TAC 291.3(h)(1)(C); 22 TAC 291.3(h)(2); Tex. Occ. Code 562.1045","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"medication disposal statement","v":"Required. Written patient information and the prescription container label must include the statement 'Do not flush unused medications or pour down a sink or drain', unless the drug appears on the FDA flush list. The statute requires the statement on the container label or in the other required prescription information.","c":"Tex. Occ. Code 562.0062; 22 TAC 291.33(c)(1)(B); 22 TAC 291.33(c)(7)(A)","st":"statute","ed":"2026-03-01","df":"no federal analogue"},{"k":"pharmacists practicing outside a pharmacy","v":"A pharmacist practicing outside a licensed pharmacy must notify consumers that complaints may be filed with the board, giving the board's mailing address, internet site address and telephone number plus a toll-free complaint number - either by a prominently posted sign or electronic messaging system in text no smaller than ten-point Times Roman where there is an office serving walk-in patients, or by written notice in type no smaller than ten-point Times Roman each time services are provided, included in each written contract or on each bill. Facilities where staff administer drugs are exempt.","c":"22 TAC 295.11(a)","st":"regulation","ed":"2018-09-16","df":"no federal analogue"},{"k":"font standard for written information","v":"Written patient information must be in plain language at a font no smaller than ten-point Times Roman; where the container label is printed smaller than ten-point Times Roman, written information must be supplied in a readable size.","c":"22 TAC 291.33(c)(1)(B); 22 TAC 291.33(c)(7)(B)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"bilingual delivery notice","v":"For home or other off-site deliveries, and for direct-to-patient central fill deliveries of non-controlled prescriptions, a bilingual English and Spanish label or sheet must carry the pharmacy's contact information, including local and toll-free numbers.","c":"22 TAC 291.33(c)(1)(F); 22 TAC 291.125(c)(2)(A)(ii); 22 TAC 291.104(b)(3)(E)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"price disclosure (SETTLED \u2014 not a posting requirement)","v":"NOT a posted-notice requirement. Tex. Occ. Code 562.003 imposes an affirmative duty at the point of sale: if the cash price of a drug or biological product is lower than the patient's copayment under their prescription drug insurance plan, the pharmacist shall offer the patient the option of paying the lower price instead of the copayment. The duty is not conditioned on the patient asking, and no sign or posted notice is required. This is a copay-clawback provision, not a price-posting provision \u2014 candidates who read the section heading alone get it wrong.","c":"Tex. Occ. Code 562.003","st":"statute","ed":"2015-09-01","df":"no federal analogue"},{"k":"opioid warning notice","v":"Texas law does not address this. I located no Texas requirement for a posted or dispensed opioid warning notice.","c":"n/a","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-C-06","facts":[{"k":"community pharmacy (Class A)","v":"Prescription drugs and devices, and nonprescription Schedule V controlled substances, must be stored within THE prescription department or in a locked storage area. The pharmacist-in-charge is responsible for procurement and storage, with input from other staff permitted. Texas does not mandate a safe or a separately locked cabinet for controlled substances within the prescription department, and does not require dispersal through the stock.","c":"22 TAC 291.33(f)(1)(B); 22 TAC 291.33(f)(1)(A)","st":"regulation","ed":"2026-03-01","df":"true"},{"k":"institutional pharmacy (Class C) - differs by schedule","v":"Yes, the answer differs by setting AND by schedule. In a Class C pharmacy, schedule II controlled substances must be kept in a locked storage area, together with other drugs requiring additional security. This is more prescriptive than the federal rule, which permits dispersal of Schedule II through the stock.","c":"22 TAC 291.74(b)(2)(C)","st":"regulation","ed":"2024-03-07","df":"true"},{"k":"temperature","v":"All drugs must be stored at the temperatures required by the USP/NF and by the board's storage rule, which defines freezer as -25 to -10 degrees C, cold as not exceeding 8 degrees C with a refrigerator at 2 to 8 degrees C, cool as 8 to 15 degrees C, controlled room temperature as 15 to 30 degrees C, warm as 30 to 40 degrees C, excessive heat as above 40 degrees C, and a dry place as not exceeding 40 percent average relative humidity at controlled room temperature. The pharmacy must maintain temperatures suitable for drug storage with a refrigerator in the appropriate range.","c":"22 TAC 291.33(f)(1)(C); 22 TAC 291.15; 22 TAC 291.33(b)(1)(E)","st":"regulation","ed":"2008-09-07","df":"false"},{"k":"expired drugs","v":"Drugs may not be dispensed past an expiration date. Expired items must be removed from stock, quarantined and disposed of properly.","c":"22 TAC 291.33(f)(2); 22 TAC 291.74(f)(5)(B)(ii)(III)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"nonprescription Schedule V","v":"Schedule V products containing codeine or dihydrocodeine or their salts require a prescription. Other nonprescription Schedule V products containing no more than 15 mg of opium per 29.5729 ml or 28.35 g may be distributed by a pharmacist only, limited to 240 ml or 48 solid units per purchaser in any 48-hour period, to a purchaser at least 18 years old, with suitable identification from an unknown purchaser, recorded in a bound record book with the purchaser's name and address, product and quantity, date, and the pharmacist's signature or initials.","c":"22 TAC 291.33(f)(3)","st":"regulation","ed":"2026-03-01","df":"true"},{"k":"federal storage rule still applies","v":"The federal physical security requirements for controlled substances apply independently of the Texas rules.","c":"21 CFR 1301.75","st":"regulation","ed":null,"df":"true"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-C-07","facts":[{"k":"general rule","v":"When no pharmacist is on site, the prescription department must be locked by key, combination or other mechanical or electronic means so as to prohibit access by unauthorized individuals.","c":"22 TAC 291.33(b)(2)(B)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"who may be designated to enter","v":"The pharmacist-in-charge or the owner may designate individuals who may enter the prescription department for the performance of non-dispensing functions. The pharmacy must keep written records of non-employees who access the prescription department when no pharmacist is on site.","c":"22 TAC 291.33(b)(2)(C)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"who may unlock it","v":"Only individuals named OR titled IN writing by the pharmacist-in-charge - for example a 'relief' or 'floater' pharmacist - may unlock the prescription department, except in emergencies. A backup key or access instructions may be kept in a secure location outside the prescription department.","c":"22 TAC 291.33(b)(2)(D)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"duplication of keys and codes","v":"Locks, keys or codes may not be duplicated without the authorization of the pharmacist-in-charge or the owner.","c":"22 TAC 291.33(b)(2)(B)(ii)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"during a temporary absence with the pharmacist on site","v":"A single-pharmacist store may leave the department open briefly if at least one pharmacy technician remains, the pharmacist stays on site and immediately available, the pharmacist reasonably believes security will hold (otherwise the department must be closed and staff cleared out), and a posted notice gives the return time and states that technicians may process orders but a pharmacist must verify them before delivery. Only trained technicians may perform listed tasks during the absence, a pharmacist must verify all their work and conduct a drug regimen review on return, and in multi-pharmacist stores breaks must be staggered so the department is never unstaffed.","c":"22 TAC 291.33(b)(3)(A)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"during a temporary absence with the pharmacist off site","v":"The department must be secured with entry procedures. Technicians may NOT perform technician duties while the pharmacist is off site. An agent may deliver previously verified prescriptions during absences of NO more than TWO consecutive hours in any 24-hour period, subject to a posted notice, documented absences, a locked department and no preparation of new prescriptions, with a delivery record of date and time. An automated dispensing and delivery system may be used for patient pickup of verified prescriptions.","c":"22 TAC 291.33(b)(3)(B)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"temporary closure for loss of PIC","v":"Where a pharmacy is temporarily closed for lack of a pharmacist-in-charge, access to the prescription department is allowed only when a pharmacist is present.","c":"22 TAC 291.5","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"institutional setting","v":"Only individuals authorized by the pharmacist-in-charge may enter a Class C pharmacy. When no pharmacist is on duty, only a designated licensed nurse or practitioner may remove drugs, and only for a bona fide patient, with a record made at the time of withdrawal and pharmacist verification within 72 hours (full-time pharmacist) or 7 days (part-time or consultant).","c":"22 TAC 291.74(b)(2)(A); 22 TAC 291.74(e)(1)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-C-08","facts":[{"k":"enclosure and entry","v":"The Class C pharmacy must be enclosed and lockable, and only individuals authorized by the pharmacist-in-charge may enter. The pharmacist on duty is responsible for security, including safeguards against theft or diversion of controlled substances.","c":"22 TAC 291.74(b)(2)(A); 22 TAC 291.74(b)(2)(B)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"Schedule II storage","v":"Schedule II controlled substances must be kept in a locked storage area, along with other drugs requiring additional security.","c":"22 TAC 291.74(b)(2)(C)","st":"regulation","ed":"2024-03-07","df":"true"},{"k":"removal when no pharmacist is on duty","v":"Only a designated licensed nurse or practitioner may remove drugs, and only for a bona fide patient, with a record required at the time of withdrawal. The pharmacist must verify the withdrawals within 72 hours where the institution has a full-time pharmacist, or within 7 days where the pharmacist is part-time or a consultant.","c":"22 TAC 291.74(e)(1)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"floor stock removal","v":"Floor stock may be removed only in the original manufacturer's container or a prepackaged container, and only by a designated licensed nurse or practitioner. Each withdrawal must record the drug name, strength, dosage form, quantity, floor stock location, date and time, and the signature or electronic signature of the person removing it, with pharmacist verification within 7 days.","c":"22 TAC 291.74(e)(2)(A); 22 TAC 291.74(e)(2)(B); 22 TAC 291.74(e)(2)(C); 22 TAC 291.74(e)(2)(D)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"accountability records","v":"Schedule II distribution records must show the patient, prescriber, drug name, dosage form and strength, time, date and quantity administered, the administering individual, returns and waste, with waste witnessed and cosigned. Floor stock records for Schedules II-V must show the same categories, be kept separate from patient records, and be reviewed by a pharmacist against medication orders at intervals NOT exceeding 30 days. A Schedule II perpetual inventory is required and must be reconciled on the annual inventory date.","c":"22 TAC 291.75(c)(4)(C); 22 TAC 291.75(c)(5)(A); 22 TAC 291.75(c)(5)(B); 22 TAC 291.75(c)(5)(C); 22 TAC 291.75(c)(4)(B); 22 TAC 291.17(f)(1)","st":"regulation","ed":"2021-06-09","df":"true"},{"k":"annual inventory coverage","v":"The Class C annual inventory must be kept at the pharmacy and must cover all controlled substances in the pharmacy and in any other department of the institution, with pharmacy stock listed separately and stock in other departments identified by department.","c":"22 TAC 291.17(f)(2)","st":"regulation","ed":"2019-06-20","df":"true"},{"k":"rural hospital variation","v":"A rural hospital may use a pharmacy technician for certain floor stock duties; distribution records must be kept two years and the pharmacist must verify them within 7 days.","c":"22 TAC 291.74(e)(3); Tex. Occ. Code 562.1011","st":"regulation","ed":"2024-03-07","df":"no federal analogue"},{"k":"supervision level by bed count","v":"A Class C pharmacy in an institution with more than 100 beds requires continuous on-site supervision by a pharmacist while open for pharmacy services; an institution with 100 beds OR fewer requires pharmacist services on a part-time or consulting basis based on the institution's needs.","c":"Tex. Occ. Code 562.101","st":"statute","ed":"2019-09-01","df":"no federal analogue"},{"k":"expired drugs and disposal policies","v":"Written policies must address disposal of unusable drugs and supplies, and outdated drugs must be quarantined until properly disposed of.","c":"22 TAC 291.74(f)(1)(F); 22 TAC 291.74(f)(5)(B)(ii)(III)","st":"regulation","ed":"2024-03-07","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-C-09","facts":[{"k":"emergency medication kits permitted","v":"Yes. A provider pharmacy - Class A, Class C, Class E, or a Department of Veterans Affairs or other federal pharmacy - may supply an emergency medication kit to a facility regulated under Health and Safety Code Chapter 242 (nursing and convalescent homes) or Chapter 252. A Class E provider pharmacy must be within 20 miles of the facility.","c":"22 TAC 291.121(b); Tex. Occ. Code 562.108","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"who determines contents","v":"The kit's contents are determined jointly by the consultant pharmacist, the pharmacist-in-charge, the medical director and the director of nurses. Contents are limited to drugs needed for a situation where a drug cannot be supplied by the provider pharmacy within a reasonable time.","c":"22 TAC 291.121(b)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"access","v":"Access is limited to pharmacists and to licensed health care personnel employed by the facility.","c":"22 TAC 291.121(b)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"notification of entry","v":"The remote site must notify the provider pharmacy of each entry into the kit.","c":"22 TAC 291.121(b)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"multiple provider pharmacies","v":"Where more than one provider pharmacy supplies a site, the pharmacies must have a written agreement.","c":"22 TAC 291.121(b)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"automated pharmacy systems at LTC facilities","v":"Separately from kits, a Class A or Class C pharmacy may dispense through an automated pharmacy system at a facility regulated under Chapter 242 or 252, where drugs are administered by a licensed health care professional. A pharmacist at the provider pharmacy must release the initial dose and conduct a drug regimen review before release; supervision may be electronic; accuracy must be tested at least every six months and after any upgrade.","c":"22 TAC 291.121(a)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"destruction of patients' dispensed drugs at the facility","v":"Governed by the consultant pharmacist destruction regime with the enumerated witness list - see D3-B-19.","c":"22 TAC 303.1(a)","st":"regulation","ed":"2023-03-07","df":"no federal analogue"},{"k":"unused drugs returned by certain pharmacists","v":"Statutory provisions address unused drugs returned by certain pharmacists and limit liability.","c":"Tex. Occ. Code 562.1085; Tex. Occ. Code 562.1086","st":"statute","ed":null,"df":"no federal analogue"},{"k":"exact approved kit contents list","v":"Texas law does not address this. As a board-published list of permitted drugs. The rule sets who decides and the limiting principle rather than naming drugs.","c":"22 TAC 291.121(b)","st":"silent","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-C-10","facts":[{"k":"storage temperature requirements","v":"Yes, required. All drugs must be stored at the temperatures required by the USP/NF and by the board's storage rule. The pharmacy must maintain temperatures suitable for drug storage and a refrigerator maintained in the range suitable for refrigerated drugs.","c":"22 TAC 291.33(f)(1)(C); 22 TAC 291.15; 22 TAC 291.33(b)(1)(E)","st":"regulation","ed":"2008-09-07","df":"false"},{"k":"defined ranges","v":"The board defines the ranges: freezer -25 to -10 degrees C (-13 to 14 F); cold not exceeding 8 degrees C (46 F), with a refrigerator at 2 to 8 degrees C (36 to 46 F); cool 8 to 15 degrees C (46 to 59 F), with a refrigerator usable instead unless a monograph says otherwise; room temperature as the temperature prevailing in a working area; controlled room temperature 15 to 30 degrees C (59 to 86 F); warm 30 to 40 degrees C (86 to 104 F); excessive heat above 40 degrees C (104 F); and a dry place not exceeding 40 percent average relative humidity at controlled room temperature or the equivalent water vapor pressure at other temperatures. Where freezing could cause breakage or loss of strength, potency or destructive alteration, the label must instruct the product be protected from freezing.","c":"22 TAC 291.15","st":"regulation","ed":"2008-09-07","df":"false"},{"k":"continuous monitoring or logging requirement","v":"Texas law does not address this. Texas requires temperatures to be maintained but I located no rule requiring continuous temperature monitoring, a temperature log, or a minimum/maximum thermometer in a Class A pharmacy.","c":"22 TAC 291.33(b)(1)(E); 22 TAC 291.15 (no monitoring or logging duty)","st":"silent","ed":null,"df":"false"},{"k":"excursion documentation","v":"No Texas provision on this was located. No requirement to document a temperature excursion, or a procedure for assessing drugs exposed to one, appears in the general storage rules. The one adjacent Texas duty is after a fire or disaster: drugs exposed to excessive heat, smoke or other damaging conditions may not be dispensed, and potentially adulterated or damaged drugs may be distributed only under the Texas Food, Drug, and Cosmetic Act.","c":"22 TAC 291.3(g)(2)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"delivery temperature","v":"Temperature IS expressly regulated in transit: common carrier packaging must maintain a temperature range suitable for the drug, by temperature tags, time-temperature strips, insulated packaging, gel ice packs or a combination; employee or same-day courier delivery must keep the drug within the USP or manufacturer's range until the patient or agent receives it. A pharmacist must refuse common carrier delivery of any drug the pharmacist judges may be clinically compromised by that method, and must replace or arrange replacement of a drug compromised in transit.","c":"22 TAC 291.12(b)(3); 22 TAC 291.12(c)(2); 22 TAC 291.12(b)(5); 22 TAC 291.12(d)(3)","st":"regulation","ed":"2024-06-10","df":"true"},{"k":"sterile compounding settings","v":"Pharmacies compounding sterile preparations are subject to separate environmental requirements under 22 TAC 291.133. Those requirements were NOT retrieved and are not stated here \u2014 must be read before publication.","c":"22 TAC 291.133; 22 TAC 291.36; 22 TAC 291.77","st":"regulation","ed":"2026-03-01","df":"false"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D4-D-01","facts":[{"k":"may prescriptions be delivered or mailed","v":"Yes. A Class A, A-S, E or E-S pharmacy may deliver prescription drugs, at the request of the patient or the patient's agent, by common carrier such as the U.S. Mail, by its own employee, or by a same-day courier service. A carrier offering same-day courier service is excluded from the common-carrier provision and falls under the employee/courier provision instead.","c":"22 TAC 291.12(a); 22 TAC 291.12(b); 22 TAC 291.12(c)","st":"regulation","ed":"2024-06-10","df":"no federal analogue"},{"k":"packaging","v":"Drugs delivered by common carrier must be in commercially available tamper-evident packaging, and deliveries must follow nationally recognized standards such as manufacturer or USP standards.","c":"22 TAC 291.12(b)(2); 22 TAC 291.12(b)(1)","st":"regulation","ed":"2024-06-10","df":"no federal analogue"},{"k":"temperature","v":"Common carrier packaging must maintain a temperature range suitable for the drug, using temperature tags, time-temperature strips, insulated packaging, gel ice packs or a combination. Employee or same-day courier delivery must keep the drug within the USP or manufacturer's range until the patient or agent receives it.","c":"22 TAC 291.12(b)(3); 22 TAC 291.12(c)(2)","st":"regulation","ed":"2024-06-10","df":"true"},{"k":"signature requirement","v":"Texas law does not address this. 291.12 imposes no signature-on-receipt requirement. A signature IS required in one narrow case: where an agent delivers previously verified prescriptions during a pharmacist's temporary absence, the delivery record must include the date, prescription number, patient name, phone number and signature.","c":"22 TAC 291.12 (silent as to signature); 22 TAC 291.33(b)(3)(A)(iv)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"identification requirement","v":"Texas law does not address this. The pharmacy must have a system to ensure correct delivery, but no patient identification check is prescribed. Identification is required in the separate nonprescription Schedule V context, where an unknown purchaser must provide suitable identification.","c":"22 TAC 291.33(c)(1)(F); 22 TAC 291.33(f)(3)(B)(iv)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"information that must accompany an off-site delivery","v":"Written information with the prescription; a toll-free line if delivering outside the local calling area; a bilingual English and Spanish label or sheet with the pharmacy's contact information; temperature-appropriate packaging; and a system to ensure correct delivery. Counseling information requirements apply to all deliveries, and the patient or agent must be notified that a delivery has occurred.","c":"22 TAC 291.33(c)(1)(F); 22 TAC 291.12(d)(1); 22 TAC 291.12(d)(2)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"irregularities and compromised deliveries","v":"The pharmacy must give patients or agents a way to report problems with timeliness, the drug's condition on arrival, or receipt of the wrong drug. The dispensing pharmacist must refuse common carrier delivery of any drug the pharmacist judges may be clinically compromised by that method. Where a pharmacist finds a drug was compromised in transit, the pharmacy must replace it or arrange replacement, either by promptly delivering a new one or by promptly contacting the prescriber so the patient can fill it elsewhere.","c":"22 TAC 291.12(b)(4); 22 TAC 291.12(b)(5); 22 TAC 291.12(d)(3)","st":"regulation","ed":"2024-06-10","df":"no federal analogue"},{"k":"records","v":"Records must be kept for two years of when drugs were sent and delivered, and of patient complaints about compromised deliveries. Complaints may be documented in the patient profile. A permanent record must be kept of complaints about a prescription for a Texas resident lost during delivery.","c":"22 TAC 291.12(d)(4); Tex. Occ. Code 562.105","st":"regulation","ed":"2024-06-10","df":"no federal analogue"},{"k":"do controlled substances differ","v":"Only by cross-reference. The rule requires compliance with all state and federal laws and rules on delivering controlled substances but sets no separate Texas delivery standard for them. One hard bar exists elsewhere: a central fill pharmacy may NOT deliver controlled substance prescriptions directly to patients.","c":"22 TAC 291.12(d)(5); 22 TAC 291.125(c)(2)(A)(ii)","st":"regulation","ed":"2024-06-10","df":"true"},{"k":"delivery at the pharmacy itself","v":"Prescriptions may be delivered at the pharmacy only when a pharmacist is present, except under the temporary-absence provisions.","c":"22 TAC 291.33(c)(1)(E)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-D-02","facts":[{"k":"permitted delivery destinations","v":"The pickup-and-delivery rule enumerates them. A pharmacist or pharmacy may, at the patient's request, use its own employee or a common carrier such as the U.S. Mail to pick up a prescription from a prescriber's office or home, the patient's residence or workplace, or a hospital or medical care facility; and to deliver to a prescriber's office (for dangerous drugs, or for a single dose of a controlled substance administered in the office), the patient's residence, the patient's workplace IF THE patient IS present TO accept IT, or a hospital or medical care facility.","c":"22 TAC 291.9(b)","st":"regulation","ed":"2024-12-30","df":"no federal analogue"},{"k":"workplace delivery requires the patient to be present","v":"Yes - the rule expressly conditions workplace delivery on the patient being present to accept it. It imposes no equivalent presence condition for delivery to the patient's residence.","c":"22 TAC 291.9(b)","st":"regulation","ed":"2024-12-30","df":"no federal analogue"},{"k":"unattended delivery at a residence","v":"NOT expressly addressed. Delivery to the patient's residence is permitted without a stated presence condition, and 291.12 imposes no signature requirement, which together suggest unattended residential delivery is not prohibited. But no rule says so, and the pharmacy must still have a system to ensure correct delivery, must notify the patient or agent that a delivery occurred, and must maintain the temperature range until the patient or agent receives it.","c":"22 TAC 291.9(b); 22 TAC 291.12(d)(2); 22 TAC 291.12(c)(2); 22 TAC 291.33(c)(1)(F)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"delivery to a third party","v":"Delivery may be made at the request of the patient or the patient's agent, and to a prescriber's office or a hospital or medical care facility. Beyond 'the patient's agent', third-party delivery is not addressed.","c":"22 TAC 291.12(b); 22 TAC 291.9(b)","st":"regulation","ed":"2024-06-10","df":"no federal analogue"},{"k":"lockers and automated pickup","v":"A locker-style arrangement is permitted only in the specific form Texas authorizes: an automated dispensing and delivery system at a remote delivery site, under which the patient must be counseled by a Texas-licensed pharmacist through audio or video and must have the option to use the system. Such a system may also be used at the pharmacy for patient pickup of previously verified prescriptions while the pharmacist is off site.","c":"22 TAC 291.121(d); 22 TAC 291.33(b)(3)(B)(iii)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"prohibited pickup arrangements","v":"A pharmacy may NOT solicit, collect, pick up or advertise for pickup of prescriptions at any location other than a pharmacy licensed and in good standing with the board. This is the general bar that unlicensed drop-off and pickup points run into.","c":"22 TAC 291.9(a)","st":"regulation","ed":"2024-12-30","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"},{"id":"D4-D-03","facts":[{"k":"are drive-through windows permitted","v":"Texas law does not address this. - no rule either authorizing or prohibiting them. 22 TAC 291.33 was read subsection by subsection and does not mention drive-through windows anywhere, including in the environment, security, or prescription dispensing and delivery subsections.","c":"22 TAC 291.33 (silent)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"counseling duty applies regardless","v":"Silent but covered by the general counseling rule, which is not location-limited. A pharmacist must counsel on each new prescription - one not dispensed to the patient in the same dosage and strength in the past year - and on request. Counseling must be oral unless the patient is not at the pharmacy or a barrier exists, and must be documented with the pharmacist's initials or identification code. The patient may refuse counseling and the refusal must be documented. Only a pharmacist may provide verbal drug information or answer drug questions, and staff and computer systems may not screen patients to limit pharmacist interaction.","c":"22 TAC 291.33(c)(1)(B); 22 TAC 291.33(c)(1)(C); 22 TAC 291.33(c)(1)(D)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"confidential counseling area","v":"A pharmacy serving the public must have a confidential counseling area readily accessible to both patients and pharmacists, not in a drug storage area, and designed to maintain privacy, with the board able to weigh proximity to checkout, foot traffic, physical barriers and evidence of overheard conversations. Nothing exempts a drive-through from the counseling obligation, though the rule does not say how the confidential-area requirement maps onto one.","c":"22 TAC 291.33(b)(1)(C)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"},{"k":"pharmacist must be present for delivery at the pharmacy","v":"Prescriptions may be delivered at the pharmacy only when a pharmacist is present, except under the temporary-absence provisions.","c":"22 TAC 291.33(c)(1)(E)","st":"regulation","ed":"2026-03-01","df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"low"},{"id":"D4-D-04","facts":[{"k":"may a pharmacy use a courier","v":"Yes. A pharmacy may deliver through its own employee or through a same-day courier service at the patient's or agent's request. The pharmacy is responsible for any delivery problems, and the drug must stay within the USP or manufacturer's temperature range until the patient or agent receives it. A common carrier such as the U.S. Mail may also be used, under the separate common-carrier conditions.","c":"22 TAC 291.12(c); 22 TAC 291.12(c)(1); 22 TAC 291.12(c)(2); 22 TAC 291.12(b)","st":"regulation","ed":"2024-06-10","df":"no federal analogue"},{"k":"may a pharmacy use a locker at a remote site","v":"Only as an automated dispensing and delivery system at a remote delivery site. The patient must be counseled by a Texas-licensed pharmacist through audio or video and must have the option to use the system rather than being required to.","c":"22 TAC 291.121(d)","st":"regulation","ed":"2023-12-04","df":"no federal analogue"},{"k":"must the remote site be registered","v":"For telepharmacy remote sites - remote health care sites and remote dispensing sites - the board issues a license for each site, which must be displayed there, with application resubmitted every two years with the provider pharmacy's renewal and closure reported within ten days. For a remote delivery site under the automated dispensing and delivery provision, I could not confirm from the rule text whether a separate board license or registration is required. No separate provision was located for a courier or locker used outside the telepharmacy licensing scheme.","c":"22 TAC 291.121(c); 22 TAC 291.121(d)","st":"silent","ed":null,"df":"no federal analogue"},{"k":"hard limit on unlicensed pickup points","v":"A pharmacy may not solicit, collect, pick up or advertise for pickup of prescriptions at any location other than a pharmacy licensed and in good standing with the board.","c":"22 TAC 291.9(a)","st":"regulation","ed":"2024-12-30","df":"no federal analogue"},{"k":"emergency remote pharmacy and satellite pharmacy","v":"Two further site types exist with their own rules: an emergency remote pharmacy license, and a satellite pharmacy.","c":"22 TAC 291.127; 22 TAC 291.129","st":"regulation","ed":null,"df":"no federal analogue"}],"ver":"2026-10-14","pc":null,"vol":"medium"}]}