Question of the Week

Two independent limits, and whichever arrives first ends the prescription. No Schedule III or IV prescription may be filled or refilled more than six months after the date on which it was issued, and none may be refilled more than five times. A prescriber writing six refills does not raise the ceiling; the sixth simply cannot be dispensed.

21 C.F.R. § 1306.22(a)

Transposing the pair into “six refills in five months.” It is five refills, six months.

Where the partial fill happens because the pharmacist is unable to supply the full quantity, the remaining portion may be filled within 72 hours of the first partial filling — the clock starts at the partial fill, not at the issue date. If the remainder is not or cannot be supplied in that window, the pharmacist must notify the prescribing practitioner, and no further quantity may be supplied beyond 72 hours without a new prescription.

21 C.F.R. § 1306.13(a)

Two things get fumbled here: applying the 72-hour clock to every partial fill, and starting it from the wrong date.

Partial filling of a Schedule II prescription at the request of the prescribing practitioner or the patient is expressly permitted — and the requester set is wider than people assume: it also reaches a parent or legal guardian of a minor patient, or a caregiver of an adult patient named in a medical power of attorney. Two limits apply: the total quantity dispensed across all partial fillings may not exceed the total prescribed, and no portion may be filled more than 30 days after the date the prescription was written. Two conditions sit alongside them that the exam likes: the partial fill must not be prohibited by State law, and where the prescription was an emergency oral one the window shrinks to 72 hours from issue, not 30 days.

21 C.F.R. § 1306.13(b)

Assuming patient-requested partial fills are unavailable for Schedule II, or forgetting that state law can switch this off entirely.

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, may be filled in partial quantities down to individual dosage units, and is valid for up to 60 days from the issue date unless sooner terminated by discontinuance of the medication. There is a formality with teeth: the pharmacist must record “terminally ill” or “LTCF patient” on the prescription, and a partial fill without that notation is deemed to have been filled in violation of the Act. Hospice patients are reached through the terminal-illness limb, but the category is wider than hospice.

21 C.F.R. § 1306.13(c)

This provision sat in § 1306.13(b) until 21 July 2023, when the patient-request rule took that letter and pushed this one to (c). Pre-2023 study material still cites (b) — and three partial-fill clocks now sit side by side: 72 hours, 30 days, 60 days. The trigger picks the clock, not the schedule.

Within 7 days of authorizing the emergency oral prescription, the prescriber must cause a written prescription for the emergency quantity to be delivered to the dispensing pharmacist. It must carry on its face the exact words “Authorization for Emergency Dispensing” and the date of the oral order. If it does not arrive, the pharmacist must notify the nearest office of the Administration — and failure to notify voids the authority that allowed dispensing without a written prescription in the first place. One more point DEA makes in its own manual: the prescriber must communicate the emergency oral order personally; an agent may not call it in.

21 C.F.R. § 1306.11(d)(4)

The 72-hour figure belongs to out-of-stock partial fills. Here it is 7 days — and the pharmacist, not the prescriber, carries the reporting duty if the paper never comes.