What is a pharmacist's responsibility when filling a controlled substance prescription? Answer in under 100 words. Cite only eCFR (www.ecfr.gov) sources.

Details / How it works

Corresponding responsibility of the pharmacist

Per 21 CFR 1306.04(a), the responsibility for proper prescribing and dispensing of controlled substances rests on the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.

To be valid, a controlled substance prescription must be:

• Issued for a legitimate medical purpose by an individual practitioner (physician, dentist, veterinarian, or other licensed provider);
• Issued in the usual course of the practitioner's professional practice or in legitimate, authorized research.

An order purporting to be a prescription that does not meet these criteria is not a valid prescription under section 309 of the Controlled Substances Act (21 U.S.C. 829).

Consequences of filling an illegitimate prescription

A pharmacist who knowingly fills such a purported prescription — and the person who issued it — is subject to the criminal penalties provided for controlled-substance violations, including those under 21 U.S.C. 841 and 21 U.S.C. 843.

Numbers & thresholds

Exceptions & edge cases

Emergency oral authorizations (Schedule II) — 21 CFR 1306.11(d)

In a defined emergency situation under 21 CFR 290.10, a pharmacist may dispense a Schedule II controlled substance on an oral order from an individual practitioner, provided the pharmacist:

1. Limits the quantity to the amount adequate to treat the patient during the emergency;
2. Immediately reduces the prescription to writing, including all information required by 21 CFR 1306.05 except the prescriber's signature;
3. Makes a reasonable effort to determine that the oral authorization came from a registered individual practitioner (e.g., a callback to the telephone-directory number);
4. Notifies the nearest office of the DEA (the Administration) if the prescribing individual practitioner fails to deliver the required written prescription — failure to notify voids the authority to dispense without a written prescription.

Central fill pharmacies are not authorized under this paragraph to prepare Schedule II prescriptions on an oral authorization from a retail pharmacist or individual practitioner.