What are the requirements for Schedule II prescriptions? Answer in under 100 words. Cite only eCFR (www.ecfr.gov) sources.

Details / How it works

Under 21 CFR § 1306.11, a pharmacist may dispense a Schedule II controlled substance (a prescription drug as determined under section 503 of the Federal Food, Drug, and Cosmetic Act) only pursuant to a written prescription signed by the practitioner. A paper prescription may be transmitted via facsimile, provided the original manually signed prescription is presented to the pharmacist for review prior to actual dispensing. The original prescription shall be maintained in accordance with § 1304.04(h).

Exceptions & edge cases

The facsimile serves as the original written prescription (maintained under § 1304.04(h)) for three specific scenarios:

• (e) Schedule II narcotic substances compounded for direct patient administration by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion.
• (f) Schedule II substances for a resident of a Long Term Care Facility.
• (g) Schedule II narcotic substances for a patient enrolled in a Medicare-certified (Title XVIII) or state-licensed hospice care program, with the practitioner noting hospice status on the prescription.

In an emergency situation as defined in § 290.10, a pharmacist may dispense upon oral authorization from a prescribing individual practitioner, subject to strict conditions: the quantity is limited to the emergency period; the prescription is immediately reduced to writing containing all information required by § 1306.05 (except the signature); the pharmacist must make a reasonable effort to verify the practitioner's identity; within 7 days the practitioner must deliver a written prescription marked "Authorization for Emergency Dispensing"; and the pharmacist must notify the nearest office of the Administration (DEA) if the practitioner fails to deliver the follow-up. Central fill pharmacies are not authorized to prepare Schedule II prescriptions based on oral authorizations.