How may Schedule III through V drugs be prescribed? Answer in under 100 words. Cite only eCFR (www.ecfr.gov) sources.

Details / How it works

Per 21 CFR § 1306.21(a), a pharmacist may dispense a Schedule III, IV, or V controlled substance that is a prescription drug (as determined under section 503(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 353(b)) only pursuant to one of four methods:

1. A paper prescription signed by the practitioner;
2. A facsimile (fax) copy of a signed paper prescription transmitted by the practitioner or the practitioner's agent to the pharmacy;
3. An electronic prescription that meets the requirements of 21 CFR part 1306 and 21 CFR part 1311; or
4. An oral (telephone) prescription made by an individual practitioner and promptly reduced to writing by the pharmacist, containing all information required in § 1306.05 except for the practitioner's signature.

Under § 1306.21(b), an individual practitioner may administer or dispense Schedule III–V substances directly in the course of professional practice without a prescription, subject to § 1306.07. Under § 1306.21(c), an institutional practitioner may administer or dispense (but not prescribe) such substances pursuant to a written prescription, fax, electronic prescription, oral prescription reduced to writing, or a medication order for immediate administration, subject to § 1306.07.

Exceptions & edge cases

• Purpose of issue (21 CFR § 1306.04): A prescription for a Schedule III, IV, or V controlled substance must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. A corresponding responsibility rests with the dispensing pharmacist. Prescriptions issued outside the usual course of treatment are not valid, and violators are subject to penalties under 21 U.S.C. §§ 841, 843.
• Opioid use disorder treatment (§ 1306.04(c)–(d)): A practitioner may issue a Schedule III, IV, or V prescription for use in detoxification or maintenance treatment, provided the prescription complies with all applicable federal and state laws and the requirements of section 309A of the CSA (21 U.S.C. § 829a) and § 1306.07(f). Such prescriptions may not be used to supply a practitioner with stock for general dispensing to patients.
• Institutional practitioners: Authorized to administer or dispense, but not to prescribe, Schedule III–V controlled substances.