Title 21 CFR reference
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United States • Title 21 CFR • Part 1306
Part 1306 — PART 1306—PRESCRIPTIONS
Part 1306 of Title 21 outlines the regulations for prescriptions in the United States, focusing on the requirements for issuing, filling, and refilling prescriptions for controlled substances. It details the information that must be included on a prescription, the conditions under which prescriptions can be issued, and the responsibilities of practitioners and dispensers.
What this part covers
- Prescriptions for controlled substances must contain specific information: full name and address of patient, drug name, strength, dosage form, quantity prescribed, directions for use, and name, address, and DEA registration number of the prescriber.
- Prescriptions must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
- Electronic prescriptions are permitted if they meet specific requirements, including security and audit trail provisions.
- Refilling of prescriptions for Schedule III, IV, and V controlled substances is allowed up to five times within six months of the prescription date.
- Dispensing of prescriptions must be done by a registered practitioner or pharmacist, ensuring the prescription is valid and complete.
- Recordkeeping requirements for prescriptions are detailed, including retention periods and accessibility for inspection.
Regulatory Context
This document sits within United States CFR and is most useful when linked to operational submission, quality, and inspection workflows.
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