Title 21 CFR reference
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United States • Title 21 CFR • Part 1308
Part 1308 — PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES
Part 1308 of Title 21 outlines the schedules of controlled substances, categorizing them based on their potential for abuse and accepted medical use. It details the specific substances within each schedule and the regulations governing their handling, manufacturing, distribution, and dispensing.
What this part covers
- Establishes five schedules (I, II, III, IV, V) for controlled substances.
- Lists specific drugs and chemical compounds within each schedule.
- Defines criteria for classifying substances into schedules based on abuse potential and medical utility.
- Outlines regulatory requirements for registration, recordkeeping, and security for handlers of controlled substances.
- Specifies requirements for prescription, dispensing, and import/export of controlled substances.
- Provides a mechanism for adding, deleting, or rescheduling substances.
- References the Controlled Substances Act (CSA) as the legal basis for these regulations.
Regulatory Context
This document sits within United States CFR and is most useful when linked to operational submission, quality, and inspection workflows.
United StatesCFR