Title 21 CFR reference
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United States • Title 21 CFR • Part 1301
Part 1301 — PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
Part 1301 of Title 21 outlines the requirements for the registration of manufacturers, distributors, and dispensers of controlled substances with the Drug Enforcement Administration (DEA). It details the application process, renewal procedures, recordkeeping obligations, and security requirements necessary to handle controlled substances.
What this part covers
- Establishes the framework for DEA registration for all entities involved in the manufacture, distribution, dispensing, importing, exporting, and research of controlled substances.
- Specifies the application forms, fees, and information required for initial registration and renewal.
- Outlines the recordkeeping requirements, including inventories, order forms, and dispensing records, that registrants must maintain.
- Details the security measures necessary to prevent diversion and theft of controlled substances, varying based on the schedule and quantity of substances handled.
- Covers the procedures for suspension, revocation, and denial of registration.
- Addresses specific requirements for bulk manufacturers, distributors, researchers, analytical labs, and narcotic treatment programs.
- Includes provisions for import and export permits for controlled substances.
- Mandates reporting of suspicious orders and theft or significant loss of controlled substances.
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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