Title 21 CFR reference
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United States • Title 21 CFR • Part 1309
Part 1309 — PART 1309—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS
Part 1309 outlines the registration requirements for manufacturers, distributors, importers, and exporters of List I chemicals under the Drug Enforcement Administration (DEA). It details the application process, recordkeeping obligations, and security measures necessary for handling these controlled substances.
What this part covers
- Establishes registration requirements for entities involved with List I chemicals.
- Specifies procedures for applying for registration, including necessary information and fees.
- Mandates recordkeeping for all transactions involving List I chemicals.
- Outlines security requirements to prevent diversion of List I chemicals.
- Details reporting obligations for suspicious orders and theft/loss.
- Covers import and export procedures for List I chemicals.
- Addresses renewal of registrations and changes in business operations.
- Defines List I chemicals and their significance in drug manufacturing.
Regulatory Context
This document sits within United States CFR and is most useful when linked to operational submission, quality, and inspection workflows.
United StatesCFR