Code of Federal Regulations > Title 21 > Chapter II > Part 1304 - PART 1304—RECORDS AND REPORTS OF REGISTRANTS

U.S. Code of Federal Regulations

Regulations most recently checked for updates: Nov 22, 2025

GENERAL INFORMATION

§ 1304.01 - Scope of part 1304.

§ 1304.02 - Definitions.

§ 1304.03 - Persons required to keep records and file reports.

§ 1304.04 - Maintenance of records and inventories.

§ 1304.05 - Records of authorized central fill pharmacies and retail pharmacies.

§ 1304.06 - Records and reports for electronic prescriptions.

INVENTORY REQUIREMENTS

§ 1304.11 - Inventory requirements.

CONTINUING RECORDS

§ 1304.21 - General requirements for continuing records.

§ 1304.22 - Records for manufacturers, distributors, dispensers, researchers, importers, exporters, registrants that reverse distribute, and collectors.

§ 1304.23 - Records for chemical analysts.

§ 1304.24 - Records for maintenance treatment programs, mobile narcotic treatment programs, and detoxification treatment programs.

§ 1304.25 - Records for treatment programs that compound narcotics for treatment programs and other locations.

§ 1304.26 - Additional recordkeeping requirements applicable to drug products containing gamma-hydroxybutyric acid.

REPORTS

§ 1304.31 - Reports from manufacturers importing narcotic raw material.

§ 1304.32 - Reports of manufacturers importing coca leaves.

§ 1304.33 - Reports to Automation of Reports and Consolidated Orders System (ARCOS).

ONLINE PHARMACIES

§ 1304.40 - Notification by online pharmacies.

§ 1304.45 - Internet Web site disclosure requirements.

§ 1304.50 - Disclosure requirements for Web sites of nonpharmacy practitioners that dispense controlled substances by means of the Internet.

§ 1304.55 - Reports by online pharmacies.