Part 1304 — Records and Reports of Registrants
Current through Sep 8, 2026
Authority: 21 U.S.C. 821, 823(j), 827, 831, 871(b), 958(e)-(g), and 965, unless otherwise noted.
Sections
- § 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.
- § 1304.11 Inventory requirements.
- § 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.
- § 1304.27 Additional recordkeeping requirements applicable to emergency medical services agencies.
- § 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).
- § 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.