Office of Diversion Control, US Department of Justice, Drug Enforcement Administration

Title 21 Code of Federal Regulations

PART 1304 — RECORDS AND REPORTS OF REGISTRANTS

GENERAL INFORMATION

Section 1304.01 Scope of Part 1304.

Section 1304.02 Definitions.

Section 1304.03 Persons required to keep records and file reports.

Section 1304.04 Maintenance of records and inventories.

Section 1304.05 Records of authorized central fill pharmacies and retail pharmacies.

Section 1304.06 Records and reports for electronic prescriptions.

INVENTORY REQUIREMENTS

Section 1304.11 Inventory requirements.

CONTINUING RECORDS

Section 1304.21 General requirements for continuing records.

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

Section 1304.23 Records for chemical analysts.

Section 1304.24 Records for maintenance treatment programs and detoxification treatment programs.

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

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

REPORTS

Section 1304.31 Reports from manufacturers importing narcotic raw material.

Section 1304.32 Reports of manufacturers importing coca leaves.

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

ONLINE PHARMACIES

Section 1304.40 Notification by online pharmacies.

Section 1304.45 Internet website disclosure requirements.

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

Section 1304.55 Reports by online pharmacies.

Authority: 21 U.S.C. 821, 827, 831, 871(b), 958(e)-(g), and 965, unless otherwise noted.

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Printing Office (GPO).

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Office of Diversion Control  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539