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The Electronic Code of Federal Regulations (e-CFR) is a regularly updated, unofficial editorial compilation of CFR material and Federal Register amendments produced by the National Archives and Records Administration's Office of the Federal Register (OFR) and the Government Publishing Office.

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Electronic Code of Federal Regulations

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e-CFR Data is current as of March 25, 2015

Title 21Chapter IIPart 1304

TITLE 21—Food and Drugs




General Information

Scope of part 1304.
Persons required to keep records and file reports.
Maintenance of records and inventories.
Records of authorized central fill pharmacies and retail pharmacies.
Records and reports for electronic prescriptions.

Inventory Requirements

Inventory requirements.

Continuing Records

General requirements for continuing records.
Records for manufacturers, distributors, dispensers, researchers, importers, exporters, registrants that reverse distribute, and collectors.
Records for chemical analysts.
Records for maintenance treatment programs and detoxification treatment programs.
Records for treatment programs that compound narcotics for treatment programs and other locations.
Additional recordkeeping requirements applicable to drug products containing gamma-hydroxybutyric acid.


Reports from manufacturers importing narcotic raw material.
Reports of manufacturers importing coca leaves.
Reports to Automation of Reports and Consolidated Orders System (ARCOS).

Online Pharmacies

Notification by online pharmacies.
Internet Web site disclosure requirements.
Disclosure requirements for Web sites of nonpharmacy practitioners that dispense controlled substances by means of the Internet.
Reports by online pharmacies.

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