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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION
DEPARTMENT OF JUSTICE
 
PART 1304RECORDS AND REPORTS OF REGISTRANTS
 

 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.

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

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