Title 21

PART 1304

Part 1304 - Records And Reports Of Registrants

PART 1304 - RECORDS AND REPORTS OF REGISTRANTS Authority:21 U.S.C. 821, 827, 831, 871(b), 958(e)-(g), and 965, unless otherwise noted.

21:9.0.1.1.5.0.13SUBJGRP 13
   General Information
21:9.0.1.1.5.0.13.1SECTION 1304.01
   1304.01 Scope of part 1304.
21:9.0.1.1.5.0.13.2SECTION 1304.02
   1304.02 Definitions.
21:9.0.1.1.5.0.13.3SECTION 1304.03
   1304.03 Persons required to keep records and file reports.
21:9.0.1.1.5.0.13.4SECTION 1304.04
   1304.04 Maintenance of records and inventories.
21:9.0.1.1.5.0.13.5SECTION 1304.05
   1304.05 Records of authorized central fill pharmacies and retail pharmacies.
21:9.0.1.1.5.0.13.6SECTION 1304.06
   1304.06 Records and reports for electronic prescriptions.
21:9.0.1.1.5.0.14SUBJGRP 14
   Inventory Requirements
21:9.0.1.1.5.0.14.7SECTION 1304.11
   1304.11 Inventory requirements.
21:9.0.1.1.5.0.15SUBJGRP 15
   Continuing Records
21:9.0.1.1.5.0.15.8SECTION 1304.21
   1304.21 General requirements for continuing records.
21:9.0.1.1.5.0.15.9SECTION 1304.22
   1304.22 Records for manufacturers, distributors, dispensers, researchers, importers, exporters, registrants that reverse distribute, and collectors.
21:9.0.1.1.5.0.15.10SECTION 1304.23
   1304.23 Records for chemical analysts.
21:9.0.1.1.5.0.15.11SECTION 1304.24
   1304.24 Records for maintenance treatment programs and detoxification treatment programs.
21:9.0.1.1.5.0.15.12SECTION 1304.25
   1304.25 Records for treatment programs that compound narcotics for treatment programs and other locations.
21:9.0.1.1.5.0.15.13SECTION 1304.26
   1304.26 Additional recordkeeping requirements applicable to drug products containing gamma-hydroxybutyric acid.
21:9.0.1.1.5.0.16SUBJGRP 16
   Reports
21:9.0.1.1.5.0.16.14SECTION 1304.31
   1304.31 Reports from manufacturers importing narcotic raw material.
21:9.0.1.1.5.0.16.15SECTION 1304.32
   1304.32 Reports of manufacturers importing coca leaves.
21:9.0.1.1.5.0.16.16SECTION 1304.33
   1304.33 Reports to Automation of Reports and Consolidated Orders System (ARCOS).
21:9.0.1.1.5.0.17SUBJGRP 17
   Online Pharmacies
21:9.0.1.1.5.0.17.17SECTION 1304.40
   1304.40 Notification by online pharmacies.
21:9.0.1.1.5.0.17.18SECTION 1304.45
   1304.45 Internet Web site disclosure requirements.
21:9.0.1.1.5.0.17.19SECTION 1304.50
   1304.50 Disclosure requirements for Web sites of nonpharmacy practitioners that dispense controlled substances by means of the Internet.
21:9.0.1.1.5.0.17.20SECTION 1304.55
   1304.55 Reports by online pharmacies.