§821. Rules and regulations — Inbound Citations

Implementing Regulations (Code of Federal Regulations)

Statutory authority for 246 regulations in the Code of Federal Regulations.

• 21 C.F.R. § 1301.01 — Scope of this part 1301.

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• 21 C.F.R. § 1301.02 — Definitions. Link

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• 21 C.F.R. § 1301.03 — Information; special instructions.

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• 21 C.F.R. § 1301.11 — Persons required to register; requirement of modification of registration authorizing activity as an online pharmacy.

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• 21 C.F.R. § 1301.12 — Separate registrations for separate locations.

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• 21 C.F.R. § 1301.13 — Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities.

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• 21 C.F.R. § 1301.14 — Filing of application; acceptance for filing; defective applications.

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• 21 C.F.R. § 1301.15 — Additional information.

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• 21 C.F.R. § 1301.16 — Amendments to and withdrawal of applications.

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• 21 C.F.R. § 1301.17 — Special procedures for certain applications.

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• 21 C.F.R. § 1301.18 — Research protocols.

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• 21 C.F.R. § 1301.19 — Special requirements for online pharmacies.

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• 21 C.F.R. § 1301.20 — Registration for emergency medical services agencies.

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• 21 C.F.R. § 1301.21 — Exemption from fees.

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• 21 C.F.R. § 1301.22 — Exemption of agents and employees; affiliated practitioners.

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• 21 C.F.R. § 1301.23 — Exemption of certain military and other personnel.

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• 21 C.F.R. § 1301.24 — Exemption of law enforcement officials.

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• 21 C.F.R. § 1301.25 — Registration regarding ocean vessels, aircraft, and other entities.

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• 21 C.F.R. § 1301.26 — Exemptions from import or export requirements for personal medical use.

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• 21 C.F.R. § 1301.27 — Separate registration by retail pharmacies for installation and operation of automated dispensing systems at long term care facilities.

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• 21 C.F.R. § 1301.28-1301.29 — [Reserved]

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• 21 C.F.R. § 1301.31 — Administrative review generally.

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• 21 C.F.R. § 1301.32 — Action on applications for research in Schedule I substances.

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• 21 C.F.R. § 1301.33 — Application for bulk manufacture of Schedule I and II substances.

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• 21 C.F.R. § 1301.34 — Application for importation of Schedule I and II substances.

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• 21 C.F.R. § 1301.35 — Certificate of registration; denial of registration.

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• 21 C.F.R. § 1301.36 — Suspension or revocation of registration; suspension of registration pending final order; extension of registration pending final order.

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• 21 C.F.R. § 1301.37 — Order to show cause.

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• 21 C.F.R. § 1301.41 — Hearings generally.

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• 21 C.F.R. § 1301.42 — Purpose of hearing.

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• 21 C.F.R. § 1301.43 — Request for hearing or appearance; waiver; default.

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• 21 C.F.R. § 1301.44 — Burden of proof.

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• 21 C.F.R. § 1301.45 — Time and place of hearing.

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• 21 C.F.R. § 1301.46 — Final order.

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• 21 C.F.R. § 1301.51 — Modification in registration.

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• 21 C.F.R. § 1301.52 — Termination of registration; transfer of registration; distribution upon discontinuance of business.

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• 21 C.F.R. § 1301.71 — Security requirements generally.

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• 21 C.F.R. § 1301.72 — Physical security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs; storage areas.

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• 21 C.F.R. § 1301.73 — Physical security controls for non-practitioners; compounders for narcotic treatment programs; manufacturing and compounding areas.

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• 21 C.F.R. § 1301.74 — Other security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs.

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• 21 C.F.R. § 1301.75 — Physical security controls for practitioners.

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• 21 C.F.R. § 1301.76 — Other security controls for practitioners.

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• 21 C.F.R. § 1301.77 — Security controls for freight forwarding facilities.

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• 21 C.F.R. § 1301.78-1301.79 — [Reserved]

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• 21 C.F.R. § 1301.80 — Security controls for emergency medical services agencies.

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• 21 C.F.R. § 1301.90 — Employee screening procedures.

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• 21 C.F.R. § 1301.91 — Employee responsibility to report drug diversion.

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• 21 C.F.R. § 1301.92 — Illicit activities by employees.

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• 21 C.F.R. § 1301.93 — Sources of information for employee checks.

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• 21 C.F.R. § 1302.01 — Scope of part 1302.

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• 21 C.F.R. § 1302.02 — Definitions.

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• 21 C.F.R. § 1302.03 — Symbol required; exceptions.

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• 21 C.F.R. § 1302.04 — Location and size of symbol on label and labeling.

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• 21 C.F.R. § 1302.05 — Effective dates of labeling requirements.

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• 21 C.F.R. § 1302.06 — Sealing of controlled substances.

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• 21 C.F.R. § 1302.07 — Labeling and packaging requirements for imported and exported substances.

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• 21 C.F.R. § 1302.08 — False labeling of anabolic steroids.

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• 21 C.F.R. § 1303.01 — Scope of part 1303.

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• 21 C.F.R. § 1303.02 — Definitions.

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• 21 C.F.R. § 1303.03 — Types of quotas.

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• 21 C.F.R. § 1303.04 — Subcategories of manufacturing and procurement quotas.

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• 21 C.F.R. § 1303.05 — Estimation of Diversion.

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• 21 C.F.R. § 1303.11 — Aggregate production quotas.

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• 21 C.F.R. § 1303.12 — [Reserved]

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• 21 C.F.R. § 1303.13 — Adjustments of aggregate production quotas.

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• 21 C.F.R. § 1303.15 — Procurement quotas.

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• 21 C.F.R. § 1303.16 — Inventory allowance for procurement quotas.

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• 21 C.F.R. § 1303.17 — Abandonment of procurement quota.

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• 21 C.F.R. § 1303.21 — Individual manufacturing quotas.

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• 21 C.F.R. § 1303.22 — Procedure for applying for individual manufacturing quotas.

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• 21 C.F.R. § 1303.23 — Procedure for fixing individual manufacturing quotas.

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• 21 C.F.R. § 1303.24 — Inventory allowance for individual manufacturing quotas.

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• 21 C.F.R. § 1303.25 — Increase in individual manufacturing quotas.

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• 21 C.F.R. § 1303.26 — Reduction in individual manufacturing quotas.

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• 21 C.F.R. § 1303.27 — Abandonment of quota for Individual Manufacturing Quota.

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• 21 C.F.R. § 1303.31 — Hearings generally.

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• 21 C.F.R. § 1303.32 — Purpose of hearing.

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• 21 C.F.R. § 1303.33 — Waiver or modification of rules.

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• 21 C.F.R. § 1303.34 — Request for hearing or appearance; waiver.

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• 21 C.F.R. § 1303.35 — Burden of proof.

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• 21 C.F.R. § 1303.36 — Time and place of hearing.

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• 21 C.F.R. § 1303.37 — Final order.

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• 21 C.F.R. § 1304.01 — Scope of part 1304.

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• 21 C.F.R. § 1304.02 — Definitions.

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• 21 C.F.R. § 1304.03 — Persons required to keep records and file reports.

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• 21 C.F.R. § 1304.04 — Maintenance of records and inventories.

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• 21 C.F.R. § 1304.05 — Records of authorized central fill pharmacies and retail pharmacies.

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• 21 C.F.R. § 1304.06 — Records and reports for electronic prescriptions.

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• 21 C.F.R. § 1304.11 — Inventory requirements.

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• 21 C.F.R. § 1304.21 — General requirements for continuing records.

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• 21 C.F.R. § 1304.22 — Records for manufacturers, distributors, dispensers, researchers, importers, exporters, registrants that reverse distribute, and collectors.

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• 21 C.F.R. § 1304.23 — Records for chemical analysts.

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• 21 C.F.R. § 1304.24 — Records for maintenance treatment programs, mobile narcotic treatment programs, and detoxification treatment programs.

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• 21 C.F.R. § 1304.25 — Records for treatment programs that compound narcotics for treatment programs and other locations.

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• 21 C.F.R. § 1304.26 — Additional recordkeeping requirements applicable to drug products containing gamma-hydroxybutyric acid.

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• 21 C.F.R. § 1304.27 — Additional recordkeeping requirements applicable to emergency medical services agencies.

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• 21 C.F.R. § 1304.31 — Reports from manufacturers importing narcotic raw material.

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• 21 C.F.R. § 1304.32 — Reports of manufacturers importing coca leaves.

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• 21 C.F.R. § 1304.33 — Reports to Automation of Reports and Consolidated Orders System (ARCOS).

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• 21 C.F.R. § 1304.40 — Notification by online pharmacies.

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• 21 C.F.R. § 1304.45 — Internet Web site disclosure requirements.

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• 21 C.F.R. § 1304.50 — Disclosure requirements for Web sites of nonpharmacy practitioners that dispense controlled substances by means of the Internet.

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• 21 C.F.R. § 1304.55 — Reports by online pharmacies.

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• 21 C.F.R. § 1305.01 — Scope of part 1305.

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• 21 C.F.R. § 1305.02 — Definitions.

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• 21 C.F.R. § 1305.03 — Distributions requiring a Form 222 or a digitally signed electronic order.

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• 21 C.F.R. § 1305.04 — Persons entitled to order Schedule I and II controlled substances.

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• 21 C.F.R. § 1305.05 — Power of attorney.

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• 21 C.F.R. § 1305.06 — Persons entitled to fill orders for Schedule I and II controlled substances.

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• 21 C.F.R. § 1305.07 — Special procedure for filling certain orders.

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• 21 C.F.R. § 1305.11 — Procedure for obtaining DEA Forms 222.

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• 21 C.F.R. § 1305.12 — Procedure for executing DEA Forms 222.

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• 21 C.F.R. § 1305.13 — Procedure for filling DEA Forms 222.

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• 21 C.F.R. § 1305.14 — Procedure for endorsing DEA Forms 222.

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• 21 C.F.R. § 1305.15 — Unaccepted and defective DEA Forms 222.

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• 21 C.F.R. § 1305.16 — Lost and stolen DEA Forms 222.

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• 21 C.F.R. § 1305.17 — Preservation of DEA Forms 222.

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• 21 C.F.R. § 1305.18 — Return of unused DEA Forms 222.

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• 21 C.F.R. § 1305.19 — Cancellation and voiding of DEA Forms 222.

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• 21 C.F.R. § 1305.20 — [Reserved]

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• 21 C.F.R. § 1305.21 — Requirements for electronic orders.

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• 21 C.F.R. § 1305.22 — Procedure for filling electronic orders.

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• 21 C.F.R. § 1305.23 — Endorsing electronic orders.

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• 21 C.F.R. § 1305.24 — Central processing of orders.

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• 21 C.F.R. § 1305.25 — Unaccepted and defective electronic orders.

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• 21 C.F.R. § 1305.26 — Lost electronic orders.

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• 21 C.F.R. § 1305.27 — Preservation of electronic orders.

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• 21 C.F.R. § 1305.28 — Canceling and voiding electronic orders.

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• 21 C.F.R. § 1305.29 — Reporting to DEA.

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• 21 C.F.R. § 1306.01 — Scope of part 1306.

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• 21 C.F.R. § 1306.02 — Definitions.

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• 21 C.F.R. § 1306.03 — Persons entitled to issue prescriptions.

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• 21 C.F.R. § 1306.04 — Purpose of issue of prescription.

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• 21 C.F.R. § 1306.05 — Manner of issuance of prescriptions.

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• 21 C.F.R. § 1306.06 — Persons entitled to fill prescriptions.

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• 21 C.F.R. § 1306.07 — Administering or dispensing of narcotic drugs.

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• 21 C.F.R. § 1306.08 — Electronic prescriptions.

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• 21 C.F.R. § 1306.09 — Prescription requirements for online pharmacies.

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• 21 C.F.R. § 1306.11 — Requirement of prescription.

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• 21 C.F.R. § 1306.12 — Refilling prescriptions; issuance of multiple prescriptions.

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• 21 C.F.R. § 1306.13 — Partial filling of prescriptions.

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• 21 C.F.R. § 1306.14 — Labeling of substances and filling of prescriptions.

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• 21 C.F.R. § 1306.15 — Provision of prescription information between retail pharmacies and central fill pharmacies for prescriptions of Schedule II controlled substances.

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• 21 C.F.R. § 1306.21 — Requirement of prescription.

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• 21 C.F.R. § 1306.22 — Refilling of prescriptions.

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• 21 C.F.R. § 1306.23 — Partial filling of prescriptions.

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• 21 C.F.R. § 1306.24 — Labeling of substances and filling of prescriptions.

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• 21 C.F.R. § 1306.25 — Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes.

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• 21 C.F.R. § 1306.26 — Dispensing without prescription.

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• 21 C.F.R. § 1306.27 — Provision of prescription information between retail pharmacies and central fill pharmacies for initial and refill prescriptions of Schedule III, IV, or V controlled substances.

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• 21 C.F.R. § 1306.28-1306.49 — [Reserved]

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• 21 C.F.R. § 1306.51 — Telemedicine prescribing of schedule III-V medications for the treatment of Opioid Use Disorder.

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• 21 C.F.R. § 1306.52 — Other circumstances where Department of Veterans Affairs practitioners may prescribe controlled substances via the practice of telemedicine.

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• 21 C.F.R. § 1307.01 — Definitions.

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• 21 C.F.R. § 1307.02 — Application of State law and other Federal law.

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• 21 C.F.R. § 1307.03 — Exceptions to regulations.

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• 21 C.F.R. § 1307.11 — Distribution by dispenser to another practitioner.

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• 21 C.F.R. § 1307.13 — Incidental manufacture of controlled substances.

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• 21 C.F.R. § 1307.14 — Delivery of controlled substances to designated locations of emergency medical services agencies.

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• 21 C.F.R. § 1307.15 — Delivery of controlled substances in emergency situations.

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• 21 C.F.R. § 1307.22 — Delivery of surrendered and forfeited controlled substances.

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• 21 C.F.R. § 1307.31 — Native American Church.

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• 21 C.F.R. § 1307.41 — Temporary extension of certain COVID-19 telemedicine flexibilities for prescription of controlled medications.

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• 21 C.F.R. § 1311.01 — Scope.

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• 21 C.F.R. § 1311.02 — Definitions.

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• 21 C.F.R. § 1311.05 — Standards for technologies for electronic transmission of orders.

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• 21 C.F.R. § 1311.08 — Incorporation by reference.

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• 21 C.F.R. § 1311.10 — Eligibility to obtain a CSOS digital certificate.

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• 21 C.F.R. § 1311.100 — General.

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• 21 C.F.R. § 1311.102 — Practitioner responsibilities.

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• 21 C.F.R. § 1311.105 — Requirements for obtaining an authentication credential—Individual practitioners.

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• 21 C.F.R. § 1311.110 — Requirements for obtaining an authentication credential—Individual practitioners eligible to use an electronic prescription application of an institutional practitioner.

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• 21 C.F.R. § 1311.115 — Additional requirements for two-factor authentication.

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• 21 C.F.R. § 1311.116 — Additional requirements for biometrics.

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• 21 C.F.R. § 1311.120 — Electronic prescription application requirements.

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• 21 C.F.R. § 1311.125 — Requirements for establishing logical access control—Individual practitioner.

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• 21 C.F.R. § 1311.130 — Requirements for establishing logical access control—Institutional practitioner.

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• 21 C.F.R. § 1311.135 — Requirements for creating a controlled substance prescription.

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• 21 C.F.R. § 1311.140 — Requirements for signing a controlled substance prescription.

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• 21 C.F.R. § 1311.145 — Digitally signing the prescription with the individual practitioner's private key.

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• 21 C.F.R. § 1311.15 — Limitations on CSOS digital certificates.

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• 21 C.F.R. § 1311.150 — Additional requirements for internal application audits.

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• 21 C.F.R. § 1311.170 — Transmission requirements.

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• 21 C.F.R. § 1311.20 — Coordinators for CSOS digital certificate holders.

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• 21 C.F.R. § 1311.200 — Pharmacy responsibilities.

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• 21 C.F.R. § 1311.205 — Pharmacy application requirements.

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• 21 C.F.R. § 1311.210 — Archiving the initial record.

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• 21 C.F.R. § 1311.215 — Internal audit trail.

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• 21 C.F.R. § 1311.25 — Requirements for obtaining a CSOS digital certificate.

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• 21 C.F.R. § 1311.30 — Requirements for storing and using a private key for digitally signing orders.

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• 21 C.F.R. § 1311.300 — Application provider requirements—Third-party audits or certifications.

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• 21 C.F.R. § 1311.302 — Additional application provider requirements.

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• 21 C.F.R. § 1311.305 — Recordkeeping.

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• 21 C.F.R. § 1311.35 — Number of CSOS digital certificates needed.

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• 21 C.F.R. § 1311.40 — Renewal of CSOS digital certificates.

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• 21 C.F.R. § 1311.45 — Requirements for registrants that allow powers of attorney to obtain CSOS digital certificates under their DEA registration.

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• 21 C.F.R. § 1311.50 — Requirements for recipients of digitally signed orders.

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• 21 C.F.R. § 1311.55 — Requirements for systems used to process digitally signed orders.

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• 21 C.F.R. § 1311.60 — Recordkeeping.

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• 21 C.F.R. § 1312.01 — Scope of part 1312.

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• 21 C.F.R. § 1312.02 — Definitions.

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• 21 C.F.R. § 1312.03 — Forms applicable to this part.

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• 21 C.F.R. § 1312.11 — Requirement of authorization to import.

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• 21 C.F.R. § 1312.12 — Application for import permit; return information.

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• 21 C.F.R. § 1312.13 — Issuance of import permit.

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• 21 C.F.R. § 1312.14 — Distribution of import permits.

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• 21 C.F.R. § 1312.15 — Shipments in greater or less amount than authorized.

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• 21 C.F.R. § 1312.16 — Amendment, cancellation, expiration of import permit.

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• 21 C.F.R. § 1312.17 — Special report from importers.

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• 21 C.F.R. § 1312.18 — Import declaration.

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• 21 C.F.R. § 1312.19 — Distribution of import declaration.

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• 21 C.F.R. § 1312.21 — Requirement of authorization to export.

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• 21 C.F.R. § 1312.22 — Application for export or reexport permit; return information.

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• 21 C.F.R. § 1312.23 — Issuance of export permit.

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• 21 C.F.R. § 1312.24 — Distribution of export permit.

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• 21 C.F.R. § 1312.25 — Amendment, cancellation, expiration of export permit.

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• 21 C.F.R. § 1312.26 — Records required of exporter.

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• 21 C.F.R. § 1312.27 — Export/reexport declaration.

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• 21 C.F.R. § 1312.28 — Distribution of export declaration.

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• 21 C.F.R. § 1312.29 — Domestic release prohibited.

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• 21 C.F.R. § 1312.30 — Schedule III, IV, and V non-narcotic controlled substances requiring an import and export permit.

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• 21 C.F.R. § 1312.31 — Schedule I: Application for prior written approval.

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• 21 C.F.R. § 1312.32 — Schedules II, III, IV: Advance notice.

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• 21 C.F.R. § 1312.41 — Hearings generally.

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• 21 C.F.R. § 1312.42 — Purpose of hearing.

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• 21 C.F.R. § 1312.43 — Waiver or modification of rules.

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• 21 C.F.R. § 1312.44 — Request for hearing or appearance; waiver.

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• 21 C.F.R. § 1312.45 — Burden of proof.

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• 21 C.F.R. § 1312.46 — Time and place of hearing.

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• 21 C.F.R. § 1312.47 — Final order.

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• 21 C.F.R. § 1317.01 — Scope.

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• 21 C.F.R. § 1317.05 — Registrant disposal.

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• 21 C.F.R. § 1317.10 — Registrant return or recall.

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• 21 C.F.R. § 1317.15 — Reverse distributor registration requirements and authorized activities.

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• 21 C.F.R. § 1317.30 — Authorization to collect from non-registrants.

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• 21 C.F.R. § 1317.35 — Collection by law enforcement.

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• 21 C.F.R. § 1317.40 — Registrants authorized to collect and authorized collection activities.

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• 21 C.F.R. § 1317.55 — Reverse distributor and distributor acquisition of controlled substances from collectors or law enforcement.

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• 21 C.F.R. § 1317.60 — Inner liner requirements.

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• 21 C.F.R. § 1317.65 — Take-back events.

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• 21 C.F.R. § 1317.70 — Mail-back programs.

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• 21 C.F.R. § 1317.75 — Collection receptacles.

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• 21 C.F.R. § 1317.80 — Collection receptacles at long-term care facilities.

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• 21 C.F.R. § 1317.85 — Ultimate user delivery for the purpose of recall or investigational use of drugs.

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• 21 C.F.R. § 1317.90 — Methods of destruction.

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• 21 C.F.R. § 1317.95 — Destruction procedures.

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Citations to 21 U.S.C. § 821 as a whole

• 48 U.S.C. § 1972(a)(1)

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  (1) that the United States shall carry out the provisions of part C of the Controlled Substances Act (21 U.S.C. 821 et seq.) as necessary to provide for the lawful distribution of controlled substances in the freely associated states; and