Part 1301 — Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances
Current through Sep 8, 2026
Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952, 956, 957, 958, 965.
Source: 36 FR 7778, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.
Sections
- § 1301.01 Scope of this part 1301.
- § 1301.02 Definitions. Link
- § 1301.03 Information; special instructions.
- § 1301.11 Persons required to register; requirement of modification of registration authorizing activity as an online pharmacy.
- § 1301.12 Separate registrations for separate locations.
- § 1301.13 Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities.
- § 1301.14 Filing of application; acceptance for filing; defective applications.
- § 1301.15 Additional information.
- § 1301.16 Amendments to and withdrawal of applications.
- § 1301.17 Special procedures for certain applications.
- § 1301.18 Research protocols.
- § 1301.19 Special requirements for online pharmacies.
- § 1301.20 Registration for emergency medical services agencies.
- § 1301.21 Exemption from fees.
- § 1301.22 Exemption of agents and employees; affiliated practitioners.
- § 1301.23 Exemption of certain military and other personnel.
- § 1301.24 Exemption of law enforcement officials.
- § 1301.25 Registration regarding ocean vessels, aircraft, and other entities.
- § 1301.26 Exemptions from import or export requirements for personal medical use.
- § 1301.27 Separate registration by retail pharmacies for installation and operation of automated dispensing systems at long term care facilities.
- §§ 1301.28-1301.29 [Reserved]
- § 1301.31 Administrative review generally.
- § 1301.32 Action on applications for research in Schedule I substances.
- § 1301.33 Application for bulk manufacture of Schedule I and II substances.
- § 1301.34 Application for importation of Schedule I and II substances.
- § 1301.35 Certificate of registration; denial of registration.
- § 1301.36 Suspension or revocation of registration; suspension of registration pending final order; extension of registration pending final order.
- § 1301.37 Order to show cause.
- § 1301.41 Hearings generally.
- § 1301.42 Purpose of hearing.
- § 1301.43 Request for hearing or appearance; waiver; default.
- § 1301.44 Burden of proof.
- § 1301.45 Time and place of hearing.
- § 1301.46 Final order.
- § 1301.51 Modification in registration.
- § 1301.52 Termination of registration; transfer of registration; distribution upon discontinuance of business.
- § 1301.71 Security requirements generally.
- § 1301.72 Physical security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs; storage areas.
- § 1301.73 Physical security controls for non-practitioners; compounders for narcotic treatment programs; manufacturing and compounding areas.
- § 1301.74 Other security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs.
- § 1301.75 Physical security controls for practitioners.
- § 1301.76 Other security controls for practitioners.
- § 1301.77 Security controls for freight forwarding facilities.
- § 1301.78-1301.79 [Reserved]
- § 1301.80 Security controls for emergency medical services agencies.
- § 1301.90 Employee screening procedures.
- § 1301.91 Employee responsibility to report drug diversion.
- § 1301.92 Illicit activities by employees.
- § 1301.93 Sources of information for employee checks.