21 CFR Part 1301 — Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances
- § 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.
- § 1301.21— 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— Exemption from separate registration for practitioners dispensing or prescribing Schedule III, IV, or V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment.
- § 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.
- § 1301.90— 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.