U.S. Code of Federal Regulations

Regulations most recently checked for updates: May 30, 2023

All TitlesTitle 21Chapter IIPart 1301 - PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES

GENERAL INFORMATION
§ 1301.01 - Scope of this part 1301.
§ 1301.02 - Definitions.Link
§ 1301.03 - Information; special instructions.

REGISTRATION
§ 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.

EXCEPTIONS TO REGISTRATION AND FEES
§ 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.
§ 1301.29 - [Reserved]

ACTION ON APPLICATION FOR REGISTRATION: REVOCATION OR SUSPENSION OF REGISTRATION
§ 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.

HEARINGS
§ 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.

MODIFICATION, TRANSFER AND TERMINATION OF REGISTRATION
§ 1301.51 - Modification in registration.
§ 1301.52 - Termination of registration; transfer of registration; distribution upon discontinuance of business.

SECURITY REQUIREMENTS
§ 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.

EMPLOYEE SCREENING—NON-PRACTITIONERS
§ 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.
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