Office of Diversion Control, US Department of Justice, Drug Enforcement Administration

Title 21 Code of Federal Regulations

PART 1301 — REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES

GENERAL INFORMATION

Section 1301.01 Scope of Part 1301

Section 1301.02 Definitions

Section 1301.03 Information; special instructions

REGISTRATION

Section 1301.11 Persons required to register

Section 1301.12 Separate registrations for separate locations

Section 1301.13 Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities

Section 1301.14 Filing of application; acceptance for filing; defective applications

Section 1301.15 Additional information

Section 1301.16 Amendments to and withdrawal of applications

Section 1301.17 Special procedures for certain applications

Section 1301.18 Research protocols

Section 1301.19 Special requirements for online pharmacies

EXCEPTIONS TO REGISTRATION AND FEES

Section 1301.21 Exemption from fees

Section 1301.22 Exemption of agents and employees; affiliated practitioners

Section 1301.23 Exemption of certain military and other personnel

Section 1301.24 Exemption of law enforcement officials

Section 1301.25 Registration regarding ocean vessels, aircraft, and other entities

Section 1301.26 Exemption from import or export requirements for personal medical use

Section 1301.27 Separate registration by retail pharmacies for installation and operation of automated dispensing systems at long term care facilities

Section 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

ACTION ON APPLICATIONS FOR REGISTRATION: REVOCATION OR SUSPENSION OF REGISTRATION

Section 1301.31 Administrative review generally

Section 1301.32 Action on applications for research in Schedule I substances

Section 1301.33 Application for bulk manufacture of Schedule I and II substances

Section 1301.34 Application for importation of Schedule I and II substances

Section 1301.35 Certificate of registration; denial of registration

Section 1301.36 Suspension or revocation of registration; suspension of registration pending final order; extension of registration pending final order

Section 1301.37 Order to show cause

HEARINGS

Section 1301.41 Hearings generally

Section 1301.42 Purpose of hearing

Section 1301.43 Request for hearing or appearance; waiver

Section 1301.44 Burden of proof

Section 1301.45 Time and place of hearing

Section 1301.46 Final order

MODIFICATION, TRANSFER AND TERMINATION OF REGISTRATION

Section 1301.51 Modification in registration

Section 1301.52 Termination of registration; transfer of registration; distribution upon discontinuance of business

SECURITY REQUIREMENTS

Section 1301.71 Security requirements generally

Section 1301.72 Physical security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; storage areas

Section 1301.73 Physical security controls for non-practitioners; compounders for narcotic treatment programs; manufacturing and compounding areas

Section 1301.74 Other security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs

Section 1301.75 Physical security controls for practitioners

Section 1301.76 Other security controls for practitioners

Section 1301.77 Security controls for freight forwarding facilities

EMPLOYEE SCREENING — NON-PRACTITIONERS

Section 1301.90 Employee screening procedures

Section 1301.91 Employee responsibility to report drug diversion

Section 1301.92 Illicit activities by employees

Section 1301.93 Sources of information for employee checks

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Printing Office (GPO).

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Office of Diversion Control  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539