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 this Part 1301.

Section 1301.02 Definitions.

Section 1301.03 Information; special instructions.

REGISTRATION

Section 1301.11 Persons required to register; requirement of modification of registration authorizing activity as an online pharmacy.

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.

Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952, 953, 956, 957, 958, 965.

Source: 36 FR 7778, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

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