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Electronic Code of Federal Regulations

e-CFR data is current as of January 27, 2020

Title 21Chapter IIPart 1301


TITLE 21—Food and Drugs

CHAPTER II—DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE

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

rule

General Information

§1301.01
Scope of this part 1301.
§1301.02
Definitions.
§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.
§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; 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.
§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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