21 C.F.R. PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES


TITLE 21-Food and Drugs

CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE

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

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�1301.01
Scope of this part 1301.
�1301.02
Definitions.
�1301.03
Information; special instructions.
�1301.11
Persons required to register.
�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.
�1301.21
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.
�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; 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.
�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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