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Title 21
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Part 1301
FEDERAL · 21 CFR
Part 1301 — Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances
50 sections · Title 21: Food and Drugs
§ 1301.01
Scope of this part 1301.
§ 1301.02
Definitions. Link
§ 1301.03
Information; special instructions.
§ 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.
§ 1301.20
Registration for emergency medical services agencies.
§ 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
§ 1301.29 [Reserved]
§ 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; default.
§ 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; 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.
§ 1301.78-1301.79
§ 1301.78-1301.79 [Reserved]
§ 1301.80
Security controls for emergency medical services agencies.
§ 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.