21 CFR Part 1301 - PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
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General Information (§§ 1301.01 - 1301.03)
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Registration (§§ 1301.11 - 1301.19)
- § 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.
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Exceptions to Registration and Fees (§§ 1301.21 - 1301.29)
- § 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]
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Action on Application for Registration: Revocation or Suspension of Registration (§§ 1301.31 - 1301.37)
- § 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.
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Modification, Transfer and Termination of Registration (§§ 1301.51 - 1301.52)
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Security Requirements (§§ 1301.71 - 1301.77)
- § 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.
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Employee Screening—Non-Practitioners (§§ 1301.90 - 1301.93)
The following state regulations pages link to this page.
Arkansas
Colorado
Georgia
Iowa
Michigan
Mississippi
Nevada
North Carolina
Ohio
Tennessee
Washington
Wyoming