21 CFR Part 1301 - REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
- General Information
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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.
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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.
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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
- Modification, Transfer and Termination of Registration
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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
Title 21 published on 2012-04-01
no entries appear in the Federal Register after this date.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
Title 21 published on 2012-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 1301 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-30699 RIN 1117-AB18 Docket No. DEA-316 DEPARTMENT OF JUSTICE, Drug Enforcement Administration Notice of proposed rulemaking. Electronic comments must be submitted and written comments must be postmarked on or before February 19, 2013. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after midnight Eastern Time on the last day of the comment period. 21 CFR Parts 1300, 1301, 1304, 1305, 1307, 1317, and 1321 This rule proposes requirements to govern the secure disposal of controlled substances by both DEA registrants and ultimate users. These regulations would implement the Secure and Responsible Drug Disposal Act of 2010 (Pub. L. 111-273) by expanding the options available to collect controlled substances from ultimate users for purposes of disposal to include: Take-back events, mail-back programs, and collection receptacle locations. These proposed regulations contain specific language to continue to allow law enforcement agencies to voluntarily conduct take-back events, administer mail-back programs, and maintain collection receptacles. These regulations propose to allow authorized manufacturers, distributors, reverse distributors, and retail pharmacies to voluntarily administer mail-back programs and maintain collection receptacles. In addition, this proposed rule expands the authority of authorized retail pharmacies to voluntarily maintain collection receptacles at long term care facilities. This proposed rule also reorganizes and consolidates existing regulations on disposal, including the role of reverse distributors.