21 CFR 1301.73 - Physical security controls for non-practitioners; compounders for narcotic treatment programs; manufacturing and compounding areas.

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There is 1 rule appearing in the Federal Register for 21 CFR 1301. View below or at eCFR (GPOAccess)
§ 1301.73 Physical security controls for non-practitioners; compounders for narcotic treatment programs; manufacturing and compounding areas.
All manufacturing activities (including processing, packaging and labeling) involving controlled substances listed in any schedule and all activities of compounders shall be conducted in accordance with the following:
(a) All in-process substances shall be returned to the controlled substances storage area at the termination of the process. If the process is not terminated at the end of a workday (except where a continuous process or other normal manufacturing operation should not be interrupted), the processing area or tanks, vessels, bins or bulk containers containing such substances shall be securely locked, with adequate security for the area or building. If such security requires an alarm, such alarm, upon unauthorized entry, shall transmit a signal directly to a central station protection company, or local or state police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant.
(b) Manufacturing activities with controlled substances shall be conducted in an area or areas of clearly defined limited access which is under surveillance by an employee or employees designated in writing as responsible for the area. “Limited access” may be provided, in the absence of physical dividers such as walls or partitions, by traffic control lines or restricted space designation. The employee designated as responsible for the area may be engaged in the particular manufacturing operation being conducted: Provided, That he is able to provide continuous surveillance of the area in order that unauthorized persons may not enter or leave the area without his knowledge.
(c) During the production of controlled substances, the manufacturing areas shall be accessible to only those employees required for efficient operation. When it is necessary for employee maintenance personnel, nonemployee maintenance personnel, business guests, or visitors to be present in or pass through manufacturing areas during production of controlled substances, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.
[36 FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 39 FR 37984, Oct. 25, 1974]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-11-25; vol. 79 # 227 - Tuesday, November 25, 2014
    1. 79 FR 70085 - Exemption From Registration for Persons Authorized Under U.S. Nuclear Regulatory Commission or Agreement State Medical Use Licenses or Permits and Administering the Drug Product DaTscan TM
      GPO FDSys XML | Text
      DEPARTMENT OF JUSTICE, Drug Enforcement Administration
      Interim final rule with request for comment.
      Effective November 25, 2014. Interested persons may file written comments on this interim final rule pursuant to 5 U.S.C. 553. Electronic comments must be submitted, and written comments must be postmarked, on or before January 26, 2015. 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 Part 1301

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 1301 after this date.

  • 2014-11-25; vol. 79 # 227 - Tuesday, November 25, 2014
    1. 79 FR 70085 - Exemption From Registration for Persons Authorized Under U.S. Nuclear Regulatory Commission or Agreement State Medical Use Licenses or Permits and Administering the Drug Product DaTscan TM
      GPO FDSys XML | Text
      DEPARTMENT OF JUSTICE, Drug Enforcement Administration
      Interim final rule with request for comment.
      Effective November 25, 2014. Interested persons may file written comments on this interim final rule pursuant to 5 U.S.C. 553. Electronic comments must be submitted, and written comments must be postmarked, on or before January 26, 2015. 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 Part 1301