10 CFR 32.21 - Radioactive drug: Manufacture, preparation, or transfer for commercial distribution of capsules containing carbon-14 urea each for

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There is 1 rule appearing in the Federal Register for 10 CFR 32. View below or at eCFR (GPOAccess)
§ 32.21 Radioactive drug: Manufacture, preparation, or transfer for commercial distribution of capsules containing carbon-14 urea each for “in vivo” diagnostic use for humans to persons exempt from licensing; Requirements for a license.
(a) An application for a specific license to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution capsules containing 37 kBq (1 µCi) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each for “in vivo” diagnostic use, to persons exempt from licensing under § 30.21 of this chapter or the equivalent regulations of an Agreement State will be approved if:
(1) The applicant satisfies the general requirements specified in § 30.33 of this chapter, provided that the requirements of § 30.33(a) (2) and (3) of this chapter do not apply to an application for a license to transfer byproduct material manufactured, prepared, processed, produced, packaged, or repackaged pursuant to a license issued by an Agreement State;
(2) The applicant meets the requirements under § 32.72(a)(2) of this part;
(3) The applicant provides evidence that each capsule contains 37 kBq (1 µCi) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process);
(4) The carbon-14 urea is not contained in any food, beverage, cosmetic, drug (except as described in this section) or other commodity designed for ingestion or inhalation by, or topical application to, a human being;
(5) The carbon-14 urea is in the form of a capsule, identified as radioactive, and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and
(6) The applicant submits copies of prototype labels and brochures and the NRC approves these labels and brochures.
(b) Nothing in this section relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing drugs.
[62 FR 63640, Dec. 2, 1997, as amended at 66 FR 64738, Dec. 14, 2001]

Title 10 published on 2014-01-01

The following are only the Rules published in the Federal Register after the published date of Title 10.

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  • 2014-12-19; vol. 79 # 244 - Friday, December 19, 2014
    1. 79 FR 75735 - Organizational Changes and Conforming Amendments
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      NUCLEAR REGULATORY COMMISSION
      Final rule.
      This final rule is effective on December 19, 2014.
      10 CFR Parts 1, 2, 30, 31, 32, 34, 35, 37, 40, 51, 61, 62, 70, 71, 72, 73, 74, 75, 140, and 150

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United States Code

Title 10 published on 2014-01-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 10 CFR 32 after this date.

  • 2014-12-19; vol. 79 # 244 - Friday, December 19, 2014
    1. 79 FR 75735 - Organizational Changes and Conforming Amendments
      GPO FDSys XML | Text
      NUCLEAR REGULATORY COMMISSION
      Final rule.
      This final rule is effective on December 19, 2014.
      10 CFR Parts 1, 2, 30, 31, 32, 34, 35, 37, 40, 51, 61, 62, 70, 71, 72, 73, 74, 75, 140, and 150