10 CFR 35.204 - Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.

§ 35.204 Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.
(a) A licensee may not administer to humans a radiopharmaceutical that contains:
(1) More than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m); or
(2) More than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 microcurie of strontium-82 per millicurie of rubidium-82 chloride); or more than 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 microcurie of strontium-85 per millicurie of rubidium-82).
(b) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration of the first eluate after receipt of a generator to demonstrate compliance with paragraph (a) of this section.
(c) A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical shall, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with paragraph (a) of this section.
(d) If a licensee is required to measure the molybdenum-99 concentration or strontium-82 and strontium-85 concentrations, the licensee shall retain a record of each measurement in accordance with § 35.2204.
[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 55932, Oct. 1, 2007]

Title 10 published on 2014-01-01

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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 35 after this date.

  • 2014-07-21; vol. 79 # 139 - Monday, July 21, 2014
    1. 79 FR 42224 - Medical Use of Byproduct Material—Medical Event Definitions and Training and Experience
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      NUCLEAR REGULATORY COMMISSION
      Draft guidance; request for comment.
      Submit comments by November 18, 2014. Comments received after this date will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date.
      10 CFR Parts 30, 32 and 35