{"data":{"id":"us/10-cfr-35.204","jurisdiction":"us","citation":"10 CFR 35.204","heading":"Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.","body":"(a) A licensee may not administer to humans a radiopharmaceutical that contains:\n(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\n(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).\n(b) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with paragraph (a) of this section.\n(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.\n(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.\n(e) The licensee shall report any measurement that exceeds the limits in paragraph (a) of this section at the time of generator elution, in accordance with § 35.3204.","path":["Title 10—Energy","CHAPTER I—NUCLEAR REGULATORY COMMISSION","PART 35—MEDICAL USE OF BYPRODUCT MATERIAL","Subpart D—Unsealed Byproduct Material—Written Directive Not Required"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-10.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:09Z","sha256":"58a2c5b5db4204aadf8d3c9a577d41e66286f6c71f5fb5d5cdfb480a68b25281","source_id":"us-cfr","stale":true,"prev":"us/10-cfr-35.200","next":"us/10-cfr-35.290"},"notice":"GroundRules: Original legal text. Not legal advice."}