3701:1-58-35 Permissible molybdenum-99 concentration.

(A) A licensee may not administer to humans a radiopharmaceutical that contains more than 0.15 kilobecquerel, or 0.15 microcurie of molybdenum-99 per megabecquerel, or millicurie of technetium-99m.

(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 rule.

(C) If a licensee is required to measure the molybdenum-99 concentration, the licensee shall retain a record of each measurement in accordance with rule 3701:1-58-85 of the Administrative Code.

Effective: 08/15/2005

R.C. 119.032 review dates: 08/15/2010

Promulgated Under: 119.03

Statutory Authority: 3748.02, 3748.04

Rule Amplifies: 3748.04