Section 17-7 - Radiopharmaceuticals as CSPs (a). Standards for the production of Positron Emission Tomography (PET) drugs are addressed in USP Chapter 823 Radiopharmaceuticals for Positron Emission Tomography - Compounding, while USP Chapter 797 applies to the further handling, manipulation, or use of the product once it is released as a finished drug product from a production facility. - (i) For the purpose of this Section, the following shall be designated low-risk level radiopharmaceutical CSPs:
- (A) Radiopharmaceuticals compounded from sterile components in closed sterile containers, using appropriately shielded vials and syringes in a properly functioning and certified ISO Class 5 PEC located in an ISO Class 8 or cleaner air environment.
- (B) Compounded Radiopharmaceuticals with a volume of 100 mL or less for a single-dose injection or not more than 30 mL taken from a multiple-dose container.
- (ii) Radiopharmaceuticals prepared as Low-Risk Level CSPs with 12-Hour or Less BUD shall be prepared in a properly designated and segregated compounding area.
- (iii) Radiopharmaceutical vials designed for multi-use, compounded with technetium-99m, exposed to ISO Class 5 environment, and punctured by needles with no direct contact contamination may be used up to the time indicated by manufacturer recommendations or as established by stability testing.
- (iv) Technetium-99m/molybdenum-99 generator systems shall be stored and operated under conditions recommended by the manufacturer and applicable state and federal regulations in an ISO Class 8 or cleaner air environment.
059-17 Wyo. Code R. § 17-7