059-17 Wyo. Code R. §§ 17-17 - Radiopharmaceuticals as CSPs
(a) Radiopharmaceuticals compounded from
sterile components in closed, sterile containers, and with a volume of 100 mL
or less for a single-dose injection, or no more than 30 mL taken from a
multiple-dose container, are considered low-risk level CSPs and shall comply
with the requirements in this Chapter.
(b) Radiopharmaceuticals shall be compounded
using appropriately shielded vials and syringes, in a properly functioning and
certified PEC, located in an ISO Class 8 or cleaner SEC.
(c) Radiopharmaceuticals vials designed for
multi-use, compounded with technetium-99m, exposed to ISO Class 5 environments
and punctured by needles with no direct contact contamination, may be used up
to the time indicated by the manufacturer's recommendations.
(d) Technetium-99m/molybdenum-99 generator
systems shall be stored and operated under conditions recommended by
manufacturers, and applicable state and federal regulations.
(i) Generator systems shall be eluted in an
ISO Class 8 or cleaner air environment, to permit special handling, shielding,
and air flow requirements.
(e) Direct visual inspection of
radiopharmaceutical CSPs containing high concentrations of doses of
radioactivity, shall be conducted to limit acute and chronic radiation exposure
to a level that is as low as reasonably achievable (ALARA).
(f) A sterile compounding pharmacy with a SCA
may compound radiopharmaceutical CSPs as low-risk level CSPs and shall not
assign a BUD greater than twelve (12) hours at controlled room temperature, or
twenty-four (24) hours at refrigerated temperature.
Notes
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