SECTION 535:15-10-15. Compounding of non-sterile radiopharmaceuticals

(a)   The unique circumstances and requirements for radiopharmaceutical preparations necessitate specific stipulations that must not only satisfy pharmaceutical drug quality, but also consider crucial radiation safety concerns to operators. Facility design and variation in certain chapter standards may be required and shall be documented with supporting evidence upon request.

(b)   Radiopharmaceuticals prepared for oral administration shall be designated as, and conform to, the standards for non-sterile preparations. Any variation in certain chapter standards may be required to meet radiation safety concerns to operators and shall be documented with supporting evidence upon request.

[Source: Added at 26 Ok Reg 2276, eff 7-1-09]