USP publishes new safety standards for radiopharmaceuticals

The U.S. Pharmacopeia (USP) recently published a new chapter outlining minimum standards for preparing, compounding, dispensing and packaging sterile and non-sterile radiopharmaceuticals that are part of state-licensed activities.

“General Chapter <825> Radiopharmaceuticals— Preparation, Compounding, Dispensing, and Repackaging” is important to Society of Nuclear Medicine and Molecular Imaging (SNMMI) members because it addresses the specific safety needs of nuclear pharmacies and nuclear medicine departments along with patient safety information, according to an SNMMI statement.

“It is essential members review and compare the practices and procedures in place in their facility against what is included in the new USP chapter,” the statement read. “Items like facility design, competency of staff, and infection control practices are critical areas that might need attention and review.”

The FDA, along with local and federal agencies are responsible for ensuring institutions comply with the new USP requirements going into effect Dec. 1.

“SNMMI commends USP in this effort to provide a reasonable and rational basis for the protection of patients from unsafe practices when preparing, compounding, dispensing, and repackaging radiopharmaceuticals.”

SNMMI is currently reviewing the chapter, noting that it includes many recommendations it submitted in November 2018.