USP shares new chapter on radiopharmaceutical safety

The U.S. Pharmacopeia (USP) has published a new chapter on the minimum standards required to prepare, compound, dispense and repackage both sterile and non-sterile radiopharmaceuticals associated with state-licensed activities. The Society of Nuclear Medicine & Molecular Imaging (SNMMI) noted in a prepared statement that it is currently reviewing the text, which includes changes sparked by the group’s recommendations.

“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,” according to the SNMMI statement. “Items like facility design, competency of staff, and infection control practices are critical areas that might need attention and review.”

“General Chapter <825> Radiopharmaceuticals— Preparation, Compounding, Dispensing, and Repackaging” is available on the USP website. Additional information from the USP is available here.

The chapter takes effect on Dec. 1. Regulators, including the FDA and other government agencies, are responsible for seeing that these requirements are met from that date going forward.

“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,” according to the SNMMI statement.