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USP Plans to Establish New Chapter for Radiopharmaceuticals and Calls for Candidates on Expert Panel

June 2, 2017

The USP announced the prospectus for a new General Chapter <825> Compounding-Radiopharmaceuticals. The purpose of the chapter is to provide clear and effective USP public standards that meet patient and practitioner needs for compounded sterile radiopharmaceuticals today and in the future. The proposed new general chapter will delineate compounding activities for radiopharmaceuticals and provide standards associated with these activities. When complete, General Chapter <825> will contain standards for this class of products.

As previously reported, SNMMI submitted comments to USP recommending that a new chapter be established to address the ambiguity in the field of nuclear pharmacy, which threatens the availability and the safe usage of radiopharmaceuticals in the U.S. SNMMI commends the USP on the recently established chapter. To read the full announcement on the new chapter, visit the USP website.

Additionally, USP is seeking applications for a new expert panel (EP), with a focus on compounding practices in Nuclear Pharmacy. Specifically, the EP will be asked to develop a new general chapter below 1000 that will reflect current practices which are consistent with the state and federal compounding guidelines as they apply to nuclear pharmacy practice. The proposed new general chapter will delineate compounding activities for radiopharmaceuticals and provide standards associated with these activities. Specifically, the panel will develop a chapter that allows flexibility, clarity, ease-of-use, risk/benefit, and evidence-based approaches to standard development.

For more information on the expert panel and the Call for Candidates announcement visit the USP website. Interested members are encouraged to apply online for consideration.