On January 30, 2026, the Society of Nuclear Medicine and Molecular Imaging (SNMMI) commented on the United States Pharmacopeia's (USP's) proposed revisions to USP General Chapter <825> Radiopharmaceuticals Preparation, Compounding, Dispensing, and Repackaging. Chapter <825> was initially developed in response to public comments received on the 2015 proposed revision of USP General Chapter <797> Pharmaceutical Compounding Sterile Preparations and a 2016 white paper prepared by the SNMMI Committee on Radiopharmaceuticals.

SNMMI's white paper noted challenges in applying Chapter <797> to radiopharmaceuticals, in light of their unique characteristics, and the lack of a universally accepted public standard that clearly and effectively delineates common practices within the practice of nuclear pharmacy. The white paper recommended that the USP draft a new general chapter entitled "Radiopharmaceutical Preparation, Compounding and Dispensing Sterile Preparations."

SNMMI in its general comments recommended that USP consider harmonizing the 1-hour immediate use beyond use date (BUD) in Chapter <825> with the 4-hour immediate use BUD in Chapter <797>. SNMMI also noted that the application of a single uniform standard across a wide range of practice settings presents significant challenges, given the highly diverse workflows and settings the chapter encompasses. SNMMI further noted that some sections lacked clarity regarding applicability outside of nuclear pharmacy operations for example, in hospital and clinical practice settings. In addition, SNMMI made numerous comments on specific sections of the draft chapter.

SNMMI's comment on the proposed revisions to Chapter <825> is available here.