SNMMI submitted comments to the FDA on draft guidance “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies.” The guidance explains that, under current law, radiopharmaceuticals compounded or repackaged by state-licensed nuclear pharmacies and federal facilities are subject to all applicable provision of the FD&C Act related to the production of drugs. However, FDA recognizes that state-licensed pharmacies and federal facilities sometimes compound or repackage radiopharmaceuticals for patients who need them without obtaining FDA approval or meeting certain other requirements.
According to FDA, “the policies proposed in the draft guidances attempt to strike an important balance between patient access to radiopharmaceuticals compounded or repackaged by state-licensed nuclear pharmacies, federal facilities, and outsourcing facilities, and the risks that such unapproved drugs present to patients.”
SNMMI is broadly supportive of the direction of this guidance. As previously stated, SNMMI strongly recommends that FDA work with USP to develop a common understanding of activities defined and involved in the compounding of radiopharmaceuticals.
SNMMI has submitted comments on other general guidances related to compounding, but has long awaited specific guidance for radiopharmaceuticals. The society also recently provided recommendations to USP on sterile compounding of radiopharmaceuticals. SNMMI commends the FDA for the release of this guidance and encourages the FDA to support USP in the public standard setting process.