March 27, 2015
On March 24, 2015, SNMMI submitted comments to FDA regarding the distinction between nuclear pharmacy and manufacturing. The society's comments are part of ongoing efforts on to ensure radiopharmaceutical products be given adequate consideration in the policymaking process. SNMMI believes there is a need for public guidance on how the FDA will exercise enforcement discretion of radiopharmaceutical compounding.
The society submitted comments and met with FDA in September 2014. As follow up to the FDA discussions in September 2014, SNMMI’s Joint Compounding Task Force has worked with other medical societies and industry to more specifically define radiopharmaceutical compounding and preparation and sent a final report to the FDA in late November 2014. How the FDA defines “radiopharmaceutical compounding” and “radiopharmaceutical preparation” will become very important in our guidance. SNMMI defines “radiopharmaceutical preparation” to mean either activities performed in accordance with the instructions in the FDA-approved labeling, or minor deviations from those instructions. Nuclear pharmacies are an essential link in patient care, as they provide patient-specific unit dose radiopharmaceutical products to hospitals and clinics throughout the U.S.
SNMMI continues to monitor this situation closely.