SNMMI Develops USP Recommendations for Compounded Sterile Radiopharmaceuticals

December 28, 2016 — The Society of Nuclear Medicine and Molecular Imaging (SNMMI) has developed United States Pharmacopeia (USP) recommendations for compounded sterile radiopharmaceuticals. The recommendations aim to address certain common practices in the field of nuclear pharmacy that are not adequately defined by generally accepted practice standards. The society believes there is confusion in the field of nuclear pharmacy, which threatens the availability and the safe usage of radiopharmaceuticals in the United States. The recommendations are a response to these challenges. 

The recommendations were developed by SNMMI's Committee on Radiopharmaceuticals (COR) and approved by SNMMI's Board of Directors. The COR worked with several professional organizations and trade associations in an attempt to rectify the situation. Our efforts to date have met with some success, but have still fallen short of realizing suitable standards that are generally accepted for common practices in nuclear pharmacy. The COR believes that the USP, as the world’s leading organization for the development and maintenance of public standards, can play a critical role in the resolution of these challenges. 

There are three recommendations detailed in a SNMMI white paper: 

1. Establish an expert panel to delineate common practices that are defined as sterile compounding within the practice of nuclear pharmacy.
2. Create a public standard for the preparation, compounding, and dispensing of sterile radiopharmaceuticals with the practice of nuclear pharmacy.
3. Reinstate an expert committee dedicated to all standards for radiopharmaceuticals.

On September 29, SNMMI President Sally Schwarz sent the letter to the USP, where it is currently under consideration. Further details will be provided as they become available.

Access the complete document at http://snmmi.files.cms-plus.com/SNMMI-USP-Recommendations-Final_2016.pdf


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