October 13, 2016
SNMMI recently submitted comments to FDA regarding the Draft Guidance for Industry: Insanitary Conditions at Compounding Facilities. The draft guidance is intended to help drug compounders address insanitary conditions at their facilities. FDA's new guidance details procedures compounders can put in place to ensure their facilities are sanitary and actions they can take when insanitary conditions are found. According to the agency, the new guidance is intended to apply to a wide array of products, including: compounded human and animal drugs; repackaged drug products; compounded or repackaged radiopharmaceuticals; and mixed, diluted, or repackaged biological products. The guidance will apply to pharmacies, federal facilities, physicians' offices, and outsourcing facilities that compound or repackage human or animal drugs (including radiopharmaceuticals) or that mix, dilute, or repackage biological product.
SNMMI believes the draft guidance has the potential to provide valuable information and guidance to technical and physical condition requirements that are applicable to the safe compounding of sterile pharmaceuticals. SNMMI agrees and supports that sterile compounded radiopharmaceuticals must be fully compliant with the 501(a) (2) (A) adulteration provisions of the FD&C Act.
Sterile radiopharmaceuticals play a pivotal role in the current world of molecular Imaging. Approximately 18 million studies are performed yearly in Nuclear Medicine that rely on the administration of sterile radiopharmaceuticals. For many years SNMMI has played an active role as an advocate for the establishment of safe practices and procedures directed at ensuring the safety and quality of radiopharmaceuticals and the security of the radiopharmaceutical distribution system in support of the provision of medical imaging services.
The inclusion of radiopharmaceuticals in this guidance is of special interest to SNMMI considering the current exemption or exclusion of sterile compounded radiopharmaceuticals under the most recent version of the 2013 Drug Quality and Security Act. With the release of this draft guidance, and in view of the current status of regulatory limbo with respect to FDA regulatory guidance for the sterile preparation and compounding of radiopharmaceuticals, SNMMI brought forward specific concerns within the proposed draft guidance.
SNMMI highlighted that sterile compounding of radiopharmaceuticals involves a consideration of shielding and other radiation safety practices that are well recognized in current Nuclear Pharmacy and Nuclear Medicine practice. SNMMI believes that these unique considerations are not well addressed in the current proposed draft guidance and provided several examples that illustrate this area of concern, which can be found in the full comment letter. The examples include considerations unique to sterile radiopharmaceuticals which could be misconstrued as unsanitary conditions under the draft guidance document.