Insanitary Conditions at Compounding Facilities

APhA is pleased to submit these comments on FDAs revised draft guidance for industry entitled Insanitary Conditions at Compounding Facilities, (hereinafter referred to as the Guidance). Founded in 1852 as the American Pharmaceutical Association, APhA represents 64,000 pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians, and others interested in improving medication use and advancing patient care. APhA members provide care in all practice settings, including community pharmacies, hospitals, long-term care facilities, community health centers, managed care organizations, hospice settings, and the uniformed services. (See, attached .PDF letter for full comments). Thank you again for the opportunity to provide comments on this important issue and we are happy to serve as a resource for FDA. If you have any questions or require additional information, please contact Michael Baxter, Director of Regulatory Affairs, at mbaxter@aphanet.org or by phone at (202) 429-7538..

Dear Sir/Madam: APhA is pleased to submit these comments on FDA's draft guidance entitled "Insanitary Conditions at Compounding Facilities, Guidance for Industry" (the "Guidance"). Founded in 1852 as the American Pharmaceutical Association, APhA represents more than 62,000 pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians, and others interested in improving medication use and advancing patient care. APhA members provide care in all practice settings, including community pharmacies, hospitals, long-term care facilities, community health centers, managed care organizations, hospice settings, and the uniformed services. As APhA has previously stated in other communications to FDA, we are pleased that the Agency responded to our members' feedback and issued a notice of a change to its procedure for inspections to determine if compounders are 503A facilities before applying cGMPs. While APhA appreciates FDA continuing to offer additional clarity regarding acceptable compounding practices, we have concerns about the language of some of the provisions in the Guidance and caution that in some cases, FDA appears to go beyond congressional intent by imposing higher standards on compounding pharmacists and pharmacies than required by states. In addition, APhA is concerned that some of the examples provided by FDA do not account for the differences in the practice of nuclear pharmacy and pharmacists working with radiopharmaceuticals. As FDA is aware, there continues to be ambiguity regarding the applicability of FDA's Drug Quality and Security Act (DQSA) regulatory activity on the practice of nuclear pharmacy because it is specifically exempted from 503A, and preexisting FDA guidance also exempts it from CGMPs. Only adding to the confusion is the fact that most of the work of nuclear pharmacies or of pharmacists handling radiopharmaceuticals is not actually "compounding." While compounding pharmacies create what are essentially new drug products designed to meet patient needs, most nuclear pharmacies are preparing radiopharmaceuticals from kits that are already FDA-approvedactivity that falls outside of the Food, Drug, and Cosmetic Act's (FD&C) definition of "compounding." APhA has previously requested that FDA expeditiously issue regulatory documents to provide clarity to nuclear pharmacists and pharmacies when handling radiopharmaceuticals and also recommends additional modifications to the draft Guidance to reflect this unique practice setting (see full text of attached comment letter). APhA appreciates FDA's efforts to provide additional guidance for individuals and entities with regard to compounding and looks forward forthcoming guidance providing regulatory clarity to pharmacists and pharmacies handling and preparing radiopharmaceuticals. We are happy to be a resource for FDA, especially with regard to the practice of nuclear pharmacy. Thank you again for the opportunity to provide comments on this important issue. If you have any questions or require additional information, please contact Michael Baxter, Director of Regulatory Affairs, at mbaxter@aphanet.org or by phone at (202) 429-7538. Sincerely, Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA Executive Vice President and CEO cc:Stacie S. Maass, RPh, JD, Senior Vice President, Pharmacy Practice and Government Affairs