Compounding and Repackaging of Radiopharmaceuticals By State-Licensed Nuclear Pharmacies and Federal Facilities; Draft Guidance for Industry; Availability

APhA thanks FDA for the opportunity to submit these comments on the draft guidance entitled Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities, Guidance for Industry (hereinafter, the "Guidance"). (See, attached .PDF for full comments). 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, physician offices, ambulatory clinics, managed care organizations, hospice settings, and the uniformed services. APhA appreciates FDA's efforts to provide regulatory clarity to pharmacists and pharmacies handling, preparing and repackaging radiopharmaceuticals. We would like to reiterate our willingness 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