Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability

APhA is pleased to submit these comments on FDA's draft guidance on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A (the "Guidance").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. APhA supports FDA's efforts to ensure drug quality and security for the provision of safe, effective medications, including compounded medications, is of paramount importance to our members. Compounding is an important part of pharmacy practice as it permits patients with unique medical needs to have access to vital medications when commercially available dosage forms do not exist. Furthermore, while we appreciate FDA providing some flexibility related to compounding of "commercially available" products, because there are a number of additional, notable situations that require the compounding of commercially available drugs, APhA requests modifications to the Guidance in order to meet patients' health care needs. (See, full attached comment letter). Thank you again for the opportunity to provide comments on this important issue. APhA looks forward to continuing to work with the FDA and other stakeholders to construct a compounding framework that ensures patient access to appropriate, safe and effective compounded drug products. We hope to be a resource for FDA and are happy to be of assistance in any way possible. 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