Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act

APhA is pleased to submit these comments on the FDA's draft guidance on the Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act (the "Guidance") .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 is committed to working with FDA and other stakeholders to make certain that nothing like what occurred at the New England Compounding Center (NECC) happens again. As FDA is aware, compounding is an important part of pharmacy practice because it permits patients with unique medical needs to have access to vital medications when commercially available dosage forms do not exist. APhA supports FDA's efforts to ensure drug quality and security as the provision of safe, effective medications, including compounded medications, is of paramount importance to our members. However, APhA continues to have concerns that FDA's interpretation and implementation of the Drug, Quality and Security Act ("DQSA") is negatively impacting patients' access to these necessary compounded medications. Specifically, APhA is troubled that the Guidance prohibits compounding for office use/administration, further restricts the quantity of product that can be compounded in advance of a patient-specific prescription, overestimates the ability of 503B facilities to meet patient compounding needs, and appears to define what constitutes a valid prescription. APhA looks forward to continuing to work with the FDA and other stakeholders to construct a framework in accordance with current statutory authority and congressional intent that ensures patients have access to safe and effective medications. It is important in developing and implementing DQSA, FDA remembers Congress' objective to ensure an appropriate place for customized compounding of medications in today's modern health care system. We hope to be a resource for FDA and are happy to be of assistance in any way possible. 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.