Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act

The American Pharmacists Association (APhA) is pleased to submit comments on FDA's recent revised draft guidance for industry entitled "Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act" ("revised draft guidance"). Pls. see attached .PDF for full comments. APhA is the only organization advancing the entire pharmacy profession. Our expert staff, and strong volunteer leadership, including many experienced pharmacists, allow us to deliver vital leadership to help pharmacists, pharmaceutical scientists, student pharmacists and pharmacy technicians find success and satisfaction in their work, while advocating for changes that benefit them, their patients and their communities. Many of our members are affected by the policies laid out in this revised draft guidance and we sought their input in developing these comments. APhA appreciates the increased flexibility FDA provided by removing the 1-mile restriction on hospital and health-system compounded products without first receiving a valid prescription order (including a chart order) for an identified individual patient. As FDA found, that policy did not take into consideration the structure of health systems, many of which operate under a centralized compounding model and may service patients at facilities at other sites located outside a 1-mile radius that do not have compounding capabilities. To ensure that that hospital and health-system compounding can continue to meet patient needs, APhA offers the following recommendations to improve the revised draft guidance to make it workable: •Remove the restriction that compounded drug products must be used or discarded within 24-hours of transfer out of the pharmacy. •Adopt the USP beyond use date (BUD) requirements. •Clarify the revised draft guidance only applies to sterile compounding. •Refrain from urging a "503B-first" approach. Thank you for considering our recommendations. We look forward to FDA improving the revised draft guidance to ensure patients in hospitals and health-systems have access to the safe and effective compounded medications they need. If you have any questions or require additional information, please contact Michael Baxter, Senior Director of Regulatory Policy, at mbaxter@aphanet.org.

APhA is pleased to submit these comments on FDA's draft guidance on Hospital and Health System Compounding under the Federal Food, Drug, and Cosmetic Act (the "Guidance").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 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. 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. While APhA appreciates that the Guidance allows hospitals and health systems some flexibility in distributing compounded drug products prior to a patient-specific prescription, 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 necessary compounded medications. 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. 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.