Memorandum of Understanding Addressing Certain Distributions of Compounded Drug Products Between the States and the Food and Drug Administration; Revised Draft; Availability

APhA is pleased to submit these comments regarding the revised draft standard Memorandum of Understanding between FDA and the States Regarding Interstate Distribution of Compounded Human Drug Products (hereinafter, the revised draft MOU). 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 appreciates in the revised draft MOU, FDA, in response to our previous comments, made changes in what constitutes inordinate amounts and provides additional state flexibility. However, APhA continues to have concerns with language in the revised draft MOU we believe conflicts with previous FDA policy and Congresss intent when it passed the Drug, Quality and Security Act (DQSA). Accordingly, we detail changes to the revised draft MOU necessary to safeguard both patient and provider access to compounded medications. (See, attached .PDF for full comments). APhA looks forward to continuing to work with the FDA and other stakeholders to construct a framework that enhances safety and quality without compromising patient access to vital 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.