Industry Submits Comments (Nearly 3000) and the Agency Listens: Revised Draft Standard MOU Addressing Section 503A’s Limits on Interstate Shipments of Compounded Medications

By Karla L. Palmer — FDA’s Commissioner Scott Gottlieb, M.D., announced last Friday, September 7, 2018, FDA’s publication of its revised draft Memorandum of Understanding (“MOU”) between states and FDA addressing interstate shipment of compounded medications. This is the third draft MOU published by FDA that involves interstate shipment of compounded medications; recall FDA’s first attempt was way back in 1999 (for which received over 6,000 comments) (see our previous post here). FDA’s third attempt is quite different than its first two attempts both in terms of its definition of what is an “inordinate amount” of compounded products shipped interstate, and how States and FDA are supposed to regulate those compounders that may ship inordinate amounts of compounded medications interstate. Section 503A of the Federal Food, Drug, and Cosmetic Act (“FDCA”) requires FDA and states to enter into a MOU (developed in…

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