Friday, March 6, 2015

Last Updated: March 6 2015 Article by Lee H. Rosebush, Cory J. Fox and Dena S. Kessler United States: FDA Issues Draft Memorandum Of Understanding For 503A Drug Compounding

Included in the flurry of guidance documents recently issued by the FDA concerning human drug compounding is a long-awaited document of great importance to mail-order pharmacy compounders and entities that rely on interstate distribution of prescription compounded drugs—a Draft Memorandum of Understanding (MOU) between the FDA and each of the 50 states. As previously discussed, this MOU has been the subject of controversy since section 503A of the FFDCA was first enacted in 1997 and this controversy again took center stage following enactment of the DQSA in 2013. more

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