In a status report filed March 3rd with the U.S. District Court for D.C., FDA will suspend the implementation of the MOU (Memorandum of Understanding) and engage in a formal rulemaking process. This is a huge win for compounding pharmacies and the industry – the FDA will conduct a formal notice-and-comment rulemaking to implement its MOU with states for interstate shipments of compounds.
Read MoreWhen the Food, Drug & Cosmetic Act (FD&C Act) was passed in 1997, the FDA was expected to draft a memorandum of understanding (MOU) of the interstate distribution of compounds. The MOU was supposed to be endorsed by each state and serve as an interagency consensus on how to track and regulate inordinate amounts of compounds shipped across state lines. A system would be put in place that would help FDA identify, inspect, and assess patient safety of these facilities. Finally, more than 23 years after the FD&C Act was passed, the FDA has released its final draft of the MOU.
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