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Judge Says FDA Must Rework Oversight of Compounding Pharmacies

September 27, 2021

A federal court has ruled that the FDA must do more work on its regulation of compounding pharmacies before it can enforce a final standard issued last year.

Judge Christopher Cooper of the U.S. District Court for the District of Columbia ruled last week that the agency violated procedure in producing the “standard Memorandum of Understanding,” which establishes an agreement between individual state pharmacy boards and the FDA.

Congress required the FDA to develop this document in 1997 when it passed Section 503A of the federal Food, Drug and Cosmetic Act (FDCA), but it wasn’t finalized until last October.

Seven compounding pharmacies sued to challenge the final document, and Cooper has found in their favor to the extent that the FDA must now “either certify that it will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis.”

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