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March 04, 2022

The FDA Will Make New Rules for Drug Compounding

In October 2020, the FDA had issued a memorandum of understanding  (“MOU”), which it drafted in consultation with the National Association of Boards of Pharmacy (“NABP”), for states to sign onto regarding investigations of certain complaints and of distribution of an inordinate amount of pharmacy compounded drug products. The same day the MOU was issued, the FDA was sued by several compounding pharmacies in the U.S. District Court for the District of Columbia. The pharmacies argued that by issuing the MOU, the FDA had violated the Regulatory Flexibility Act, which requires agencies to analyze the compliance burdens regulations could place on small businesses. And had failed to follow the Administrative Procedure Act's notice-and-comment rulemaking process.

In September 2021,  U.S. District Judge Christopher Cooper ruled in favor of the pharmacies and remanded the MOU to FDA. On February 22, in a status report to the Court, the FDA advised  that it planned to undertake the thorough rulemaking process to implement the contents of the MOU, which would require a notice and comment period and could take years to complete.