Pharmacies Sue FDA Over Compounded Drug Agreements

Law360 (October 28, 2020, 3:03 PM EDT) -- A group of pharmacies has accused the U.S. Food and Drug Administration of exceeding its authority by developing new agreements with states that upend long-standing regulations on compounding pharmacies, a move the group says will limit interstate commerce and add burdensome reporting requirements.

The FDA's recent memorandum of understanding, or MOU, that created new regulations to fully implement a decades-old rule governing pharmacy compounding under the Federal Food, Drug, and Cosmetic Act is deeply flawed and improperly developed, Wellness Pharmacy Inc. and other pharmacies said in their suit filed in D.C. federal court Tuesday.

"The final standard MOU is defective both...

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