Pharmacies Rip FDA Bid To End Compound Drugs Reg Case

Law360 (March 17, 2021, 8:16 PM EDT) -- A group of pharmacies challenging the U.S. Food and Drug Administration's new regulations concerning compounded medication distribution told a D.C. federal court Wednesday that its lawsuit is ripe for judicial review, slamming the agency's claim that the case is premature.

Wellness Pharmacy Inc., Women's International Pharmacy Inc. and five other pharmacies that make compound drugs said that while the agency will begin in October to enforce a limit on interstate distribution of compounded drugs against pharmacies in states that do not sign on to the new rules, their two procedural claims warrant immediate review by the court. The pharmacies made this...

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