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September 23, 2022

Ninth Circuit Denies Pharmaceutical Company State Compounding Suit on Implied Preemption Grounds

The U.S. Court of Appeals for the Ninth Circuit denied a state suit by Nexus Pharmaceuticals against a compounding company. The Ninth Circuit held the Federal Food, Drug and Cosmetic Act (FDCA) impliedly preempted the pharmaceutical company’s claim that the compounding company violated 21 U.S.C. § 353b, which prohibits a third party from circumventing FDA approval for compounded drugs, if the compound is “essentially a copy” of an existing drug. The Ninth Circuit held the FDCA grants the FDA exclusive enforcement authority, including whether to determine if a drug is “essentially a copy” for purposes of the FDCA. As a result, the Ninth Circuit barred the pharmaceutical company from attempting to evade the federal legal framework by pleading a violation under state law. See Nexus Pharmaceuticals v. Central Admixture Pharmacy, No. 20-56227, (Ninth Circ., Sept. 13, 2022)

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