October 27, 2020

California State Board of Pharmacy Wins Ninth Circuit Appeal: Outsourcing Facilities Subject to State Regulation

On June 17, the U.S. Ninth Circuit Court of Appeals issued its ruling in the case Fusion IV Pharmaceuticals, Inc. v. Anne Sodergren and California State Board of Pharmacy; et al, affirming a lower court decision that California’s state law regulating outsourcing facilities is not preempted by federal law. Partner Libby Baney and associate Jonathan Keller coauthored an article about this ruling and its potential impact on the future of state and federal regulation of outsourcing facilities for the American Society of Pharmacy Law’s September/October 2020 newsletter.

The case in question has been closely watched by boards of pharmacy, as it addresses a state board’s ability to concurrently regulate federally-registered outsourcing facilities. Along with outlining the progression of the case, Baney and Keller question what the arguments it raises regarding federal preemption of state law and the concurrent state regulation of an Food and Drug Administration registered outsourcing facility will mean for outsourcing facilities outside of California’s jurisdiction and other state boards of pharmacy.

“One thing is clear – state boards of pharmacy now have a federal appellate court opinion ruling that outsourcing facilities are subject to state oversight and regulation,” they say.

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