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doi:10.3389/fphys.2018.01186

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In fact, at least one law firm that specializes in healthcare and pharmacy law cases believes that the FDCA preempts 503A compounding patent infringement claims. This conclusion, which was reiterated in a February 2025 webinar, is based on the fact that compounding 503A pharmacies are specifically exempted from the only section of FDCA that deals with patents (21 U.S