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A Category 1 listing only means a compound can be legally prepared by 503A compounding pharmacies it does not make BPC-157 an FDA-approved drug

Shashank Upadhye, a founding partner of Upadhye Tang LLP an IP & FDA boutique law firm in Chicago and author of Generic Pharmaceutical Patent & FDA Law, a textbook now in its 14th edition, served as chief in-house counsel at three leading pharmaceutical companies: Apotex, Inc., Sandoz-Novartis, and Eon Labs, Inc

Shifting Market Landscape As more affordable, FDA-approved options (such as Zepbound and Wegovys new vial system) become accessible, consumer motivation to seek out compounded equivalents diminishes

PMCID: PMC11609469

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