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What stands out: Enforcement focus on mass-marketing, not patient-specific compounding Clear limits on advertising claims, including prohibitions on calling compounded products generic, the same as, or clinically proven Reinforcement of FD&C Act authorities, including misbranding provisions and Section 503A requirements Shift as shortages resolve, removing the legal basis for broad compounding of GLP-1 drugs Expanded compliance tools, including warning letters, seizure, and injunction where violations persist Bottom line: This signals a firmer FDA posture as the GLP-1 market matures, reinforcing long-standing distinctions between FDA-approved drugs and unapproved compounded preparations, particularly when promoted directly to consumers at scale
doi: 10.7326/0003-4819-154-2-201101180-00300 17 DaviesMJBergenstalRBodeBKushnerRFLewinASkjothTVet al
Shelygin Iu A, Alekseev MV, Rybakov EG, Eropkin PV
Evidence boundary No published clinical trial has tested BPC-157 + TB-500 together
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