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* Correspondence: Andriy Yabluchanskiy, [email protected] Disclaimer All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers

Bottom line: even if the FDA eventually recommends that certain peptides can be compounded under Section 503A, many stakeholders could still be blocked by the requirement to source pharmaceutical-grade API from an FDA-registered establishment with a Certificate of Analysis and by FDAs demonstrated willingness to police marketing claims around compounded drugs

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