In the article “Peptides Policy is Shifting Toward Sanctioned Compounding" published in Law360, Dominick DiSabatino and Audrey Mercer discuss the shift in federal policy that has moved compounded peptides from a gray/black market toward tighter oversight.
The current administration is signaling a “verified compounder” framework that could move many peptides back to Category 1 for compounding under the Food, Drug and Cosmetic Act Section 503A, but only with heightened inspection and monitoring. Even if access expands, the advertising landscape is expected to remain highly restricted. Overall, the window for unregulated peptide sales is closing and companies able to meet stricter compliance expectations will be best positioned.
Read the full article here.