HHS Lets Pharmacies Compound Six Peptides the FDA Hasn't Approved

Compounding pharmacies can now prepare BPC-157, Semax and four other peptides under strict rules, even though FDA staff reportedly opposed the move.

Health and Human Services Secretary Robert F. Kennedy Jr. has introduced an "interim enforcement discretion policy" permitting compounding pharmacies to prepare six peptides, BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax, without HHS pursuing enforcement action, according to Allure. Attorney Dustin Robinson of LumaLex Law, who advises businesses in the peptide industry, called the move "genuinely new territory."

The policy follows a July recommendation from the FDA's Pharmacy Compounding Advisory Committee to add the peptides to a list that compounding pharmacies can legally draw from, though that recommendation alone didn't make it official policy. Pharmacies now qualify for protection only if they source ingredients from FDA-registered manufacturers, provide a certificate of analysis confirming purity and the absence of contaminants, limit each product to a single peptide in a specific approved form, and require a prescription rather than selling over the counter.

None of the six peptides carries full FDA approval. Allure reported that the Associated Press found FDA staff helped draft the policy's safety requirements but had little say in the decision itself and opposed it.

HHS Lets Pharmacies Compound Six Peptides the FDA Hasn't Approved

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