HHS Temporarily Clears Path for Small Pharmacies to Compound Six Peptides
HHS says it will temporarily allow small compounding pharmacies to make six peptides, but the policy is enforcement discretion, not FDA approval.
By Reuven
The U.S. Department of Health and Human Services said Wednesday it will temporarily allow small compounding pharmacies to make six peptides available by prescription.
The six are BPC-157, TB-500, epitalon, MOTS-c, KPV and semax. They have been promoted online for everything from tissue repair to better skin, but there are no published clinical trials showing that these peptides work in humans for any condition.
What the Policy Does
HHS is using what is called enforcement discretion. In practice, the government will not act against small compounding pharmacies, known as 503A pharmacies, that make these six peptides. The policy does not apply to the larger 503B outsourcing facilities.
It does not change the peptides' legal status and it is not FDA approval. HHS made clear that the policy does not amount to FDA approval and does not establish that the peptides are safe or effective. The agency says pharmacies will need patient-specific prescriptions, traceable ingredients, quality testing and safety reporting.
HHS says the goal is to give patients an alternative to unregulated sellers of these products online.
Background
In July, a panel of advisers to the FDA voted in favor of expanded access to the six peptides through compounding pharmacies. At the same meeting, the FDA's own scientists recommended against loosening the existing restrictions. In 2023, the FDA classified 19 peptides as unsafe to compound.
Health Secretary Robert F. Kennedy Jr. has been a vocal supporter of peptides.
Reaction
The Alliance for Pharmacy Compounding welcomed the decision as a more accountable alternative to gray-market products, but cautioned that it may take time before pharmacies can begin dispensing them. Because only smaller facilities are covered, supply may also be limited.
Consumer advocacy group Public Citizen criticized the move, saying all peptide substances should go through the standard FDA approval process. Doctors have warned that unregulated peptide products may be contaminated or inaccurately dosed.
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