An advisory committee to the US Food and Drug Administration (FDA) has narrowly voted to recommend adding six peptides to a list of ingredients that licensed pharmacies can use to make customised medicines.
The Pharmacy Compounding Advisory Committee voted over two days to support the inclusion of BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax. The decision is not final and will require approval from the FDA before any changes take effect.
The move could change how some patients access these compounds, which have become widely discussed online for claims related to recovery, metabolism and anti-ageing. However, FDA staff scientists opposed all of the proposed additions, warning there is not enough clinical evidence to support their use.
Sharp division in the panel
The vote highlighted a clear split between external advisers and FDA scientists. Six of the eight recently appointed committee members are reported to run clinics that already offer peptide-based treatments.
Supporters of the move argued that allowing regulated compounding could reduce harm by steering patients away from an unregulated online market where these substances are often sold as “research chemicals”.
However, critics, including FDA scientists and public health experts, warned that adding the peptides could give the impression of official approval without strong safety or effectiveness data.
One peptide, emideltide, was rejected by the committee due to particularly weak evidence. It had been proposed for conditions such as narcolepsy and opioid withdrawal, but studies were limited and not consistent in method or scale.
What compounding would allow
If approved by the FDA, the decision would not place these peptides on pharmacy shelves as standard medicines. Instead, it would allow specially licensed compounding pharmacies to prepare them for individual patients with a doctor’s prescription.
These compounded products would still bypass some of the safeguards required for fully approved drugs, including large clinical trials and long-term safety monitoring.
FDA scientists have also raised concerns about inconsistent formulations and potential safety risks, including immune reactions.
What happens next
The advisory vote is non-binding. The FDA will now review meeting records, public comments and evidence before deciding whether to propose formal rule changes. That process could take up to a year.
The timeline could be shortened if senior health officials push for faster action. Some officials have previously expressed support for expanding access to peptides, framing restrictions as a driver of unregulated use.
If adopted, the change would be seen as a significant development for telehealth companies, wellness clinics and medical spas, which could expand access to peptide-based treatments. Pharmaceutical companies, however, have warned it could create a regulatory loophole around the standard drug approval process.
For now, the FDA has not made a final decision, and the peptides remain unapproved for general use outside limited compounding settings.