FDA Moves to Reevaluate Several Peptides

The Food and Drug Administration (FDA) recently announced its intention to reevaluate the status of several popular peptides such as BPC-157, KPV, and Semax. On April 15th the FDA released a letter informing the public that several peptides which had been prohibited to compound would be reexamined at a meeting of the Pharmacy Compounding Advisory Committee (PCAC) this summer. The letter, along with the list of effected peptides, is available here.

This raises the possibility that these peptides could be placed in a more favorable category which would allow pharmacies to compound them and make them. It is important to understand that this is just the beginning of the process and does not mean that the compound restrictions are lifted yet.

For pharmacies and outsourcing facilities to compound a medication, it must fall into an exemption under the FDA rules. Pharmacies may only use active pharmaceutical ingredients (called bulk drug substances) that meet one of three conditions:

• The substance is a component of an FDA approved drug;
• The substance is documented in a monograph under the United States Pharmacopeia (USP) or the National Formulary (NF); or
• The substance appears on the FDA’s bulk drug substance list.

In the case of these peptides, they are not yet FDA approved and they do not have official monographs. This leaves the “Bulk Lists” as the only available route.

The FDA is still in the process of finalizing its approved bulk drug substances lists; during this process it has adopted an interim policy that creates three categories of bulk drug substances. Substances can be nominated to the lists and then are placed in one of the three categories.

• Category 1 are substances that may be eligible for inclusion on the bulk drug substances list. They have sufficient supporting information for the FDA to evaluate and do not appear to pose significant safety risks.
• Category 2 substances also have sufficient supporting information, but the FDA has identified significant safety risks.
• Category 3 are substances that were nominated but lack supporting information for the FDA to evaluate.

The FDA says that they would not take action against a compounder for using a Category 1 substance but would consider taking action for those that use Category 2 or 3 substances. The issue is that in 2023 many popular peptides were placed in the Category 2 bulk compounding list. This closed off routes for compounding these substances.

In late February, Health Secretary Robert F. Kennedy Jr. signaled his intention to have these substances reevaluated to make them available again. As with anything related to government agencies, this doesn’t happen overnight. The FDA’s April 15th letter included a list of peptide bulk substances that it was removing from Category 2 effective April 22nd because the nominator had withdrawn the nomination. But each of the substances would be reviewed for potential inclusions at the PCAC either during the July 2026 meeting or before February 2027. Details about this PCAC meeting can be found at this link.

It is important to understand that with this letter these bulk drug substances will no longer be on the Category 2 lists but neither will they appear as Category 1. Compounding pharmacies will need to wait to see the outcome of the July 23-24 meeting before being able to employ these bulk drug substances in compounding.

AmSpa tracks the latest changes in aesthetic wellness and regenerative medicine legislation, recently welcoming the FDA to clarify federal oversight requirements for med spas at Medical Spa Show. Keep up with important notices year-round when you become a member of the American Med Spa Association.