Overview:

The FDA's Pharmacy Compounding Advisory Committee recommended adding six of seven peptides to the federal bulk drug substances list for compounding pharmacies, marking a significant step toward expanding regulated access to the compounds while broader questions about their safety and effectiveness remain unresolved.

Guest Opinion

The FDA’s Pharmacy Compounding Advisory Committee met on Thursday and Friday, July 23-24, 2026, convening to consider whether seven peptides should be be made more widely available. Six of the seven received a green light, so to speak.

This committee is subject to the Federal Advisory Committee Act (FACA), which requires its members to be non-federal employees. Its meetings must be open to the press, and its documents are subject to the Freedom of Information Act. It is a standard way for the federal government to conduct business when outside professional and expert opinions are needed, although the committee’s recommendations are advisory only.

A Very Brief History of the FDCA

The Pure Food and Drug Act of 1906 was enacted in response to public outrage over food tampering and hidden ingredients in drugs, such as opium and alcohol, but perhaps was driven most by the reaction to Upton Sinclair’s book The Jungle. Although the book was intended to expose the poor working conditions of immigrants, its depiction of shocking food processing and canning practices in Chicago instead sparked widespread concern about food safety.

The Food, Drug, and Cosmetic Act was enacted in 1938 to protect the public from adulterated or misbranded foods, drugs, devices, and cosmetics after a poisoning incident involving an antibiotic that killed 100 people.

A Very Short Explanation of a Peptide

We are already acquainted with the famous GLP-1 drugs for obesity and insulin, which are peptides.

A peptide looks like a chain of beads, with each bead representing an amino acid and each link a peptide bond. A peptide is a relatively short chain of two to 50 amino acids. A protein is much longer, more complex, and folded. The chain has a nitrogen group at one end and a carbon group at the other.

The Science—and Lack of Science

Peptides are promising, as we have seen with GLP-1 drugs for obesity. Others are claimed to help by “enhancing muscle strength, boosting the immune system, reducing inflammation, and helping the body heal from injury.”

They are promising, but there is not yet sufficient science demonstrating their efficacy, a requirement for FDA drug approval. Likewise, there is little evidence showing they are dangerous or have side effects that would warrant significant concern. More research is needed.

In the meantime, Secretary of Health and Human Services Robert F. Kennedy Jr. has argued they should be made available to the public without unnecessary hurdles.

Peptides are not illegal, but they are not approved for human consumption. They can be purchased for “research use” in what amounts to a gray market that likely knows many of these peptides are actually being purchased for consumption. Secretary Kennedy has argued that making peptides available through FDA-regulated processes would eliminate the risks posed by these mail-order “research use” peptides.

Compounding pharmacies exist to prepare medications that are needed but not FDA approved, or not approved in the dosage required, for example. Compounding pharmacies must follow best practices and ensure that both the process and the final product are sanitary. The materials they may use are limited to those included on the bulk drug list under Section 503A of the Food, Drug, and Cosmetic Act.

Here are the seven peptides and their proposed uses considered by the committee:

  • BPC-157: Recommended for inclusion; proposed to treat ulcerative colitis.
  • KPV: Recommended for inclusion; proposed for wound healing and reducing inflammation.
  • TB-500: Recommended for inclusion; proposed to promote wound healing.
  • MOTS-c: Recommended for inclusion; proposed for insulin resistance, obesity, and osteoporosis.
  • Epitalon: Recommended for inclusion (7-4 vote); marketed for insomnia and longevity.
  • Semax: Recommended for inclusion (8-5 vote); promoted for migraines and neurological conditions.
  • Emideltide: Rejected (6-7 vote); had been under review for opioid withdrawal and chronic insomnia.

The seventh peptide, emideltide, was rejected because of “potentially dangerous downstream consequences,” according to one committee member. It has the potential to be addictive, and that concern was enough to tip the vote against it. FDA staff reportedly opposed all seven peptides because of the lack of scientific evidence supporting their efficacy.

The committee is expected to review five more peptides by the end of February 2027.

New Regulations for Peptides

As mentioned earlier, GLP-1 is a type of glucagon peptide that has received FDA approval as a drug. The approval process begins with safety testing in laboratory animals or, in the future, simulated computer models to determine whether the compound is safe. An LD50 may be established—that is, the dose expected to kill 50% of the test population—as a standardized measure of toxicity.

If the drug passes safety testing, it is then evaluated in the laboratory for efficacy: Does it actually do what it claims, such as treating obesity? If it passes that stage, it can then be tested in humans, first for safety and then for efficacy. There are often setbacks along this regulatory pathway, and many drugs never make it to the finish line.

The development of GLP-1 into a highly successful commercial drug, along with the recent consideration of these seven peptides for inclusion on the bulk drug list, suggests there will likely be more peptide drug applications in the future. In anticipation of that, the FDA has published new protocols for testing peptides during the drug approval process.

Final Thoughts

There is an interesting dynamic at work here. Making peptides available by prescription through compounding pharmacies could reduce the gray market and perhaps prevent the emergence of a black market, ultimately making their use safer for everyone.

It is unfortunate that adverse events are not routinely reported for bulk drugs. For FDA-approved drugs, adverse event reporting has long been an invaluable tool for monitoring the safety of new medications after they reach the market.

Finally, the committee only makes recommendations. It is still up to the FDA to publish a proposed rule and seek public comment before any changes become final.

To read more articles by Professor Sutton go to:  https://profvictoria.substack.com/ 

Professor Victoria Sutton (Lumbee) is a law professor on the faculty of Texas Tech University. In 2005, Sutton became a founding member of the National Congress of American Indians, Policy Advisory Board to the NCAI Policy Center, positioning the Native American community to act and lead on policy issues affecting Indigenous communities in the United States.