The FDA’s Pharmacy Compounding Advisory Committee is scheduled to meet this summer to discuss whether certain peptides should be allowed to be used from compounding pharmacies, suggesting a 2023 decision by the FDA could be reversed.
The advisory committee will meet on July 23 and July 24 to consider the potential use of the seven peptides in specific uses, including ulcerative colitis, wound healing, obesity, and opioid withdrawal, according to a Federal Register notice. Each peptide in the table is proposed for inclusion in the 503A bulk list, which designates bulk drug substances from which physicians and pharmacies can compound drugs.
In September 2023, FDA removed 17 drug substances from consideration on the 503A bulk list by redesignating them as Category 2 substances, citing a number of potential safety concerns.
Category 2 means that the FDA will “consider” taking action against formulators found to be using the specific substances in question because the FDA has “identified significant safety risks associated with the use of these substances in compounding.”
The agency’s rationale for restricting the seven peptide drug substances currently under discussion in July largely centers on the lack of “sufficient information” regarding their safety when administered to humans. In addition to safety issues, there is often no significant evidence of efficacy to support these products’ claims, according to the Associated Press.
The agency’s possible change of heart comes after Department of Health Secretary Robert F. Kennedy Jr., who has promoted the use of peptides, recently told podcaster Joe Rogan that he is a “huge fan” of peptides and has used them in the past with “really good results” for previous injuries.
Kennedy said the FDA “unlawfully” designated peptides as Category 2 under the Biden administration, resulting in a “black market” for the products. The health secretary told Logan that he wants to make “approximately 14” peptides more available and noted that the FDA will soon take “some new action” to that end.
Peptides are short chains of amino acids that are found in some approved medicines, such as GLP-1 medicines, but there is growing buzz about unapproved peptides as influencers and celebrities promote the medicines as innovative wellness tools. Advocates for the drug’s use in compounded medicines argue that the FDA’s 2023 action on peptides is an overreach and is not supported by sufficient evidence, while former FDA officials say the decision was underpinned by safety concerns, ProPublica reported last month.
Meanwhile, the FDA has recently taken a tougher stance on drug compounders, particularly regarding combinations of GLP-1 drugs for weight loss. After Novo Nordisk and Eli Lilly’s combination versions of GLP-1 were made illegal following a shortage of branded drugs, many compounding pharmacies advanced the “personalization” argument, arguing that selling personalized combination drugs was still legal.
Hims & Hers, one of the companies involved in formulating GLP-1, praised the FDA advisory committee’s plan as “an important step toward moving these treatments from the gray market to more trusted channels,” Pat Carroll, M.D., the company’s chief medical officer, said in a press release Wednesday.
The July meeting comes after the FDA will soon end its nine-month lack of advisory committee meetings. The FDA’s drug compounding task force last met in late 2024 to discuss other drug substances that could be added to the 503A list.
