FDA considers adding a dozen peptides to its bulk drug compounding list
The US Food and Drug Administration’s (FDA) has called on its Pharmacy Compounding Advisory Committee to discuss whether a dozen peptide drugs should be eligible for compounding by licensed facilities. These peptides are used to treat opioid use disorder, wound healing, insomnia, and ulcerative colitis.
Specifically, the agency is considering whether to add a dozen specific peptides to its Section 503A bulks drug list, which lists active pharmaceutical ingredients (APIs), or bulk drug substances, that 503A pharmacies can use for compounding medications. These ingredients are not part of a USP/NGF monograph or an approved drug product.
FDA previously categorized more than a dozen peptides as category 2 substances and deemed them unsafe for bulk compounding in 2023.
Now, FDA said its Pharmacy Compounding Advisory Committee will meet twice in the coming months—on 23-24 July 2026 and again before the end of February 2027—to discuss the addition of 12 peptides to the 503A Bulks List.
The announcement comes after public remarks by Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. championing the use of peptides. During a podcast with Joe Rogan on 27 February that he is a “big fan” of peptides. He claimed that the FDA illegally reclassified 19 peptides to Category 2 during the Biden administration. Kennedy asserted that FDA can only make such a classification if there are safety concerns associated with the drug and claimed that these peptides do not pose any safety risks.
Kennedy mentioned that after the ban on certain products, a black market developed, resulting in the production of "very, very substandard" ingredients. He emphasized that by reintroducing these products to the compounding list, a legal market could be established, which would ensure that consumers receive quality products made from safely sourced ingredients. Additionally, he announced that the FDA would soon take action regarding peptides.
In a notice, FDA announced that its advisory committee would review the following seven peptides in July:
- BPC-157-related bulk drug substances (free base and acetate) for ulcerative colitis
- KPV-related bulk drug substances (free base and acetate) for wound healing and inflammatory conditions
- TB-500-related bulk drug substances (free base and acetate) for wound healing
- MOTs-C-related bulk drug substances (free base and acetate) for obesity and osteoporosis
- Emideltide (free base and acetate) for opioid withdrawal, chronic insomnia and narcolepsy
- Semax (free base and acetate) for cerebral ischemia and trigeminal neuralgia
- Epitalon (free base and acetate) for insomnia
Additionally, in an early announcement posted to its website, FDA said the committee will meet again before the end of February 2027 to discuss five additional peptides:
- Cathelicidin (LL-37)
- GHK-Cu
- Dihexa acetate
- Melanotan II
- Mechano Growth Factor, Pegylated (PEG-MGF)
The agency has announced the creation of a docket to collect public comments regarding the July meeting. The docket number is FDA-2025-N-6895, and it will remain open until 22 July 2026. Any comments received by 9 July will be presented to the committee. A public docket has not been made available for the latter meeting.
