On April 16, 2026, the U.S. Food & Drug Administration (FDA) announced it will convene the Pharmacy Compounding Advisory Committee (PCAC) on July 23 and 24, 2026, to discuss permitting compounding pharmacies to prepare certain peptides used for ulcerative colitis (UC), wound healing, obesity, insomnia, opioid withdrawal, inflammatory conditions, and osteoporosis, among other conditions. Although these peptides have been used, companies have not studied them for safety or efficacy, and FDA has not conducted a rigorous assessment of their use. In the past, FDA has declined to add these substances to the bulk compounding list because of safety and/or efficacy concerns.
These peptides are under consideration for addition to the FDA’s list of bulk substances that may be used by compounding pharmacies.
This list is important because it identifies bulk drug substances that may be legally compounded, provided the substances meet the following requirements:
- Comply with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, if one exists, and the applicable USP chapter on pharmacy compounding;
- Are components of FDA-approved drug products if an applicable USP or NF monograph does not exist; or
- Appear on FDA’s list of bulk drug substances that can be used in compounding (503A bulks list) if such a monograph does not exist and the substance is not a component of an FDA-approved drug product.
In addition, bulk drug substances must be accompanied by a valid certificate of analysis and must have been manufactured by an establishment registered with FDA.
If these peptides are added to the bulk compounding list, compounding pharmacies would be permitted to use them to prepare compound products.
The list of peptides to be discussed by PCAC are listed below.
| Bulk drug substance | Uses evaluated |
| BPC-157 (free base) BPC-157 acetate | UC |
| KPV (free base) KPV acetate | Wound healing and inflammatory conditions |
| TB-500 (free base) TB-500 acetate | Wound healing |
| MOTs-C (free base) MOTs-C acetate | Obesity and osteoporosis |
| Emideltide (free base) Emideltide acetate | Opioid withdrawal, chronic insomnia, and narcolepsy |
| Semax (free base) Semax acetate | Cerebral ischemia, migraine, and trigeminal neuralgia |
| Epitalon (free base) Epitalon acetate | Insomnia |
Although there is wide interest among influencers and consumers in compounded peptides for the above indications, as well as for general wellness and anti-aging, it is important to understand that limited data are available regarding the safety and efficacy of these products. U.S. Department of Health & Human Services (HHS) Secretary Robert F. Kennedy Jr. has stated that he has used peptides in the past with favorable results and has expressed interest in making them more accessible through legitimate suppliers. These developments, along with broader public interest, may be contributing to FDA’s consideration of whether to permit peptide use in compounding.
The PCAC will review the available clinical evidence in deciding whether to recommend adding these peptides to the FDA bulk compounding list.
Why Potentially Lifting the Restriction Is Important
- If permitted, access to higher-quality peptides may increase.
- Compounding pharmacies could legally prepare products using these peptides.
- Demand may shift away from unregulated or illicit markets.
- These peptides may become more widely accepted, even in light of lack of robust clinical data on safety and efficacy.
