FDA to Consider Lifting Restrictions on Numerous Compounded Peptides

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:

1. Comply with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, if one exists, and the applicable USP chapter on pharmacy compounding;
2. Are components of FDA-approved drug products if an applicable USP or NF monograph does not exist; or
3. 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.

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.

We will continue to monitor the deliberations of the PCAC on these peptides.

As noted in our earlier blog post, FDA recently clarified its position on compounded glucagon-like peptide-1 (GLP-1) peptides. FDA expressly stated that compounding, regularly or in inordinate amounts, a drug product that is essentially a copy of a commercially available drug product is impermissible. See our blog titled “FDA Clarifies Policies for Pharmacy Compounders of GLP-1 Products.”

Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, our Health Care & Life Sciences Sector, or to our Innovative Technology Sector with any questions.