HHS opens a limited compounding path for six unapproved peptides, including BPC-157

The notice, titled “Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances,” was filed with the Federal Register on October 28, 2026 (Doc. 2026-22192) and signed by HHS Secretary Robert F. Kennedy, Jr. It follows the July 23 to 24, 2026 meeting at which FDA’s Pharmacy Compounding Advisory Committee voted to recommend six peptides for the 503A bulks list, against the recommendation of FDA staff briefing documents.

What it does

According to a Holland & Knight summary, HHS will not prioritize enforcement against compounding of the six peptides if ten conditions are met. These include sourcing from FDA-registered facilities with a certificate of analysis, CGMP manufacturing, a single active ingredient, documented bioavailability for oral products, and reporting of serious adverse events to MedWatch. The policy applies until a final rule addresses each peptide’s bulks list status, and HHS may revise or withdraw it at any time.

What it does not do

The notice states that compounded drugs are not FDA-approved and that FDA does not review their safety, effectiveness or quality before marketing. The policy does not add these peptides to the 503A bulks list and does not establish any rights. Public comments (Docket HHS-OASH-2026-0496) are open for two weeks after publication.

Youthful take

Regulatory access does not equal clinical evidence. Most data on these peptides come from animal and cell studies. Anyone considering a compounded peptide should do so only under a licensed physician, with a pharmacy that can document sourcing and testing. For deeper coverage, see YouthfulPeptide.com.