HHS will not take enforcement action on 503A compounding of six peptides, including BPC-157 and TB-500
By Editorial Team · Published 2026-10-28
On October 28, 2026, the U.S. Department of Health and Human Services filed an "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances" with the Federal Register (FR Doc. 2026-22192, Docket HHS-OASH-2026-0496), published October 30, 2026 and signed by HHS Secretary Robert F. Kennedy, Jr.
The notice states that HHS "does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance found in Appendix A," while FDA develops the 503A bulk drug substances list through rulemaking.
The six peptides named in the policy are BPC-157, TB-500, epitalon, MOTS-c, Semax and KPV. According to legal analyses of the policy's Appendix B (FDA Law Blog, Hyman Phelps; Luma Lex Law), discretion is limited to specific forms and routes: BPC-157 acetate (subcutaneous, intramuscular, oral and topical); TB-500 acetate and MOTS-c acetate (subcutaneous or intramuscular injection); epitalon acetate (subcutaneous or intramuscular injection, dispensed in intermittent courses); Semax free base (intranasal); and KPV acetate (topical and oral).
Reported conditions include patient-specific prescriptions only (no office stock or wholesale distribution), an active ingredient made by an FDA-registered manufacturer that complies with current good manufacturing practice, analytical testing (identity, sequence, purity, potency, impurities, endotoxins and others), a single listed peptide per product (no combinations), labeling stating the product is compounded and not for resale, and reporting of serious adverse events through FDA MedWatch.
The policy does not approve any of these peptides, and HHS says it "does not establish any rights for any person and is not binding on HHS or the public." HHS states it "may revisit application of this interim policy (in whole or in part) if, among other things, a safety signal or product quality issue arises." Reported coverage excludes 503B outsourcing facilities and products sold as "research use only."
GHK-Cu, retatrutide and ipamorelin are not on the list. The Pharmacy Compounding Advisory Committee is reported to meet before the end of February 2027 to consider five more peptides: LL-37 (cathelicidin), GHK-Cu, dihexa acetate, melanotan II and pegylated mechano growth factor.
Public comments are open for two weeks after publication on regulations.gov, Docket HHS-OASH-2026-0496.
Primary source: https://www.federalregister.gov/d/2026-22192
Peptide Wiki Analysis
What this update means for peptide patients · Drafted 2026-10-30 via Peptide Wiki editorial
This is the most significant federal change for peptide access since FDA placed several of these compounds, including BPC-157, in its "Category 2" bulk-substances list (substances raising significant safety risks) in 2023. It does not make the peptides FDA-approved and it does not change their legal status for over-the-counter or "research chemical" sales. What changes is that a licensed 503A compounding pharmacy or physician can prepare these six peptides for an individual patient with a prescription, within the routes and conditions above, without HHS expecting to bring enforcement action.
Practically, people interested in these compounds now have a prescription-and-pharmacy path for six of them, with sourcing and testing requirements that research-grade vendors are not held to. Route matters: for example, the policy as described covers Semax only as a nasal product and KPV only topically or by mouth.
The policy is interim and can be withdrawn. Reporting notes it departed from FDA staff scientists' recommendations, so expect continued debate, possible revisions after the comment period, and final decisions only when FDA completes 503A bulks-list rulemaking for each peptide. State pharmacy and medical-board rules still apply and can be stricter; Louisiana's SB 253 (Act 374), for example, already protected prescribers using 503A/503B-sourced peptides in that state.
This page is educational and is not medical or legal advice. Talk to a licensed clinician about whether any compounded peptide is appropriate for you, and check your state's rules.