HHS Lets Pharmacies Compound 6 Peptides: What It Says

What HHS published and when

The Department of Health and Human Services (HHS) filed the notice "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances" (docket HHS-OASH-2026-0496) on October 28, 2026. Signed by Secretary Robert F. Kennedy Jr., it was published in the Federal Register on October 30¹. Comments are accepted until two weeks after publication¹; a law firm puts that date at November 13².

The official text says HHS "does not intend to take enforcement action" against a State-licensed pharmacy, Federal facility or licensed physician compounding a product with a peptide in Appendix A. Its stated reason: "significant interest" in these peptides and "the lack of availability of approved products"¹. The same document calls itself a draft, says it "does not establish any rights for any person" and is "not binding on HHS or the public"¹.

The six peptides and the routes allowed

The policy works substance by substance and route by route, not as a blanket authorization³. Per Appendix B, as summarized by two law firms³⁵:

• BPC-157 (acetate): subcutaneous, intramuscular, oral or topical.
• TB-500 and MOTS-c (acetate): subcutaneous or intramuscular injection.
• Epitalon (acetate): subcutaneous or intramuscular, in intermittent courses.
• Semax (free base): intranasal.
• KPV (acetate): topical or oral.

Conditions for falling under the discretion

One legal summary lists ten conditions, all of which must be met². The ones that matter most to a physician or pharmacy:

• The original bulk manufacturer must be FDA-registered and follow current good manufacturing practice (cGMP), with a certificate of analysis (COA) that shows its location²³.
• A purity percentage alone is not enough: testing must cover identity, potency, impurities, solvents, elemental impurities and microbiology, including endotoxins for injectables⁵.
• A single active ingredient per product; no blends²³.
• The only device allowed with the product is an FDA 510(k)-cleared syringe²³.
• Serious adverse events and quality problems go to MedWatch and to the states²³.
• Mandatory label: "This is a compounded drug product. Not for resale."²
• A patient-specific prescription is still required⁶.

What the policy is not

It does not add the six peptides to the 503A bulks list, is not FDA approval and does not cover 503B outsourcing facilities²⁵. CJC-1295, ipamorelin, AOD-9604 and emideltide (DSIP) are outside it⁵. HHS says it may revisit the policy "if a safety signal or product quality issue arises"¹.

The formal list requires an FDA rule through notice and comment, a process that can take 12 to 24 months⁶; one legal analysis notes that in 15 years only six substances have moved from the interim 503A list to a final rule that way³. The same analysis says it is unclear whether states will follow the policy³.

The clash with FDA scientists

The Pharmacy Compounding Advisory Committee (PCAC) met July 23-24 and recommended six of seven peptides against the view of FDA's scientific staff⁶⁷. That team recommended against all seven, citing unresolved questions about substance identity, limited efficacy data, immunogenicity and impurity risks for injectables, and approved alternatives; on epitalon it noted there are no registered clinical trials⁷. FDA briefing materials said the available studies, including five on BPC-157, were too limited to establish safety or effectiveness⁶.

The policy came through a different channel. According to the Associated Press, cited by Healio, FDA scientific staffers had little input and opposed it; six people said the document "faced overwhelming pushback" from them⁴. HHS describes the policy as a "more controlled alternative" to products from foreign manufacturers that "pose a safety risk"⁴, and a law firm summarizes its aim as to "discourage the continued, widespread use of certain research-use-only peptides"².

What the published evidence says

The literature is uneven. A 2026 review in Pharmaceuticals gathers the work on BPC-157 in tendon, ligament and muscle injury⁹; a narrative review published October 8, 2026 examines the mechanistic, preclinical and clinical evidence for epitalon and epithalamin¹⁰; and a review in the International Journal of Pharmaceutical Compounding analyzes the PCAC recommendations and industry safety standards¹¹. None replaces controlled trials of safety and efficacy, which is exactly what FDA scientists say is missing⁷.

Usage data show why HHS acted. A preprint of clinical notes found BPC-157 users rose from 4 in early 2020 to 134 in early 2026; among those who documented a source, 36% used a compounding pharmacy and 35% a gray-market vendor⁶. Catherine Varney, DO (UVA Health), told AJMC that gray-market peptides often contain 5% to 75% of the labeled amount and some contain arsenic at up to 10 times the acceptable level⁶. Louisiana, meanwhile, has had a law (Act 374) since August 1, 2026 that bars licensing boards from prohibiting prescribers from providing peptides from compliant sources⁶.

What comes next

• Public comment: until two weeks after October 30, on regulations.gov¹².
• More peptides: in April FDA removed 12 peptides from Category 2 and expects another PCAC consultation before February 2027 on five more; leaving Category 2 does not make a substance eligible for compounding⁸.
• Formal rulemaking: FDA could propose adding some or all of the peptides to the 503A list¹².
• International context: the same week, a Victorian coroner in Australia found that CJC-1295 and ipamorelin, peptides this policy does not cover, triggered a cardiac arrest and asked for a review of their prescribing¹²¹³.