BPC-157, GHK-Cu and US peptide compounding: what changed?

First, what is compounding?

Compounding generally means that a pharmacist or physician prepares or changes a medicine for an individual patient. In the US, section 503A describes conditions for certain compounded medicines to qualify for specified exemptions. A compounded medicine is not an FDA-approved product: FDA has not reviewed that particular product for safety, effectiveness and quality before marketing. It can still serve a clinical need in an appropriate case.34

What did HHS announce?

The Department of Health and Human Services (HHS) described circumstances in which it does not intend to take enforcement action against specified compounders using certain peptide bulk ingredients. This applies while the relevant list is developed through rulemaking. The 30 October 2026 Federal Register notice calls the policy draft and says it is nonbinding and creates no rights. HHS says it may revisit it, for example if safety or quality issues arise. It is a US federal policy snapshot, not a determination of an individual product’s legal status.43

Which six names appear in the policy?

Appendix A names BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. Appendix B narrows the chemical form and route addressed for each substance. BPC-157 acetate includes forms for injection under the skin (subcutaneous), injection into muscle (intramuscular), use by mouth (oral) and application to the skin (topical). TB-500 and MOTS-c acetates list injection under the skin or into muscle. Epitalon acetate specifies those injectable routes in intermittent courses. KPV acetate lists oral and topical forms, while Semax free base lists use inside the nose (intranasal). These describe the policy document, not directions for use or proof that any route is safe or effective.3

What conditions make the policy narrower?

The document describes several conditions that apply together. These include an individual prescription, specified ingredient identity and route, supplier and quality documents, reporting, and a product with only one listed active ingredient. For oral forms it describes an additional expectation of documentation of human bioavailability for the particular formulation. Meeting one condition or finding an ingredient on a list does not establish that every condition is met. For product-document limitations, see what a certificate of analysis can and cannot show.3

Does this make GLOW or KLOW approved?

No. GLOW and KLOW are seller-defined names, and their ingredients can vary. Some described combinations contain several active ingredients, whereas the HHS policy describes a single-active-ingredient condition. GHK-Cu is not among its six Appendix A names. These facts do not establish that every product sold under a stack name is identical, nor do they decide its status under every applicable law. Compare GLOW, KLOW and the ingredients and intended aims.3

What is planned for 2027?

FDA says it plans to convene its Pharmacy Compounding Advisory Committee before the end of February 2027 to discuss possible inclusion of GHK-Cu, cathelicidin LL-37, dihexa acetate, melanotan II and pegylated mechano growth factor on the 503A bulk-substances list. When checked on 6 November 2026, FDA said the meeting time and location were still to be scheduled. The committee gives nonbinding advice. A meeting agenda does not guarantee inclusion, product approval or extension of the HHS policy.

In its May 2026 nomination record, FDA lists GHK-Cu except injectable routes as under evaluation and records that the injectable nomination was withdrawn. FDA separately identifies injectable GHK-Cu as raising safety concerns. This distinction does not establish the safety or approval of any product.125

Why can the scientific and policy conclusions differ?

FDA scientific staff assessed the evidence and quality questions for nominated substances; the advisory committee gave advice; HHS then described its own rationale for a conditional enforcement position. Those are distinct steps. HHS discusses access and additional information, while the underlying evidence can still leave important safety and effectiveness questions unresolved. For one example, see what human BPC-157 research actually shows.63

How can I check the current position?

Check the dated HHS document and Federal Register notice, the FDA meeting page, the exact ingredient and formulation, and applicable state requirements. Policies, meeting dates and rules can change. A pharmacist or qualified legal professional can help interpret a particular situation; a seller’s statement or this general guide cannot establish whether a specific product is lawful or appropriate. For cross-border questions, see the travel guidance.45