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Peptides
8 min read
Updated Oct 29, 2026.
Part of The Sommar Peptide Guide. Statuses below are as of FDA's pages dated Apr 22 and May 14, 2026, and HHS's policy filed Oct 28, 2026, checked Oct 29, 2026.
The short answer
It depends on the peptide and on how it was made. Some peptides are FDA-approved drugs. Some can be compounded by a licensed pharmacy with a prescription. Many popular ones, like BPC-157, are not approved by FDA for any use and are not on the list pharmacies need to compound them [1][2]. Since Oct 28, 2026, HHS says it won't take enforcement action against licensed compounders of six of them, BPC-157 included, while that list goes through rulemaking [12].
How compounding works: 503A and 503B
Compounding is a pharmacy making a drug for a specific patient. Compounded drugs are not FDA-approved, and FDA does not check their safety, effectiveness or quality before they are sold [3].
503A pharmacies are state-licensed pharmacies that compound for individual patients with a prescription. State boards of pharmacy oversee them day to day [3]. A 503A pharmacy can only use a bulk ingredient that meets one of three conditions [1]:
It has a USP or NF monograph (an official quality standard).
It is a component of an FDA-approved drug.
It is on FDA's 503A bulks list.
503B outsourcing facilities register with FDA, follow federal manufacturing quality rules (CGMP) and are inspected by FDA on a risk-based schedule [3]. They run under their own bulks policy.
FDA's Categories 1, 2 and 3
A peptide with no monograph that is not part of an approved drug has to get on the 503A bulks list. Pharmacies nominate it. While FDA reviews a nomination, it sorts the substance into a category [1].
Category | What FDA says | What it means for compounding |
|---|---|---|
1 | Nominated with enough information to evaluate. May be eligible for the list. | FDA "does not intend to take action" against a pharmacy using it, if the guidance's conditions are met. |
2 | Enough information to evaluate, but FDA has found "significant safety risks." | FDA "would consider taking action" against a pharmacy using it. |
3 | Nominated without enough information to evaluate. | Same as Category 2: FDA "would consider taking action." |
Source: FDA, content current as of May 14, 2026 [1].
Peptide examples, as of FDA's Category 2 page dated Apr 22, 2026 [2]:
Category 2, pharmacies (503A): kisspeptin-10. The only peptide left.
Category 2, outsourcing facilities (503B): GHRP-2, GHRP-6 and ipamorelin.
Category 3, pharmacies: GHRP-2 and GHRP-6.
Category 1: topical and other non-injectable GHK-Cu, since May 14, 2026 [1].
What "removed from Category 2" means
In Sept 2024, FDA removed 5 peptides from Category 2 after the people who nominated them withdrew: AOD-9604, CJC-1295, ipamorelin (503A side), thymosin alpha-1 and selank [2][4]. In Apr 2026, 12 more came off the same way [2][5]:
BPC-157, TB-500, KPV, MOTS-c, semax, epitalon, emideltide (DSIP), LL-37, dihexa, PEG-MGF, melanotan II and injectable GHK-Cu.
Removal means FDA no longer lists them as a significant safety risk on that page.
What removal does not mean:
It does not put a peptide on the 503A bulks list. None of these is on it [1].
It does not make a peptide FDA-approved. None is approved by FDA for any use.
It does not mean FDA found it safe. In Jul 2026, FDA staff still recommended against all 7 peptides it brought to its advisory panel [6][7].
The July 2026 panel votes
FDA's Pharmacy Compounding Advisory Committee (PCAC) met Jul 23 to 24, 2026. FDA staff recommended against all 7 peptides on the agenda. The committee voted to recommend 6 of them for the 503A bulks list anyway [7][8].
Peptide | Vote (yes, no, abstain) |
|---|---|
BPC-157 | 8, 6, 1 |
TB-500 | 8, 6, 1 |
KPV | 8, 6, 1 |
MOTS-c | 7, 5, 2 |
Semax | 8, 5, 1 |
Epitalon | 7, 4, 1 |
Emideltide (DSIP) | 6, 7, 1 (not recommended) |
The semax and epitalon counts come from a single source [7].
These votes are advice. FDA makes the decision, and adding a substance to the 503A bulks list takes notice-and-comment rulemaking [7]. Until that happens, a yes vote changes nothing on the list.
Earlier panels went the other way. In Dec 2024 the committee voted against CJC-1295, AOD-9604 (0 to 12) and thymosin alpha-1 (4 to 17) [9]. A second 2026 meeting, for LL-37, injectable GHK-Cu, dihexa, melanotan II and PEG-MGF, is expected before the end of Feb 2027 [10].
HHS's interim peptide policy (Oct 28, 2026)
On Oct 14, 2026, HHS and FDA sent an "Interim Access Policy for Compounding Using Certain Peptides" to the White House budget office for review [10][11]. AP reported, citing two people familiar with the plan, that it would use enforcement discretion and include BPC-157 [11]. HHS filed the policy for public inspection on Oct 28, 2026, under the name "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances." It publishes in the Federal Register Oct 30, 2026, and comments open for 2 weeks after that [12].
HHS says it does not intend to take enforcement action against a state-licensed pharmacy, a federal facility or a licensed physician that compounds one of six peptides, when every condition in the policy is met [12][13]:
Peptide | Routes covered |
|---|---|
BPC-157 acetate | Under the skin, into muscle, oral, topical |
TB-500 acetate | Under the skin or into muscle |
MOTS-c acetate | Under the skin or into muscle |
Epitalon acetate | Under the skin or into muscle, in intermittent courses |
Semax free base | Nasal |
KPV acetate | Topical or oral |
These are the six the advisory panel voted for in Jul 2026. The conditions include one active ingredient per product, a bulk ingredient from an FDA-registered maker that follows good manufacturing practice, reporting serious side effects and quality problems to FDA and states, and the label "This is a compounded drug product. Not for resale" [13].
What the policy does not do [12][13]:
It does not approve any peptide. Compounded drugs are not approved by FDA.
It does not put any peptide on the 503A bulks list.
It does not name outsourcing facilities (503B).
It does not cover any other peptide. CJC-1295, ipamorelin, GHK-Cu, selank, DSIP, kisspeptin-10 and the rest keep their prior status.
It is interim and not binding. It lasts while the 503A bulks list goes through rulemaking, and HHS may revisit it in whole or in part if a safety signal or quality problem shows up [12]. Status as of Oct 29, 2026. Read the full breakdown in HHS's Oct 28 peptide policy. The FDA Peptide Tracker logs each step.
What about research-peptide sites?
Many peptides on this page are sold online as "research use only" or "not for human consumption." That label is the seller saying the product is not for people.
What these products skip:
A prescriber who reviews your health history.
A licensed pharmacy compounding for you, and any quality check for human use.
FDA's stated concerns for these peptides include impurities, immune reactions and missing human safety data [2][6]. More on telling them apart: Prescription vs Research Peptides.
What can be prescribed today
FDA-approved peptide drugs, like insulin, by prescription.
Compounded peptides whose ingredient meets one of the three 503A conditions, or sits in Category 1, made by a licensed pharmacy with a prescription [1].
The six peptides in HHS's interim policy, when a state-licensed pharmacy, federal facility or licensed physician compounds them under every condition the policy sets. HHS says it won't take enforcement action then. That is enforcement discretion, not approval, and HHS can change it [12].
Sermorelin is an example of the second group. It is a different peptide from the ones above, with a US approval history, and licensed pharmacies compound it under 503A. Compounded sermorelin is not FDA-approved. More in What Is Sermorelin?
FAQ
Are peptides legal in the US? Some are. Approved peptide drugs and compounded peptides on an allowed pathway can be prescribed. Most peptides sold online for "research" are not approved by FDA for any use.
Is BPC-157 legal now? It came off Category 2 in Apr 2026 and the panel voted 8 to 6 for it in Jul 2026. On Oct 28, 2026 HHS filed an interim policy saying it won't take action against licensed pharmacies, federal facilities or licensed physicians compounding BPC-157 acetate under its conditions [12]. It is still not approved by FDA for any use and not on the 503A bulks list. HHS can revise the policy.
What is FDA Category 2? FDA's list of compounding substances that "may present significant safety risks." FDA would consider taking action against a pharmacy that compounds with them [1][2].
Does a PCAC yes vote make a peptide legal? No. The committee advises. FDA decides, and the list changes only through rulemaking [7].
Which peptide is still on the 503A Category 2 list? Kisspeptin-10, as of FDA's page dated Apr 22, 2026 [2].
Sources
FDA. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (content current as of May 14, 2026). https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (content current as of Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
FDA. Compounding and the FDA: Questions and Answers. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
Reed Smith. FDA removes certain peptide bulk drug substances from Category 2 (2024). https://www.reedsmith.com/de/perspectives/2024/10/fda-certain-peptide-bulk-drug-substances-category-2-503a-bulks-pcac
Frier Levitt. FDA Peptides "Do Not Compound" List Update (Apr 16, 2026). https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/
FDA. Pharmacy Compounding Advisory Committee briefing, BPC-157 (Jul 2026). https://www.fda.gov/media/193343/download
Bass Berry. FDA Advisory Committee Recommends Six Peptides for Compounding (Jul 31, 2026). https://bassberry.com/news/fda-advisory-committee-recommends-six-peptides-for-compounding-what-the-evaluation-criteria-tell-us-about-the-road-ahead/
AJMC. FDA Panel Backs 6 Peptides for Compounding (Jul 31, 2026). https://www.ajmc.com/view/fda-panel-backs-6-peptides-for-compounding
FDA. Dec 4, 2024 Pharmacy Compounding Advisory Committee, voting results. https://www.fda.gov/media/185642/download
Holland & Knight. Peptides at a Crossroads: What Wellness Providers Need to Know (Oct 16, 2026). https://www.hklaw.com/en/insights/publications/2026/10/peptides-at-a-crossroads-what-wellness-providers-need-to-know
AP via ABC News. Trump administration advances plan for peptide drugs (Oct 15, 2026). https://abcnews.com/Business/wireStory/trump-administration-advances-plan-peptide-drugs-favored-rfk-137299803
HHS. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. Docket HHS-OASH-2026-0496, FR Doc 2026-22192 (filed for public inspection Oct 28, 2026; scheduled to publish in the Federal Register Oct 30, 2026). https://public-inspection.federalregister.gov/2026-22192.pdf
Hyman, Phelps and McNamara, FDA Law Blog. The PEPTIDE-L Wave Reaches HHS: Enforcement Discretion … Not the Finish Line (Oct 28, 2026). https://www.thefdalawblog.com/2026/10/the-peptide-l-wave-reaches-hhs-enforcement-discretion-not-the-finish-line/
Sommar Club does not prescribe or sell BPC-157, TB-500, kisspeptin-10 or any other Category 2 or formerly Category 2 peptide named here. This page is for education only. It is not legal advice. Compounded sermorelin is not FDA-approved. FDA statuses change; check the as-of dates and the FDA Peptide Tracker.
