Safety
Which peptides are legal to compound in 2026? A dated tracker
Peptide FDA and compounding status, checked 30 Oct 2026: the six peptides under the HHS interim policy and their routes, what is not covered, and the timeline.
By Julian Caraulani · Updated October 30, 2026 · Reviewed by Dr. A. Goher, MBBS
As of 30 October 2026, six single peptides may be compounded by state-licensed 503A pharmacies on a patient-specific prescription under an interim HHS policy: BPC-157, TB-500, MOTS-c, Semax, Epitalon and KPV, each limited to set routes (Federal Register 2026-22192). None is FDA-approved, and the policy can be withdrawn. Most other popular peptides have no such cover.
This page is a tracker. Each row says what the federal documents said on the day we checked them, with a link to the document. Compounded drugs are not FDA-approved, the HHS policy is interim, and status can change quickly, so check the date at the top of each table. For what the policy requires in detail, see the HHS peptide policy explained.
The six peptides covered by the HHS interim policy (checked 30 Oct 2026)
HHS says it "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" (Federal Register). Appendix A lists six peptides, and Appendix B limits each one to a salt form and a set of routes:
| Peptide | Form HHS names | Routes covered | Federal status | Source |
|---|---|---|---|---|
| BPC-157 | BPC-157 acetate | Subcutaneous, intramuscular, oral, topical | Interim HHS enforcement discretion, 503A only. Not FDA-approved | HHS policy, Appendix B |
| TB-500 | TB-500 acetate | Subcutaneous or intramuscular injection | Interim HHS enforcement discretion, 503A only. Not FDA-approved | HHS policy |
| MOTS-c | MOTS-c acetate | Subcutaneous or intramuscular injection | Interim HHS enforcement discretion, 503A only. Not FDA-approved | HHS policy |
| Semax | Semax free base | Intranasal only | Interim HHS enforcement discretion, 503A only. Not FDA-approved | HHS policy |
| Epitalon | Epitalon acetate | Subcutaneous or intramuscular injection, dispensed in intermittent courses | Interim HHS enforcement discretion, 503A only. Not FDA-approved | HHS policy |
| KPV | KPV acetate | Topical and oral only (no injection) | Interim HHS enforcement discretion, 503A only. Not FDA-approved | HHS policy |
The HHS policy file on hhs.gov blocks automated readers, so we read it by hand in a browser on 30 October 2026. A route not in the table, such as injectable KPV, is outside the policy. For oral products the policy adds a condition: "if a peptide is compounded in an oral dosage form, the compounder is expected to maintain documentation confirming that the specific formulation provided to a patient achieves an adequate level of oral bioavailability in humans" (HHS policy). Our oral vs injection BPC-157 guide covers what that means for buyers.
Programs for three of the six are already listed on this site: BPC-157 from $149 a month, TB-500 from $149 and MOTS-c from $199. See BPC-157 prices, TB-500 prices and MOTS-c prices.
Peptides with no federal cover (checked 30 Oct 2026)
Leaving FDA's Category 2 list did not make a peptide compoundable. Under section 503A, pharmacies "may only compound drug products using bulk drug substances that" have a USP or NF monograph, are components of FDA-approved drugs, or appear on the 503A bulks list (FDA 503A page). The peptides below meet none of those tests, are not in FDA's Category 1, and are not in the HHS appendix. FDA now lists most of them under "Bulk drug substances nominated but withdrawn" on its safety risks page.
| Peptide | Federal status | Source |
|---|---|---|
| GHK-Cu, injectable | Nomination withdrawn. Not on the 503A bulks list, not in the HHS policy | FDA safety risks page |
| LL-37 (cathelicidin) | Nomination withdrawn. Not covered | FDA safety risks page |
| Ipamorelin acetate | 503A nomination withdrawn. Still in Category 2 for 503B outsourcing facilities, added 29 September 2023 | FDA safety risks page |
| CJC-1295 | Nomination withdrawn. Not covered | FDA safety risks page |
| AOD-9604 | Nomination withdrawn. Not covered | FDA safety risks page |
| Selank acetate (TP-7) | Nomination withdrawn. Not covered | FDA safety risks page |
| Melanotan II | Nomination withdrawn. Not covered | FDA safety risks page |
| Dihexa acetate | Nomination withdrawn. Not covered | FDA safety risks page |
| PEG-MGF | Nomination withdrawn. Not covered | FDA safety risks page |
| Emideltide (DSIP) | Nomination withdrawn. Reviewed by the advisory committee on 24 July 2026 but left out of the HHS policy | FDA safety risks page |
| Thymosin alpha-1 | Nomination withdrawn. Not covered | FDA safety risks page |
FDA's safety text still sits beside each name. For melanotan II, FDA writes: "Published case reports discuss serious adverse events including melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism" (FDA). For dihexa, PEG-MGF and KPV, FDA says it found no human exposure data at all.
GHK-Cu has a split status. FDA's May 2026 list puts "GHK-Cu (except for injectable routes of administration)" back in Category 1 (FDA category list, updated 14 May 2026). For Category 1, FDA states it "does not intend to take action against a compounder for compounding drugs using bulk drug substances listed in category 1, provided that the conditions described in the guidance document are met" (FDA 503A page). So topical GHK-Cu sits under FDA's older interim policy, while injectable GHK-Cu has no cover.
Price checked Oct 30 · Cancel anytime · Medication included · No email needed
Approved, compoundable and off-limits peptides (checked 30 Oct 2026)
| Peptide | Federal status | Source |
|---|---|---|
| Sermorelin | No FDA-approved product on the market. The former brand, Geref, was withdrawn, and FDA found it was not withdrawn for safety or effectiveness reasons. Pharmacies compound it on a prescription; our reading is that it qualifies as a component of a formerly approved drug | Federal Register, 2013 |
| Tesamorelin | FDA-approved as Egrifta WR and Egrifta SV for one use: excess abdominal fat in adults with HIV and lipodystrophy. A compounded or research-labeled version is not that approved product | DailyMed, Egrifta WR |
| NAD+ | FDA Category 1 (under evaluation). Compounded versions are not FDA-approved | FDA category list |
| Glutathione | FDA Category 1 (under evaluation). Compounded versions are not FDA-approved | FDA category list |
| Retatrutide | Investigational. FDA says it cannot be compounded | FDA GLP-1 page |
On retatrutide FDA is blunt: "Retatrutide and cagrilintide cannot be used in compounding under federal law" (FDA). Any offer of compounded retatrutide is outside the law, and this site does not list one. The Egrifta label says the drug is "indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy" (DailyMed). For sermorelin in depth, see sermorelin FDA status; programs start at $94 a month on the sermorelin price page.
Timeline: from Category 2 to the HHS policy
- September 2023. FDA placed BPC-157 and other peptides in Category 2 for 503A. HHS's appendix says TB-500 "was in Category 2 from September 29, 2023, until April 22, 2026" (HHS policy).
- April 2026. The nominators withdrew their nominations and FDA moved the peptides to its withdrawn list, effective 22 April 2026 per the HHS appendix. FDA's notice of the advisory meeting was published on 16 April 2026 (Federal Register 2026-07361). News reports date FDA's announcement to 15 April; we could not find an FDA page carrying that date.
- 23 and 24 July 2026. FDA's Pharmacy Compounding Advisory Committee reviewed BPC-157, KPV, TB-500 and MOTS-c on the first day, and emideltide, Semax and Epitalon on the second (FDA meeting page). HHS's appendix says the committee voted in favor of each of the six and that FDA's drug center recommended against each one. The meeting page had posted briefing documents and the agenda but no minutes or vote tallies when we checked.
- 28 to 30 October 2026. HHS filed its enforcement-discretion policy on 28 October, and it was published on 30 October with a two-week comment window (Federal Register).
- Before the end of February 2027. FDA "intends to consult the Pharmacy Compounding Advisory Committee (PCAC) before the end of February 2027 regarding the potential inclusion of GHK-Cu" (FDA category list). Trade reports say LL-37, dihexa, PEG-MGF and melanotan II are on the same track; we could not confirm that on an FDA page.
What "legal to compound" means for the six
The policy is not a license. It describes when HHS will not enforce, and it lasts "Until a peptide bulk drug substance is addressed in a final rule as being included or not included on the 503A bulks list" (HHS policy). The notice also says it "does not establish any rights for any person and is not binding on HHS or the public" (Federal Register).
Three limits matter most to a buyer. The product must contain one peptide only, so a BPC-157 and TB-500 blend is outside it (see BPC-157 vs TB-500). It must come from a 503A pharmacy filling a prescription for you. And it does not reach research-use-only vials: FDA told one such seller that "evidence obtained from your website establishes that your products are intended to be drugs for human use" (FDA warning letter, TXP Innovations). Our guide to research vs prescription peptides covers that gap.
The policy speaks for federal enforcement. It does not change state pharmacy law, and a state board can set its own rules, so availability may differ by state.
FAQ
Which peptides are legal to compound in 2026?
Six peptides may be compounded by 503A pharmacies on a patient-specific prescription under an interim HHS policy published 30 October 2026: BPC-157, TB-500, MOTS-c, Semax, Epitalon and KPV. Each is limited to set routes, such as intranasal for Semax and topical or oral for KPV. NAD+, glutathione and topical GHK-Cu sit in FDA's Category 1. None of these compounded products is FDA-approved. Checked 30 Oct 2026.
What is the FDA status of these peptides?
FDA has approved none of the six HHS-policy peptides. The policy comes from the HHS Secretary, not an FDA approval, and HHS's appendix records that FDA's drug center recommended against listing each one. Tesamorelin is the exception in this group of names: it is FDA-approved as Egrifta for one narrow use, and a compounded or research-labeled version is not that approved product.
Is GHK-Cu legal to compound?
Status depends on the route. FDA's 14 May 2026 list put GHK-Cu, except for injectable routes, back in Category 1, where FDA does not intend to act if its guidance conditions are met. Injectable GHK-Cu is on FDA's withdrawn list and is not in the HHS policy, so it has no federal cover. FDA plans an advisory review of GHK-Cu before the end of February 2027.
Can pharmacies compound ipamorelin, CJC-1295 or AOD-9604?
Not under any federal policy we found. All three appear on FDA's list of nominations that were withdrawn, none is on the 503A bulks list or in Category 1, and none is in the HHS appendix. Ipamorelin is also still in Category 2 for 503B outsourcing facilities. A program offering them is outside both the FDA and HHS frameworks.
Is retatrutide legal to compound?
No. FDA states that retatrutide cannot be used in compounding under federal law, that it is not a component of an FDA-approved drug, and that it has not been found safe and effective for any condition. Retatrutide is still investigational. FDA has warned telehealth companies, ingredient distributors and outsourcing facilities over it, and this site lists no retatrutide offers.
Are peptide blends covered by the HHS policy?
No. One condition is that the compounded product contains only a single active ingredient listed in Appendix A. HHS says single-ingredient products make it easier to link adverse events to one substance. A blend of BPC-157 with TB-500, or any peptide with an unlisted ingredient, falls outside the policy even when each peptide alone is covered.
How long will this tracker stay accurate?
Not long, possibly. HHS says it may revisit the policy if a safety signal or product quality issue arises, and the policy ends for each peptide once FDA finalizes a rule including or excluding it. Comments close two weeks after 30 October 2026. We date every table and recheck the federal documents when they change.
Compare licensed prescription programs and their full prices on the best programs page, or go straight to BPC-157 prices.