Peptide legal status in 2026: 16 substances checked against FDA and WADA
As of October 15, 2026, only one of the 16 peptides and related injectables in our table, tesamorelin, has an FDA-approved product; three (glutathione, NAD and non-injectable GHK-Cu) sit in FDA’s interim Category 1; kisspeptin-10 remains in Category 2; and the other 11, including BPC-157 and TB-500, sit in no compounding category at all.
Qualification: “no category” is not a written ban, but it leaves no established federal route to compound the substance.
Peptide marketing blurs four questions: is there an approved drug, can a pharmacy legally compound it, has an FDA committee reviewed it, and is it banned in sport? This page answers all four for each substance, with the agency page behind each answer. It is built from our open peptide status dataset and FDA’s July 2026 advisory-committee materials.
Where does each peptide stand on October 15, 2026?
“Withdrawn from Category 2” means FDA moved the substance off its safety-risk list because the people who nominated it withdrew the nomination, not because FDA found it safe.
| Substance | FDA-approved product? | 503A compounding status | FDA advisory committee (PCAC) 2026 | WADA 2027 |
|---|---|---|---|---|
| BPC-157 | No | None. Withdrawn from Category 2 (April 2026) | Reviewed July 23; reported 8–6 to recommend | S0, named |
| TB-500 (thymosin beta-4 fragment) | No | None. Withdrawn from Category 2 | Reviewed July 23; reported 8–6 to recommend | S2.3 (thymosin-β4 derivatives) |
| KPV | No | None. Withdrawn from Category 2 | Reviewed July 23; reported 8–6 to recommend | Not named; may fall under S0 |
| MOTs-C | No | None. Withdrawn from Category 2 | Reviewed July 23; reported 7–5 to recommend | Not named; may fall under S0 |
| Semax | No | None. Withdrawn from Category 2 | Reviewed July 24; reported 8–5 to recommend | Not named; may fall under S0 |
| Epitalon | No | None. Withdrawn from Category 2 | Reviewed July 24; reported 7–4 to recommend | Not named; may fall under S0 |
| DSIP (emideltide) | No | None. Withdrawn from Category 2 | Reviewed July 24; reported 6–7 against | Not named; may fall under S0 |
| CJC-1295 | No | None. Withdrawn from Category 2 | Not scheduled | S2.2.4 (GHRH analogue), named |
| Ipamorelin | No | None for 503A; still Category 2 for 503B | Not scheduled | S2.2.4 (GH secretagogue), named |
| AOD-9604 | No | None. Withdrawn from Category 2 | Not scheduled | S2.2.3 (GH fragment), named |
| Sermorelin | No current product (Geref discontinued) | None | Not scheduled | S2.2.4 (GHRH analogue), named |
| GHK-Cu, injectable | No | None. Withdrawn from Category 2 | Due before end of February 2027 | Not named; may fall under S0 |
| GHK-Cu, non-injectable | No | Category 1 (re-added May 2026) | Due before end of February 2027 | Not named; may fall under S0 |
| Kisspeptin-10 | No product found | Category 2 (significant safety risks) | Not scheduled | S2.2.1 (kisspeptin analogues) |
| Glutathione | No product found | Category 1 | Not scheduled | Not named; IV over 100 mL/12 h banned (M2.2) |
| NAD (NAD+) | No product found | Category 1 | Not scheduled | Not named; IV over 100 mL/12 h banned (M2.2) |
| Tesamorelin | Yes: Egrifta WR, HIV-associated abdominal fat only | Approved-drug ingredient | Not scheduled | S2.2.4 (GHRH analogue), named |
The count: 1 approved product (tesamorelin), 3 in Category 1, 1 still in Category 2 for 503A pharmacies (kisspeptin-10; ipamorelin is still in Category 2 for 503B outsourcing facilities), and 11 in no category. That is 11 of 16, or 69%, with no settled compounding route.
What does each status mean for you?
An FDA-approved product exists
Tesamorelin is sold as Egrifta WR, a 1.28 mg daily injection approved to reduce excess abdominal fat in adults with HIV and lipodystrophy. Its label says it is not indicated for weight-loss management. A clinician can prescribe it off-label, and the manufacturer does not publish a list price on its website. Compounded tesamorelin is not the approved product. See our tesamorelin page.
Category 1
Category 1 is an interim, enforcement-discretion list: FDA says it does not intend to act against a 503A pharmacy that compounds these substances for an individual patient with a prescription while the agency evaluates them. That is permission by forbearance, not approval, and it says nothing about whether the substance works. Glutathione, NAD and non-injectable GHK-Cu (creams, for example) are here; injectable GHK-Cu is not. See NAD+ and GHK-Cu.
Category 2
Category 2 means FDA has identified significant safety risks. For 503A pharmacies the May 14, 2026 list holds six substances; kisspeptin-10 is the one in our table.
No category
This is where most popular peptides now sit, including BPC-157, TB-500, CJC-1295 and sermorelin. FDA’s interim policy covers substances nominated before January 7, 2025 and placed in a category; a withdrawn nomination leaves the substance outside both lists. A pharmacy that compounds it relies on its own legal reading, and FDA has not said it will refrain from acting. Ask any clinic that offers these peptides which pharmacy fills the order and on what legal basis.
“Research use only”
None of the statuses above makes a research-chemical website lawful. On August 24, 2026 FDA warned five such sellers that products including tesamorelin, retatrutide and PT-141 were unapproved new drugs despite their disclaimers. More in research peptides vs prescription peptides.
What changed in 2026?
Three events reshaped the table: the April withdrawals, the July advisory committee and the October interim-policy filing. WADA’s 2027 list also adds “peptides” to the examples in its S0 class and warns that an unnamed peptide may still be prohibited.
| Date | What happened | Source |
|---|---|---|
| April 2026 (page current as of April 22) | FDA lists BPC-157, TB-500, CJC-1295, AOD-9604, ipamorelin, KPV, MOTs-C, Semax, Epitalon, DSIP, injectable GHK-Cu and others as nominations withdrawn from Category 2 | FDA |
| May 14, 2026 | Interim categories updated: non-injectable GHK-Cu added back to Category 1; Category 2 for 503A now holds six substances, including kisspeptin-10 | FDA categories PDF |
| July 23–24, 2026 | PCAC reviews seven peptides; FDA staff propose not adding BPC-157 or TB-500; reported votes favour six of seven | FDA meeting page |
| August 24, 2026 | FDA warning letters to five “research use only” peptide sellers | FDA (example: 734884) |
| September 21, 2026 | WADA publishes the 2027 Prohibited List; S0 now names “peptides” among its examples | WADA |
| October 14, 2026 | HHS and FDA send an “Interim Access Policy for Compounding Using Certain Peptides” to White House review (RIN 0910-ZD94) | Our explainer |
Three worked examples
1. A clinic quotes NAD+ injections. NAD sits in Category 1, so a 503A pharmacy can compound it for you with a prescription. Price is the next question. Oak Longevity’s own page on October 15, 2026 listed NAD+ at “$175 a month, regularly $199”. A year at the sale price is $175 × 12 = $2,100; at the regular price it is $199 × 12 = $2,388, a $288 difference. Neither figure buys evidence: human NAD+ injection studies are small and short. See NAD+.
2. An athlete is offered tesamorelin. It is the only approved product in the table, yet WADA lists it under S2.2.4 for 2026 and 2027. A tested athlete would need a therapeutic use exemption even for the approved drug, and the approved use is narrow: HIV-associated abdominal fat.
3. A telehealth program lists sermorelin. Sermorelin has no current approved product and sits in no category; FDA’s 2013 notice only says the discontinued brand, Geref, was not withdrawn for safety or effectiveness reasons. On October 15, 2026, NexLife’s sermorelin page showed $130 and “Sold out”; Oak Longevity shows its price only after an assessment. Ask which pharmacy compounds it.
What this means for you
- If an approved product exists for your condition, start there; for weight loss see the GLP-1 pricing database. Background: peptide legality.
- For a Category 1 substance, a prescription from a licensed clinician filled by a named, licensed 503A pharmacy is the lawful route.
- For a substance in no category, expect change: the interim access policy could open a route for some peptides. Do not prepay months of treatment.
- Never buy from “research use only” sellers. FDA treats those products as unapproved drugs, and nobody checks their sterility or dose.
- If you compete in tested sport, check the WADA list and your federation before taking any of these.
Frequently asked questions
Did FDA approve BPC-157 when it left Category 2?
No. FDA lists BPC-157 among nominations withdrawn from Category 2, which means it is no longer on the safety-risk list but has not been placed anywhere else. It has no FDA-approved product, is not on the 503A bulks list and is not in Category 1, so a pharmacy has no established federal route to compound it as of October 15, 2026.
Which peptides on this list can a 503A pharmacy compound today?
Under FDA’s interim policy, glutathione, NAD and non-injectable GHK-Cu sit in Category 1, which means FDA does not intend to act against a 503A pharmacy that compounds them for a patient with a prescription while it evaluates them. Tesamorelin is the ingredient of an approved drug. The other peptides in the table sit in no category.
What did the July 2026 advisory committee decide?
The Pharmacy Compounding Advisory Committee advises FDA; it does not decide. A law-firm account of the July 23–24 meeting reports votes in favour of adding BPC-157, KPV, TB-500, MOTs-C, Semax and Epitalon to the 503A bulks list and against DSIP. FDA had not acted on those votes as of October 15, 2026.
Are these peptides banned in sport?
Most are. WADA’s 2027 list names BPC-157 under S0 and CJC-1295, sermorelin, tesamorelin, ipamorelin, AOD-9604 and TB-500 under S2; approved tesamorelin still needs a therapeutic use exemption. GHK-Cu, glutathione and NAD+ are not named, but IV infusions over 100 mL in 12 hours are banned outside hospital care.
Will the interim access policy change this table?
Possibly. HHS and FDA sent an interim access policy for compounding certain peptides to White House review on October 14, 2026, according to the OIRA review list. Its contents are not public. We will update this table when a policy is published and record the change with its date.
Sources
- FDA — Interim 503A bulk drug substance categories (PDF) — updated May 14, 2026
- FDA — Certain bulk drug substances that may present significant safety risks (withdrawn nominations) — current as of April 22, 2026
- FDA — Pharmacy Compounding Advisory Committee, July 23–24, 2026 — read October 15, 2026
- FDA briefing document — BPC-157 — July 2026
- McDermott Will & Schulte — reported PCAC votes — July 27, 2026
- WADA — 2027 Prohibited List — published September 21, 2026; effective January 1, 2027
- FDA — warning letter 734884 (Royal Peptides) — August 24, 2026
- Federal Register — Geref determination, 78 FR 14096 — March 4, 2013
- Oak Longevity — longevity pricing — read October 15, 2026
- NexLife — sermorelin product page — read October 15, 2026