Peptides in 2026: FDA status, evidence and legality
As of October 15, 2026, only a few substances sold by peptide clinics have an FDA-approved product — tesamorelin (Egrifta WR, one use), levocarnitine and cyanocobalamin — while NAD, glutathione, methylcobalamin and non-injectable GHK-Cu sit in FDA’s Category 1 for compounding. BPC-157, TB-500, CJC-1295 and ipamorelin have no established compounding route.
Status of every substance we cover
| Substance | FDA-approved product | 503A interim status | WADA 2026 |
|---|---|---|---|
| BPC-157 | None, in any country | No category (withdrawn from Cat. 2, April 2026); PCAC voted 8–6 to recommend (reported) | S0, prohibited |
| TB-500 | None | No category (withdrawn from Cat. 2); PCAC voted 8–6 to recommend (reported) | S2.3, prohibited |
| GHK-Cu | None found | Non-injectable: Category 1. Injectable: no category | Not named |
| CJC-1295 | None | No category (withdrawn from Cat. 2) | S2.2.4, prohibited |
| Ipamorelin | None | 503A: no category. 503B: Category 2 | S2.2.4, prohibited |
| CJC-1295 + ipamorelin | None | Neither component in a 503A category | Both S2.2.4, prohibited |
| Sermorelin | Geref discontinued; FDA: not withdrawn for safety or effectiveness (2013) | Not in any category; approved-component route not confirmed by FDA | S2.2.4, prohibited |
| Tesamorelin | Egrifta WR, for abdominal fat in adults with HIV and lipodystrophy only | Not in interim categories; compounded versions not approved | S2.2.4, prohibited |
| NAD+ | None found | Category 1 (NAD, NADH) | Not named; IV over 100 mL/12 h prohibited (M2.2) |
| Glutathione | None found | Category 1 | Not named; M2.2 IV limit |
| L-carnitine | Levocarnitine injection (CARNITOR) | Acetyl-L-carnitine: Category 1 | Not named; M2.2 IV limit |
| MIC-B12 | Cyanocobalamin injections; no MIC combination | Methylcobalamin, choline chloride: Category 1 | B12 not prohibited; M2.2 IV limit |
Each substance page has a fuller “Status at a glance” table with the source and read date for every row, plus the human and animal evidence kept apart.
Three groups, not one
Approved products. Tesamorelin is approved as Egrifta WR for reducing excess abdominal fat in adults with HIV and lipodystrophy, and its label says it is “not indicated for weight loss management.” Levocarnitine injection (CARNITOR) and cyanocobalamin injections are approved drugs. Approval covers the labelled use, not every use a clinic advertises.
Category 1 substances. NAD, glutathione, methylcobalamin, acetyl-L-carnitine and non-injectable GHK-Cu may be compounded by licensed 503A pharmacies while FDA evaluates them. That is enforcement discretion. It is not approval, and it says nothing about whether they work.
No established route. BPC-157, TB-500, CJC-1295, ipamorelin, AOD-9604 and injectable GHK-Cu are not approved, not on the bulks list and in no category. Sermorelin sits in an unresolved position: no category, but a formerly approved product (Geref) that FDA said was not withdrawn for safety or effectiveness.
How FDA’s compounding categories work
FDA sorts nominated bulk substances into three interim categories while it decides what goes on the 503A bulks list (page current as of May 14, 2026):
- Category 1: “These substances may be eligible for inclusion on the 503A bulks list.” FDA does not intend to act against licensed pharmacies compounding them while it evaluates them. Examples: NAD, NADH, glutathione, methylcobalamin, acetyl-L-carnitine and non-injectable GHK-Cu.
- Category 2: “FDA has identified significant safety risks relating to the use of these substances in compounding.” As of the May 14, 2026 PDF the 503A Category 2 list is cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate, kisspeptin-10 and quinacrine for intrauterine use.
- Category 3: substances that “may be eligible” but “were nominated with insufficient supporting information for FDA to evaluate them.”
FDA also says it “does not intend to place bulk drug substances nominated on or after January 7, 2025, into these categories.” A substance in no category — BPC-157, TB-500, CJC-1295, ipamorelin and AOD-9604 since April 2026 — gets none of that enforcement discretion.
October 2026: what changed
- April 2026 — Category 2 withdrawals. FDA moved BPC-157, TB-500, CJC-1295, ipamorelin, AOD-9604, injectable GHK-Cu and other peptides off its Category 2 list after the nominators withdrew them. FDA lists them as “nominated but withdrawn” (page current as of April 22, 2026). They were not moved into Category 1.
- July 23–24, 2026 — advisory committee. FDA’s Pharmacy Compounding Advisory Committee reviewed BPC-157, KPV, TB-500, MOTs-C, emideltide (DSIP), Semax and Epitalon. FDA staff proposed not adding BPC-157 or TB-500. A law-firm account reports the committee voted 8–6 (one abstention) to recommend BPC-157, KPV and TB-500 (McDermott, July 27, 2026). A vote is advice; FDA has taken no final action.
- October 14–15, 2026 — interim access policy under White House review. The OIRA review site lists “Interim Access Policy for Compounding Using Certain Peptides” from HHS/FDA (RIN 0910-ZD94, stage: Notice), received October 14, 2026 and pending review; no text has been published (reginfo.gov). Reuters reported the filing on October 15 (Reuters), and the AP, citing two people, said it would let pharmacies make some popular peptides, including BPC-157. Which peptides, on what terms and from when are not public. Our running table: peptide legal status 2026.
The net effect for patients on October 15, 2026: the substances people most often ask about, BPC-157 and TB-500, are still outside every compounding category, and an interim policy that might change that has been drafted but not published. On the anti-doping side, the 2027 WADA list, in force January 1, 2027, adds “peptides” to the examples in its S0 class and leaves the named peptide entries unchanged.
Guides in this section
- Which peptides can a pharmacy legally compound? — the 503A routes, 503B and state law.
- Research peptides vs prescription peptides — FDA’s August 2026 warning letters.
- Peptide safety — what FDA has said about each substance’s risks.
- How to verify a peptide provider — a checklist you can run in 15 minutes.
- Peptide telehealth programs — why we do not rank them yet.
- Peptide therapy overview — what the term covers.
Frequently asked questions
Which peptides are FDA-approved?
Of the substances on this page, tesamorelin is the one peptide with a current FDA-approved product, Egrifta WR, approved only for excess abdominal fat in adults with HIV and lipodystrophy. Levocarnitine and cyanocobalamin injections are approved but are not peptides. BPC-157, TB-500, CJC-1295 and ipamorelin are not approved.
What is the difference between Category 1 and no category?
Category 1 means FDA does not intend to act against licensed 503A pharmacies that compound the substance while it evaluates it. A substance in no category gets no such discretion and, unless it has another lawful basis, has no established compounding route.
Did anything change for peptides in October 2026?
Not yet in law. Reuters reported on October 15, 2026 that HHS and FDA sent an interim access policy for compounding certain peptides to White House review. Its contents are not public. Until FDA publishes it, the statuses on this page stand.
Are peptides banned in sport?
Many are. WADA’s 2026 list names BPC-157 (S0), TB-500 (S2.3), CJC-1295, sermorelin, tesamorelin and ipamorelin (S2.2.4), all prohibited at all times. The 2027 list adds “peptides” as an example in S0, so unnamed peptides may also be prohibited.
Where do these statuses come from?
From FDA’s 503A bulks page and categories PDF (both May 14, 2026), FDA’s list of withdrawn Category 2 nominations (April 22, 2026), FDA advisory committee documents, FDA warning letters and the WADA Prohibited Lists, all read on October 15, 2026.
New this month: what is known about FDA’s peptide interim access policy · a status table for 16 peptides (FDA and WADA).
Sources
- FDA — Bulk drug substances used in compounding under section 503A (page current as of May 14, 2026) (read October 15, 2026)
- FDA — Interim policy categories for 503A and 503B bulk drug substances (PDF, updated May 14, 2026) (read October 15, 2026)
- FDA — Certain bulk drug substances for use in compounding that may present significant safety risks (page current as of April 22, 2026) (read October 15, 2026)
- FDA — July 23–24, 2026 meeting of the Pharmacy Compounding Advisory Committee (page current as of August 6, 2026) (read October 15, 2026)
- McDermott Will & Schulte — PCAC backs majority of peptides in two-day public meeting (July 27, 2026; reported vote counts) (read October 15, 2026)
- FDA — EGRIFTA WR (tesamorelin) prescribing information, supplement approved March 25, 2025 (read October 15, 2026)
- Drugs@FDA — NDA 020182, CARNITOR (levocarnitine) injection (read October 15, 2026)
- Federal Register 78 FR 14096 (March 4, 2013) — determination that GEREF was not withdrawn for safety or effectiveness (read October 15, 2026)
- World Anti-Doping Agency — Prohibited List (2026 list in force) (read October 15, 2026)
- OIRA (reginfo.gov) — Interim Access Policy for Compounding Using Certain Peptides, RIN 0910-ZD94 (pending EO 12866 review) (read October 15, 2026)
- Reuters via Yahoo News — FDA takes step to change peptide compounding access (October 15, 2026) (read October 15, 2026)
- World Anti-Doping Agency — 2027 Prohibited List (published September 21, 2026; in force January 1, 2027) (read October 15, 2026)