Peptide therapy: what it is, what is approved and what is legal in 2026
As of October 15, 2026, “peptide therapy” is a marketing term covering three groups: FDA-approved drugs used for their labelled purpose, such as tesamorelin as Egrifta WR; substances FDA lets licensed pharmacies compound under Category 1, such as NAD and glutathione; and peptides with no established legal route, such as BPC-157. Which group a product is in matters more than the label “peptide”.
What “peptide therapy” means
A peptide is a short chain of amino acids. Insulin and the GLP-1 medicines semaglutide and tirzepatide are peptides, and they are among the best-studied drugs in medicine. When a clinic advertises “peptide therapy”, though, it usually means something else: injections such as BPC-157, TB-500, CJC-1295, ipamorelin and sermorelin, often bundled with non-peptide drips like NAD+ and glutathione, sold for recovery, body composition, sleep or ageing.
Those products share a delivery method and a sales channel. They do not share a regulatory status or an evidence base.
The three groups
1. Approved drugs. Tesamorelin is approved as Egrifta WR to reduce excess abdominal fat in HIV-infected adults with lipodystrophy, and its label says “Not indicated for weight loss management.” Levocarnitine (CARNITOR) and cyanocobalamin injections are also approved. These have real trial data behind their labelled uses.
2. Category 1 compounds. NAD, NADH, glutathione, methylcobalamin, acetyl-L-carnitine and non-injectable GHK-Cu may be compounded by licensed 503A pharmacies while FDA evaluates them. Legal to prescribe through that route; not approved; not proven for the marketed uses.
3. No established route. BPC-157, TB-500, CJC-1295, ipamorelin, AOD-9604 and injectable GHK-Cu are not approved and sit in no FDA category after April 2026. Sermorelin is a contested case.
Status of each substance
| 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| BPC-157 | None, in any country | No category (withdrawn from Cat. 2, April 2026); PCAC voted 8–6 to recommend (reported) | S0, prohibited |
| TB-500 | None | No category (withdrawn from Cat. 2); PCAC voted 8–6 to recommend (reported) | S2.3, prohibited |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| CJC-1295 | None | No category (withdrawn from Cat. 2) | S2.2.4, prohibited |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 |
What the evidence looks like
Outside the approved products, the evidence for peptide therapy is mostly mechanistic and preclinical. Many studies show a peptide changes a hormone level or heals tissue in animals; few controlled human trials show the outcomes clinics sell. FDA’s own reviews say clinical data on CJC-1295 are limited and that it found no human exposure data for TB-500. We separate human from animal evidence on each substance page and do not cite trials we could not source.
How legitimate peptide care works
- A licensed clinician evaluates you, including whether an approved treatment fits better.
- The prescription goes to a named, state-licensed pharmacy that can tell you its legal basis for compounding the substance.
- Someone monitors you and agrees in advance what result means stopping.
- No “research use only” products, ever. FDA warned five such sellers on August 24, 2026.
Use our provider verification checklist and read peptide safety before you pay anyone.
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.
For peptide therapy as a whole: group 3 may shrink if the interim access policy is published, but until then the three groups above are accurate as of October 15, 2026.
Frequently asked questions
Is peptide therapy legal?
Some of it. Approved drugs used as prescribed are legal, and Category 1 substances such as NAD and glutathione can be compounded by licensed pharmacies. Peptides such as BPC-157, TB-500, CJC-1295 and ipamorelin have no established compounding route as of October 15, 2026.
Is peptide therapy FDA-approved?
Only specific products for specific uses. Tesamorelin is approved as Egrifta WR for abdominal fat in adults with HIV and lipodystrophy. Most peptides sold for recovery, anti-ageing or body composition are not approved for any use.
Does peptide therapy work?
For approved products, within their labels, trials support them. For most wellness peptides the evidence is largely animal and mechanistic, and controlled human trials of the advertised outcomes are scarce or absent.
Are GLP-1 drugs peptides?
Yes. Semaglutide and tirzepatide are peptides with large human trials behind their approved uses. They are covered in our GLP-1 section, and compounded versions have their own rules.
Sources
- 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)
- 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 — Bulk drug substances used in compounding under section 503A (page current as of May 14, 2026) (read October 15, 2026)
- FDA warning letter — Royal Peptides LLC, 734884 (August 24, 2026) (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)