Regulatory fact, as of October 2026: FDA's Category 2 holds kisspeptin-10, ipamorelin, GHRP-2, GHRP-6 and MK-677, while BPC-157, TB-500 and 15 others moved to its withdrawn list. FDA-approved peptides are the only finished products the FDA has reviewed. Compounding is lawful only when the ingredient qualifies, which rules out BPC-157 and most research peptides today. A “research use only” label does not make a product legal to sell for people, and anti-doping rules apply on top of all of it.
Every FDA warning letter that names a peptide since 2021, with the date, the recipient, the peptides and a link to the letter: FDA warning letters to peptide sellers. Outside the US, the TGA, Health Canada, the MHRA and Medsafe have issued their own notices: peptide warnings by country.
New trials, FDA changes and side-effect reports, written in plain English. Every result says whether it was tested in people or in animals.
Every peptide FDA has placed in Category 2, plus the ones it now lists as nominated but withdrawn. Category 2 means FDA found significant safety concerns. Withdrawn means the nominator pulled the nomination, which leaves the peptide in no category and with no lawful 503A compounding route. Each row shows the date we last checked it against FDA.
| Peptide | FDA status | Committee review | Source |
|---|---|---|---|
| Kisspeptin-10 | Category 2 For 503A pharmacies since September 29, 2023 | No review announced | FDA Category 2 pageChecked |
| MK-677 (ibutamoren) | Category 2 For 503B since December 29, 2022 and 503A since September 29, 2023 | No review announced | FDA Category 2 pageChecked |
| Ipamorelin | Category 2 For 503B outsourcing facilities since September 29, 2023. Its 503A nomination was withdrawn | No review announced | FDA Category 2 pageChecked |
| GHRP-2 | Category 2 For 503B, injectable and nasal use, since September 29, 2023 | No review announced | FDA Category 2 pageChecked |
| GHRP-6 | Category 2 For 503B since September 29, 2023 | No review announced | FDA Category 2 pageChecked |
| BPC-157 | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee voted 8 to 6 for the bulks list on July 23, 2026 (reported). No proposed rule yetFDA staff review: the criteria weigh against adding it to the 503A bulks list (FDA briefing document) | FDA Category 2 pageChecked |
| TB-500 | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee voted 8 to 6 for the bulks list on July 23, 2026 (reported). No proposed rule yetFDA staff review: the criteria weigh against adding it to the 503A bulks list (FDA briefing document) | FDA Category 2 pageChecked |
| KPV | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee voted 8 to 6 for the bulks list on July 23, 2026 (reported). No proposed rule yetFDA staff review: the criteria weigh against adding it to the 503A bulks list (FDA briefing document) | FDA Category 2 pageChecked |
| MOTS-c | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee voted 7 to 5 for the bulks list on July 23, 2026 (reported). No proposed rule yetFDA staff review: the criteria weigh against adding it to the 503A bulks list (FDA briefing document) | FDA Category 2 pageChecked |
| Epitalon | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee voted 7 to 4 for the bulks list on July 24, 2026 (reported). No proposed rule yetFDA staff review: the criteria weigh against adding it to the 503A bulks list (FDA briefing document) | FDA Category 2 pageChecked |
| Semax | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee voted 8 to 5 for the bulks list on July 24, 2026 (reported). No proposed rule yetFDA staff review: the criteria weigh against adding it to the 503A bulks list (FDA briefing document) | FDA Category 2 pageChecked |
| DSIP (emideltide) | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee voted 7 to 6 against adding it on July 24, 2026 (reported)FDA staff review: the criteria weigh against adding it to the 503A bulks list (FDA briefing document) | FDA Category 2 pageChecked |
| GHK-Cu | Category 1 For every route except injection, since May 14, 2026. The injectable nomination was withdrawn | FDA plans a committee review before the end of February 2027 | FDA 503A category listChecked |
| Melanotan II | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee review expected before the end of February 2027 (reported) | FDA Category 2 pageChecked |
| LL-37 | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee review expected before the end of February 2027 (reported) | FDA Category 2 pageChecked |
| Dihexa | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee review expected before the end of February 2027 (reported) | FDA Category 2 pageChecked |
| PEG-MGF | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee review expected before the end of February 2027 (reported) | FDA Category 2 pageChecked |
| CJC-1295 | Withdrawn Nominated but withdrawn. Was in Category 2 | Not reviewed in July 2026 | FDA Category 2 pageChecked |
| AOD-9604 | Withdrawn Nominated but withdrawn. Was in Category 2 | Not reviewed in July 2026 | FDA Category 2 pageChecked |
| Selank | Withdrawn Nominated but withdrawn. Was in Category 2 | Not reviewed in July 2026 | FDA Category 2 pageChecked |
| Thymosin alpha-1 | Withdrawn Nominated but withdrawn. Was in Category 2 | Not reviewed in July 2026 | FDA Category 2 pageChecked |
| VIP | Category 1 Under evaluation for 503A | No review announced | FDA 503A category listChecked |
| Thymulin | Category 3 Nominated for 503A without enough supporting information | No review announced | FDA 503A category listChecked |
Vote counts marked reported come from McDermott Will & Schulte, July 27, 2026; FDA had not posted minutes on the meeting page when we checked. No proposed rule adding a peptide to the 503A bulks list had appeared in the Federal Register as of October 16, 2026, and 21 CFR 216.23(a) still lists six substances, none of them peptides. Every step on BPC-157, dated and sourced: is BPC-157 legal in 2026.
Link to this tracker by its row: each peptide has its own anchor, such as /peptides/guides/legal-status/#bpc-157. The CSV holds every row with its FDA source link and check date.
Staate. "FDA compounding status of peptides: Category 2 and withdrawn list tracker." Last checked October 16, 2026. https://staate.co/peptides/guides/legal-status/#tracker
<iframe src="https://staate.co/embed/fda-peptide-tracker/" title="FDA compounding status of peptides, tracked by Staate" width="100%" height="640" loading="lazy" style="border:1px solid #d9e4df;border-radius:12px;max-width:100%"></iframe> <p style="font:13px/1.5 sans-serif;margin:6px 0 0">Source: <a href="https://staate.co/peptides/guides/legal-status/#tracker">Staate, FDA peptide compounding status tracker</a></p>
Each category means something specific about who checked the product and what rules it was made under. Tap one to see what it means, who regulates it and the latest FDA action.
The FDA reviewed clinical trial data showing the drug works for a specific use and that its benefits outweigh its risks, then approved a label that states how it is used. This is the only category where the finished product itself has been reviewed.
Federal law, plus the FDA's interim policy, gives a 503A pharmacy four routes to use a bulk ingredient. If a peptide fails all four, there is no lawful pathway, whatever a clinic or website says.
A 503A pharmacy may use it for a patient, but may not regularly make copies of a drug that is on the market.
Semaglutide, tirzepatide, tesamorelinA 503A pharmacy may use it if the bulk ingredient comes from an FDA-registered supplier.
OxytocinA 503A pharmacy may use it.
No research peptide as of October 2026FDA does not generally act against compounding while it reviews the nomination.
GHK-Cu except by injection. Not BPC-157, TB-500, CJC-1295 or ipamorelinThis is where BPC-157, TB-500, CJC-1295, ipamorelin, melanotan II and most research peptides sit as of October 2026. Category 2 substances such as GHRP-2 and kisspeptin-10 end up here too.
"BPC-157 came off Category 2 in April 2026, so pharmacies can make it now."
It came off Category 2 because the people who nominated it withdrew the nomination. That leaves it in no category at all, which is weaker than Category 1. The July 2026 advisory vote recommended adding it to the bulks list, but only a final FDA rule does that. FDA staff had recommended against it, citing a lack of evidence that it works. Every step so far, dated and sourced: is BPC-157 legal in 2026.
FDA places GHRP-2, GHRP-6, ipamorelin, kisspeptin-10, ibutamoren and a group of other peptides, BPC-157 among them, in Category 2.
FDA confirms the tirzepatide shortage is over.
FDA declares the semaglutide shortage over.
Grace periods end for 503A and then 503B compounders making semaglutide copies.
FDA says it will restrict GLP-1 ingredients used in mass-marketed compounded drugs and act on misleading ads.
The FDA list, updated April 22, shows BPC-157, TB-500, CJC-1295 and 14 others as "nominated but withdrawn."
FDA puts GHK-Cu back in Category 1 for every route except injection, after one nominator said it meant to withdraw only the injectable form.
Advisory committee recommends BPC-157, KPV and TB-500 for the 503A bulks list, 8 to 6 on each with 1 abstaining, and MOTS-c 7 to 5 (reported).
The committee recommends epitalon (7 to 4) and semax (8 to 5), and votes 7 to 6 against DSIP (reported).
FDA warning letters to five "research use only" peptide sellers.
What changed on this page and when.
Added an embeddable copy of the tracker table for other sites, with the same rows and check dates. Checked the advisory committee meeting page: FDA has still not posted minutes for the July 23 and 24 votes.
Added the FDA staff conclusion for the seven peptides reviewed in July 2026, each linked to its FDA briefing document (all seven: the criteria weigh against listing). Added a last-checked date to every row, a CSV download and a suggested citation. Rechecked the FDA Category 2 page, the 503A category list, the Federal Register and 21 CFR 216.23: no change since October 15.
Added the Category 2 tracker table with an FDA source on every row, the July 24 votes on epitalon, semax and DSIP, the July 23 vote on MOTS-c, and GHK-Cu's return to Category 1 for non-injectable use. Checked the Federal Register and 21 CFR 216.23: no peptide has been added to the 503A bulks list.
Status checked against the FDA Category 2 page, the FDA shortage announcements and the WADA 2026 Prohibited List.
FDA approval, pharmacy compounding and WADA, side by side. Amber means there is no approved product, no lawful compounding route, or a ban in sport.
Status checked October 15, 2026 against the FDA Category 2 list (current as of April 22, 2026), the FDA 503A category list (updated May 14, 2026), the FDA shortage announcements and the WADA 2026 Prohibited List. Rules change; each source is linked below.
These substances are prohibited at all times, in and out of competition. The list says each class covers substances with similar structure or effect, so a peptide does not need to be named to be banned.
| Section | What it covers | Peptides named or covered |
|---|---|---|
| S0 Non-approved substances | Any drug not approved for human use by any health authority | BPC-157 (named), retatrutide, melanotan II and other unapproved peptides not listed elsewhere |
| S2.2.1 | Peptides that raise testosterone in males | hCG, LH, gonadorelin, kisspeptin and its analogs |
| S2.2.3 | Growth hormone, analogs and fragments | AOD-9604, hGH 176-191 |
| S2.2.4 | Growth hormone releasing factors | CJC-1295, sermorelin, tesamorelin, ipamorelin, ibutamoren (MK-677), GHRP-2, GHRP-6, hexarelin |
| S2.3 | Growth factors and modulators | Thymosin beta-4 and TB-500, IGF-1 and analogs, mechano growth factors |
| Not listed | Not named on the 2026 list | Semaglutide, tirzepatide, oxytocin |
Every peptide on staate, row by row, with its WADA section, the list wording and the year it was first named: the WADA banned peptides list.
Ask where the vial comes from. A 503A pharmacy has no lawful ingredient pathway for BPC-157 today, so the product is either compounded outside the rules or bought as a research chemical.
Since the shortages ended, a pharmacy may make it only when your prescriber documents a change you need from the approved product. A cheaper price on its own is not that reason.
WADA bans most healing and growth hormone peptides at all times, and a research-only label does not change that. Check the current list and your federation before using any peptide.
This guide covers US law. Australia, the UK and the EU regulate these products differently, and some peptides approved abroad are not approved in the US.
This guide explains how the rules work. It is not legal advice for any individual, clinic or business.
We email when a final rule, warning letter wave or WADA update changes what this page says. Daily peptide brief, free, every source linked.