Peptide FDA status tracker: where BPC-157 and every other molecule stands

Almost every argument about peptide legality comes from collapsing four different situations into the word "legal". They are not the same, and only one of them means a pharmacy may legally compound the substance from bulk today.

Approved. FDA has reviewed and approved a drug containing the molecule. Semaglutide, tirzepatide, tesamorelin, bremelanotide. There is a label, a manufacturer and a legal supply chain.

Category 1, under evaluation. Not an approved drug and not yet on the final 503A bulks list, but nominated with enough support that FDA is evaluating it. Under its interim policy FDA generally does not object to pharmacies compounding with a Category 1 substance while that evaluation runs. This is the only non-approved route a pharmacy can rely on. Glutathione, NAD and GHK-Cu for topical use are here; none of the injectable peptides sold to consumers is.

Category 2. FDA has identified significant safety risks. Compounding from bulk is not a defensible position.

Nominated but withdrawn. The nomination that would have put the substance on the list was pulled by whoever filed it. The substance leaves the Category 2 table without being permitted. It is not on the 503A bulks list and not in Category 1, so a pharmacy still has no lawful basis to compound it from bulk: withdrawing the nomination removed the safety flag, not the restriction. This is where most of the consumer peptide market sits, and it is the one most often read as clearance.

A fifth situation exists and is worth naming: never nominated at all. A substance nobody ever asked FDA to consider has no status, which is not the same as clearance.

Since 28 October 2026 one more applies to six withdrawn peptides: HHS enforcement discretion. HHS has said it will not take action against licensed pharmacies and physicians that compound BPC-157, TB-500, KPV, MOTS-c, epitalon or semax for a named patient, if ten conditions are met, while FDA decides by rulemaking whether to list them ^[11]. The substances are still not on the 503A list; the policy is a decision not to enforce, and HHS can change it. Our report on the policy sets out the conditions and the route allowed for each. From 2 November 2026 LegitScript, the private certifier whose seal many telehealth sites display, no longer refuses certification to sellers of the six that meet those conditions; that changes no legal status (what it means for its seal).

`Approved` means an FDA-approved drug product exists. `Category 1` means FDA is evaluating the substance and generally does not object to compounding with it meanwhile. `Category 2` means FDA has flagged safety risks. `Withdrawn` means the nomination was pulled: off the safety list, with still no route for a pharmacy to compound it. Dates are the date of the last status change FDA has published, not the date we checked.

Ipamorelin is listed twice by FDA, in two tables that are usually read as alternatives. It sits in Category 2 under the 503B interim policy — outsourcing facilities, safety risks identified — while its 503A nomination was withdrawn, which is why it also appears in the withdrawn table ^[1]. FDA's own withdrawn-table entry says so explicitly, noting that it "also appears in the table above because it is in category 2 under the 503B interim policy".

The practical consequence: a clinic telling you ipamorelin is "no longer on the FDA's problem list" is describing one of the two entries and ignoring the other.

FDA's Pharmacy Compounding Advisory Committee reviewed seven peptides on 23-24 July 2026 and recommended six of them — BPC-157, KPV, TB-500, MOTS-c, epitalon and semax — for the 503A bulks list, rejecting only emideltide. In every case it voted against FDA's own reviewers, who had proposed rejecting all seven. Our report on the meeting carries the full vote record with timestamps into FDA's webcast.

What that changed in law: nothing, so far. Committee recommendations are advisory. Adding a substance to the 503A list happens through rulemaking — a proposed rule, a comment period, a final rule — and for these six that process has not started and has no published timeline. As of 16 September 2026 all six remain in the withdrawn table, exactly where they were before the vote ^[1].

A seller citing the July vote as permission is citing a recommendation as though it were a rule.

What came next was not a rule either. On 28 October 2026 HHS filed a policy saying it will not act against 503A compounding of the six under ten conditions: a single peptide per product, the routes it names for each, a certificate of analysis from an FDA-registered manufacturer, and adverse-event reporting to MedWatch among them ^{[11] [12]}. The Federal Register notice calls it a draft and takes comments until 13 November 2026 ^[12].

Semaglutide, tirzepatide and liraglutide were never in this system. They are approved drugs, and the mass compounding of semaglutide and tirzepatide from 2022 to 2024 was legal only because of the shortage carve-out, which let 503B outsourcing facilities compound from a substance while it sat on FDA's shortage list. Both came off that list in early 2025, and the carve-out closed with them. Liraglutide was never the same phenomenon; it appears here because the 2026 proposal names it alongside the other two.

On 30 April 2026 FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list permanently — the agency stating it has found no clinical need for bulk compounding of these molecules. The comment period, first set to end in June and then extended to 30 July 2026, has closed. No final rule has been published as of 15 October 2026. Until one is, the proposal is a statement of intent, not law; what already binds is the loss of the shortage pathway.

For what remains legally possible, and what "patient-specific" actually covers, see compounded vs branded.

Two of those three have no timeline at all, which is itself the honest answer to "when will this be settled".

A note on what "no date published" means here. A substance reaches the 503A bulks list only through notice-and-comment rulemaking — a proposed regulation, a comment period, then a final one. FDA says so itself: it addresses nominated substances "on a rolling basis through notice-and-comment rulemaking." An advisory committee is consulted; it does not place anything on the list, and FDA has published no timetable for responding to the July 2026 recommendations. Until a final regulation issues, FDA treats the recommended substances as unapproved new drugs — which is what it did on 24 August 2026, when it wrote to five peptide sellers whose websites it had reviewed during the month of the vote. See the letters. Letters to compounding pharmacies are a separate enforcement track with its own register.

Every status change on this page is recorded here, with the date we made it and the date FDA's own document carries. A row that changes without an entry here is a mistake.