PCAC recommended 6 of 7 peptides. None is legal to compound today.
0 legal to compound today
6 of 7 recommended by the panel (Reuters, July 23–24, 2026) · none is on FDA’s 503A bulks list (FDA, checked October 24, 2026)
- BPC-157Gray marketPanel said yes July 23–24, 2026 · FDA staff said no · not legal yet8 yes, 6 no, 1 abstain (Reuters, July 23, 2026)
- KPVGray marketPanel said yes July 23–24, 2026 · FDA staff said no · not legal yet8 yes, 6 no, 1 abstain (Reuters, July 23, 2026)
- TB-500Gray marketPanel said yes July 23–24, 2026 · FDA staff said no · not legal yet8 yes, 6 no, 1 abstain (Reuters, July 23, 2026)
- MOTS-cGray marketPanel said yes July 23–24, 2026 · FDA staff said no · not legal yet7 yes, 5 no, 2 abstain (Reuters, July 23, 2026)
- Emideltide (DSIP)Gray marketPanel said no July 24, 2026 · FDA staff said no · not legal to compound6 yes, 7 no, 1 abstain (Reuters, July 24, 2026)
- EpitalonGray marketPanel said yes July 23–24, 2026 · FDA staff said no · not legal yet7 yes, 4 no (STAT, July 24, 2026)
- SemaxGray marketPanel said yes July 23–24, 2026 · FDA staff said no · not legal yet8 yes, 5 no, 1 abstain (Reuters, July 24, 2026)
Independent tracking of the FDA Pharmacy Compounding Advisory Committee's review of 12 peptides for the Section 503A Bulk Drug Substances List (7 voted July 23–24, 2026). Updated as the FDA rulemaking moves.
A status change on this page appears on the changes page and in the feed the moment it deploys.
The interim access policy: what’s known, what isn’t →
Key Dates History
Timeline as it happened
- Before the end of February 2027 — Second PCAC meeting
- FDA plans a second meeting of its Pharmacy Compounding Advisory Committee to review five more peptides: GHK-Cu (non-injectable routes only), Melanotan II, cathelicidin (LL-37), dihexa acetate and PEG-MGF. Exact date pending FDA’s announcement.
- — Peptide access policy under OMB review
- A notice from HHS and FDA titled “Interim Access Policy for Compounding Using Certain Peptides” (RIN 0910-ZD94) is pending review at the Office of Management and Budget, whose record lists it as received October 14, 2026, with no legal deadline; the record carries no text and names no substance, and the notice has not been issued.
- — FDA statement on retatrutide and cagrilintide
- FDA’s statement on unapproved GLP-1 drugs used for weight loss says retatrutide and cagrilintide cannot be used in compounding under federal law, and that they are not components of FDA-approved drugs.
- — RYZ101 designated an orphan drug
- FDA designated RYZ101 (actinium-225 DOTATATE) an orphan drug for the treatment of gastroenteropancreatic neuroendocrine tumors, with RayzeBio as sponsor; a designation is not an approval.
- — Five FDA warning letters to online research-peptide sellers
- FDA sent warning letters to five online sellers of research peptides, each calling the products it names “unapproved new drugs under section 505(a)” of the FD&C Act and saying that “introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a)”, despite labels marketing them for research use; across the five, the products named are semaglutide, tirzepatide, retatrutide, SS-31 (elamipretide), tesamorelin, PT-141 (bremelanotide), survodutide and mazdutide, ipamorelin in two blends with tesamorelin and, in four of the letters, bacteriostatic water marketed for reconstituting them.
- — Mounjaro heart indication
- The Mounjaro (tirzepatide) label added an indication to reduce the risk of major cardiovascular events in adults with type 2 diabetes at high risk of them.
- — 503B comments close
- Comments closed on FDA’s proposal to keep semaglutide, tirzepatide and liraglutide off the 503B bulks list (the period was extended to this date by 91 FR 38719, June 26, 2026); FDA had published no final decision by October 3, 2026.
- — PCAC votes, day two
- The committee voted to recommend Epitalon and Semax for the 503A bulks list, Epitalon by 7 to 4, as STAT reported, and Semax by 8 to 5 with 1 abstention, as Reuters reported; FDA staff had recommended against both.
- — PCAC votes against DSIP
- The committee voted against adding emideltide (DSIP) to the 503A bulks list, by 7 to 6 with 1 abstention, as Reuters reported; FDA staff had recommended against it too.
- — Macrilen pediatric labeling
- FDA approved Macrilen’s pediatric labeling (supplement S-005, Best Pharmaceuticals for Children Act), which records the failed children’s study and adds no pediatric use.
- — PCAC votes, day one
- FDA’s Pharmacy Compounding Advisory Committee voted to recommend BPC-157, KPV, TB-500 and MOTS-c for the 503A bulks list, by 8 to 6 with 1 abstention for the first three and 7 to 5 with 2 abstentions for MOTS-c, as Reuters reported; FDA staff had recommended against all four.
- — Docket closed
- Docket FDA-2025-N-6895 stopped accepting new public comments at 11:59 PM ET.
- — Public comment cutoff
- Public comment cutoff for the committee’s review: comments submitted on or before this date were provided to the committee at its July meeting.
- — Warning letter names Prostamax
- An FDA warning letter (reference 729447) to a US seller of research peptides called its “Prostamax” and “Gonadorelin” unapproved new drugs, despite their “research use only” labels.
- — GHK-Cu back in Category 1
- FDA’s 503A categories list, updated May 14, 2026, put GHK-Cu back in Category 1 for non-injectable routes only, after one nominator said it had meant to withdraw only the injectable route.
- — Proposal on the 503B bulks list
- FDA proposed not to include semaglutide, tirzepatide and liraglutide on the 503B bulks list, from which outsourcing facilities may compound even when a drug is not in shortage.
- — Category 2 removal takes effect
- FDA’s updated 503A list recorded the 12 peptides as removed from Category 2, for the same reason: withdrawn nominations. The removal left them in no category; it did not make any of them legal to compound.
- — Meeting notice published
- A Federal Register notice announced the two-day meeting of FDA’s Pharmacy Compounding Advisory Committee on July 23–24, 2026, and established a public docket.
- — Category 2 removal notice
- FDA posted notice that 12 peptides would leave Category 2 of its 503A list after seven days, because their nominations had been withdrawn.
- — Bydureon withdrawals listed again
- FDA listed the Bydureon approvals (NDAs 022200 and 209210) as withdrawn again, in a second Federal Register notice.
- — Orforglipron approved as Foundayo
- FDA approved orforglipron as Foundayo tablets (NDA 220934, Eli Lilly), to reduce excess body weight.
- — Imcivree approval expanded
- FDA expanded Imcivree (setmelanotide) to acquired hypothalamic obesity in patients aged 4 and older.
- — Warning letter on thymosin beta-4
- An FDA warning letter to a US outsourcing facility called thymosin beta-4 products unapproved new drugs and unlicensed biological products, which are not eligible for the compounding exemptions of sections 503A and 503B.
- — Mounjaro approved for children
- FDA approved Mounjaro (tirzepatide) for type 2 diabetes in children 10 years and older.
- — Warning letter names larazotide
- An FDA warning letter to a US distributor of drug ingredients named larazotide acetate among ingredients it supplied to pharmacies that are ineligible for compounding under section 503A.
- — NMN may be sold as a supplement
- FDA concluded that NMN is not excluded from the definition of a dietary supplement, reversing its 2022 position.
- — Elamipretide approved as Forzinity
- FDA granted elamipretide (SS-31) accelerated approval as Forzinity, the first treatment for Barth syndrome, in patients who weigh at least 30 kg.
- — Byetta and Bydureon approvals withdrawn
- FDA withdrew the approvals of Byetta, Bydureon and Bydureon BCise (NDAs 021773, 022200 and 209210) at AstraZeneca’s request, because the products were no longer marketed.
- — Egrifta WR approved
- FDA approved Egrifta WR, the F8 formulation of tesamorelin (BLA 022505/S-020).
- — FDA’s 503B list updated
- FDA updated its 503B categories list, for outsourcing facilities; the version the site reads puts ipamorelin, GHRP-6 and ibutamoren (MK-677) in Category 2 (significant safety risks), GHRP-2 there for injectable and nasal routes, and acetyl hexapeptide-3 (Argireline) and thymosin alpha-1 in Category 3.
- — Tirzepatide grace periods end
- FDA’s grace periods for compounding tirzepatide, which followed its finding that the shortage was over, ended.
- — Semaglutide shortage over
- FDA declared the shortage of semaglutide injection products (Ozempic and Wegovy) resolved.
Checked 24 Oct 2026
On July 23-24, 2026 the FDA Pharmacy Compounding Advisory Committee (PCAC) voted on the first seven of the 12 peptides that FDA had removed from Category 2 in April after their nominations were withdrawn. The committee recommended six for inclusion on the Section 503A Bulks List — BPC-157, KPV, TB-500, MOTS-c, Semax, and Epitalon — and voted against one, Emideltide (DSIP). FDA staff scientists had recommended against all seven before the vote. A recommendation is advisory, not a rule: nothing at the pharmacy counter has changed for any of these compounds. FDA says it will host a second PCAC meeting on the remaining five peptides before the end of February 2027 (FDA).
Vote Results
FDA’s questions document lists 14 votes, one on each compound’s free base and one on its acetate, and holds no tally (FDA, questions); FDA’s meeting page posts no vote record (FDA, meeting page). The counts on this page are the ones the news reports gave, one count per compound, each with its source: Reuters for six (July 23; July 24, Semax; July 24, emideltide) and STAT for Epitalon, 7–4 (July 24), which Reuters gave no count for. None of them says whether its count was the vote on the free base, the acetate or both.
Three legal events, not one
"Recommended" is not the same as "legal to compound." Three separate legal events sit between the July 2026 vote and legal 503A compounding — only one of them has happened.
Already done (April 2026): Category 2 removal. FDA posted notice on April 15, 2026 that the 12 peptides would be removed from Category 2 after seven calendar days, and the removal took effect April 22. FDA's stated reason: the nominations were withdrawn by the nominators. The same notice pointed to FDA's announced plan to take each peptide to the PCAC. The removal happened months before the vote and is not itself a change in what pharmacies can compound.
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PCAC vote — July 23-24, 2026
The advisory committee reviewed FDA's scientific briefing, heard from the public, and voted. The vote is advisory. It is not a rule, not a law, and not binding on FDA. Committee members can — and here did — vote against their own agency's staff position on six of the seven compounds.
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FDA agency decision — no announced date
FDA now weighs the committee record, its own scientific review, and public comments received during the docket period, then decides whether to move forward with a rulemaking. Still not a rule. Still not law. FDA has not published a timeline for this decision.
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Notice-and-comment rulemaking — no announced date
If FDA proceeds, it publishes a proposed rule, opens a formal public comment period, considers comments, and publishes a final rule with an effective date. Only when that final rule takes effect does a compound become legally compoundable from bulk drug substance under 503A. This step has not begun for any of the seven July 2026 compounds.
Until the final step completes, nothing at any 503A compounding pharmacy has changed for any of these peptides. FDA is not bound by the committee's recommendation.
What Happens Next
FDA rulemaking on the seven July compounds: no deadline announced. FDA will review the committee record and public comments. If FDA moves forward, expect a proposed rule notice in the Federal Register, followed by a comment period (typically 60–90 days), followed at some later date by a final rule.
Second PCAC meeting — before end of February 2027 (exact date TBD): five additional peptides are on the agenda (FDA).
- GHK-Cu (noninjectable routes only) Gray market · No FDA ruling on the injectable — not on any list
- Melanotan II Gray market · No FDA ruling — not on any list
- Cathelicidin (LL-37) Gray market · No FDA ruling — not on any list
- Dihexa acetate Gray market · No FDA ruling — not on any list
- PEG-MGF (Pegylated Mechano Growth Factor) Gray market · No FDA ruling — not on any list
Sources
- FDA advisory committee meeting page (July 23-24, 2026)
- FDA — PCAC July 23-24, 2026 Voting Questions (PDF; official 14-question voting document)
- FDA — 503A categories list, updated April 15, 2026 (archived copy; gives seven days' notice that the 12 peptides leave Category 2, and why)
- FDA — 503A categories list, updated April 22, 2026 (archived copy; records the removals)
- Federal Register notice 2026-07361 (91 FR 20465, published April 16, 2026)
- Regulations.gov docket FDA-2025-N-6895 (closed July 22, 2026)
- FDA — the next PCAC meeting (content current as of April 15, 2026: “FDA will host an advisory committee meeting before the end of February 2027”; its agenda, the five peptides above)
- 21 CFR 216.23, the 503A bulks list (six substances; none of the seven; read October 24, 2026)
- Reuters, July 23, 2026: “FDA advisers back first four of seven unapproved peptides under review for looser rules” (news report; the counts for BPC-157, KPV, TB-500 and MOTS-c)
- Reuters, July 24, 2026: “FDA panel votes to exclude peptide emideltide from pharmacy compounding list” (news report; emideltide’s count)
- Reuters, July 24, 2026: “FDA advisory panel recommends peptide Semax be added to pharmacy compounding list” (news report; Semax’s count)
- Reuters, July 24, 2026: “FDA advisers recommend relaxing US rules on compounding peptides” (news report; six of seven recommended; the recommendations non-binding)
- STAT, July 24, 2026: “FDA advisory panel narrowly rejects compounding of one peptide, backs two others” (news report; Epitalon’s count)