Article
The 12 peptides removed from Category 2 in April 2026
None of the 12 peptides the FDA removed from Category 2 on April 15, 2026 has been placed in Category 1 or on the 503A bulks list. All 12 sit in no category, so a 503A pharmacy has no FDA policy to rely on for any of them. The FDA's advisory committee recommended six in July, an advisory vote only, and five more go to the committee before the end of February 2027.
No peptide was reclassified to Category 1 in April 2026. What the FDA did on April 15 was remove 12 peptides from Category 2 because the parties who had nominated them for compounding withdrew those nominations, and place them in no category at all. If you remember the story as "14 peptides back to Category 1," you're remembering a February podcast statement, not the April notice that followed it.
This page gives you the list you came for, says where each of the 12 actually went, shows what the FDA wrote about each one when it restricted them, and answers the question underneath the question: whether a 503A pharmacy can make any of them for your patient today.
Regulatory information from a licensed prescriber, not legal advice for your practice.
Which 12 peptides left Category 2, and where are they now?
The FDA's interim 503A category list, republished May 14, 2026, is the document that settles this. The 12 substances removed from Category 2 in April appear in none of its three categories and are not on the separate 503A bulks list. Seven of them went to the Pharmacy Compounding Advisory Committee on July 23 and 24 (the FDA's meeting page carries the archived webcast); the other five are scheduled for a session that the FDA's April 16, 2026 Federal Register notice says will be held before the end of February 2027.
| Substance | July 2026 committee outcome (as reported; FDA minutes pending), or scheduled session | Status on the FDA list (May 14, 2026) | What a 503A pharmacy can do today |
|---|---|---|---|
| BPC-157 | Recommended, 8 to 6, one abstention | No category; not on bulks list | No FDA policy to rely on |
| KPV | Recommended, 8 to 6, one abstention | No category; not on bulks list | No FDA policy to rely on |
| TB-500 (thymosin beta-4 fragment) | Recommended, 8 to 6, one abstention | No category; not on bulks list | No FDA policy to rely on |
| MOTS-c | Recommended, 7 to 5, two abstentions | No category; not on bulks list | No FDA policy to rely on |
| Semax | Recommended, 8 to 5, one abstention (McDermott only) | No category; not on bulks list | No FDA policy to rely on |
| Epitalon | Recommended, 7 to 4, one abstention (McDermott only; also reported as 7 to 5) | No category; not on bulks list | No FDA policy to rely on |
| DSIP (emideltide) | Not recommended, 6 to 7, one abstention | No category; not on bulks list | No FDA policy to rely on |
| Cathelicidin LL-37 | Scheduled before February 2027 | No category; not on bulks list | No FDA policy to rely on |
| Dihexa acetate | Scheduled before February 2027 | No category; not on bulks list | No FDA policy to rely on |
| GHK-Cu (injectable) | Scheduled before February 2027 | No category; not on bulks list | No FDA policy to rely on |
| Melanotan II | Scheduled before February 2027 | No category; not on bulks list | No FDA policy to rely on |
| PEG-MGF | Scheduled before February 2027 | No category; not on bulks list | No FDA policy to rely on |
The vote counts are as reported; the FDA's final minutes are pending. The BPC-157, KPV, TB-500, MOTS-c and DSIP counts are from AJMC and McDermott Will & Emery's account of the July meeting. AJMC gives no numbers for Semax or Epitalon, so those two counts rest on McDermott alone. Goodwin's May note summarizes the February 2027 schedule.
One clarification on GHK-Cu, because it's the row people misread. The injectable form was among the 12 removed from Category 2 on April 15. The non-injectable form was in Category 1 before April, was briefly pulled on April 22 when the nominator's withdrawal was read as covering both routes, and was restored to Category 1 on May 5 after the nominator clarified it meant only the injectable route. Non-injectable GHK-Cu, including topical, is in Category 1 today. Injectable GHK-Cu is in no category and waits for the 2027 session.
The last column is the same for all 12 on purpose. Six of them have a favorable committee vote, and six don't, and on the FDA's list that distinction doesn't exist yet. How the three categories work, and what happened to the other seven peptides placed in Category 2 in 2023, is covered on Scriptura's federal peptide rules page.
Why did the FDA remove 12 peptides, not 14?
On the February 27, 2026 episode of the Joe Rogan Experience (#2461), HHS Secretary Robert F. Kennedy Jr. said he expected an announcement "within a couple of weeks," said he hoped the substances would "end up with a place where people have access from ethical suppliers," and described the FDA's 2023 placement of 19 peptides in Category 2 as illegal, as reported by Frier Levitt's summary of the appearance. We found no HHS transcript of the episode. NPR reported it as changing the status of "about 14" peptides.
The FDA placed 19 peptides in Category 2 on September 29, 2023. Five of them (AOD-9604, CJC-1295, ipamorelin acetate, thymosin alpha-1, and Selank acetate) had already been removed in September 2024 on withdrawn nominations. Two of the remaining 14 (ibutamoren mesylate and kisspeptin-10) never moved, because their nominators never withdrew; they're still in Category 2 today. The other 12 are the ones on this page.
So "about 14" was a reasonable description of what was left in Category 2 in February. What the FDA did with them in April was narrower than the coverage suggested: it took 12 out of one category and put them in none. Orrick's read of the April notice said it at the time: removal from Category 2 does not, by itself, place a substance on the 503A bulks list or into Category 1, and until the FDA affirmatively does one of those things, compounding it carries regulatory risk. Five months on, that's still where the 12 are.
The word "reclassified" did a lot of work in the spring coverage. It implies a substance went from one box to another. On the FDA's list, the 12 went from one box to no box, which is a different thing with different consequences for the pharmacy holding the prescription.
What happened the last time peptides left Category 2?
If you want to know what the April removal means, the September 2024 removal is the closest precedent, and the FDA's own meeting records show how it played out.
Five peptides left Category 2 effective September 27, 2024, by the same mechanism: their nominators withdrew. The FDA then took most of them to the committee anyway. The final summary minutes for October 29, 2024 record that ipamorelin was voted down 0 to 12 with one abstention, and note a committee member's comment that how often a drug is prescribed says nothing about whether it is safe or effective.
The December 4, 2024 minutes record CJC-1295 voted down 0 to 13 in its free base form, AOD-9604 voted down 0 to 12, and thymosin alpha-1 voted down 4 to 17 in both forms, with the majority citing a lack of convincing effectiveness data for the uses under review. Selank was never scheduled.
Two years later, none of the five is in any category, and none is on the bulks list. Removal from Category 2 gave them a hearing, and the committee voted against every one it reviewed.
The 2026 twelve differ in one respect: six of them won their committee vote, which none of the 2024 five did. They're identical in the respect that matters this week. A favorable vote and an unfavorable vote leave a substance in the same place on the FDA's list until the agency acts.
What did the FDA write about each of the 12 peptides?
The FDA's own website still carries its stated concerns about all 12, published as of April 22, 2026.
The agency keeps a page titled Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026. It has two tables. The first lists what is in Category 2 now. The second is headed "bulk drug substances nominated but withdrawn," and it carries the FDA's stated concerns for every substance that has left Category 2 by withdrawal. All 12 are in that second table, with their entries intact. The nomination came off. The finding didn't.
Here is what the FDA says about each, paraphrased from that page. Read it before you decide what a favorable committee vote is worth.
BPC-157. Possible immunogenicity for certain routes of administration, complexities with peptide-related impurities and API characterization, and no or only limited safety information for the proposed routes; the agency says it lacks enough information to know whether the drug would cause harm.
KPV. The FDA has not identified any human exposure data for KPV by any route, and says it lacks important information on any safety issue, including whether the drug would cause harm.
TB-500 (thymosin beta-4 fragment). Immunogenicity risk from aggregation and impurities; the FDA has not identified any human exposure data for drug products containing the fragment.
MOTS-c. Immunogenicity risk and API characterization complexities; no human exposure data identified by any route.
Semax. Immunogenicity risk from aggregation and impurities; no or limited safety information for the proposed routes.
Epitalon. Immunogenicity risk from aggregation and impurities; no safety information identified for the proposed route.
DSIP (emideltide). Immunogenicity risk and characterization complexities; no safety information identified for the proposed route.
Cathelicidin LL-37. Immunogenicity risk and characterization complexities; insufficient safety information; and the FDA adds that nonclinical findings suggest detrimental effects on male reproduction and that the substance can be protumorigenic in some tissues.
Dihexa acetate. No human exposure data identified by any route; the FDA says it lacks important information on whether the drug would cause harm.
GHK-Cu (injectable). Immunogenicity risk from aggregation and impurities; limited human data to inform safety.
Melanotan II. Immunogenicity risk from aggregation and impurities, and the FDA cites published case reports of serious adverse events including melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome, and priapism.
PEG-MGF. Significant immunogenicity risk and characterization complexities; no human exposure data by any route.
For nine of the 12, the FDA's stated problem is an absence: no human data, or not enough to say. For three (LL-37, Melanotan II, and to a lesser degree GHK-Cu), the agency points to specific findings. Either way, the entries date from the September 2023 placements and were still published as of April 22, 2026. The FDA's scientific staff also recommended against adding any of the seven peptides under review in July, according to the agency's briefing document. The committee disagreed six times. The staff position is on the record, and so are these entries.
The same page, as of April 22, 2026, still lists ipamorelin acetate in Category 2 under the 503B interim policy (it was only the 503A nomination that was withdrawn in 2024), and lists ibutamoren mesylate in both 503A and 503B Category 2 with a reference to a hip-fracture trial that was terminated early on a potential congestive heart failure signal. Neither is among the 12, but both come up in the same conversations.
What can a 503A pharmacy do with these 12 peptides today?
The same as in March: nothing with an FDA policy behind it.
The rule a 503A pharmacy works under is short. It may compound from a bulk ingredient that is a component of an FDA-approved drug, has a USP or NF monograph, or is on the 503A bulks list. While that list is being built out, a Category 1 listing stands in under the FDA's interim policy, which says the agency does not intend to take action against a compounder using a Category 1 substance if the guidance conditions are met.
None of the 12 meets any of those conditions. A pharmacy compounding any of them is doing so with no FDA policy behind it, and that is true for BPC-157 with its 8-to-6 vote, exactly as it is for Melanotan II with no vote at all.
The July votes were advisory. As of mid-September, Frier Levitt's update confirms the FDA has made no final determination on the six recommended substances, and the agency has published no proposed rule and no change to its enforcement posture. McDermott Will & Emery expects informal enforcement discretion for the recommended six while rulemaking runs. That's counsel's expectation, not a published FDA position, and a pharmacy that acts on it is taking the risk itself.
What this means at the counter, in practice, is worth spelling out, because the calls have already started.
If a pharmacy tells you it can now compound BPC-157 because "it came off the list," ask which list. If the answer is Category 2, the pharmacy is right about the removal and wrong about what it permits. Ask whether the substance is on the 503A bulks list or in Category 1. It isn't, and the pharmacy should be able to say so.
If a patient asks why you can't prescribe something the FDA "un-banned," the honest answer is that the FDA took its safety label off but hasn't put anything in its place, and that the committee vote in July was a recommendation the agency hasn't acted on. The FDA's own page still carries the concern it wrote in 2023.
If you're supervising NPs or PAs, the same answer applies to their prescribing, and in Alabama the board's May 2026 notice makes the supervising physician responsible for it. What "no category" means for you, as opposed to the pharmacy (your state board, your carrier, your civil exposure) is a separate question with a separate answer; Scriptura's state-by-state prescribing rules cover the state side. The short version: the Alabama notice prohibits research-grade peptides without reference to any FDA category, and a favorable federal vote doesn't bind a state board.
What caveat came with the committee vote?
If you're going to cite the July vote to a board or a carrier, know what else is on the record. The Washington Post reported the week before the meeting that FDA officials had raised conflict-of-interest concerns while the panel was being assembled, and that at least seven committee members have ties to peptide businesses or clinics. The FDA's draft meeting roster lists each member's affiliation. An HHS spokesperson told NPR that all committee members had gone through the standard ethics review and vetting process.
That context doesn't change the votes. It does change how much weight a regulator will give them, and a prescriber who leans on the vote in a hearing should expect the other side to have read the same articles.
What would make these peptides compoundable?
For any of the 12 to become compoundable under 503A, the FDA has to do one of two things: propose and finalize a rule adding the substance to the 503A bulks list, or place it in Category 1 under the interim policy. Neither has happened for any of the 12.
The rulemaking route has a track record. In its February 2019 final rule, the first for the 503A bulks list (21 CFR 216.23), the FDA placed six substances on the list and declined four, after committee review and public comment. Nothing requires the FDA to follow the committee; the 2019 rule declined substances, and the agency's own staff opposed all seven of this year's.
Buchanan Ingersoll & Rooney's post-vote analysis notes that no statutory deadline requires the FDA to publish a proposed or final rule after a committee recommendation. Sheppard Mullin estimated in June that rulemaking could take twelve to twenty-four months or longer, and NPR reported after the July vote that it could stretch into next year or 2028.
The Category 1 route is quieter and would take effect sooner, but the FDA's January 2025 guidance said the agency does not intend to place newly nominated substances into the interim categories, and it has not signaled an exception. If it made one, the FDA's category list PDF would show it in the "updates" section at the top.
The next scheduled events are an FDA decision on the six recommended in July, which has no date, and the committee session on the other five, expected before the end of February 2027. How a committee recommendation becomes a rule, and how long that has taken before, is tracked on Scriptura's federal timeline for peptide compounding.
How do you check the FDA's category list yourself?
We update this page after the FDA acts. Three documents let you check without waiting for anyone.
The category list PDF is the one that matters for the 12. The date at the top tells you when it last changed. The "updates" section on page one logs every addition and removal with the reason. Below that are the three category lists in order. If a peptide from this page appears under Category 1, the FDA has given it a conditional safe harbor. If it appears under Category 2, it hasn't. If it appears nowhere, which is where all 12 are today, a pharmacy has nothing to rely on.
The safety-risks page tells you whether the FDA's stated concern has been revised or withdrawn. As of its April 22, 2026 update, the entries for all 12 were still published.
The 503A bulks list itself, linked from the FDA's 503A page, is the final list of substances approved by rule. None of the 19 peptides from 2023 are on it.
The categories, the bulks list, the committee calendar, and state board notices each move on their own schedule, and the next move on any of them changes what this page says.
Frequently asked questions
Which 12 peptides did the FDA remove from Category 2 in April 2026?
BPC-157, LL-37, Dihexa, DSIP, Epitalon, GHK-Cu (injectable), KPV, PEG-MGF, Melanotan II, MOTS-c, Semax, and TB-500. All 12 left Category 2 because their nominators withdrew, not because of any FDA finding.
Were the 12 peptides reclassified to Category 1 in April 2026?
No. The FDA removed them from Category 2 and placed them in no category. None appears in Category 1 on the FDA's list updated May 14, 2026.
Why did the FDA remove 12 peptides when Secretary Kennedy said 14?
Two of the 19 never moved because their nominators did not withdraw, and five had already left in 2024. The 12 are the ones whose nominations were withdrawn in 2026.
Can a 503A compounding pharmacy make BPC-157 or TB-500 today?
Not with any FDA policy behind it. Neither is on the 503A bulks list or in Category 1. The July 2026 committee votes were advisory, and the FDA has not proposed a rule.
Which of the 12 peptides got a favorable PCAC vote in July 2026?
BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax. DSIP was voted down. LL-37, Dihexa, GHK-Cu, Melanotan II, and PEG-MGF are scheduled for a session before February 2027.
Did removal from Category 2 mean the FDA withdrew its safety concern?
No. The FDA states that a substance it has identified as a potential safety risk may be absent from Category 2 because its nomination was withdrawn. Its BPC-157 concerns remain published.
When could any of the 12 peptides become legal to compound under 503A?
Only after the FDA proposes and finalizes a rule adding a substance to the 503A bulks list, or places it in Category 1. As of May 14, 2026, neither has happened for any of the 12.
How do you get the next Category 2 update?
This page will be out of date the day the FDA acts on the July recommendations, and again when the February 2027 session votes.
If your chart doesn't currently record where each peptide came from and which pathway the pharmacy relied on, book a short demo to see how Scriptura structures that record around the whole patient. Clinicians verify their license before platform access.
