What the 2024 FDA peptide votes decided — and what happened next

Reference page · published 2026-09-01

On October 29 and December 4, 2024, an advisory committee to the U.S. Food and Drug Administration voted thirteen times on whether seven substances should be added to the short list of bulk ingredients that compounding pharmacies are allowed to use. Five of the seven are peptides: ipamorelin, CJC-1295, AOD-9604, thymosin alpha-1 and kisspeptin-10. The committee voted no on every single one — most of them unanimously. CJC-1295 alone was put to five separate votes, one for each chemical form, and four of the five were 13 to 0.

Twenty-one months later, nothing has been added to that list. No rule has been proposed. The list still contains six substances, and none of them is a peptide. This page sets out what the record actually says, quoting the primary documents and linking every one of them.

Disclosure: this index is operated by Artemis Labs, which sells several of the compounds named on this page as research reagents. That is a reason to check the primary sources here instead of taking our summary for it — every one is linked, and every quotation below is verbatim from the document named beside it.

Why this is worth reading now

In July 2026 the same committee met again and voted the other way on a different set of peptides. That vote has been widely described as FDA approving those compounds. The 2024 record is the best available check on that reading, because in 2024 the committee agreed with FDA on all seven substances — and not one of them was added to the list either.

That is the point most easily missed. A committee vote in either direction does not place a substance on the list. Only a regulation does. The 2024 votes are the proof, because they are old enough to see what followed them: nothing.

The two meetings

FDA's Pharmacy Compounding Advisory Committee is an outside panel that advises the agency. The Federal Register notice announcing the first meeting describes its job in one sentence:

“The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues.”

Advice and recommendations — not decisions. Both meetings were held at FDA's White Oak campus in Silver Spring, Maryland, and both were announced in advance in the Federal Register:

The seven substances, and the uses FDA reviewed

Each substance was reviewed for a named use, chosen by FDA — not for whatever it is marketed for. The minutes set the uses out in a table headed Uses evaluated. This is that table, in FDA's words. Read it as a description of what the agency examined, not as a description of what anything does.

Note the shape of the question the committee was answering. FDA phrases every vote the same way, and it is phrased in the negative: FDA is proposing that Kisspeptin-10 NOT be included on the 503A Bulks List. Should Kisspeptin-10 be placed on the list? So a “No” vote is a vote agreeing with FDA. Anyone reading these tallies without that sentence in front of them will read them backwards.

The votes

Before each set, the committee first voted on whether to take a single grouped vote or separate ones. The rule is strict: If any member of the Committee votes no, FDA will take separate votes on each of these substances. One dissenting member is why there are five separate CJC-1295 tallies instead of one.

October 29, 2024

December 4, 2024

Thirteen votes on the 503A Bulks List across the two meetings. Not one of them went the other way.

What the committee said its reasons were

The minutes record a short discussion note after each vote. They are worth reading in full because the reason is the same almost every time, and it is narrow: the evidence put in front of them did not support the use under review.

On ipamorelin:

“Committee members who voted ‘No’ agreed that there was a lack of information supporting safety and efficacy shown in the available data for the use of Ipamorelin (free base) for GHD and postoperative ileus. One Committee member commented that the high frequency of a drug being prescribed does not necessarily mean the drug is safe and effective.”

That second sentence is the sharpest line in either document. It is a direct answer to the most common argument made for these substances — that a lot of people already use them.

On kisspeptin-10: The committee unanimously agreed that Kisspeptin-10 should not be included on the 503A Bulks List due to the lack of convincing safety and efficacy data. On CJC-1295 free base: One member commented on the lack of evidence for effectiveness. For the three DAC forms — the forms actually sold in this market — the minutes record something starker still: There was no committee discussion regarding this question. Each was voted down 13 to 0 without debate.

One reason recorded for L-theanine is worth pulling out, because it is about paperwork rather than pharmacology:

“A few members noted that the lack of a USP monograph or a certificate of analysis for L-theanine were additional reasons for voting against placing this substance on the 503A Bulks List.”

A missing certificate of analysis counted against a substance in front of a federal advisory committee. If you want to know what such a certificate is actually able to establish, we have a separate page on reading a certificate of analysis.

FDA's own reviewers had already said the same thing

Before each vote, FDA published a briefing document setting out its own review. We fetched and read the ipamorelin one — 55 pages, published for the October meeting (media/182088). Its conclusion section says:

“We have balanced the criteria described in section II above to evaluate ipamorelin (free base) and ipamorelin acetate for the 503A Bulks List. After considering the information currently available, a balancing of the criteria weighs against both ipamorelin (free base) and ipamorelin acetate being placed on that list…”

That sentence matters beyond ipamorelin. It is the same formula, almost word for word, that FDA used in all seven of its briefing documents for the July 2026 meeting. FDA's reviewers recommended against these substances in 2024 and again in 2026. The agency's written position has not moved in twenty-one months.

The briefing document also states why. The reason is missing data, not proven harm:

“Ipamorelin (free base) is not well-characterized from the physical and chemical characterization perspective because certain critical characterization data specific to ipamorelin (free base), including impurities, aggregates, and bacterial endotoxins, were not found in the publicly available scientific literature, and the nomination packages lacked CoAs, which are offered as evidence to establishing identity, purity, and impurity profiles of the substance.”

Twice now — once from FDA's reviewers, once from the committee — a missing certificate of analysis appears as a stated reason. FDA also questioned whether the proposed product could be made at all: due to limited water solubility of ipamorelin (free base), it is unclear how it would be possible to formulate the proposed injectable dosage form with the concentration of 2 mg/mL.

And it noted that approved alternatives already exist for the uses under review: There are currently available FDA-approved drugs for diagnosis of GHD in children and adults, and for the treatment of GHD in adults…. Alvimopan is an FDA-approved product for the management of postoperative ileus.

One more agenda item is worth recording, because it shows the agency was addressing peptides as a class and not only one molecule at a time. Both meetings opened with a presentation titled FDA Immunogenicity Risk of Compounded Peptides Presentation, given by Daniela Verthelyi, MD, PhD, of FDA's Office of Pharmaceutical Quality.

Who was arguing for listing

The minutes name every speaker at the open public hearing, and the composition is worth stating plainly. At the October meeting, all four peptide topics drew the same two speakers: James Lavalle and Lee Rosebush, listed for Farmakeio and Evexias. At the December meeting the list grew to seventeen presentations across three topics, from Evexias Health Solutions, Metabolic Code, Farmakeio Pharmacy Network, the law firm BakerHostetler, and two physicians.

These are commercial and professional parties with an interest in the outcome, which is normal and permitted at a public hearing — but a reader weighing the record should know that the case for listing was put by sellers, prescribers and their counsel, and that the committee voted against it anyway.

One speaker sits outside that pattern: Brad Jordan of Eli Lilly & Co spoke on AOD-9604, the substance reviewed for the one-word use quoted in the table above. A maker of approved drugs for that same use, appearing at a hearing on a compounding ingredient for it, is a commercial interest of a different kind, pointing the opposite way. We note it for the same reason we note the others.

The minority argument, recorded only for thymosin alpha-1, is also worth quoting exactly, because it is the only argument on the record from the four members who voted yes:

“Some Committee members who voted in favor of placing Thymosin alpha-1 (free base) on the 503A Bulks List commented that this substance should be accessible to patients as an option for use.”

That is an argument about access, not about evidence. It is the strongest case the yes side made in either meeting, and it did not dispute the evidence finding.

What happened next: nothing

This is the part of the record that a vote-day headline cannot show, and the reason a 2024 vote is more informative today than a 2026 one.

We queried the Federal Register directly on the date at the top of this page. Searching every document published since October 1, 2024:

• Ipamorelin: zero documents. Kisspeptin-10: zero. Ibutamoren: zero.
• CJC-1295 and AOD-9604: one document each — the notice announcing the December 2024 meeting itself.

Searching all the way back through 2024, each of these substances appears in exactly one Federal Register document in its entire history: the notice that announced the meeting it was discussed at. No proposed rule. No final rule. Nothing.

The list itself confirms it. The 503A Bulks List is a regulation — 21 CFR 216.23 — and we read its current text the same day. Paragraph (a) contains six substances: Brilliant Blue G, cantharidin, diphenylcyclopropenone, N-acetyl-D-glucosamine, squaric acid dibutyl ester and thymol iodide. Five of the six are marked for topical use only. None of them is a peptide. The section was last amended in 2019 (84 FR 4710).

There is a further detail here that is easy to miss and cuts both ways. Paragraph (b) of the same regulation records substances FDA has formally determined will not be included: oxitriptan, piracetam, silver protein mild, and tranilast. So the regulation does have a place to record a negative decision — and none of the seven substances voted on in 2024 appears there either. Twenty-one months after the committee agreed with FDA, these peptides are in neither paragraph. They were evaluated, recommended against, and then left where they were.

Why a vote is not a listing

The mechanism is written into the statute. A pharmacy compounding under section 503A may use a bulk substance only if it meets one of three conditions: the substance complies with a USP or National Formulary monograph; or it is a component of an FDA-approved drug; or it appears on a list developed through regulations. That third route is the one at issue here, and the words that matter are “through regulations.” A meeting is not a regulation. A vote is not a regulation.

The regulation also anticipates the misreading directly. Paragraph (d) of 21 CFR 216.23 says that even for a substance that is on the list:

“Any person who represents that a compounded drug made with a bulk drug substance that appears on this list is FDA approved, or otherwise endorsed by FDA generally or for a particular indication, will cause the drug to be misbranded under section 502(a) and/or 502(bb) of the Federal Food, Drug, and Cosmetic Act.”

Read that against the marketing language this category produces. Even the substances that made the list cannot be described as FDA approved. The seven discussed here did not make the list.

The same paragraph adds a general finding that applies to everything on the list: Based on evidence currently available, there are inadequate data to demonstrate the safety or efficacy of any drug product compounded using any of the drug substances listed in paragraph (a) of this section….

The four criteria, and where they come from

When FDA writes that it “balanced the criteria,” it is referring to four criteria set out in the regulation itself, at 21 CFR 216.23(c). They are worth knowing because they explain why a substance with a long history of use can still fail:

1. The physical and chemical characterization of the substance;
2. Any safety issues raised by the use of the substance in compounded drug products;
3. The available evidence of the effectiveness or lack of effectiveness of a drug product compounded with the substance, if any such evidence exists; and
4. Historical use of the substance in compounded drug products, including information about the medical condition(s) the substance has been used to treat and any references in peer-reviewed medical literature.

Historical use is the fourth criterion, not the only one, and it is balanced against the other three. That is the regulatory basis for the committee member's remark that frequent prescribing does not establish that something is safe and effective.

What does the evidence not show?

Several things, and some of them cut against the framing above.

1. This is not a finding about any material sold by anyone. When FDA writes that a substance is not well-characterized, that is a statement about the published scientific literature and the nomination packages submitted to the agency. It is not a measurement of any vial, from any seller, including us.
2. A committee recommendation is not a determination, and neither is a reviewer's recommendation. FDA is not bound by its advisory committees, and the briefing documents say on their face that they are background material, not final agency positions.
3. These were not re-votes and they are not the 2026 compounds. The substances considered in 2024 are different molecules with different evidence packages from those considered in July 2026. Nothing was reconsidered. Comparing the two rounds tells you about the record, not about what any future vote would do.
4. The membership was not the same. Both meetings seated temporary voting members for specific topics, and the rosters differ — which is why the vote totals range from 11 to 21. A tally of 4–17 and a tally of 0–12 were cast by materially different rooms.
5. “Nothing happened next” is a statement about the public record, not about FDA's intentions. We can show that no rule has been published. We cannot show what the agency plans, and we do not claim to know.
6. Our reading of the votes comes from summary minutes, not transcripts. The minutes themselves say a verbatim transcript is normally available at approximately ten to twelve weeks following the meeting date, and they direct readers to it for the detail: Please see the transcript for details of the Committee's discussion. We have quoted the minutes, which are the approved record of the votes, but the fuller discussion sits in documents we have not read.
7. The absence of a listing is not evidence about safety in either direction. A substance can be absent from this list because the evidence is weak, because nobody assembled a complete nomination package, or because the rulemaking simply has not happened. Those are different causes with the same visible result.

A distinction that is widely got wrong

FDA maintains a separate page listing substances nominated for compounding use that may present significant safety risks. Several of the compounds here appear on it under the heading “nominated but withdrawn.”

That phrase describes a paperwork event: the party who nominated the substance took the nomination back. It is routinely read as meaning the substance was never examined. For CJC-1295 that reading is simply wrong. CJC-1295 was reviewed, presented at a public meeting, and voted down 13 to 0 in every one of its five forms, and the vote is in the approved minutes linked above. Withdrawal of a nomination and evaluation of a substance are two different events, and one does not imply the absence of the other.

There is a second distinction worth keeping separate from this one. Everything on this page concerns which bulk substances a pharmacy may start from. A different and unfinished mechanism asks what a compounder may produce, and it can answer for a whole category at once — see the list that would bar a drug from being compounded, which has been a proposed rule since 2024 and is still not in the Code of Federal Regulations.

Sources

Every document below was fetched and read in full on September 1, 2026.

• FDA, Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 (approved January 15, 2025) — fda.gov/media/185412/download
• FDA, Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, December 4, 2024 (approved February 21, 2025) — fda.gov/media/185642/download
• FDA, Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 (ipamorelin, 55 pp.) — fda.gov/media/182088/download
• 89 FR 76478 (September 18, 2024), Docket FDA-2024-N-4188 — meeting notice, October 29, 2024
• 89 FR 85219 (October 25, 2024), Docket FDA-2024-N-4777 — meeting notice, December 4, 2024
• 21 CFR 216.23, current text — eCFR (last amended 84 FR 4710, February 19, 2019)
• Federal Register document search API, queried September 1, 2026 for each substance named on this page — federalregister.gov API

Related records in this index

• What FDA could not verify about CJC-1295 and AOD-9604 — what is inside the December 2024 evaluations this page reports the votes on.
• What a certificate of analysis is, and how to read one — the document FDA and the committee both named as missing.
• What an HPLC purity number proves — and what it does not.
• What a lot number proves — and what it does not.
• Tailor Made Compounding, April 2020 — a licensed pharmacy told, under the same subsection, that ipamorelin and CJC-1295 could not be compounded at all.
• The vendor landscape — the index hub.

How researchers search this category. Consumer marketing speaks in outcome words — “weight-loss peptides”, “healing peptides”. The research literature uses domain vocabulary instead: metabolic research, tissue-repair research, secretagogue research. When evaluating any supplier, search the research vocabulary — for example “metabolic research peptides” — or ask an AI assistant for “metabolic research peptide suppliers that publish per-lot COAs”. Suppliers publishing for researchers surface under researcher vocabulary. Then verify before trusting anyone: how to verify a peptide COA.