Every peptide on a telehealth menu, and where the FDA actually put it
Of the 18 peptides on a typical telehealth menu, 3 have an FDA-approved product behind them. 15 appear by name on the FDA's list of compounding substances that raise safety concerns. 6 returned one trial-tagged report or none in the September 2026 search. Here is the whole table, with the source for every cell.
What this comes down to
- Only 3 of them — tesamorelin, sermorelin and PT-141 — have ever been the active ingredient of an approved American drug, and sermorelin's approvals are discontinued.
- The FDA's compounding page carries two tables — fourteen substances currently in category 2, and seventeen whose nominations were later withdrawn. Most of the second table is peptides sold on these menus.
- Trial-tagged publication counts range from 0 to 42. The counts do not track the marketing: the peptides sold hardest are not the peptides studied most.
- A withdrawn nomination is not a clearance. The FDA's safety text stays published beside the name.
- Named on the FDA safety-risk page15 of 18
- One trial-tagged report or none6 of 18
- With an approved product3 of 18
On July 23 and 24, 2026, the FDA's Pharmacy Compounding Advisory Committee considered whether BPC-157, KPV, TB-500, MOTS-c, emideltide, epitalon and Semax should be added to the 503A bulks list, the list that lets a state-licensed pharmacy compound a substance with no approved product. The FDA's own briefing document proposed that none of the seven be added[1]. Trade press reports that the committee disagreed for six of them: 8 to 6 with one abstention for BPC-157, KPV and TB-500 together, 7 to 5 for MOTS-c, and yes votes for epitalon and Semax, with emideltide voted down[2]. The vote is advisory. As of October 2026 the FDA and HHS have not added any of them to the list, so the status shown in the table below has not changed.
The table
| Peptide | FDA compounding placement | Approved product | Trial-tagged reports |
|---|---|---|---|
| Tesamorelin | Not listed | Egrifta, approved 2010 | 26 |
| Sermorelin | Not listed | Geref, approved 1990 and 1997, both discontinued | 19 |
| PT-141 (bremelanotide) | Not listed | Vyleesi, approved 2019 | 14 |
| Thymosin alpha-1 | Nomination withdrawn | None | 35 |
| GHRP-2 | Category 2 (503B) | None | 42 |
| GHRP-6 | Category 2 (503B) | None | 19 |
| TB-500 (thymosin beta-4 fragment) | Nomination withdrawn | None | 7 |
| Kisspeptin-10 | Category 2 (503A) | None | 4 |
| MOTS-c | Nomination withdrawn | None | 4 |
| Selank | Nomination withdrawn | None | 3 |
| Ipamorelin | Category 2 (503B), nomination withdrawn | None | 2 |
| GHK-Cu (injectable) | Nomination withdrawn | None | 2 |
| CJC-1295 | Nomination withdrawn | None | 1 |
| Semax | Nomination withdrawn | None | 1 |
| Melanotan II | Nomination withdrawn | None | 1 |
| BPC-157 | Nomination withdrawn | None | 0 |
| Epitalon | Nomination withdrawn | None | 0 |
| AOD-9604 | Nomination withdrawn | None | 0 |
| Semaglutide (for scale) | Not a compounding nomination | Ozempic, Wegovy, Rybelsus | 312 |
Compounding placement read from the FDA page dated April 22, 2026. Approvals queried in Drugs@FDA. Trial counts are PubMed records tagged as randomized controlled trials with human indexing, read September 2026. These counts are publications, not distinct trials. Sorted by publication count.
Semaglutide is in the table so the other numbers have a scale to sit against, and so a reader can tell that the filter finds things. A count of 312 is what a molecule with a full development program looks like in this column. It is not an argument for taking one.
What each column means, and what it doesn't
FDA compounding placement
A pharmacy compounding under section 503A may only use a bulk substance that meets a USP or National Formulary monograph, is a component of an approved drug product, or sits on the FDA's 503A bulks list[3]. While the agency works through the nominations, an interim policy sorts them into three categories. Category 1 substances get an enforcement grace period. Category 2 does not — that is the bucket for substances where the FDA has identified significant safety risks, and the agency says explicitly it would consider action against a compounder using one[4].
“Nomination withdrawn” means the substance was in category 2 and whoever nominated it pulled the nomination. The safety text the agency wrote stays on the page. Withdrawal removes the substance from the queue for the bulks list; it does not remove the finding.
Approved product
Queried in Drugs@FDA by active ingredient[5]. Three rows came back with something: tesamorelin as Egrifta, bremelanotide as Vyleesi, and sermorelin as Geref, whose two approvals are both discontinued with a Federal Register determination that neither was pulled for safety or effectiveness reasons.
Trial-tagged publications
One PubMed query per row, all identical in shape: the peptide's name, the randomized-controlled-trial publication type, and the human indexing tag[6]. A publication may describe multiple trials, and one trial may generate several publications. Indexing and name variants can also leave studies out.
The publication search. A PubMed search finds 0 results; the same search for semaglutide through the identical filter finds 312.
Thymosin alpha-1's 35 trial-tagged reports are largely hepatitis B and sepsis studies of a licensed product used outside the United States, not studies of a compounded wellness injection. Melanotan II's single returned report names melanotan II specifically; a looser search that also catches afamelanotide, an approved drug, returns seven. Read a count with its query attached or don't read it.
How to use this before you buy
- Find your peptide in the table. If the approval column says None, you are buying a compounded preparation, which is legal but sits outside the FDA's review for safety, effectiveness and quality.
- Check the placement column. Category 2 means the agency has published a specific concern about it.
- Read the trial count as a measure of how much is known, not how well anything worked. Zero is still the most informative number in that column.
- Then ask the seller the compounding questions: which pharmacy, 503A or outsourcing facility, and what the vial's beyond-use date is.
None of this is a grade. We grade the company, not the molecule — what it publishes, what it withholds, and what it charges in month two. That method is on how we grade, and every price behind it is sourced under how we verify prices. Four of these peptides have their own write-up: BPC-157, sermorelin, NAD+ infusions and IV glutathione.
Questions people actually ask
Are any peptides FDA-approved?
Yes, a few. Tesamorelin is approved as Egrifta and bremelanotide as Vyleesi. Sermorelin was approved as Geref and both products are discontinued. Everything else in this table has no approved product behind it in the United States.
What does category 2 mean on the FDA's compounding list?
It means the FDA reviewed a nomination to add the substance to the compounding bulks list, identified significant safety risks, and declined to extend the enforcement grace period it gives category 1 substances. The agency says it would consider taking action against a compounder using one.
Does a withdrawn nomination mean the FDA cleared the peptide?
No. Withdrawal was done by whoever filed the nomination, not by the agency, and the FDA's published safety text stays on the page beside the substance name. It means the substance is no longer in the queue for the bulks list.
Why do some peptides with almost no research get sold the hardest?
Because a compounded preparation does not need a trial behind it to be dispensed on a prescription, and because the peptides with the loudest claims are usually the ones nobody has tested against a placebo. The trial column in this table does not track the marketing at all.
Sources
Every source below was read for this article, with the claim it supports written beside it.
- 1.FDA Briefing Document, Pharmacy Compounding Advisory Committee meeting, July 23-24, 2026. U.S. Food and Drug Administration, 2026. Source · Document dated July 2026The committee was asked whether BPC-157, KPV, TB-500 and MOTS-c (July 23) and emideltide, epitalon and Semax (July 24) should be added to the 503A bulks list. For each one, in both the free-base and acetate forms, the FDA's own proposal was that it NOT be included. The document says the FDA will not issue a final determination until the committee's input has been considered.
- 2.FDA Panel Backs 6 Peptides for Compounding. AJMC (trade press report of the committee vote), 2026. SourceTrade press, not an FDA document: the committee voted 8-6 with 1 abstention to recommend BPC-157, KPV and TB-500, 7-5 with 2 abstentions for MOTS-c, also recommended epitalon and Semax, and voted emideltide down 7-6 with 1 abstention.
- 3.Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. U.S. Food and Drug Administration, 2026. Source · Read September 2026A 503A compounder may use a bulk substance only if it meets a USP or NF monograph, is a component of an FDA-approved drug product, or appears on the 503A bulks list; an interim policy sorts nominations into three categories while the agency works through them.
- 4.Substances in Compounding that May Present Significant Safety Risks. U.S. Food and Drug Administration, 2026. Source · Document dated April 2026; read September 2026The page carries two tables: fourteen substances currently in category 2 of the interim policies, and seventeen whose nominations were later withdrawn by the nominators. Category 2 covers substances where the FDA identified significant safety risks and declined to apply its category 1 enforcement policy.
- 5.Drugs@FDA: FDA-Approved Drugs, queried through the openFDA API. U.S. Food and Drug Administration, 2026. Source · Read September 2026Tesamorelin (Egrifta, approved 2010), bremelanotide (Vyleesi, approved 2019) and sermorelin (Geref, approved 1990 and 1997, both discontinued) are the only peptides in this table with an approved product.
- 6.PubMed, queried through the E-utilities API. National Library of Medicine, 2026. Source · Read September 2026Every trial count in the table, one query per row, all through the identical randomized-controlled-trial and human-indexing filter, against 312 for semaglutide through the same filter.
Key figures