Substance statuses last verified: 20 August 2026
Editorial update, 13 September 2026: Navigation, scope and the explanation of the bulk-substance criteria were updated. Individual substance classifications retain the verification date above.
This tracker covers selected peptides and related compounds. It explains the regulatory distinctions used in the tables below, with links to FDA, eCFR and Federal Register sources. It is not a complete catalogue of peptide medicines or a determination about an individual prescription.
Peptide marketing uses "legal," "approved" and "compoundable" interchangeably. They are four different things: an approved drug, the statutory list, a conditional promise not to prosecute, and nothing at all.
The approved-product table gives four examples from the substances covered here; it is not an exhaustive list of FDA-approved peptide medicines. The remaining sections distinguish the statutory 503A bulks list from FDA's interim enforcement categories and discuss uncertainties. For a specific product's approval history and labeling, consult Drugs@FDA.
The 23–24 July 2026 advisory committee votes were recommendations. They changed nothing: 21 CFR 216.23 is unchanged since 19 February 2019, no proposed rule has published, and no peptide has been added to the 503A Bulks List.
The law, in one paragraph
The bulk-substance criteria appear in 21 U.S.C. 353a(b)(1)(A)(i). FDA explains them as a sequence: a substance must comply with an applicable USP or NF monograph if one exists; if none exists, it must be a component of an FDA-approved drug product; if neither applies, it must appear on the 503A bulks list. FDA also specifies certificate-of-analysis and manufacturer-registration requirements. Meeting a bulk-substance criterion does not by itself establish that a particular compounded prescription meets all 503A requirements.
Categories 1, 2 and 3 are an interim enforcement-discretion policy FDA runs while it works through nominated substances. Per FDA's 503A page (updated 14 May 2026): Category 1, FDA "does not intend to take action"; Category 2, FDA "has identified significant safety risks"; Category 3, insufficient information. Categories 2 and 3 have the same effect — FDA "would consider taking action against a compounder."
The part the peptide internet gets backwards: a substance in no category is worse off than one in Category 2, because discretion attaches only to Category 1. A withdrawn nomination buys nothing.
Tier 1 — FDA-approved drug products
Approved drugs with labels, indications and real trial evidence. Not compounding questions at all.
Scroll horizontally to read every column. Keyboard users: focus the table area, then use the left and right arrow keys.
| Substance | Brand | Approved for | Evidence anchor |
|---|---|---|---|
| Tesamorelin | Egrifta, Egrifta SV, Egrifta WR | Reduction of excess visceral abdominal fat in HIV-associated lipodystrophy | Falutz, NEJM 2007, PMID 18057338; Falutz, JCEM 2010, PMID 20554713 (N=806) |
| Semaglutide | Ozempic, Wegovy, Rybelsus | Type 2 diabetes; chronic weight management; cardiovascular risk reduction | STEP 1 and SELECT |
| Tirzepatide | Mounjaro, Zepbound | Type 2 diabetes; chronic weight management; obstructive sleep apnoea | SURMOUNT-1 |
| Bremelanotide (PT-141) | Vyleesi | Acquired, generalized HSDD in premenopausal women only | RECONNECT, PMID 31599840; FDA label |
Two warnings. Approval is indication-specific: tesamorelin's trials ran in HIV-positive patients with a fat-redistribution syndrome, and Vyleesi's label says it is not indicated for postmenopausal women or men. Most marketing for both is off-label. And the evidence attaches to the approved product, not a compounded or grey-market copy.
That second point now matters for the GLP-1s. Shortage-based compounding of semaglutide and tirzepatide ended in 2025, and a 1 May 2026 Federal Register notice proposes that semaglutide, tirzepatide and liraglutide not be included on the 503B clinical-need list. It is not final. If finalized, compounded access to the three best-evidenced peptide drugs closes while the worst-evidenced ones are argued onto a different list.
Tier 2 — the actual 503A Bulks List
This is the list the statute cares about: 21 CFR 216.23, last amended by 84 FR 4710 on 19 February 2019. Here it is in full, because the emptiness is the point.
Scroll horizontally to read every column. Keyboard users: focus the table area, then use the left and right arrow keys.
| Substance | Restriction | Status under 216.23 |
|---|---|---|
| Brilliant Blue G | — | Permitted, 216.23(a) |
| Cantharidin | Topical use only | Permitted, 216.23(a) |
| Diphenylcyclopropenone | Topical use only | Permitted, 216.23(a) |
| N-acetyl-D-glucosamine | Topical use only | Permitted, 216.23(a) |
| Squaric acid dibutyl ester | Topical use only | Permitted, 216.23(a) |
| Thymol iodide | Topical use only | Permitted, 216.23(a) |
| Oxitriptan; Piracetam; Silver Protein Mild; Tranilast | — | Determined not to be included, 216.23(b) |
Six permitted substances, four expressly excluded, no peptides either way. Anyone who says a peptide is "on the FDA list" is describing something that does not exist.
Tier 3 — Category 1 enforcement discretion
Category 1 is not lawfulness. It is FDA stating a present intention. The list runs to 47 substances as of 14 May 2026. The peptide- and hormone-relevant entries:
- NAD and NADH (nicotinamide adenine dinucleotide, and the disodium reduced form)
- Glutathione
- Enclomiphene citrate
- Methylcobalamin
- GHK-Cu — except injectable routes
- Vasoactive intestinal peptide
- Pregnenolone
The conditions matter more than the listing. Under FDA's interim policy guidance, the discretion applies only where the substance is in Category 1, every manufacturer of the bulk substance is registered under section 510, a valid certificate of analysis accompanies it, and all other 503A conditions are met. Products compounded where those circumstances are not all present "are not within the scope of the policy described in this guidance." A Category 1 substance from an unregistered manufacturer falls outside it — a supply-chain question no patient can answer from a website.
Note the irony: topical GHK-Cu has the clearest pathway in this tier and the thinnest human evidence, while the injectable version everyone markets sits in Tier 4.
Tier 4 — no pathway at all
This is where nearly every peptide people buy ends up. "No pathway" covers six genuinely different situations, and collapsing them loses information.
4a. Removed from Category 2, recommended by PCAC, rulemaking pending
BPC-157, KPV, TB-500, MOTS-c, Semax, Epitalon.
On 15 April 2026 FDA republished the interim 503A list, removing twelve peptides from Category 2. The mechanism was not a clearance. The nominators withdrew the nominations. Frier Levitt: "Removal from Category 2 does not render these bulk drug substances eligible for compounding under section 503A."
At the 23–24 July 2026 Pharmacy Compounding Advisory Committee meeting (docket FDA-2025-N-6895, closed 22 July 2026), six of the seven substances reviewed were recommended. Tallies are trade-press sourced, FDA having posted no minutes as of the meeting page's 6 August 2026 update: BPC-157 8-6-1 in favor, KPV 8-6-1, TB-500 8-6-1, MOTS-c 7-5-2, Semax 8-5-1, Epitalon 7-4-1.
Two under-reported facts. FDA's own review team recommended rejecting all seven, so the committee voted against its agency's scientists six times out of seven. And the panel drew scrutiny for including more peptide prescribers and producers than historical rosters.
BPC-157 is the worked example. Four gates: removed from Category 2, but by nomination withdrawal, so no discretion attaches; recommended by PCAC, but non-binding; rulemaking not started, eight to twelve months an optimistic floor; and none of it bears on approval or effectiveness. One gate cleared, three standing.
4b. Removed from Category 2, then rejected by PCAC
Emideltide (DSIP). The committee voted 6 for, 7 against, 1 abstaining — the only rejection of the two days. Some coverage reported "7-6 with 1 abstention, rejected," which is incoherent. Two independent legal sources report 6-7-1; that is the figure we use.
4c. Removed from Category 2, still awaiting PCAC review
GHK-Cu (injectable routes only), Dihexa acetate, Cathelicidin LL-37, PEG-MGF, Melanotan II. FDA's PCAC meetings page queues all five for a meeting before the end of February 2027. No date is set. Until then: no category, no discretion.
4d. Nomination withdrawn, never reviewed
CJC-1295, thymosin alpha-1, AOD-9604, Selank. These sit in the "nominated but withdrawn" table on FDA's safety-risk page. No committee ever voted. FDA separately cited "increased heart rate and systemic vasodilatory reaction" for CJC-1295.
Thymosin alpha-1 needs a correction, because it is routinely described as approved. It is not. NIH's NCATS Inxight Drugs record: thymalfasin "is not approved by the FDA but it is widely used in China and some other countries." Its US orphan designations are not approvals.
4e. Affirmatively voted down by PCAC
Ipamorelin, kisspeptin-10, ibutamoren mesylate, L-theanine. On 29 October 2024 the committee voted 12-0-1 against adding ipamorelin to the 503A Bulks List. Also rejected that day: L-theanine (1 for, 12 against), ibutamoren mesylate (1 for, 13 against), kisspeptin-10 (0 for, 11 against). The minutes and briefing document are public. This is the strongest no in the framework.
4f. 503B Category 2 — an identified safety risk
Ipamorelin acetate, GHRP-2 (injectable and nasal routes), GHRP-6 were added to the 503B Category 2 list on 29 September 2023. On ipamorelin, FDA wrote that it "may pose risk for immunogenicity... due to the potential for aggregation or peptide-related impurities," that it "contains unnatural amino acids," and that a published study "identified serious adverse events including death when ipamorelin was administered intravenously." For GHRP-2, FDA cited "death of critically ill study subjects, infection and pancreatitis"; for GHRP-6, cortisol effects and raised blood glucose. Both GHRPs are separately in 503A Category 3.
Get this right: ipamorelin is in 503B Category 2, not 503A Category 2. The 503A Category 2 list is six substances — cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate, kisspeptin-10, intrauterine quinacrine hydrochloride. Ipamorelin's 503A position is "withdrawn, and voted down 12-0-1."
Safety warning: melanotan II
Melanotan II is not merely unapproved. It has a documented harm record. A 20-year-old woman developed histologically confirmed cutaneous melanoma after a three-to-four week course of self-injected melanotan II (Hjuler and Lorentzen, Dermatology 2014, PMID 24355990). A 39-year-old man who self-injected internet-purchased product reached a creatine kinase of 17,773 IU/L within twelve hours, with rhabdomyolysis and renal dysfunction (Nelson, Bryant and Aks, Clin Toxicol 2012, PMID 23121206). Eruptive dysplastic naevi, melanonychia, priapism and encephalopathy are also reported (DermNet).
The mechanism compounds the risk. Users stimulate melanocytes pharmacologically, increase UV exposure because tanning gets easier, and darken existing moles — obscuring the visual changes clinicians rely on to catch melanoma early. Regulators in the US, UK and elsewhere have issued warnings. It has no approved indication anywhere in the world.
Sermorelin: the special case
Sermorelin is the most-sold peptide in US telehealth and the least understood, and its status cannot be read off any category list. GEREF (sermorelin acetate) was genuinely approved: NDA 19-863 on 28 December 1990 as a pituitary diagnostic, NDA 20-443 on 26 September 1997 for paediatric idiopathic growth hormone deficiency. Holder EMD Serono requested withdrawal on 2 December 2008, and FDA withdrew approval effective 18 June 2009, at 74 FR 23407.
Then apply the three gates.
- USP or NF monograph? No. An FDA-commissioned University of Maryland CERSI report, December 2020: "there is no current United States Pharmacopeia (USP) monograph for sermorelin acetate" and "sermorelin acetate is not available as an FDA-approved product."
- Component of an approved drug? The approval was withdrawn in 2009. This is the contested gate, below.
- On the 503A Bulks List? No. See Tier 2.
Sermorelin appears nowhere in FDA's 503A nominations document as updated 14 May 2026 — not Category 1, 2 or 3. It is outside the framework entirely.
The conflict in FDA's own documents
Here honest reporting requires arguing against our own conclusion. FDA's 503B nominations list, updated 21 March 2025, lists "Sermorelin Acetate**" in Category 1, with a legend reading "** Designates bulk drug substances that are components of FDA approved drugs." That annotation is the origin of essentially every "sermorelin is a component of an approved drug" claim in telehealth.
Compounders make a second argument: on 26 February 2013 FDA determined GEREF was not withdrawn for reasons of safety or effectiveness, keeping it in the Orange Book Discontinued Drug Product List and allowing ANDAs to reference it (78 FR 14095).
Our assessment — our inference, not an FDA position — is that the double asterisk is a stale legacy annotation. Two things support that. The same list marks "Gonadorelin Acetate**", and gonadorelin's only NDA (019687, Lutrepulse) is likewise discontinued, so the annotation has outlived the approvals underneath it. And it sits in a 503B document, where "component of an approved drug" is not a statutory pathway at all, so the note cannot be doing legal work where it appears.
What we could not verify: FDA has never published a determination resolving whether a withdrawn approval satisfies gate (ii). We looked for an FDA adjudication, a guidance statement and case law, and found none. Anyone who tells you this is settled, in either direction, is telling you something FDA has not said.
503B outsourcing facilities are differently situated: sermorelin is in 503B Category 1, which is discretion rather than lawfulness, and it is not on the 503B bulks list (five substances, no peptides). But nearly all telehealth sermorelin comes from 503A pharmacies, where the three gates apply. And sermorelin has real regulatory-grade evidence for paediatric GHD and pituitary diagnostics, while we found none for the anti-aging uses it is now prescribed for. The absence is the finding. Full documentation: our sermorelin deep-dive.
Master table
How to read this table
"FDA status" is the substance's position in FDA's own documents, not a judgement about safety. "Lawful 503A compounding?" answers only the statutory question; "no" does not mean unobtainable, it means the pharmacy and prescriber are outside the statute. "Human evidence" is an independent axis — a substance can be lawfully prescribed with nothing behind it. "Prohibited in sport" is a third, marked "our inference" where a substance falls within a class definition without being named.
Scroll horizontally to read every column. Keyboard users: focus the table area, then use the left and right arrow keys.
| Peptide | Commonly sold as | FDA status | Lawful 503A compounding? | Human evidence | Prohibited in sport? |
|---|---|---|---|---|---|
| BPC-157 | "Body protection compound," gut and injury peptide | Not approved. Removed from 503A Cat 2, Apr 2026, by nomination withdrawal. In no category. PCAC recommended 8-6-1, Jul 2026 | No — fails all three gates | One RCT, by rectal enema for ulcerative colitis, which missed its endpoint. FDA found no human study by any marketed route | Yes — named in WADA S0 |
| TB-500 | Thymosin beta-4 fragment (Ac-LKKTETQ-OH) | Not approved. No category. PCAC recommended 8-6-1 | No | None. FDA: the nomination did not include and FDA did not find any information on administration to patients | Yes — thymosin-beta-4 named in S2.3 |
| KPV | Alpha-MSH tripeptide fragment | Not approved. No category. PCAC recommended 8-6-1 | No | Not established in our sources | S0 by definition (our inference) |
| MOTS-c | Mitochondrial-derived peptide | Not approved. No category. PCAC recommended 7-5-2 | No | None. FDA: no clinical studies or human exposure data by any route | S0 by definition (our inference) |
| Semax | Nootropic nasal spray | Not approved. No category. PCAC recommended 8-5-1 | No | One 1996 open-label study (N=37) negative for its main endpoint, plus meeting abstracts. FDA found insufficient evidence of effectiveness | S0 by definition (our inference) |
| Epitalon | Epithalon, "telomere peptide" | Not approved. No category. PCAC recommended 7-4-1 | No | One study, N=75, sublingual (not the nominated route), surrogate endpoint only | S0 by definition (our inference) |
| Emideltide / DSIP | Delta sleep-inducing peptide | Not approved. No category. PCAC rejected, 6-7-1 | No | Not established in our sources | S0 by definition (our inference) |
| GHK-Cu — topical | Copper peptide serum or cream | 503A Category 1, all routes except injectable | Within enforcement discretion if every guidance condition is met — not the same as lawful | Predominantly preclinical. The one clinical trial identified in a 2025 review studied a different combination product | Not verified |
| GHK-Cu — injectable | Copper peptide injection | Removed from Cat 2, Apr 2026. No category. PCAC review due before end Feb 2027 | No | None for the injectable route | Not verified |
| Melanotan II | "Tanning peptide" | Not approved anywhere. No category. PCAC review due before end Feb 2027 | No | No approved indication in any country. Documented harms include melanoma and rhabdomyolysis — see safety warning above | Likely S0; specific classification not verified |
| Cathelicidin LL-37 | LL-37 | Not approved. No category. PCAC review due before end Feb 2027 | No | None identified in our sources | S0 by definition (our inference) |
| Dihexa | Dihexa acetate | Not approved. No category. PCAC review due before end Feb 2027 | No | None identified in our sources | S0 by definition (our inference) |
| PEG-MGF | Pegylated mechano growth factor | Not approved. No category. PCAC review due before end Feb 2027 | No | None identified in our sources | Yes — MGFs named in S2.3 |
| Sermorelin | GHRH(1-29), "GH restoration" | Approval withdrawn 18 Jun 2009 (74 FR 23407). No USP monograph. Not on the bulks list. In no 503A category. Marked Cat 1 with a disputed footnote on the 503B list | No on our reading — fails all three gates. FDA has published no determination on the withdrawn-approval question | Real evidence for paediatric GHD and pituitary diagnostics. None found for the wellness indications it is sold for | Yes — named in S2.2.4 |
| Ipamorelin | GH secretagogue, usually stacked with CJC-1295 | 503B Category 2. 503A nomination withdrawn. PCAC voted 12-0-1 against, 29 Oct 2024 | No | Entered development for postoperative ileus; never approved. Trial-level detail we could not retrieve | Within the non-exhaustive GHRP/GHS class of S2.2.4 |
| CJC-1295 | With or without DAC; "modified GRF 1-29" | Not approved. Nomination withdrawn. No category | No | One published human study (PMID 16352683) showing GH rises — pharmacodynamics, not clinical outcomes | Yes — named in S2.2.4 |
| GHRP-2 | GH secretagogue | 503A Category 3; 503B Category 2 (injectable and nasal), 29 Sep 2023 | No | FDA cited death of critically ill study subjects, infection and pancreatitis | Yes — GHRP-1 to GHRP-6 named in S2.2.4 |
| GHRP-6 | GH secretagogue | 503A Category 3; 503B Category 2, 29 Sep 2023 | No | FDA cited cortisol effects and raised blood glucose via reduced insulin sensitivity | Yes — GHRP-1 to GHRP-6 named in S2.2.4 |
| Ibutamoren mesylate | MK-677 | 503A Category 2 and 503B Category 2, 29 Sep 2023. PCAC rejected 1 for, 13 against | No | Not assessed on this page | Yes — named in S2.2.4 |
| Kisspeptin-10 | Kisspeptin | 503A Category 2, 29 Sep 2023. PCAC rejected 0 for, 11 against | No | Not assessed on this page | Yes — kisspeptin covered by S2.2.1 |
| Tesamorelin | Egrifta, Egrifta SV, Egrifta WR | FDA-approved | Not applicable — approved drug product | Strong, for HIV-associated lipodystrophy specifically (PMID 18057338; PMID 20554713, N=806) | Yes — named in S2.2.4, even when legitimately prescribed |
| Thymosin alpha-1 | Thymalfasin; Zadaxin outside the US | Not FDA-approved. Nomination withdrawn. Holds orphan designations, which are not approvals | No | 11 RCTs in sepsis, but the effect loses significance in high-quality and multicentre subsets, with publication bias detected and all trials from one country | Not verified |
| AOD-9604 | hGH fragment 176-191 | Not approved. Nomination withdrawn. No category | No | Not established in our sources | Not verified |
| Selank | Anxiolytic nasal spray | Not approved. Nomination withdrawn. No category | No | Not established in our sources | Not verified |
| NAD+ / NADH | IV NAD drips, "longevity" infusions | 503A Category 1 | Within enforcement discretion if every guidance condition is met | Multiple RCTs exist for the NMN and NR precursors; the best synthesis (10 RCTs) concluded the evidence does not support them for preserving muscle mass and function over age 60 | Not verified |
| Glutathione | IV or injectable glutathione | 503A Category 1 | Within enforcement discretion if every guidance condition is met | Not assessed on this page | Not verified |
| Semaglutide | Ozempic, Wegovy, Rybelsus | FDA-approved | Shortage-based compounding ended 2025. The 1 May 2026 FR notice proposes excluding it from the 503B clinical-need list | Strong — STEP 1 and SELECT — for the approved product, not for compounded or grey-market copies | S0 does not apply to an approved drug; not named in the classes we checked |
| Tirzepatide | Mounjaro, Zepbound | FDA-approved | Same as semaglutide | Strong — SURMOUNT-1 — same product caveat | S0 does not apply to an approved drug; not named in the classes we checked |
| PT-141 / bremelanotide | Vyleesi | FDA-approved, premenopausal HSDD only | Not applicable — approved drug product | Strong but narrow (PMID 31599840). Label states it is not indicated for postmenopausal women or men | Not verified |
Where the sources conflict, and what we could not verify
The count of twelve. FDA published no Federal Register notice for the April 2026 removals; the 16 April 2026 document (2026-07361) announced the PCAC meetings. Twelve is trade-press sourced, and the National Law Review, 22 April 2026, reported seven. We use twelve because more legal write-ups corroborate it.
Vote tallies. Every July 2026 tally here is trade-press sourced; FDA had posted no minutes as of the meeting page's 6 August 2026 update. The October 2024 ipamorelin figures come from FDA's published minutes.
Anti-doping. We could not confirm the current WADA List's effective date from the primary source, or melanotan II's classification. Where a substance is not named, our S0 placement is an inference.
What would change these statuses
Four things, in rough order of likelihood.
An interim Category 1 move. FDA indicated at the July meeting it may consider placing the recommended peptides in interim Category 1 with conditions attached, possibly including adverse-event reporting and testing. That would extend discretion without making anything lawful, and it could happen with little warning.
Notice-and-comment rulemaking. The bulks list is amended only by rulemaking, and none has begun. Buchanan Ingersoll, 18 August 2026: the votes "did not amend the 503A Bulks List," no fixed statutory deadline binds FDA, and pharmacies "should not interpret the favorable votes as authorization to begin compounding." The precedent cycle ran from a December 2016 committee to a February 2019 final rule.
The February 2027 PCAC meeting. GHK-Cu injectable, Dihexa acetate, LL-37, PEG-MGF and Melanotan II are queued before the end of February 2027, no date set. A favourable vote puts those five where BPC-157 is now — still not compoundable.
The GLP-1 503B decision. The 1 May 2026 proposal to exclude semaglutide, tirzepatide and liraglutide from the 503B clinical-need list is not final. Finalization would close large-scale compounding of the best-evidenced peptide drugs on the market.
Press coverage will not change any of it. Holland & Knight, 4 August 2026: "as of this writing, these peptides still cannot be lawfully compounded, and FDA can continue to take enforcement action."
Our update policy
We re-verify every status here against primary FDA, eCFR and Federal Register sources monthly, and within 48 hours of any FDA action affecting these substances — a category-list republication, a proposed or final rule, a PCAC meeting, a Federal Register notice. Every check is dated in the "Last verified" line at the top. When a status changes we say what changed and when, rather than editing silently. There are no affiliate links on this page: we would rather it be citable than monetized.
Frequently asked questions
Which peptides removed from Category 2 are legal now?
None. They left Category 2 in April 2026 because the nominators withdrew the nominations, not because FDA cleared anything. Removal leaves a substance in no category, and discretion attaches only to Category 1.
What is the difference between Category 1 and Category 2 peptides?
Category 1 means FDA does not intend to act against a compounder, if the manufacturer is 510-registered, a valid certificate of analysis is in hand, and all other 503A conditions are met. Category 2 means FDA has identified significant safety risks and would consider acting. Neither is the law.
Is there an official FDA list of legal peptides?
There is an official list and it has no peptides on it. 21 CFR 216.23 holds six substances, none a peptide. The "FDA lists" cited in marketing are the interim category documents — enforcement policy, not authorization.
Did RFK Jr. or the current administration make peptides legal again?
No. No statutory or regulatory change has occurred. 21 CFR 216.23 has not been amended since 19 February 2019.
Can my doctor prescribe BPC-157 legally?
A prescription is necessary but nowhere near sufficient, because the defect is in the bulk substance. BPC-157 clears none of the three gates, so a 503A pharmacy compounding it is outside the statute. The exposure sits with the pharmacy and prescriber; we found no evidence of FDA enforcement against individual purchasers.
Is sermorelin legal?
On our reading it fails all three gates: the GEREF approval was withdrawn in 2009 and no USP monograph exists. FDA's 503B document carries a footnote suggesting otherwise, which we assess as stale, and FDA has never published a determination resolving it. See above, and the full deep-dive.
This is consumer research about how peptides are regulated and sold. It is not medical advice, and we are not your doctor. Nothing here should be used to start, stop or change any treatment. Talk to a licensed clinician who knows your history.
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