FDA Peptide Regulation 2025-2026: The Complete Timeline

Nothing has been added to any FDA list. Seven peptides went before an advisory committee in July 2026 and six were recommended, but a recommendation is not an agency action and the legal position of every compound is unchanged.

That single distinction accounts for most of what is written wrongly about this market, and it is why this page is organised strictly by date. The statutory machinery behind the dates is set out in compounding pharmacy versus research peptide, and the jurisdiction-by-jurisdiction snapshot in are peptides legal.

What is the position on peptide compounding as of August 2026?

Nothing has been added to any FDA list. As of August 2026 the 503A bulks list holds six substances and none of them is a peptide, FDA's active Category 2 list holds fourteen substances of which four are peptides, and the seven substances voted on in July 2026 sit exactly where they sat in June. An advisory committee recommendation is not an agency action, and no rulemaking has begun.

The chronology below runs from the September 2023 Category 2 additions to the July 2026 meeting, with the approvals, reversals and enforcement actions that landed alongside them. Three things move independently and are constantly conflated: whether a drug is approved, whether a bulk substance may be used in compounding, and whether a substance is prohibited in sport. A compound can change position on one axis and stay put on the other two.

29 September 2023: which peptides did FDA place in Category 2?

FDA added GHRP-2, GHRP-6 and ipamorelin acetate to the Category 2 list of bulk substances that may present significant safety risks on 29 September 2023, under the 503B outsourcing-facility list, on immunogenicity and aggregation grounds. CJC-1295 and AOD-9604 were placed in 503A Category 2 in September 2023. Category 2 means a substance was nominated with enough information for FDA to evaluate it, and that the agency has identified significant safety risks pending that evaluation.

FDA's own definition is worth quoting because it is narrower than how it gets reported. A Category 2 substance was "nominated with sufficient supporting information to permit FDA to evaluate" it and "may be eligible for inclusion on the 503A bulks list," but FDA "has identified significant safety risks relating to the use of these substances in compounding pending further evaluation." A substance is not legally compoundable while it sits there.

Three of those five substances are still exactly where they were placed. Ipamorelin acetate remains on the active list, as do GHRP-2 and GHRP-6, with the page current as of 22 April 2026. The reason they stayed is procedural rather than scientific, and it is explained in the April 2026 section below.

29 October and 4 December 2024: what happened at the first peptide votes?

The Pharmacy Compounding Advisory Committee rejected every peptide it looked at in 2024. On 29 October 2024 it voted on ipamorelin free base and acetate and returned 0 in favour, 12 against, with 1 abstention on both. On 4 December 2024 FDA proposed that all five CJC-1295 substances be excluded from the 503A bulks list and the committee agreed, and AOD-9604 free base and acetate were voted down 0 in favour, 12 against, 0 abstentions.

The ipamorelin briefing document is the most detailed statement FDA has published on a peptide in this process. It records that the agency identified no data supporting effectiveness for growth hormone deficiency or for postoperative ileus, flagged possible behavioural reinforcing properties and reproductive effects arising from ghrelin receptor agonism, and described the free base as poorly characterised on impurities, aggregates and endotoxin.

CJC-1295 is the case that most often gets folded into the 2026 story and does not belong there. It was placed in Category 2 in September 2023, removed in September 2024 after the nominators withdrew and referred it for advisory review, and then rejected in December 2024. It was not on the July 2026 agenda, so the December 2024 outcome stands. "Peptides are being reconsidered" is true in general and false for this one.

Six days after the CJC-1295 vote, on 10 December 2024, FDA issued a warning letter to Xcel Research LLC naming seven products including sermorelin. Despite labelling that read "FOR RESEARCH USE ONLY" and "NOT INTENDED FOR HUMAN USE," FDA held the products were unapproved new drugs in violation of sections 505(a) and 301(d) of the Food, Drug and Cosmetic Act, because website evidence established human intended use.

21 February 2025: how did the shortage resolution close the GLP-1 route?

FDA declared the semaglutide injection shortage resolved on 21 February 2025, and enforcement discretion for compounders ended on 22 April 2025 for 503A pharmacies and 22 May 2025 for 503B outsourcing facilities. FDA's shortage database now lists both Tirzepatide Injection and Semaglutide Injection as "Resolved." Compounding a drug that is essentially a copy of an approved product is permitted only while that product is in shortage, so the shortage was the permission and it has ended.

The mechanism matters more than the dates, because it is not the mechanism most people assume. Neither semaglutide nor tirzepatide ever appeared on either of FDA's bulk substances tables. The route ran through the shortage list, and closing the shortage closed the route without any listing decision at all. Belcourt, Sapowadia & White, in Annals of Pharmacotherapy, put the consequence plainly: "With the shortage of innovator semaglutide or tirzepatide products resolved, compounding pharmacies can only legally sell unique products."

FDA has since proposed permanently excluding semaglutide from the 503B bulks list, which if finalised would bar outsourcing facilities from compounding it from bulk substances regardless of any future shortage.

The corollary catches out an entire category of vendor copy. Retatrutide has never been approved, so it has never been in shortage, so no compounding route has ever existed for it — and the same reasoning applies to survodutide, cagrilintide and mazdutide. A compound cannot lose a permission it never had, and vendors describing retatrutide as "compoundable" are describing a mechanism that has never applied to it.

June to October 2025: which approvals and reversals landed?

Four things moved in five months. China's National Medical Products Administration approved mazdutide in June 2025 for weight management and again in September 2025 for glycaemic control in type 2 diabetes. FDA approved elamipretide as FORZINITY on 19 September 2025 under NDA 215244. The NMN dietary-supplement exclusion was reversed on 29 September 2025. On 21 October 2025 FDA classified a Class I recall of a GenoGenix NAD+ injection for endotoxin contamination.

Elamipretide is the clearest case of a research-market peptide becoming a real medicine. SS-31 is approved as FORZINITY, NDA 215244, from Stealth BioTherapeutics — for Barth syndrome only, in patients weighing at least 30 kg, for muscle strength only, under accelerated approval on a surrogate endpoint. That narrowness is the point: an approval is for an indication and a population, not for a molecule. Any page describing SS-31 as unapproved is out of date, including pages on this site that have not yet been corrected.

Mazdutide is approved twice and in one country. It is sold in China as Xinermei® (信尔美), and the primary source is a peer-reviewed monograph rather than a press release — Shirley M, "Mazdutide: First Approval," Drugs, December 2025 (PMID 41028652). It is not approved in the United States and is absent from FDA's novel approvals lists for 2025 and 2026.

The NMN reversal is the entry on this page most worth internalising. For years the settled position was that FDA had excluded nicotinamide mononucleotide from the dietary supplement definition. That exclusion was reversed on 29 September 2025. A confident, correct-in-2024 statement became a false statement, and every article that was never updated is now misinforming its readers — which is the argument for dating regulatory claims rather than asserting them.

The Class I recall of GenoGenix NAD+ injection, classified 21 October 2025 for endotoxin contamination, is the quality counterpart. Class I is FDA's most serious recall category, reserved for products where there is a reasonable probability that use will cause serious adverse health consequences or death.

1 April 2026: what did the orforglipron approval change?

FDA approved orforglipron as Foundayo on 1 April 2026 under NDA 220934, a Type 1 new molecular entity from Eli Lilly, for obesity only — it is not approved for type 2 diabetes. It is a tablet rather than a peptide, and it carries a boxed warning for thyroid C-cell tumours despite the label recording that orforglipron "did not produce tumors in rodents." The approval opened an oral route into a market that had been injection-only.

The postmarketing conditions deserve more attention than the boxed warning. FDA required a cardiovascular outcomes and drug-induced liver injury safety trial, a fifteen-year medullary thyroid carcinoma registry, pregnancy registries, and five years of enhanced pharmacovigilance for drug-induced liver injury. A five-year enhanced liver-injury programme is not a routine condition of approval.

For a buyer, the relevance is comparative rather than direct: it added a licensed prescription option to a category where the grey market had been arguing that no legitimate route existed. The head-to-head detail sits in oral GLP-1: orforglipron versus peptides. Note also that Foundayo is now appearing as a vendor alias for orforglipron in research-market listings, alongside older aliases such as Mod GRF 1-29 for CJC-1295 without DAC.

22 April 2026: why did FDA split the page into two tables?

FDA's page of bulk substances that may present significant safety risks, content current 22 April 2026, carries two tables rather than one. The active Category 2 list holds fourteen substances, of which four are peptides. A second table holds seventeen more, and FDA's own introductory sentence explains why they are there: "This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators." A withdrawal is not a clearance.

This is the single most misreported event in the sequence. Sixteen substances left the active list in April 2026 because the people who had nominated them pulled the nominations, which says nothing about FDA's view of the substance. FDA's accompanying note is explicit: "The nominations were withdrawn and FDA is evaluating the substances at its discretion." In several cases the agency's published safety assessment sits alongside the entry, unchanged.

Note that ibutamoren mesylate sits on the active list and is a small molecule rather than a peptide, so the peptide count there is four, not five. Note also that ipamorelin acetate appears in both columns above because FDA's tables record it in both contexts; the operative fact is that it remains on the active list, unlike BPC-157, TB-500, KPV, MOTS-c, epitalon and semax, whose nominators withdrew.

Two corrections to our own pages belong here. The live LL-37 page describes the substance as "removed from the FDA's Category 2 bulk substances list on April 22, 2026, pending Pharmacy Compounding Advisory Committee review in early 2027"; FDA's page shows it under withdrawn nominations, and we could not verify any scheduled 2027 PCAC review. The live Epithalon page describes it as having "achieved removal from FDA Category 2." Both are being corrected, and both are examples of the misreading this section describes.

23 and 24 July 2026: how did the committee overrule its own agency?

FDA staff recommended against all seven substances reviewed at the Pharmacy Compounding Advisory Committee meeting of 23–24 July 2026. The committee overrode that recommendation six times. BPC-157, KPV and TB-500 were each recommended 8–6 with one abstention, MOTS-c 7–5 with two abstentions, Semax 8–5 with one abstention and Epitalon 7–4 with one abstention. Emideltide, the nomination name for DSIP, was the only rejection, at 6 in favour, 7 against, 1 abstention.

Every tally on this page is press-derived, and that limitation is not a formality. FDA published no minutes and no transcript for the meeting. The counts come from published law-firm vote tables — Hyman Phelps & McNamara and Bass Berry — and from contemporaneous trade coverage such as STAT News, 24 July 2026. Anyone citing an exact vote as though it came from an agency document is citing something that does not exist.

The written FDA positions behind that column are unusually direct. On Semax, a briefing document published in May 2026 concluded there is "insufficient evidence of effectiveness to support use of semax (free base) or semax acetate for cerebral ischemia, migraine, or trigeminal neuralgia," and that "the evaluation criteria weigh against placing both semax (free base) and semax acetate on the list of bulk drug substances." On Epitalon, nominated for insomnia at 10 mg/mL and 3000 mcg/mL by subcutaneous injection, reviewers found no publications discussing the efficacy of epitalon in patients with insomnia — the indication under consideration — and wrote that "we believe the evaluation criteria weigh against placing epitalon (free base) or epitalon acetate on the list of bulk drug substances that can be used to compound drug products." On MOTS-c, reviewers cited the absence of human administration studies alongside immunogenicity risk from aggregates and peptide-related impurities.

The rejection is the most informative vote of the seven. A panel willing to advance six substances over its own agency's written objections still would not advance emideltide, which had been nominated for insomnia, narcolepsy and opioid use disorder.

Several compounds people expect to find here were never on the agenda: thymosin alpha-1, hexarelin, GHRP-2, GHRP-6, CJC-1295, AOD-9604 and ipamorelin. Not being reviewed is not the same as being rejected, and neither is the same as being cleared.

Which claims about the July 2026 votes survive the record?

One in six. The votes happened, and the tallies are reported accurately in most places. Everything built on top of them is wrong: FDA did not approve anything, nothing was added to any list, no rulemaking has begun, the April 2026 movement was a nominator's withdrawal rather than a clearance, and the committee's recommendations run against its own agency's written assessments rather than with them.

What changed for a buyer, and what did not?

Almost nothing changed, and one thing changed completely. Every compound reviewed in July 2026 remains an unapproved new drug that cannot be lawfully compounded, exactly as in June. What did change is the GLP-1 supply picture: the compounding route that supplied a great deal of semaglutide and tirzepatide closed across 2025, and two oral and injectable approvals since September 2025 have added licensed routes that did not previously exist.

The practical consequence is that "my clinic can get it compounded" is now a claim to test rather than assume. For most peptides it was never available; for the GLP-1s it was, briefly, and is not now. The statutory test is set out in compounding pharmacy versus research peptide, and the position outside the United States in are peptides legal.

Two FDA statements travel with everything on this page. On salt forms: these "are different active ingredients than are used in the approved drugs." On labelling: FDA "has warned companies that have illegally sold unapproved drugs... falsely labeled 'for research purposes' or 'not for human consumption.' These products have been sold directly to consumers for human use."

How do you check a regulatory claim about a peptide?

Check the date, the document and the decision-maker, in that order. Most false regulatory claims in this market are not fabricated — they are true statements about an earlier state of the record, or true statements about a committee attributed to an agency. A claim with no date attached cannot be evaluated at all, and on this subject an undated claim is more likely to be wrong than right, because four separate positions have moved since September 2023.

What does the platform data show on the compounds that moved?

The compounds the committee recommended are among the most heavily tested on this platform, and their test records were unaffected by the vote. The Purity Index records BPC-157 at 99.37 across 588 recency-weighted tests from 23 laboratories (verified August 2026), against a platform composite of 99.50, while the BPC-157 compound page shows 805 total HPLC tests averaging 99.35% across 230 verified shops (verified August 2026).

BPC-157 price data shows 66 shops in stock, a median of $5.90/mg and a lowest tracked price of $1.50/mg on a 10 mg vial (verified August 2026), with the lowest figure being the lowest of tracked sources rather than the lowest payable. Those figures exclude shipping, taxes and customs, coupon codes, bulk tiers, multi-vial kits and account-gated pricing. Peptigrity tracks 530 shops and 11,852 independent lab tests across 118 peptides, with 1,283 community reviews (verified August 2026), weighting community reviews and independently verified HPLC purity equally at 50% each, with no financial relationship influencing the ranking.

The observation worth drawing from that is negative and deliberate. A regulatory event does not change a certificate, and a compound recommended by a committee is analytically identical on 25 July to what it was on 22 July. Individual results sit in the lab test database and vendor-level scores in community-verified shop reviews.

The trial that would settle what the votes changed

Nobody has measured whether an advisory vote moves this market, and the design is not difficult. The July 2026 recommendations were widely reported as FDA action. Whether that reporting changed purchasing, pricing or listing language is an empirical question, answerable with data this platform already collects, and it would establish how much of the market's behaviour tracks the record rather than the headline.

Frequently Asked Questions

Did FDA approve BPC-157 in July 2026?

No. The Pharmacy Compounding Advisory Committee voted 8–6 with one abstention to recommend BPC-157 for the 503A bulks list, over the written objection of FDA's own reviewers. That vote is advisory and non-binding. FDA must complete formal rulemaking before anything is added, a process projected for 2027 or later, and the agency is not obliged to follow the recommendation.

What does "nominated but withdrawn" mean on FDA's page?

It means the person or company that nominated the substance for the bulks list pulled the nomination. FDA's own sentence introducing the table reads: "This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators." It is a procedural act by a third party, not a safety clearance, and FDA's published concerns often remain visible alongside the entry.

Which peptides are still on the active Category 2 list?

Four: GHRP-2, GHRP-6, ipamorelin acetate and kisspeptin-10. The fourteen-substance list also includes ibutamoren mesylate, which is a small molecule rather than a peptide, alongside cesium chloride, chloral hydrate, diethylstilbestrol, domperidone, edetate disodium, germanium sesquioxide, neomycin sulfate, quinacrine hydrochloride and tranilast. Those four peptides stayed because nobody withdrew their nominations.

Can a pharmacy still compound semaglutide or tirzepatide?

Not as an essential copy of the approved product. FDA declared the semaglutide injection shortage resolved on 21 February 2025, enforcement discretion ended on 22 April 2025 for 503A pharmacies and 22 May 2025 for 503B facilities, and the shortage database lists both Tirzepatide Injection and Semaglutide Injection as "Resolved." What survives is narrow and patient-specific, and FDA has proposed permanently excluding semaglutide from the 503B bulks list.

Why are the July 2026 vote counts described as press-derived?

Because FDA published no minutes and no transcript for the 23–24 July 2026 meeting. Every tally in circulation traces to published law-firm vote tables from Hyman Phelps & McNamara and Bass Berry, and to trade coverage. The votes are well attested across independent accounts, but they are not agency documents, and anyone citing them as such is describing a record that has not been released.

Does any of this change what is prohibited in sport?

No. Anti-doping status runs on a separate register maintained by WADA, and nothing FDA or its advisory committee did in this window altered it. Under the 2026 Prohibited List, S2.2.1 names gonadorelin and kisspeptin, S2.2.4 covers GHRH analogues including sermorelin and tesamorelin, S2.3 covers IGF-1 and its analogues, MGFs and thymosin-β4, and S4.3 names follistatin. GLP-1s are not prohibited.

Where this leaves the record

Three years of movement produced no change to what a pharmacy may lawfully compound from a peptide bulk substance. The 503A bulks list holds the same six substances it held in 2023, none of them a peptide, and the July 2026 recommendations sit with an agency that has issued no decision and begun no rulemaking. The only genuinely completed changes in the window were approvals and closures, not openings.

That is the shape of the record, and it is the opposite of the shape the coverage suggests. Elamipretide and orforglipron became real medicines, the GLP-1 compounding route closed, one supplement exclusion reversed and one injectable was recalled at Class I. Meanwhile the compounding question that generates most of the traffic remains exactly where it was on 29 September 2023.

Browse the tissue repair and healing peptides category, or our complete peptide guide with 118 compounds (verified August 2026). For per-injection volume, use the BPC-157 calculator alongside the reconstitution calculator. Compare shops through independent lab tests and community-verified shop reviews.

This article is for educational and informational purposes only and does not constitute medical advice. Peptides discussed may be investigational compounds not approved by the FDA (or equivalent regulators in your jurisdiction) for human use. Always consult a qualified healthcare provider before using any peptide or research compound. Peptigrity is an independent review platform and does not sell, endorse, or recommend specific products or vendors.