FDA Category 2 Peptides Explained: The List, Why They're Restricted, What It Means for Patients (2026)

Key takeaways

• Category 2 is a holding bin in FDA's interim compounding policy: nominated bulk substances that FDA says may present significant safety risks. A pharmacy that compounds with one is outside the policy and risks FDA action. It is not a ban on owning anything, and it is not the list of permitted substances.
• As of FDA's list updated May 14, 2026, Category 2 for 503A pharmacies holds six substances: cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate (MK-677), kisspeptin-10 and intrauterine quinacrine. Kisspeptin-10 is the only peptide among them.
• Seventeen peptides FDA put in Category 2 on September 29, 2023, including BPC-157, TB-500, CJC-1295, ipamorelin and MOTS-c, are now on FDA's list of nominations that were withdrawn. Leaving Category 2 did not make any of them compoundable.
• FDA's stated reasons were mostly the same: possible immune reactions from aggregates and impurities, products that are hard to characterize, and little or no human safety data. A few carried specific signals, such as deaths after intravenous ipamorelin and melanoma case reports with melanotan II.
• For a patient the rule is short: if a peptide is in Category 2, or left it without reaching the permitted list, no licensed US pharmacy may make it for you, and what is on offer is a research vial. The legal tracker gives the status of every major peptide.

FDA's Category 2 list is the document most people mean when they talk about an "FDA peptide ban," and one of the most misdescribed in the peptide market. It is not a ban on possession and never was. It tells compounding pharmacies which nominated ingredients FDA considers too risky to use while it decides whether to permit them. This page explains the category, sets out the full current list as we read it in FDA's own documents on October 10, 2026, tells the history of the peptides that entered and left it, and explains what each status means if you want a peptide made legally.

For the status of each individual peptide, including approved drugs and the GLP-1s, the source of truth is our legal tracker: are peptides legal?. If your question is about one compound, read is BPC-157 legal?; if it is about the headlines, read what the 'FDA peptide ban' actually changed.

Where Category 2 comes from

A state-licensed pharmacy compounding under section 503A of the Federal Food, Drug, and Cosmetic Act may use a bulk ingredient only if it passes one of three tests: it complies with a USP or National Formulary monograph, it is a component of an FDA-approved drug, or it appears on FDA's list of bulk drug substances that can be used in compounding, the 503A bulks list. The ingredient must also come with a certificate of analysis from an FDA-registered manufacturer (FDA 503A).

The permitted list is short. The final rule of February 2019 placed six substances on it: Brilliant Blue G and five topical-only ingredients (cantharidin, diphenylcyclopropenone, N-acetyl-D-glucosamine, squaric acid dibutyl ester and thymol iodide). None is a peptide. The same rule says that anyone who represents a drug compounded from a listed substance as FDA-approved misbrands it (21 CFR 216.23). A September 2019 proposal to add five more substances and reject 26 has not been finalized (FDA 503A).

FDA began collecting nominations in 2015 and evaluates them slowly, through its Pharmacy Compounding Advisory Committee (PCAC) and rulemaking. Meanwhile, an interim policy sorts the nominations into three categories:

Sources: definitions (FDA 503A); lists (FDA categories 2026).

Three details in that table are easy to miss.

Category 1 is tolerance, not permission. A Category 1 substance has not been approved for anything and is not on the bulks list. FDA has simply said it will not act against pharmacies that use it, under stated conditions, while it decides, and it can remove a substance from Category 1 at any time, for example on new safety information (FDA 503A).

The categories are closed to newcomers. FDA revised the policy so that substances nominated on or after January 7, 2025 are not placed in any category (FDA 503A). A peptide nominated today gets no interim tolerance; it waits for a rule.

There are two Category 2 lists. Outsourcing facilities registered under section 503B have a parallel interim policy with its own Category 2. FDA publishes both on one page, marked 503A, 503B or both (FDA Category 2).

The current Category 2 list

For 503A pharmacies, the list that matters for prescriptions

These are the six substances in 503A Category 2 on FDA's list updated May 14, 2026 (FDA categories 2026), with the date each was added and the risk FDA states for it (FDA Category 2).

Of the six, kisspeptin-10 is the only peptide. FDA's advisory committee voted 0 to 11 against adding it to the bulks list on October 29, 2024, and voted 1 to 13 against ibutamoren the same day (FDA PCAC minutes, October 2024). Our kisspeptin-10 profile covers what the human research does and does not show.

For 503B outsourcing facilities

The 503B Category 2 list has ten entries. Two are shared with 503A (ibutamoren and intrauterine quinacrine), three are peptides added on September 29, 2023 (ipamorelin acetate, GHRP-2 for injectable and nasal routes, and GHRP-6), and the rest are non-peptide drugs: chloral hydrate, diethylstilbestrol, edetate disodium (except ophthalmic use), parenteral neomycin sulfate (with narrow exceptions) and tranilast (FDA Category 2).

For GHRP-2, FDA cites immunogenicity and reports of serious adverse events, including deaths among critically ill study subjects and pancreatitis, without established causality; for GHRP-6, possible effects on cortisol and blood glucose (FDA Category 2). On the 503A side, both sit in Category 3 (FDA categories 2026).

Ipamorelin is the odd case. FDA's page lists it twice: on the withdrawn list for 503A, and in the Category 2 table "because it is in category 2 under the 503B interim policy" (FDA Category 2). Neither a 503A pharmacy nor a 503B facility has a basis to make it.

The peptides that left Category 2

On September 29, 2023, FDA added 19 substances to 503A Category 2 in a single update, almost all of them peptides sold by wellness clinics: AOD-9604, BPC-157, cathelicidin LL-37, CJC-1295, dihexa acetate, emideltide (DSIP), epitalon, injectable GHK-Cu, ibutamoren mesylate, ipamorelin acetate, kisspeptin-10, KPV, melanotan II, pegylated mechano growth factor (PEG-MGF), MOTS-c, selank acetate, semax, thymosin alpha-1 and the thymosin beta-4 fragment sold as TB-500 (FDA categories 2023). That brought 503A Category 2 to 23 entries. Compounding pharmacies that had been making these peptides stopped.

By May 2026, 17 of those 19 had come off. Twelve came off in one step: on April 15, 2026, FDA announced that BPC-157, KPV, TB-500, MOTS-c, emideltide, epitalon, semax, LL-37, dihexa, injectable GHK-Cu, PEG-MGF and melanotan II were leaving Category 2 because their nominators had withdrawn the nominations (Frier Levitt 2026). Five others (AOD-9604, CJC-1295, ipamorelin, thymosin alpha-1 and selank) appear on the same withdrawn list without a date. Only kisspeptin-10 and ibutamoren remain.

FDA keeps publishing the safety concerns for the withdrawn substances. This is what it says about each, and where each stands now.

Sources: risks (FDA Category 2); 2024 votes (FDA PCAC minutes, October 2024) (FDA PCAC minutes, December 2024); 2026 votes (HPM, July 24) (HPM, July 28); GHK-Cu (FDA categories 2026).

Every answer in the right-hand column is no. The hubs have the evidence in full: BPC-157, TB-500, CJC-1295 and ipamorelin, MOTS-c, KPV, AOD-9604, thymosin alpha-1, LL-37, dihexa, DSIP, semax and selank and GHK-Cu.

Why FDA flagged them

Read FDA's entries side by side and four reasons recur.

1. Immune reactions. Almost every peptide entry cites a risk of immunogenicity "due to the potential for aggregation and peptide-related impurities" (FDA Category 2). An injected peptide that clumps, or carries by-products of its synthesis, can provoke an immune response, and nobody has measured how often that happens with these products.
2. Not knowing what is in the vial. Many entries cite complexities in characterizing the active ingredient. For ipamorelin and GHRP-2, FDA adds that unnatural amino acids make characterization harder. At the July 2026 committee meeting, FDA's reviewers said the BPC-157 products on the market vary in amino-acid count and have no settled salt or free-base form (HPM, July 24), and that TB-500 sequences and molecular weights vary by vendor (Kelley Drye 2026).
3. No human safety data. For KPV, MOTS-c, PEG-MGF, dihexa and TB-500, FDA found no human exposure data by any route. For most of the others it found "no, or only limited" information and concluded it "lacks sufficient information to know whether the drug would cause harm" (FDA Category 2).
4. Specific signals. A few entries go further, as the tables above show: deaths with intravenous ipamorelin, cardiovascular reactions with CJC-1295, melanoma case reports with melanotan II and a heart-failure signal with ibutamoren (FDA Category 2).

Category 2 was mostly FDA saying it did not know enough, not that it had proof of harm. That cuts both ways. Sellers cite the April 2026 removals as if they cleared the peptides; nothing in FDA's documents says so, and FDA's reviewers argued against all seven peptides at the July 2026 meeting, citing missing human data, uncertain identity and immunogenicity (Kelley Drye 2026).

Leaving Category 2 is not the same as being allowed

The April 2026 removals ended the safety flag. They did not add any peptide to the bulks list, and they did not move any into Category 1. In Frier Levitt's reading at the time, removal does not make these substances eligible for 503A compounding (Frier Levitt 2026). A withdrawn peptide is in no category at all, and it still fails all three tests: it is not a component of an approved drug, it has no monograph, and it is not on the list.

What could change that is rulemaking. On July 23 and 24, 2026, the committee reviewed seven nominations for specific uses that FDA evaluated: BPC-157 for ulcerative colitis, KPV for wound healing and inflammatory conditions, TB-500 for wound healing, MOTS-c for obesity and osteoporosis, emideltide for opioid withdrawal, chronic insomnia and narcolepsy, semax for cerebral ischemia, migraine and trigeminal neuralgia, and epitalon for insomnia (Federal Register, April 16, 2026). It voted to recommend six and rejected emideltide (HPM, July 24) (HPM, July 28). The votes are advisory. FDA has to publish a proposed rule, take comments and issue a final rule before a pharmacy may use any of them, and our search of the Federal Register on October 10, 2026 found no proposed rule. Five more withdrawn peptides, LL-37, dihexa, injectable GHK-Cu, PEG-MGF and melanotan II, are due before the committee by the end of February 2027.

What each status means for you

Tesamorelin is the exception that catches people out. It is a 44-amino-acid peptide, and Egrifta's current labels list a biologics license, BLA022505 (Egrifta label): on March 23, 2020, approved products of that kind were deemed licensed biological products, and FDA's notice to compounders says biological products with deemed licenses are not eligible for the 503A and 503B compounding exemptions (FDA notice, 2020). The only legal tesamorelin is brand Egrifta on prescription. The legal tracker covers the other rows in detail, including the narrow conditions for compounded semaglutide and tirzepatide.

What that means in practice:

1. Possession is not the issue. Peptides are not controlled substances, and possessing a vial of BPC-157 is not a crime. The law acts on sellers: selling an unapproved drug for human use is illegal, and FDA's 2026 warning letters rejected "research use only" labels on websites that gave dosing guidance, reconstitution calculators or bundled bacteriostatic water (ArentFox Schiff 2026). Importing an unapproved drug for personal use is generally not permitted either. The FDA peptide ban explainer sets out what each 2026 action did.
2. A prescription does not change the category. A pharmacy may only fill a prescription from an ingredient that passes the three tests. A telehealth service that "prescribes" BPC-157 or CJC-1295 is attaching a consultation to a research vial, or using a pharmacy that is breaking the rules. See whether telehealth can prescribe peptides for how a legitimate prescription works.
3. Ask the pharmacy question. Which pharmacy, in which state, 503A or 503B, and on what basis is this substance compoundable? For anything in the "No" rows there is no good answer.
4. Compare like with like on price. A research vial is cheaper than a compounded prescription because it comes without a prescriber, a pharmacist, a label or recourse. Our peptide therapy cost guide has October 2026 prices for the peptides a pharmacy can legally make, such as sermorelin at roughly $150 to $400 a month through telehealth.
5. Use tools only with a labeled product. Our peptide calculator is built for a prescription vial with a concentration printed on a pharmacy label. FDA cited reconstitution calculators on vendor websites as evidence that research peptides were being sold for human use.

If you are new to how prescription peptide therapy works end to end, start with what peptides are and the complete guide to peptide therapy.

Category 2 timeline

Sources: (FDA Category 2) (FDA categories 2023) (FDA categories 2026) (FDA 503A) (21 CFR 216.23). The legal tracker's changelog records every update we make.

Bottom line

Category 2 is a safety flag inside a temporary policy, not a law against owning peptides. In October 2026 it holds one peptide for 503A pharmacies, kisspeptin-10, plus ipamorelin, GHRP-2 and GHRP-6 for outsourcing facilities. The 17 peptides that left it became unflagged substances with no basis for compounding, six of them recommended by a committee whose votes FDA has not acted on. Until FDA publishes a rule, no licensed pharmacy can make BPC-157, TB-500 or the rest for you. We update the tracker the day that changes.

Frequently asked questions

+−What are Category 2 peptides?

They are peptides that were nominated for FDA's list of bulk substances pharmacies may compound and that FDA placed in Category 2 of its interim policy because it identified potential significant safety risks. A pharmacy that compounds with a Category 2 substance is outside FDA's interim policy, and FDA would consider enforcement action. As of FDA's May 14, 2026 list, the only peptide still in Category 2 for 503A pharmacies is kisspeptin-10.

+−What peptides are on the FDA Category 2 list in 2026?

For 503A pharmacies, FDA's list updated May 14, 2026 has six substances: cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate (MK-677), kisspeptin-10 and quinacrine hydrochloride for intrauterine use. For 503B outsourcing facilities, Category 2 also includes ipamorelin acetate, GHRP-2 and GHRP-6. BPC-157, TB-500, CJC-1295 and fourteen other peptides are now on FDA's separate list of substances whose nominations were withdrawn.

+−Is BPC-157 still on the Category 2 list?

No. FDA announced on April 15, 2026 that BPC-157 and eleven other peptides were coming off Category 2 because their nominators had withdrawn the nominations. That did not make BPC-157 compoundable: it is not an approved-drug component, has no USP monograph and is not on the 503A bulks list. FDA's advisory committee recommended adding it in July 2026, and as of October 2026 FDA has not published a rule.

+−What does it mean when a peptide is removed from Category 2?

It means FDA no longer lists it as a substance that may present significant safety risks under the interim policy. It does not put the peptide on the permitted list, and it does not move it into Category 1, the only category FDA tolerates compounding from while it evaluates. A withdrawn peptide still fails the three legal tests, so no licensed pharmacy may compound it.

+−Why are peptides not FDA approved?

Approval requires a company to run clinical trials and submit them to FDA, and for most wellness peptides no one has. Many approved drugs are peptides, including insulin, semaglutide, tirzepatide and tesamorelin. The peptides sold for healing and longevity, such as BPC-157, TB-500 and MOTS-c, have little or no controlled human data, which is also why FDA flagged them as safety risks for compounding in 2023.

+−What peptides are banned by the FDA?

FDA does not ban possession of any peptide; peptides are not controlled substances. What FDA restricts is who may make and sell them. No licensed pharmacy may compound a peptide that is in Category 2 or that left Category 2 without reaching the permitted list, and selling any unapproved peptide for human use is illegal regardless of a research-use label. Our legal tracker lists the status of each peptide.

+−Can a compounding pharmacy make Category 2 peptides with a prescription?

No. A prescription is required for compounding, but it does not change what a pharmacy may use. The bulk substance must have a USP monograph, be a component of an FDA-approved drug or be on FDA's 503A bulks list. Category 2 substances, and peptides that left Category 2 without being listed, meet none of those tests.

+−What is the difference between Category 1 and Category 2?

Both are interim categories for substances nominated to the 503A bulks list. Category 1 substances were nominated with enough information to evaluate, and FDA does not intend to act against pharmacies that compound with them while it decides, if the guidance's conditions are met. Category 2 substances were also evaluable, but FDA identified significant safety risks, so the interim policy does not cover them. Glutathione and NAD are in Category 1; kisspeptin-10 is in Category 2.

+−Is it illegal to buy Category 2 peptides?

Possessing a peptide is not a crime, because peptides are not controlled substances. Selling an unapproved peptide for human use is illegal, and FDA's 2026 warning letters rejected research-use-only labels when sellers' websites showed the products were meant for people. Importing an unapproved drug for personal use is generally not permitted, and FDA may detain it.

Sources

1. RegulatoryFDA. Bulk drug substances nominated for use in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act: Category 1, 2 and 3 lists and updates (updated May 14, 2026). Read October 10, 2026. (2026)
2. RegulatoryFDA. Certain bulk drug substances for use in compounding that may present significant safety risks: Category 2 of the substances nominated under sections 503A and 503B, and substances nominated but withdrawn (content current as of April 22, 2026). Read October 10, 2026. (2026)
3. RegulatoryFDA. Bulk drug substances used in compounding under section 503A of the FD&C Act: the three legal tests, the 503A bulks list and the interim policy categories (content current as of May 14, 2026). Read October 10, 2026. (2026)
4. RegulatoryFDA. Bulk drug substances nominated for use in compounding under section 503A: notice of updates to categories (19 substances added to Category 2), updated September 29, 2023. Copy hosted by the Alliance for Pharmacy Compounding. (2023)
5. Regulatory21 CFR 216.23: bulk drug substances that can be used to compound drug products in accordance with section 503A (84 FR 4710, February 19, 2019). Legal Information Institute, Cornell Law School, read October 10, 2026. (2019)
6. RegulatoryFDA. Final summary minutes, Pharmacy Compounding Advisory Committee meeting of October 29, 2024 (ipamorelin, ibutamoren mesylate, kisspeptin-10, L-theanine). (2024)
7. RegulatoryFDA. Final summary minutes, Pharmacy Compounding Advisory Committee meeting of December 4, 2024 (CJC-1295, AOD-9604, thymosin alpha-1). (2024)
8. NewsFrier Levitt. FDA to remove 12 popular peptides from the Category 2 'do not compound' list. April 16, 2026. (2026)
9. RegulatoryFederal Register. Pharmacy Compounding Advisory Committee; notice of meeting; establishment of a public docket; request for comments: bulk drug substances nominated for inclusion on the section 503A bulk drug substances list (meeting July 23-24, 2026, with the uses FDA evaluated for each substance). April 16, 2026. (2026)
10. NewsPalmer KL, Snow CD, Bass M. PCAC approves four bulk drug substances for the 503A list (BPC-157, KPV, TB-500, MOTS-c). FDA Law Blog, Hyman Phelps & McNamara, July 24, 2026. (2026)
11. NewsSnow CD, Palmer KL, Bass M. PCAC adds two more bulk drug substances for the 503A list (epitalon, semax; emideltide rejected). FDA Law Blog, July 28, 2026. (2026)
12. NewsKelley Drye. FDA advisory committee recommends several peptides for compounding despite staff opposition: what stakeholders need to know. July 30, 2026. (2026)
13. NewsArentFox Schiff. RUO-ined: five peptide vendors learn that research use only is not a legal strategy (FDA warning letters of August 24, 2026). September 18, 2026. (2026)
14. RegulatoryFDA. Notice to compounders: changes that affect compounding as of March 23, 2020 (biological products with deemed biologics licenses are not eligible for the 503A and 503B exemptions). Read October 10, 2026. (2020)
15. LabelEgrifta WR (tesamorelin for injection) prescribing information, application BLA022505; DailyMed SPL published August 3, 2026, read October 10, 2026. (2026)