Are Peptides Legal? FDA Status of Every Major Peptide (2026 Tracker)

Key takeaways

• "Legal" is three questions: can you possess it (yes, peptides are not controlled substances), can a licensed pharmacy make it for you (only if it passes one of three tests in federal law), and can a company sell it to you (not without approval, whatever the label says).
• As of October 2026, the peptides a licensed US pharmacy can legally compound include sermorelin, bremelanotide (PT-141) and glutathione, plus semaglutide and tirzepatide in narrow circumstances. Tesamorelin is approved but, as a biological product, is available only as the brand Egrifta and cannot be compounded. BPC-157, TB-500, CJC-1295, ipamorelin and most "healing" and "longevity" peptides cannot be compounded.
• 2026 was the year the rules started moving: FDA took 12 peptides off its Category 2 safety-risk list in April, its advisory committee voted to recommend six of them (BPC-157, KPV, TB-500, MOTS-c, epitalon, semax) in July, and FDA has not yet acted on the votes. Nothing is permitted until it does.
• FDA also spent 2026 enforcing: 55 warning letters to telehealth companies over compounded GLP-1 marketing, and warning letters to online vendors whose "research use only" labels did not survive the dosing instructions on their websites.
• This page is updated when FDA, the Federal Register or a state board acts. The changelog is at the bottom.

Three different questions

People ask "are peptides legal?" and mean different things.

Can I possess or use it? Peptides are not scheduled under the Controlled Substances Act. Possessing a vial of BPC-157 is not a crime, and no one is prosecuted for injecting one. The one exception that behaves like a controlled substance is human growth hormone (somatropin), which is not a peptide in the marketing sense but is often sold alongside them: under 21 U.S.C. 333(e), knowingly distributing growth hormone, or possessing it with intent to distribute, for any use other than treating a disease or recognized condition where FDA has authorized that use under the drug-approval section of the Act and a physician has ordered it, is a federal felony with up to five years in prison, or ten if the recipient is under 18. A physician's order alone does not make an unapproved use lawful. That statute is why anti-aging clinics prescribe sermorelin and other secretagogues rather than growth hormone itself.

Can a licensed pharmacy make it for me? This is the question that matters for anyone who wants a labeled, accountable product, and it is governed by section 503A of the Federal Food, Drug, and Cosmetic Act and by FDA's lists, with one exclusion that catches some approved peptides: a biological product, which includes any protein longer than 40 amino acids, cannot be compounded at all. The rest of this page is mostly about it.

Can a company sell it to me? Selling a drug that is not FDA-approved for human use is illegal. Labeling it "research use only" or "not for human consumption" does not change the analysis if the seller's website, dosing guides or bundled supplies show it is intended for people. FDA said so in writing to seven online sellers in letters dated March 31, 2026, and to five more vendors on August 24, 2026.

The four legal lanes for a peptide

The three tests in the 503A lane decide most cases. Sermorelin passes because it was the active ingredient of an approved drug (Geref, withdrawn in 2008 for commercial reasons). Glutathione and NAD+ are compounded under FDA's interim policy for Category 1 substances, which lets pharmacies use a nominated substance while FDA evaluates it. BPC-157 fails all three: it has never been a component of an approved drug anywhere, there is no monograph, and it is not on the bulks list.

Biological products: approved, but never compounded

One exclusion sits outside the three tests. Under a rule published on February 21, 2020, any chain of more than 40 amino acids is a protein, and proteins are regulated as biological products (Federal Register 2020). On March 23, 2020 the approvals of protein drugs that had gone through the ordinary new-drug route were deemed biologics licenses, and FDA's notice to compounders states that biological products subject to licensure under section 351 of the Public Health Service Act, including those with deemed licenses, are not eligible for the compounding exemptions in sections 503A and 503B (FDA notice to compounders 2020). Being a component of an approved drug does not help a biological product.

That is why tesamorelin cannot be compounded. It has 44 amino acids, its approval was deemed a biologics license on March 23, 2020, and the current labels for Egrifta WR and Egrifta SV list application BLA022505 (Egrifta WR label). The only lawful tesamorelin in the United States is the brand, Egrifta WR (or Egrifta SV where still supplied), dispensed on prescription. It is approved to reduce excess abdominal fat in adults with HIV-associated lipodystrophy; a clinician may prescribe the brand off label, but insurance generally covers only the labeled use. "Compounded tesamorelin" sold by some clinics and telehealth companies is not made under a compounding exemption FDA recognizes, whatever the clinic says. The same rule keeps insulin, somatropin (growth hormone), mecasermin (IGF-1) and hCG out of compounding from bulk ingredients. FDA's warning-letter database, searched on October 10, 2026, lists five letters that mention tesamorelin, all dated August 24, 2026 and posted September 1, all to online vendors selling it with research-use labels; none was addressed to a compounding pharmacy, an outsourcing facility or a clinic.

Category 1, Category 2 and what "removed from Category 2" means

When a substance is nominated for the 503A bulks list, FDA sorts it into interim categories while the evaluation proceeds. Category 1 substances may be eligible for the list, were nominated with sufficient supporting information for FDA to evaluate them, and appear on no other FDA list; under an interim enforcement policy, pharmacies may compound them while FDA decides. That is tolerance during review, not a finding that they are safe or effective (FDA 503A page). Category 2 substances are those FDA found to raise significant safety risks, and pharmacies do not compound them. Category 3 nominations lacked enough information to evaluate.

On September 29, 2023 FDA added 19 substances to Category 2 in a single update, 18 peptides plus the small molecule ibutamoren (FDA category update 2023), including BPC-157, CJC-1295, ipamorelin, AOD-9604, thymosin alpha-1, TB-500, MOTS-c, epitalon, KPV, melanotan II and injectable GHK-Cu. On April 15, 2026, FDA announced that twelve of them were coming off Category 2 because their nominators had withdrawn the nominations. That removal ended the safety flag; it did not add anything to the permitted list, and it did not extend the Category 1 interim policy to them. By FDA's May 14, 2026 update, Category 2 for 503A holds only six substances: cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate (MK-677), kisspeptin-10 and intrauterine quinacrine. CJC-1295, ipamorelin, AOD-9604 and thymosin alpha-1 now appear on FDA's list of nominated-but-withdrawn substances, which means they are no longer flagged but still have no basis for compounding. In the words of the compounding lawyers at Frier Levitt, removal "does not make these substances eligible for compounding under section 503A."

What happened in 2026: the timeline

The tracker: status of each peptide, October 2026

"Compoundable" means a state-licensed 503A pharmacy may legally prepare it on a prescription. "Approved" means an FDA-approved product exists. Status reflects federal law; some states add restrictions.

"Research use only": what the 2026 warning letters changed

The research-chemical market has sold peptides for human use for a decade under disclaimers. In 2026 FDA made its position explicit in a series of warning letters. Seven letters dated March 31, 2026 and posted April 7 went to five research-peptide websites, including Gram Peptides (retatrutide, tirzepatide and bacteriostatic water), and to two eBay sellers of a semaglutide microneedle patch and an oral GLP-1 solution; the five letters of August 24, 2026 went to Peak Performance Peptides, Royal Peptides, NuScience Peptides, Peptide Partners and TXP Innovations over semaglutide, tirzepatide, retatrutide, tesamorelin, SS-31, PT-141, survodutide and mazdutide. Every vendor used a research-use disclaimer, and FDA rejected it in a footnote in each letter: despite the labeling, the websites showed the products were intended as drugs for human use. The evidence FDA cited was ordinary website content: dosing guidance, injection instructions, reconstitution calculators and bacteriostatic water bundled with the vials.

The letters cite sections 301(d) and 505(a) of the FD&C Act, which prohibit introducing an unapproved new drug into interstate commerce. They are addressed to sellers, not buyers. For a patient the consequence is practical rather than legal: a vendor that can be shut down at any time, a product no one has tested, and no clinician or pharmacist in the chain.

GLP-1s: the special case

Semaglutide and tirzepatide are legal, approved drugs. The question is only about compounded copies. While FDA listed the drugs as in shortage, section 503A and 503B pharmacies could compound them in quantity. FDA declared the tirzepatide shortage resolved on December 19, 2024 (FDA tirzepatide order 2024), and the semaglutide shortage on February 21, 2025 (FDA semaglutide order 2025), with short grace periods. Since then, a compounded GLP-1 is legal only for an individual patient whose documented clinical need cannot be met by the approved product, and FDA has said that commercial availability or price alone is not such a need and that adding an ingredient without a clinical rationale does not create one.

The enforcement followed in 2026: 30 warning letters to telehealth companies on March 3 and 25 more on June 16, over claims that compounded GLP-1s were the same as, or approved like, the brand products; and on May 1 a Federal Register notice proposing to keep semaglutide, tirzepatide and liraglutide off the 503B clinical-need list entirely. Our compounded semaglutide versus tirzepatide guide covers what that means when choosing a provider.

Prescribers, telehealth and states

A prescription for a peptide is valid only from a clinician licensed in the state where the patient is located at the time of the visit, which is why national telehealth companies list the states they serve. State pharmacy boards license the pharmacies and inspect 503A compounding; several states also regulate which compounded products may be shipped in. State medical boards act against prescribers who issue prescriptions without a legitimate evaluation. None of this changes the federal list of what may be compounded; it adds a layer on top.

What this means for you

1. If a licensed pharmacy can make it, get it that way. Sermorelin, PT-141, glutathione and, within limits, the GLP-1s have a legal, labeled path. Tesamorelin has one too, but only as the brand Egrifta, because no pharmacy may compound it. The price difference from a research vial buys a prescriber, a pharmacist, a label with the concentration, and a beyond-use date.
2. If no pharmacy can make it, the "legal" version does not exist yet. For BPC-157, TB-500, KPV, MOTS-c, epitalon and semax, the only honest statement in October 2026 is "recommended by a committee, not permitted." A clinic selling them is selling research vials.
3. Ask the pharmacy question. Which pharmacy, which state, 503A or 503B, and on what basis is this substance compoundable? A real answer takes ten seconds.
4. Watch this page. We update it when FDA publishes a rule, when the committee meets (next: LL-37, dihexa, injectable GHK-Cu, PEG-MGF and melanotan II, due before the end of February 2027) and when enforcement changes.

Bottom line

Peptides are legal to possess, legal to prescribe when they are approved drugs or legally compoundable, and illegal to sell as unapproved drugs regardless of the label. The 2026 advisory votes moved six popular peptides closer to the permitted list, but as of October 2026 none has arrived, and FDA's reviewers remain opposed. Until a rule is published, the legal map is the same as it was: sermorelin, bremelanotide and glutathione from a compounding pharmacy; tesamorelin as brand Egrifta only; the GLP-1s under tight conditions; everything else from no one accountable.

Changelog

• October 10, 2026 (fifth update): Added hexarelin (never nominated; fails all three tests) and IGF-1 LR3 (a biological product with no approved or compoundable form).
• October 10, 2026 (fourth update): Read FDA's Category 2 page and 503A page directly. Ipamorelin is still in Category 2 under the 503B interim policy. The 2023 placement was 19 substances on September 29, 2023. Category 1 now uses FDA's own definition. Added VIP (Category 1), the Category 3 peptides, insulin as a biological product and Louisiana Act 374.
• October 10, 2026 (third update): Corrected tesamorelin, which earlier versions of this page listed as compoundable. It is a 44-amino-acid protein regulated as a biological product since March 23, 2020 (the current Egrifta WR and Egrifta SV labels list BLA022505), and FDA does not consider biological products eligible for compounding under 503A or 503B, so the only lawful tesamorelin is brand Egrifta. Updated the takeaways, the FAQ, the lane table, the compound table, the advice and the bottom line; added a section on biological products (tesamorelin, somatropin, mecasermin, hCG) and the result of a search of FDA's warning-letter database for tesamorelin.
• October 10, 2026 (second update): Expanded the growth hormone statute summary (possession with intent to distribute, the FDA-authorized use and physician order requirements, ten years if the recipient is under 18) and added the abstention to the ipamorelin committee tally. Corrected the Selank row: FDA lists it as withdrawn from Category 2 without giving a date or reason.
• October 10, 2026 (update): Read FDA's May 14, 2026 category lists: topical GHK-Cu back in Category 1, glutathione and NAD+ in Category 1, only six substances left in Category 2. Added the December 4, 2024 committee tallies for CJC-1295, AOD-9604 and thymosin alpha-1 from FDA's minutes. Added the June 26 comment extension, the August 27 Fifth Circuit ruling and the September 18 Empower letter. Added kisspeptin-10 and ibutamoren (MK-677) with the October 29, 2024 committee tallies from FDA's minutes. Corrected the March 31, 2026 entry: seven warning letters, not one; added NAD+ Category 1 status, the elamipretide approval (September 19, 2025) and the bremelanotide 'essentially a copy' limit.
• October 10, 2026: First version. Reflects the April 15, 2026 Category 2 removals, the July 23-24, 2026 PCAC votes, the May 1, 2026 503B proposal, and the warning letters of March 3, March 31, June 16 and August 24, 2026.

Frequently asked questions

+−Is it illegal to buy or possess peptides?

Peptides are not controlled substances, so possessing them is not a crime under the Controlled Substances Act, and no one is prosecuted for having a vial of BPC-157. The law acts on the other side of the transaction: selling an unapproved drug for human use is illegal, and a research-use-only label does not change that, as FDA's 2026 warning letters state. Human growth hormone is the exception; distributing it for unapproved uses is a federal crime.

+−Is BPC-157 legal in 2026?

It is not FDA-approved, and as of October 2026 no licensed pharmacy may compound it: it is not on FDA's list of permitted bulk substances, not a component of an approved drug and has no USP monograph. It came off FDA's Category 2 safety-risk list in April 2026, and FDA's advisory committee voted 8 to 6 in July 2026 to recommend adding it to the permitted list, but FDA must complete rulemaking first and has not. Vials sold online as research chemicals are unapproved drugs when marketed for human use.

+−Can a doctor prescribe peptides?

A licensed clinician can prescribe any FDA-approved peptide drug, on or off label, and can prescribe a compounded peptide if a licensed pharmacy can legally prepare it. A prescription cannot make a non-compoundable substance compoundable, and a prescription for a research vial is not a prescription for a drug any pharmacy can fill.

+−What is FDA's Category 2 list?

When a substance is nominated for the list of bulk ingredients that 503A pharmacies may compound, FDA sorts it while the evaluation is pending. Category 1 substances may be compounded in the meantime under an interim enforcement policy; Category 2 substances are those FDA found to raise significant safety risks, and pharmacies do not compound them. Coming off Category 2 does not put a substance on the permitted list; it only ends the safety flag.

+−Are compounded semaglutide and tirzepatide still legal?

Only in limited circumstances. While the drugs were in shortage, pharmacies could compound copies in volume. FDA declared the tirzepatide shortage resolved in December 2024 and the semaglutide shortage in February 2025, after which a compounded version may be prepared only for a patient with a documented clinical need the approved product cannot meet, and never as a marketed copy. In 2026 FDA sent 55 warning letters to telehealth companies over how compounded GLP-1s were marketed, and in May 2026 proposed not to allow outsourcing facilities to use semaglutide, tirzepatide or liraglutide at all.

+−Which peptides can a compounding pharmacy legally make?

Those that pass one of three tests under section 503A: the substance has a USP monograph, it is a component of an FDA-approved drug (sermorelin, bremelanotide, semaglutide and tirzepatide within the limits above), or it appears on FDA's permitted bulk-substances list. Biological products are excluded altogether: proteins longer than 40 amino acids, including tesamorelin (Egrifta), somatropin, mecasermin and hCG, cannot be compounded under 503A or 503B even though approved versions exist. Most of the peptides marketed online for healing and anti-aging pass none of the tests.

+−Did FDA legalize BPC-157 and TB-500 in July 2026?

No. An advisory committee recommended adding six peptides to the permitted list. FDA's own reviewers had recommended against all of them, and the agency is not bound by the vote. Nothing changes until FDA publishes a rule, which the lawyers who follow the committee expect to take months at least. As of October 2026 no proposed rule has appeared in the Federal Register.

+−Is it legal to order peptides from overseas?

Importing an unapproved drug for personal use is generally not permitted; FDA may detain it and the seller is violating the law. Enforcement against individuals is rare, but the practical problems are the same as for domestic research vials: no label, no verified content, no recourse.

Sources

1. RegulatoryFDA. Compounding and the FDA: questions and answers.
2. RegulatoryFDA. Bulk drug substances used in compounding under section 503A of the FD&C Act (the 503A bulks list and interim categories).
3. RegulatoryFDA. Certain bulk drug substances for use in compounding may present significant safety risks (Category 2 list).
4. RegulatoryFDA. FDA's concerns with unapproved GLP-1 drugs used for weight loss (compounding after the shortages, salt forms, adverse event reports; content current as of October 1, 2026).
5. RegulatoryFDA. Declaratory order: resolution of shortages of tirzepatide injection products (Mounjaro and Zepbound), December 19, 2024. (2024)
6. RegulatoryFDA. Declaratory order: resolution of shortages of semaglutide injection products (Ozempic and Wegovy), February 21, 2025. (2025)
7. NewsAlliance for Pharmacy Compounding. PCAC to discuss 503A bulks list substances (ipamorelin and kisspeptin-10 on October 29, 2024; AOD-9604, CJC-1295 and thymosin alpha-1 on December 4, 2024). September 2024. (2024)
8. RegulatoryFDA. 2024 meeting materials, Pharmacy Compounding Advisory Committee (including summary minutes of the October 29 and December 4, 2024 meetings). (2024)
9. RegulatoryFDA. Final summary minutes, Pharmacy Compounding Advisory Committee meeting of October 29, 2024 (ipamorelin, ibutamoren mesylate, kisspeptin-10, L-theanine). (2024)
10. RegulatoryFDA. Final summary minutes, Pharmacy Compounding Advisory Committee meeting of December 4, 2024 (CJC-1295, AOD-9604, thymosin alpha-1). (2024)
11. RegulatoryFDA. Bulk drug substances nominated for use in compounding under section 503A: Category 1, 2 and 3 lists and updates (updated May 14, 2026). (2026)
12. 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)
13. RegulatoryLouisiana Legislature. SB 253 (2026 Regular Session), signed by the Governor May 22, 2026 as Act 374, effective August 1, 2026 (public health: provides relative to peptides). Enrolled act (enacting R.S. 37:23.5) read October 12, 2026. (2026)
14. NewsFrier Levitt. FDA to remove 12 popular peptides from the Category 2 'do not compound' list. April 16, 2026. (2026)
15. 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 (docket FDA-2025-N-6895). April 16, 2026. (2026)
16. RegulatoryFederal Register. List of bulk drug substances for which there is a clinical need under section 503B: FDA proposes not to include semaglutide, tirzepatide and liraglutide. May 1, 2026. (2026)
17. RegulatoryFDA. July 23-24, 2026 meeting of the Pharmacy Compounding Advisory Committee. (2026)
18. 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)
19. 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)
20. NewsKelley Drye. FDA advisory committee recommends several peptides for compounding despite staff opposition: what stakeholders need to know. July 30, 2026. (2026)
21. NewsBascom E. FDA committee recommends looser restrictions for several peptides. Healio Endocrine Today, July 24, 2026. (2026)
22. RegulatoryFDA. FDA warns 30 telehealth companies against illegal marketing of compounded GLP-1s. Press announcement, March 2026. (2026)
23. NewsTelehealth.org. FDA sends new round of warning letters (25 companies) over compounded GLP-1 marketing claims. June 2026. (2026)
24. RegulatoryFDA. Warning letter to Gram Peptides (retatrutide, tirzepatide and bacteriostatic water sold with research-use labels). March 31, 2026. (2026)
25. NewsPolicy Canary. The research use only loophole just closed: FDA hits seven peptide websites in a single day (warning letters dated March 31, 2026, posted April 7, 2026). April 21, 2026. (2026)
26. RegulatoryUS Court of Appeals for the Fifth Circuit. Outsourcing Facilities Association v. FDA, No. 25-10600, unpublished opinion affirming judgment for FDA, August 27, 2026. (2026)
27. NewsFrier Levitt. FDA warning letter signals new enforcement theory for compounded GLP-1 combination products (Empower Pharmacy letter of September 18, 2026). September 25, 2026. (2026)
28. 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)
29. RegulatoryFederal Register. Definition of the term 'biological product': final rule defining a protein as any alpha amino acid polymer with a specific, defined sequence greater than 40 amino acids in size. 85 FR 10057, February 21, 2020. (2020)
30. RegulatoryFDA. Notice to compounders: changes that affect compounding as of March 23, 2020 (biological products subject to licensure under section 351 of the PHS Act, including those with deemed biologics license applications, are not eligible for the exemptions in sections 503A and 503B). Content current as of March 5, 2020. (2020)
31. LabelTheratechnologies. EGRIFTA WR (tesamorelin) for injection: prescribing information. DailyMed SPL published August 3, 2026, application BLA022505 (the EGRIFTA SV SPL, setid 3d783378-b02d-4f19-99dd-0fc91a042224, published July 31, 2026, lists the same application). (2026)
32. Regulatory21 U.S.C. 333(e): prohibited distribution of human growth hormone.