# Are Peptides Legal? What FDA’s 2026 Lists Say

By Ruth Calder, Enforcement Editor (https://glpwatchdog.org/authors/ruth-calder) | Published: 2026-09-27 | Updated: 2026-11-05

Canonical page: https://glpwatchdog.org/research/are-peptides-legal

> Most peptides sold online are not approved drugs and are not on FDA’s 503A bulks list. This reads each FDA list peptide by peptide, explains why “withdrawn” is not a green light, and sets out what the HHS policy of October 28, 2026 covers for six of them.

Some peptides are legal prescription drugs, and most of the ones sold online are not. Semaglutide, the drug in Wegovy and Ozempic, is an FDA-approved peptide drug. BPC-157, TB-500, MOTS-c and most other “research peptides” have no approval for any use and are not on the list of substances a US pharmacy may use to compound. FDA’s April 2026 update lists them as “withdrawn” from its safety-risk category, and that did not make them legal to compound. In an interim policy dated October 28, 2026, HHS said it does not intend to take enforcement action against 503A pharmacies that compound six of them (BPC-157, TB-500, Epitalon, Semax, KPV and MOTS-c) under strict conditions.[22] That interim policy is not an approval, and it leaves every other research peptide where it was.

> **About this article.** Every status below comes from FDA and HHS documents we read in full between September and October 2026, linked in the references. We describe what the rules say. This is not legal advice, and it does not cover state law or personal possession; for your own situation, ask a lawyer licensed in your state.

## Three different questions hide inside “is it legal?”

Sellers and critics both blur these together, so it helps to pull them apart.

1. **Is it an FDA-approved drug?** If yes, a doctor can prescribe the approved product and a pharmacy can dispense it. Semaglutide (Wegovy, Ozempic, Rybelsus) is in this group.[15][16] BPC-157 and TB-500 are not.
2. **May a pharmacy compound it?** A compounding pharmacy mixes a drug for one patient from raw ingredients. Federal law limits which raw ingredients it may use, and most research peptides fall outside those limits.[1] Under an interim policy dated October 28, 2026, HHS does not plan to pursue 503A compounding of six of them, under set conditions.[22]
3. **Does a “research use only” label change anything?** For a seller whose website shows the product is meant for people, FDA says no.[13]

## The lists that decide what a pharmacy may compound

Under section 503A of the Food, Drug, and Cosmetic Act, a state-licensed pharmacy may compound only from ingredients that meet one of three tests: the ingredient has a USP or NF monograph, it is already an ingredient in an approved drug, or it appears on FDA’s **503A bulks list**.[1] A 503A pharmacy also needs a prescription written for one specific patient.[5]

The 503A bulks list is short. It names six substances, among them Brilliant Blue G and cantharidin for topical use. None is a peptide.[4] While FDA works through nominations for that list, an interim policy sorts nominated substances into three categories:[1]

*FDA's three interim categories for substances nominated to the 503A bulks list*

| Category | What FDA says it means | What FDA says it will do |
| --- | --- | --- |
| Category 1 | Nominated with enough information for FDA to evaluate, and may be eligible for the list | Does not intend to act against a compounder using it, if the guidance conditions are met |
| Category 2 | FDA has identified significant safety risks pending further evaluation | Would consider taking action against a compounder using it |
| Category 3 | Nominated without enough supporting information to evaluate | Would consider taking action against a compounder using it |

Two details matter for peptide buyers. First, FDA says it does not intend to place substances nominated on or after January 7, 2025 into any of these categories, so a newly nominated peptide gets no interim cover.[1] Second, a substance that is on none of these lists and meets none of the three tests has no 503A route at all.

Outsourcing facilities, regulated under section 503B, are a separate channel. They follow manufacturing-quality (CGMP) rules and are inspected by FDA on a risk-based schedule.[5] FDA’s safety-risk list marks each entry as 503A, 503B or both, which is why a peptide can be restricted in one channel and not named in the other.[3]

## What the April 2026 update shows, and why it is not a green light

FDA’s web page listing bulk substances it says may carry significant safety risks, current as of April 22, 2026, now has two tables. The first is the active Category 2 list. The second is headed “Bulk drug substances nominated but withdrawn”, which FDA describes as substances “previously in category 2” that “were withdrawn by the nominators.”[3]

Most of the peptides sold online now sit in that second table: BPC-157, TB-500 (listed as thymosin beta-4 fragment), MOTs-C, KPV, CJC-1295, epitalon, Semax, selank, emideltide (DSIP), thymosin alpha-1, [cathelicidin LL-37](https://glpwatchdog.org/research/ll-37-a-peptide-with-no-human-trials), [Melanotan II](https://glpwatchdog.org/research/melanotan-versus-the-approved-one), [AOD-9604](https://glpwatchdog.org/research/aod-9604-what-the-evidence-shows), PEG-MGF, dihexa acetate and injectable GHK-Cu.[3] FDA kept its safety notes for each. For CJC-1295, FDA points to serious adverse events, among them a faster heart rate and a vasodilatory reaction. For Melanotan II, it cites published case reports of “melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism.”[3]

> **Withdrawn is not approved.** A withdrawn nomination is not a nomination at all, so these peptides are in no interim category and are not on the 503A bulks list. They are also not approved drugs. On FDA’s lists, that leaves no 503A route for a pharmacy to compound them.[1][2][4]

Several of these peptides were then put back in front of FDA’s Pharmacy Compounding Advisory Committee, which advises the agency.[5] Its July 23 and 24, 2026 meeting took up BPC-157, KPV, TB-500 and MOTs-C on the first day and emideltide, Semax and epitalon on the second, each as a candidate for the 503A bulks list.[6] FDA’s own briefing documents for BPC-157, TB-500, MOTS-c and KPV each conclude that “a balancing of the criteria weighs against” adding them.[7][8][9][10] Those documents also say FDA “will not issue a final determination” until it has considered the committee’s input.[7]

FDA itself has not published how the committee voted. As of October 15, 2026, the meeting page offers the briefing documents, the questions, the agenda, the roster and the agency’s slides, but no summary minutes and no tally.[6] Reporters who covered both days fill that gap. According to Healio, AJMC and Pharmaceutical Executive, the committee sided against FDA’s reviewers on six of the seven peptides and turned down only [emideltide](https://glpwatchdog.org/peptides/dsip).[17][18][19] Healio reported that the free-base and acetate forms of each peptide were voted on separately and came out the same way.[17]

*July 2026 advisory committee votes on the 503A bulks list, as reported by trade press (FDA has posted no tally)*

| Peptide | Reported vote (yes–no–abstain) | Date | Outcome | Reported by |
| --- | --- | --- | --- | --- |
| BPC-157 | 8–6–1 | July 23, 2026 | Recommended | Healio, AJMC, Pharmaceutical Executive[17][18][19] |
| KPV | 8–6–1 | July 23, 2026 | Recommended | Healio, AJMC, Pharmaceutical Executive[17][18][19] |
| TB-500 | 8–6–1 | July 23, 2026 | Recommended | Healio, AJMC, Pharmaceutical Executive[17][18][19] |
| MOTs-C | 7–5–2 | July 23, 2026 | Recommended | Healio, AJMC, Pharmaceutical Executive[17][18][19] |
| Emideltide (DSIP) | 6–7–1 | July 24, 2026 | Not recommended | Healio, AJMC[17][18] |
| Semax | 8–5–1 | July 24, 2026 | Recommended | Healio[17] |
| Epitalon | 7–4–1 | July 24, 2026 | Recommended | Healio[17] |

A favorable vote is a recommendation, not a change in status. FDA’s meeting page describes the committee’s advice as non-binding, and Pharmaceutical Executive reported that putting any of these peptides on the list would take formal rulemaking.[6][19] By October 15, 2026, FDA had proposed no such rule, and the regulation that holds the 503A bulks list, last amended in 2019, still contains no peptide.[4] HHS then acted without a rule, as the next section explains.

The committee’s earlier peptide votes, by contrast, are on FDA’s own record. Minutes of its December 4, 2024 meeting record members turning down AOD-9604 by 12 votes to none, each form of [thymosin alpha-1](https://glpwatchdog.org/peptides/thymosin-alpha-1) by 17 to 4, and four of the five CJC-1295 forms by 13 to none, with CJC-1295 acetate rejected 12 to 1.[20] A further meeting on GHK-Cu, LL-37, dihexa acetate, Melanotan II and PEG-MGF is promised before the end of February 2027, but FDA has not yet announced a date.[21]

## The HHS policy of October 28, 2026

HHS published an [interim enforcement policy](https://glpwatchdog.org/research/hhs-peptide-compounding-policy-2026) on October 28, 2026 covering six of the peptides the committee backed: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. Emideltide, which the committee turned down, is not included.[22] For as long as no final rule has settled whether each one joins the 503A bulks list, HHS does not intend to take enforcement action against licensed pharmacies or physicians that compound one of the six under section 503A, provided they meet every condition in the policy.[22] HHS presents the policy as a way to draw buyers away from research-use-only peptides made by overseas suppliers, which it calls a safety risk.[22]

The policy does not approve these peptides and does not put them on the 503A bulks list. It covers compounding under section 503A, and HHS reserves the right to narrow or withdraw it if safety or quality problems surface.[22] The Federal Register notice of October 30, 2026 labels it a draft with no binding force on HHS or on the public, and gives two weeks for written comments.[23] Each peptide is covered only in a named form and by named routes:[22]

*Forms and routes covered by the HHS interim policy (Appendix B)*

| Peptide | Form named | Routes covered |
| --- | --- | --- |
| BPC-157 | Acetate | Subcutaneous, intramuscular, oral and topical |
| TB-500 | Acetate | Subcutaneous or intramuscular injection |
| Epitalon | Acetate | Injection under the skin or into muscle, in intermittent courses |
| MOTS-c | Acetate | Subcutaneous or intramuscular injection |
| KPV | Acetate | Topical and oral |
| Semax | Free base | Intranasal only |

The other conditions apply to all six.[22] The product needs a prescription written for one patient and may contain only one active ingredient, so blends and stacks fall outside the policy. The raw powder has to be made at an FDA-registered plant, and its certificate of analysis has to report tests for identity, strength, purity, endotoxin, microbes, heavy metals and other impurities and name the plant that made it. Compounders file serious adverse event and quality reports through MedWatch, FDA’s reporting system, and the patient label explains how to file one. The label must state that the product is compounded and may not be resold. An oral form needs records showing it is adequately absorbed in humans, and the only drug delivery device the policy names is an FDA-cleared syringe. Semax is limited to intranasal use, and the policy does not say which nasal device is acceptable.

None of this says the peptides work. For the human evidence on each, see our reviews of [BPC-157](https://glpwatchdog.org/research/bpc-157-what-fda-actually-said), [TB-500](https://glpwatchdog.org/research/tb-500-what-the-evidence-shows), [MOTS-c](https://glpwatchdog.org/research/mots-c-what-the-evidence-shows), [KPV](https://glpwatchdog.org/research/kpv-peptide-what-the-evidence-shows), [epitalon](https://glpwatchdog.org/research/epitalon-what-the-evidence-shows) and [Semax](https://glpwatchdog.org/research/semax-brain-imaging-without-an-outcome).

## Peptide status on FDA's lists, October 2026

This table covers peptides that FDA’s lists name. A peptide missing from it is not cleared by omission: [hexarelin](https://glpwatchdog.org/research/hexarelin-what-the-evidence-shows), for one, appears on none of FDA’s lists because nobody nominated it. Check any peptide in our [peptide status checker](https://glpwatchdog.org/tools/peptide-status-checker).

*Where each peptide stands on FDA's 503A and 503B compounding lists*

| Peptide | On the 503A bulks list? | Where FDA lists it, and the HHS policy | Our guide |
| --- | --- | --- | --- |
| BPC-157 | No | Withdrawn from Category 2; FDA briefing (May 2026) weighs against listing; covered by the HHS interim policy since October 28, 2026 | [BPC-157](https://glpwatchdog.org/peptides/bpc-157), [side effects](https://glpwatchdog.org/research/bpc-157-side-effects) |
| TB-500 (thymosin beta-4 fragment) | No | Withdrawn from Category 2; FDA briefing weighs against listing; covered by the HHS interim policy since October 28, 2026 | [TB-500](https://glpwatchdog.org/peptides/tb-500), [side effects and dosing](https://glpwatchdog.org/research/tb-500-side-effects-and-dosing) |
| MOTs-C | No | Withdrawn from Category 2; FDA briefing weighs against listing; covered by the HHS interim policy since October 28, 2026 | [MOTS-c](https://glpwatchdog.org/peptides/mots-c), [dosage and side effects](https://glpwatchdog.org/research/mots-c-dosage-and-side-effects) |
| KPV | No | Withdrawn from Category 2; FDA briefing weighs against listing; covered by the HHS interim policy since October 28, 2026 | [KPV evidence](https://glpwatchdog.org/research/kpv-peptide-what-the-evidence-shows), [oral and topical KPV](https://glpwatchdog.org/research/kpv-oral-and-topical) |
| CJC-1295 | No | Withdrawn from Category 2; not in the HHS policy | [CJC-1295 / ipamorelin](https://glpwatchdog.org/peptides/cjc-1295-ipamorelin) |
| Ipamorelin acetate | No | Category 2 for 503B outsourcing facilities since September 29, 2023; also in the withdrawn table; not in the HHS policy | [Ipamorelin](https://glpwatchdog.org/peptides/ipamorelin) |
| Kisspeptin-10 | No | Category 2 for 503A pharmacies since September 29, 2023 | [Kisspeptin evidence](https://glpwatchdog.org/research/kisspeptin-what-the-evidence-shows) |
| GHRP-2 and GHRP-6 | No | Category 2 for 503B facilities; Category 3 for 503A pharmacies |   |
| GHK-Cu | No | Category 1 for non-injectable routes only; the injectable form is in the withdrawn table | [GHK-Cu](https://glpwatchdog.org/peptides/ghk-cu) |
| Epitalon and Semax | No | Withdrawn from Category 2; covered by the HHS interim policy since October 28, 2026 | [Epitalon evidence](https://glpwatchdog.org/research/epitalon-what-the-evidence-shows), [epitalon courses](https://glpwatchdog.org/research/epitalon-dosage-and-courses), [Semax vs Selank](https://glpwatchdog.org/research/semax-vs-selank) |
| Selank, emideltide (DSIP), thymosin alpha-1, LL-37, Melanotan II, AOD-9604, PEG-MGF | No | Withdrawn from Category 2; not in the HHS policy | [DSIP](https://glpwatchdog.org/research/dsip-a-sleep-peptide-with-no-receptor) |
| Vasoactive intestinal peptide | No | Category 1 |   |
| Glutathione and NAD (often sold beside peptides) | No | Category 1 | [Glutathione](https://glpwatchdog.org/peptides/glutathione), [NAD+](https://glpwatchdog.org/peptides/nad) |
| Tesamorelin | Not applicable | A licensed biologic since March 23, 2020 (Egrifta); outside 503A and 503B | [Tesamorelin](https://glpwatchdog.org/peptides/tesamorelin) |

Sources for the table: FDA’s category lists (updated May 14, 2026), its safety-risk page (April 22, 2026), the 503A bulks list in 21 CFR 216.23, the July 2026 briefing documents and the HHS policy of October 28, 2026.[2][3][4][7][22] [GHK-Cu](https://glpwatchdog.org/research/ghk-cu-what-the-evidence-shows) has moved twice this year. FDA removed it from Category 1 on April 22, 2026, when the nominations were withdrawn, then added the non-injectable form back after one nominator clarified on May 5 that it meant to withdraw only the injectable route. FDA says it will consult the advisory committee on GHK-Cu before the end of February 2027.[2]

Of FDA’s three categories, only Category 1 comes with a stated intent not to act against a compounder, and even that is conditional and interim.[1] The HHS policy works the same way for its six peptides.[22] Neither is an approval, and neither says anything about whether a product works.

## What “research use only” means legally

Many peptide sites print “research use only” on the vial, or warn that the contents are not meant for people. FDA looks past the label to how the product is sold. In its December 2024 warning letter to Summit Research Peptides, FDA wrote: “Despite statements on your product labeling marketing your products as ‘RESEARCH USE ONLY’ and ‘INTENDED AS A RESEARCH CHEMICAL ONLY,’ evidence obtained from your websites establish that your products are intended to be drugs for human use.”[13] Because the products were unapproved new drugs, FDA said selling them across state lines violated the Act.[13]

FDA’s consumer page on GLP-1 drugs says the same about that market: companies have put false research-only labels on semaglutide, tirzepatide, retatrutide, [survodutide](https://glpwatchdog.org/research/survodutide-what-the-evidence-shows) and similar drugs, then sold them straight to consumers along with dosing instructions, and FDA “urges consumers not to purchase these products which are of unknown quality and may be harmful to their health.”[14] For how this plays out with tirzepatide specifically, see [buying tirzepatide as a research chemical](https://glpwatchdog.org/research/buy-tirzepatide-research-chemical), and for how a research-labeled vial differs from a peptide compounded under the October 2026 HHS policy, see [research use only vs compounded peptides](https://glpwatchdog.org/research/research-use-only-vs-compounded-peptides).

## Peptides that are approved drugs, and where the line sits

“Peptide” is a chemical description, not a legal status. The approved peptide drugs, with each label’s use, are listed in [FDA-approved peptides](https://glpwatchdog.org/research/fda-approved-peptides). The GLP-1 drugs are peptides: the Rybelsus label notes that semaglutide’s “peptide backbone is produced by yeast fermentation.”[16] What each one is built from, and why FDA regulates them as drugs rather than biologics, is in [are GLP-1 drugs peptides?](https://glpwatchdog.org/research/are-glp1-drugs-peptides) Wegovy, as an injection and as a tablet, is FDA-approved to reduce excess body weight in adults who have obesity, and in adults who are overweight and have at least one weight-related condition; the injection is also approved for children 12 and older with obesity.[15] Those approved products are the legal way to get semaglutide.

Compounded versions are a different matter. FDA says a compounded drug carries no FDA approval and gets no agency check of its safety, effectiveness or quality before sale, and that federal law bars compounders from using retatrutide or [cagrilintide](https://glpwatchdog.org/research/cagrilintide-what-the-evidence-shows) at all.[14] Our guide to [what cannot legally be compounded](https://glpwatchdog.org/research/what-cannot-legally-be-compounded) covers the GLP-1 side in detail.

Tesamorelin shows how an approval can still leave no compounding route. It is sold as Egrifta, but FDA lists it among the drug approvals that were deemed biologics licenses on March 23, 2020.[12] From that date, FDA said, those products “will not be eligible for the exemptions for compounded drugs under sections 503A and 503B.”[11] Brand Egrifta can be prescribed. A compounded tesamorelin has no route through either channel.

## How to check a peptide seller

1. **Find the peptide in the table above** or in our [status checker](https://glpwatchdog.org/tools/peptide-status-checker). If it is withdrawn, in Category 2 or 3, or on no list, a pharmacy has no 503A route to compound it. The exception is the six peptides in the HHS policy of October 28, 2026, and only within that policy’s forms, routes and conditions.[22]
2. **Ask who dispenses it.** A lawful compounded product comes from a named, state-licensed pharmacy or a registered outsourcing facility, on a prescription written for you. Our [pharmacy verification guide](https://glpwatchdog.org/research/how-to-verify-an-online-glp1-pharmacy) shows how to check a license.
3. **Read the label and the marketing together.** A vial marked “research use only” next to dosing advice is the pattern FDA has cited in [its warning letters to peptide sellers](https://glpwatchdog.org/research/fda-warning-letters-to-peptide-sellers).[13]
4. **Check the evidence separately from the law.** Legal status says nothing about whether a peptide works. Our review of [which peptides have human trials](https://glpwatchdog.org/research/the-peptide-menu-what-has-human-trials) covers that question, and [what FDA said about BPC-157](https://glpwatchdog.org/research/bpc-157-what-fda-actually-said) goes deeper on the most popular one.

Each peptide guide on our [peptides hub](https://glpwatchdog.org/peptides) lists the telehealth sellers we track that offer it, so you can see who prescribes what before you pay. Read more than one page of a seller’s site, because they do not always agree. [Viking Alternative Medicine](https://glpwatchdog.org/reviews/viking-alternative-medicine) lists BPC-157 among the peptides it carries, while another page on its site says clinics “can no longer legally prescribe” it. Some leave the prescriber out entirely: [Prestige Health Rx](https://glpwatchdog.org/reviews/prestige-health-rx) lists BPC-157, sermorelin and GHK-Cu among its peptides but names neither the medical group that prescribes them nor the pharmacy that fills them.

[Many GLP-1 sellers now add peptides to the same account](https://glpwatchdog.org/research/the-add-on-menu), and the steps above apply to those add-ons too. NAD+, which sits in Category 1 in the table, is on the menu at [Joey Med](https://glpwatchdog.org/reviews/joey-med), [Bodi Envi](https://glpwatchdog.org/reviews/bodi-envi) and [MANÜ Telehealth](https://glpwatchdog.org/reviews/manu-telehealth). [Stealth Health](https://glpwatchdog.org/reviews/stealth-health) lists it as well.

Sermorelin does not appear in the table at all, which is a reason to ask the pharmacy question before you pay, not a sign it is cleared. [bmiMD](https://glpwatchdog.org/reviews/bmimd), [RNK Health](https://glpwatchdog.org/reviews/myrnk) and [ReadyRx](https://glpwatchdog.org/reviews/readyrx) list it beside their compounded GLP-1 plans, and so do [Ark Health](https://glpwatchdog.org/reviews/ark-health) and [SynergenX Health](https://glpwatchdog.org/reviews/synergenx). [Ways2Well](https://glpwatchdog.org/reviews/ways2well) works the other way around: it is a lab-based clinic that prescribes peptides after a clinician consult and no longer sells semaglutide or tirzepatide.

## Common questions

## Frequently asked questions

### Are peptides legal in the US?

It depends on the peptide. FDA-approved peptide drugs such as semaglutide (Wegovy, Ozempic, Rybelsus) are legal with a prescription. Most peptides sold online are not approved drugs and are not on FDA's 503A bulks list, so a US pharmacy has no 503A route to compound them. Under an interim policy dated October 28, 2026, HHS does not plan to pursue state-licensed 503A pharmacies that compound six of them (BPC-157, TB-500, Epitalon, Semax, KPV and MOTS-c) on a patient-specific prescription and under strict conditions. That is interim enforcement discretion, not approval. This article describes FDA's rules and is not legal advice.

### Is BPC-157 still on FDA's Category 2 list?

No. FDA's safety-risk page, last updated April 22, 2026, lists BPC-157 under “Bulk drug substances nominated but withdrawn,” not in the active Category 2 table. That alone did not make it legal to compound: the 503A bulks list does not include it, and FDA's May 2026 briefing document concluded that the criteria weigh against adding it. Under an interim policy dated October 28, 2026, HHS does not plan to pursue 503A compounding of BPC-157 acetate under strict conditions.

### Did the July 2026 advisory committee approve BPC-157 or TB-500?

The committee advises FDA; it does not approve anything. At its July 23–24, 2026 meeting it reportedly voted 8–6, with one abstention, to recommend both BPC-157 and TB-500 for the 503A bulks list, according to Healio, AJMC and Pharmaceutical Executive. It also reportedly backed KPV, MOTs-C, Semax and epitalon and rejected emideltide. As of October 15, 2026, FDA had posted no tally and proposed no rule. An interim HHS policy dated October 28, 2026 then said HHS does not intend to take enforcement action against 503A compounding of those six under strict conditions, without adding any of them to the list.

### What did the HHS peptide policy of October 2026 change?

In an interim policy dated October 28, 2026, HHS said it does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians compounding BPC-157, TB-500, Epitalon, Semax, KPV or MOTS-c under section 503A, until a final rule decides whether each belongs on the 503A bulks list. Each peptide is limited to set routes, and every product needs a prescription for one named patient, only one active ingredient, raw powder from an FDA-registered plant with a test certificate, MedWatch reporting and a label marking it as compounded and not for resale. It does not approve the peptides, and it does not cover research-use-only sellers.

### Does “research use only” make a peptide legal to sell?

Not when the seller's own website shows the product is meant for people. In a December 2024 warning letter FDA said that despite “RESEARCH USE ONLY” labeling, the seller's websites established the products were intended as drugs for human use, which made them unapproved new drugs.

### Can a pharmacy compound tesamorelin?

No compounding route exists. Tesamorelin (Egrifta) was deemed a biologics license on March 23, 2020, and FDA said those products are not eligible for the compounding exemptions under sections 503A and 503B. Brand Egrifta can still be prescribed.

## References

1. U.S. Food and Drug Administration Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. FDA. 2026. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
2. U.S. Food and Drug Administration Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (updated May 14, 2026). FDA. 2026. https://www.fda.gov/media/94155/download
3. U.S. Food and Drug Administration Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. FDA. 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
4. Code of Federal Regulations 21 CFR 216.23, Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act. eCFR. 2019. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23
5. U.S. Food and Drug Administration Human Drug Compounding Laws. FDA. 2024. https://www.fda.gov/drugs/human-drug-compounding/human-drug-compounding-laws
6. U.S. Food and Drug Administration July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. FDA. 2026. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
7. U.S. Food and Drug Administration FDA Briefing Document for BPC-157-Related Bulk Drug Substances (BPC-157 (free base) and BPC-157 acetate), Pharmacy Compounding Advisory Committee, July 23-24, 2026. FDA. 2026. https://www.fda.gov/media/193343/download
8. U.S. Food and Drug Administration FDA Briefing Document for TB-500-Related Bulk Drug Substances (TB-500 (free base) and TB-500 acetate), Pharmacy Compounding Advisory Committee, July 23-24, 2026. FDA. 2026. https://www.fda.gov/media/193349/download
9. U.S. Food and Drug Administration FDA Briefing Document for MOTS-c-Related Bulk Drug Substances (MOTS-c (free base) and MOTS-c acetate), Pharmacy Compounding Advisory Committee, July 23-24, 2026. FDA. 2026. https://www.fda.gov/media/193347/download
10. U.S. Food and Drug Administration FDA Briefing Document for KPV-Related Bulk Drug Substances (KPV (free base) and KPV acetate), Pharmacy Compounding Advisory Committee, July 23-24, 2026. FDA. 2026. https://www.fda.gov/media/193346/download
11. U.S. Food and Drug Administration Notice to Compounders: Changes that affect compounding as of March 23, 2020. FDA. 2020. https://www.fda.gov/drugs/human-drug-compounding/notice-compounders-changes-affect-compounding-march-23-2020
12. U.S. Food and Drug Administration List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020. FDA. 2020. https://www.fda.gov/media/119229/download
13. U.S. Food and Drug Administration Warning Letter: Summit Research Peptides, MARCS-CMS 695607. FDA. 2024. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024
14. U.S. Food and Drug Administration FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. FDA. 2026. https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
15. Novo Nordisk WEGOVY (semaglutide) injection and WEGOVY (semaglutide) tablets, prescribing information. DailyMed. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b
16. Novo Nordisk RYBELSUS (semaglutide) tablets and OZEMPIC (semaglutide) tablets, prescribing information. DailyMed. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98
17. Bascom E FDA committee recommends looser restrictions for several peptides. Healio. 2026. https://www.healio.com/news/endocrinology/20260915/fda-committee-recommends-looser-restrictions-for-several-peptides
18. Steinzor P FDA Panel Backs 6 Peptides for Compounding. AJMC. 2026. https://www.ajmc.com/view/fda-panel-backs-6-peptides-for-compounding
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22. U.S. Department of Health and Human Services HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (with Appendices A and B), announced October 28, 2026. HHS. 2026. https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf
23. U.S. Department of Health and Human Services Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (notice of availability, 91 FR 68526, document 2026-22192). Federal Register. 2026. https://www.federalregister.gov/documents/2026/10/30/2026-22192/enforcement-discretion-policy-regarding-503a-compounding-using-certain-peptide-bulk-drug-substances

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Cite as: GLP Watchdog, Ruth Calder, "Are Peptides Legal? What FDA’s 2026 Lists Say", published 2026-09-27, updated 2026-11-05. https://glpwatchdog.org/research/are-peptides-legal

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Medical disclaimer: Nothing here is medical advice. We report on this subject; we do not treat anyone. Whether to begin a medication, supplement, or treatment, whether to adjust it, and whether to stop are questions for a clinician licensed to answer them, who knows your history.