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Peptides Explained

United States

Peptides and US law: what the FDA rules say

In short

About 9 minutes for the short version; 14 with every detail open.

  • In the US, a product meant to treat disease or change the body counts as a drug.
  • A new drug may not be sold across state lines until the FDA approves it.
  • US pharmacies may only use allowed ingredients. BPC-157 and peptides like it are not on that list.
  • In July 2026, FDA advisers backed six peptides for pharmacy use. It was advice, not a rule.
  • A 'research use only' label does not stop the FDA treating a product as a drug.
Last reviewed
A modern office and laboratory building with a glass front and long rows of windows, under a clear blue sky.
An FDA lab building in the state of Maryland, in the US. Photo: The U.S. Food and Drug Administration, FDA Bldg 62 - Exterior (Wikimedia Commons) Public domain Image details

Each section starts with the short answer. The rest is folded under “In detail”.

What does US law say about peptides?

Most peptides sold online count as unapproved drugs. Selling them breaks federal law.
US law forbids selling unapproved drugs. The July 2026 vote did not change that. Federal Food, Drug, and Cosmetic Act and FDA policy, checked on 22 October 2026. This page covers federal law only.
Under US federal law
Is selling an unapproved new drug across state lines forbidden?Yes No new drug may enter trade between states until the FDA approves it.1
Can a US pharmacy legally make BPC-157 or the other peptides voted on in 2026?No Pharmacies may only use allowed ingredients. The FDA’s list of extra allowed ingredients has six substances, and none is a peptide.2,3
Did the July 2026 advisory vote change the law?No It was advice. Only an FDA rule can add a substance to the list.4,5
Does a “research use only” label make selling legal?No The FDA judges what the seller really intends, from the whole website.6,7
Is importing an unapproved drug for yourself allowed?No “In most circumstances” it is illegal, the FDA says. Its staff may allow some cases.8

The Federal Food, Drug, and Cosmetic Act (FD&C Act) is the main US law on medicines. The Food and Drug Administration (FDA) enforces it. This page explains what the law says about products such as BPC-157, TB-500 or “research” retatrutide. It does not tell you how to get round the law. Nothing the FDA decides changes the law in the Netherlands or the rest of the EU.9

What counts as a drug

Is a peptide a drug under US law?

Yes, if it is meant to treat a disease or to change how the body works.
US law has two main tests. A product that meets either one is a drug.
TestThe question the law asks
DiseaseIs it meant to diagnose, cure, ease, treat or prevent a disease?
BodyIs it meant to change the structure or a function of the body?
How intent is judgedBy the seller’s real intent: their claims, their adverts, the product itself and how it is sold

These tests come from the definition of “drug” in the law.10 The FDA judges intent from everything the seller says and does, not only from the label.6 See research use only for how this works.

In detail The words of the law, and what makes a drug 'new'

The law defines a drug as, among other things, an article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease”. It also covers articles, other than food, meant “to affect the structure or any function of the body”.10

A new drug is a drug that experts do not generally recognise as safe and effective for the use its labelling suggests.10 In its warning letters to peptide sellers, the FDA has said that their products are new drugs for this reason.7

Intended use means the “objective intent” of the people responsible for the product. The FDA can show it from labelling claims, adverts, spoken or written statements, and the way the product is sold.6

The core rule: approval before sale

What exactly does the law forbid?

Sending or selling a new drug across state lines before the FDA has approved it.
Why a peptide with no approval, sold online, breaks US law.
  1. It is a drug. A product meant to treat disease or change the body is a drug.10
  2. It is a new drug. Experts do not generally recognise it as safe and effective.10
  3. No approval, no trade. Nobody may put a new drug into trade between states without an approved application.1
  4. The penalty. Up to one year in prison for a breach. Up to three years after an earlier conviction, or with intent to cheat or mislead.11

None of the seven peptides discussed by the FDA’s advisers in July 2026 is an FDA-approved medicine. That is why they needed a place on the 503A list.12,2 For BPC-157, the FDA found no approved product in any country.13 Semax is registered as a medicine in Russia.14

In detail What else the FDA can do

The FDA’s warning letters tell sellers what happens if they do not fix the problems. It “may lead to regulatory or legal action”, for example seizure of the products and a court order (an injunction).7 The prison terms above are maximums for criminal cases. They say what the law allows, not what usually happens.11

Can a US pharmacy make these peptides legally?

Only from allowed ingredients. The peptides voted on in 2026 are not on the FDA’s list.

The FDA's list of extra allowed ingredients has six substances. None is a peptide.

6

substances on the 503A bulks list, the FDA's list of extra ingredients pharmacies may use

What was counted 21 CFR 216.23(a), unchanged since March 2019 (eCFR text as of 15 October 2026) Source 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 Act3

Compounding means a pharmacy makes a medicine itself for one patient. US law allows this without FDA approval, but only under strict conditions.2 One condition is about the active ingredient. If it has no official quality standard and is not part of an approved drug, it must be on the FDA’s 503A bulks list.2,5

The two kinds of compounding in US law, and the ingredients each may use.
Pharmacy (section 503A)Outsourcing facility (section 503B)
WhoA licensed pharmacist or doctorA facility that makes sterile drugs and has registered with the FDA
For whomOne identified patient, on a valid prescriptionWith or without a prescription for a named patient
Which raw ingredientsOne with an official quality standard, one that is part of an approved drug, or one on the 503A listOne on the 503B list of clinical need, or one for a drug on the shortage list

Sources 2, 15

In detail The FDA's interim categories, and where the peptides stand now

While it builds the 503A list, the FDA sorts nominated ingredients into three interim categories:5

  • Category 1: nominated with enough information to evaluate. The FDA does not intend to take action against pharmacies that compound with these, if conditions are met.
  • Category 2: the FDA has found possible significant safety risks.
  • Category 3: nominated without enough supporting information.

The FDA’s page on safety risks lists BPC-157, TB-500, KPV, MOTS-c, CJC-1295, AOD-9604, Semax, Selank, epitalon, emideltide, melanotan II, thymosin alpha-1 and injectable GHK-Cu as “previously in category 2”. Their nominations were withdrawn. For most, the FDA names a risk of unwanted immune reactions, impurities, and little or no safety information.16 Ipamorelin acetate is still in category 2 for outsourcing facilities, since 29 September 2023.16

On the FDA’s list of 14 May 2026, none of these peptides is in category 1. The only exception is GHK-Cu for routes other than injection.17 The FDA also says it does not intend to sort ingredients nominated on or after 7 January 2025 into these categories at all.5

In detail A second advisory meeting is planned

The FDA says it will hold another advisory meeting “before the end of February 2027”. It will discuss LL-37, GHK-Cu, dihexa acetate, melanotan II and pegylated mechano growth factor (PEG-MGF). The date, place and public docket are still to come.18

The July 2026 advisory vote

What did the FDA's advisers decide in July 2026?

They backed six of seven peptides for pharmacy compounding. It was only advice.
The seven peptides the FDA's advisers looked at in July 2026, and what they said.
PeptideUse the FDA reviewedFDA staff proposalCommittee outcome, as reported
BPC-157Ulcerative colitisDo not addRecommended (8 to 6, 1 abstention)
KPVWound healing, inflammationDo not addRecommended
TB-500Wound healingDo not addRecommended
MOTS-cObesity, osteoporosisDo not addRecommended
Emideltide (DSIP)Opioid withdrawal, insomnia, narcolepsyDo not addNot recommended
SemaxPoor blood flow to the brain, migraine, face nerve painDo not addRecommended
EpitalonInsomniaDo not addRecommended

Sources 12, 19, 20

On 23 July 2026, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted 8–6, with one abstention, to recommend BPC-157 for the 503A list. It considered seven peptides and recommended six. These results are as reported from the public meeting: the FDA has posted no minutes.4,20 The vote is advisory and non-binding. It went against FDA staff’s own proposal.19

In detail The five points to keep in mind about this vote
  1. The vote. On 23 July 2026 the committee voted 8–6, with one abstention, to recommend BPC-157 for the 503A bulks list (count as reported from the public meeting).4,20
  2. Seven considered, six recommended. FDA documents show seven peptides on the agenda, each voted on separately as a free base and as an acetate salt: 14 questions in all.12,20 The six recommendations, and emideltide’s rejection, are as reported from the meeting. We do not print the other vote counts: the FDA has not published them, and reports differ.
  3. Only advice, against FDA staff. Advisory committees give the FDA “non-binding recommendations”.18 For all 14 forms, FDA staff had proposed that they should not be added.19
  4. Still prohibited for now. Compounding with these peptides stays unlawful until the FDA adopts the advice and completes rulemaking. The FDA adds substances to the list through notice-and-comment rulemaking.5,2
  5. Not an approval. None of these is an approved medicine in the EU, the UK or the US (Semax is registered as a medicine in Russia).14,21 A listing would let US pharmacies compound them on prescription. It would not be an approval. It would say nothing about whether they work, and it would change nothing in the EU or the Netherlands.22,3,9
In detail What a listing would mean, and what happens next

The FDA told the committee what changes when an ingredient goes on the 503A list. The compounded product is still not FDA-approved. It needs no label telling patients how to use it. It does not have to meet the manufacturing quality rules (CGMP), although dirty conditions are still banned. The pharmacy does not have to report side effects to the FDA. Unless the listing sets limits, any use and any route is allowed.22 Each salt form counts as a separate ingredient.22

The FDA says it will not decide until it has considered the committee’s input and finished its reviews.19 To add a substance, it must propose a rule, take public comments and publish a final rule.5 The last proposed rule on the 503A list dates from September 2019.5 On 22 October 2026 we found no new rule, and no notice of the next committee meeting, in the Federal Register.23 We follow this on what’s changing.

“Research use only” sellers and FDA warning letters

Does a 'research use only' label make selling legal?

No. The FDA looks at the whole website and calls such products unapproved new drugs.
What the FDA's warning letters to online peptide sellers say.
  1. The label is not enough. The sellers wrote “Research Use Only” and “not intended for human consumption”.7,24
  2. The website decides. Claims on the sellers’ own websites showed the products were meant as drugs for people.7,6
  3. So they are unapproved new drugs. Selling them across state lines without approval breaks the law.7,1
  4. The water counts too. Bacteriostatic water sold for mixing with the peptides is itself a drug, the FDA said.7

Letters from March and August 2026 named semaglutide, tirzepatide, retatrutide, SS-31, tesamorelin and PT-141.7 The FDA also warns that products falsely labelled “for research purposes” are sold to people with dosing instructions, and are of unknown quality.24 If your product did not come from a pharmacy, no regulator has checked what is in it. See product risk.

Compounded GLP-1 medicines after the shortages

Can US pharmacies still make copies of semaglutide or tirzepatide?

Not as a rule. The shortages are over, and so are the extra months to make copies.
The time to make copies ended in 2025. One FDA decision is still open. Dates from FDA statements and Federal Register notices. During a shortage, the law allows more compounding.

  • Tirzepatide: pharmacies

    shortage over on 19 December 2024; grace period ended after a court ruling of 5 March 2025

  • Tirzepatide: outsourcing facilities

    grace period to 19 March 2025

  • Semaglutide: pharmacies

    shortage over on 21 February 2025; grace period ended after a court ruling of 24 April 2025

  • Semaglutide: outsourcing facilities

    grace period to 22 May 2025

  • FDA proposal: no semaglutide or tirzepatide on the 503B list

    comments from 1 May to 30 July 2026

    Not known: final decision not yet published

Sources FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize; List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FR Doc. 2026-08552); List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period (FR Doc. 2026-12937)25,26,27 Checked

During a shortage, US law allows more compounding. Semaglutide and tirzepatide are no longer on the FDA’s shortage list or the 503B list.25 On 30 April 2026, the FDA proposed to keep them off the 503B list, because it found no clinical need.28,26

The FDA has had close to a thousand reports of side effects from semaglutide made in pharmacies.

990

reports of side effects from versions made by pharmacies, up to the end of May 2026

What was counted Reports to the FDA about compounded semaglutide up to 31 May 2026; for compounded tirzepatide, more than 730. Pharmacies that are not outsourcing facilities do not have to report, so the real numbers are likely higher. Source FDA's concerns with unapproved GLP-1 drugs used for weight loss24

In detail Salt forms, copies and fakes
  • Copies. A pharmacy may not compound, regularly or in large amounts, drugs that are “essentially copies” of a medicine on the market.2
  • Salt forms. Some compounders used semaglutide sodium or semaglutide acetate. These are different active ingredients from the one in the approved medicines. The FDA says it knows of no lawful basis for using them in compounding.24
  • Fakes. The FDA knows of counterfeit Ozempic sold in the US. Fakes can contain the wrong ingredient, too much, too little or none.24
  • Reports. Many reported side effects match those of the approved medicines. Some were linked to dosing mistakes with compounded products.24

Bringing drugs into the US for yourself

Can I import a peptide into the US for my own use?

In most cases it is illegal. FDA staff may allow some cases, but it is not a right.
What the FDA says about importing a drug for your own use.
What the FDA and the law say
The general ruleImporting drugs for personal use is illegal in most circumstances. A drug approved abroad but not in the US is illegal to import.8
When staff may be more lenientIn narrow cases, such as a serious condition with no treatment available in the US, under further conditions.8
When the FDA refusesThe product is on an import alert, looks meant for sale, seems a serious health risk, or seems to be health fraud.8
At the borderA drug that appears to break the approval rule “shall be refused admission”. If it is worth $2,500 or less (or a higher limit set by regulation), it may be destroyed, after notice.29

The FDA says it “cannot ensure the safety and effectiveness” of medicines bought from foreign sources over the internet.8

Where to report

Where can I report a side effect in the US?

To MedWatch, the FDA’s reporting system. Patients can report too, not only doctors.

Side effects. MedWatch is the FDA’s safety reporting programme “for health professionals, patients and consumers”.30 The FDA asks patients and health workers to report side effects and quality problems with compounded GLP-1 products, and with any other medicine.24

Before you report. Keep the vial, its label and any papers. Write down the batch number. Tell your doctor what you use: see talking to your doctor.

Sources

Every claim on this page links to one of these sources. Scholarly sources link to their DOI; regulatory sources to the regulator's own page.

In detail All 30 sources, numbered as in the text
  1. Legal Information Institute, Cornell Law School (text of the United States Code) (2026). 21 U.S. Code § 355 – New drugs (FD&C Act § 505). United States Code. Law law.cornell.edu — accessed 22 October 2026 ↩
  2. Legal Information Institute, Cornell Law School (text of the United States Code) (2026). 21 U.S. Code § 353a – Pharmacy compounding (FD&C Act § 503A). United States Code. Law law.cornell.edu — accessed 22 October 2026 ↩
  3. U.S. Food and Drug Administration (Electronic Code of Federal Regulations) (2019). 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. Law ecfr.gov — accessed 22 October 2026 ↩
  4. U.S. Food and Drug Administration (2026). July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. Regulator fda.gov — accessed 20 October 2026 ↩
  5. U.S. Food and Drug Administration (2026). Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. Regulator fda.gov — accessed 20 October 2026 ↩
  6. U.S. Food and Drug Administration (Electronic Code of Federal Regulations) (2026). 21 CFR 201.128 – Meaning of 'intended uses'. eCFR. Law ecfr.gov — accessed 22 October 2026 ↩
  7. U.S. Food and Drug Administration (2026). Warning Letters (searchable database). Regulator fda.gov — accessed 22 October 2026 ↩
  8. U.S. Food and Drug Administration (2025). Personal Importation. Regulator fda.gov — accessed 22 October 2026 ↩
  9. Staten-Generaal / Koninkrijk der Nederlanden (2007). Geneesmiddelenwet (BWBR0021505). wetten.overheid.nl. Law wetten.overheid.nl — accessed 20 October 2026 ↩
  10. Legal Information Institute, Cornell Law School (text of the United States Code) (2026). 21 U.S. Code § 321 – Definitions (FD&C Act § 201). United States Code. Law law.cornell.edu — accessed 22 October 2026 ↩
  11. Legal Information Institute, Cornell Law School (text of the United States Code) (2026). 21 U.S. Code § 333 – Penalties (FD&C Act § 303). United States Code. Law law.cornell.edu — accessed 22 October 2026 ↩
  12. U.S. Food and Drug Administration (2026). 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 (FR Doc. 2026-07361). Federal Register. Regulator federalregister.gov — accessed 20 October 2026 ↩
  13. U.S. Food and Drug Administration (2026). FDA Briefing Document for BPC-157-Related Bulk Drug Substances (BPC-157 (free base) and BPC-157 acetate), Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov — accessed 20 October 2026 ↩
  14. U.S. Food and Drug Administration (2026). FDA Briefing Document for Semax-Related Bulk Drug Substances (Semax (free base) and Semax acetate), Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov — accessed 22 October 2026 ↩
  15. Legal Information Institute, Cornell Law School (text of the United States Code) (2026). 21 U.S. Code § 353b – Outsourcing facilities (FD&C Act § 503B). United States Code. Law law.cornell.edu — accessed 22 October 2026 ↩
  16. U.S. Food and Drug Administration (2026). Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Regulator fda.gov — accessed 20 October 2026 ↩
  17. U.S. Food and Drug Administration (2026). Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories 1–3), updated 14 May 2026. Regulator fda.gov — accessed 20 October 2026 ↩
  18. U.S. Food and Drug Administration (2026). Meeting of the Pharmacy Compounding Advisory Committee (early announcement: meeting before the end of February 2027). Regulator fda.gov — accessed 22 October 2026 ↩
  19. U.S. Food and Drug Administration (2026). FDA Briefing Document Introduction, Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov — accessed 20 October 2026 ↩
  20. U.S. Food and Drug Administration (2026). Questions, Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov — accessed 20 October 2026 ↩
  21. European Medicines Agency (2026). Medicines (search of centrally authorised medicines and EPARs). Regulator ema.europa.eu — accessed 20 October 2026 ↩
  22. U.S. Food and Drug Administration (2026). FDA Presentations, Pharmacy Compounding Advisory Committee meeting, 23 July 2026. Regulator fda.gov — accessed 20 October 2026 ↩
  23. Office of the Federal Register (2026). Federal Register document search, 22 October 2026: FDA documents since 24 July 2026 on compounding, '503A', '503B' and the Pharmacy Compounding Advisory Committee. Federal Register. Dataset federalregister.gov — accessed 22 October 2026 ↩
  24. U.S. Food and Drug Administration (2026). FDA's concerns with unapproved GLP-1 drugs used for weight loss. Regulator fda.gov — accessed 20 October 2026 ↩
  25. U.S. Food and Drug Administration (2026). FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. Regulator fda.gov — accessed 20 October 2026 ↩
  26. U.S. Food and Drug Administration (2026). List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FR Doc. 2026-08552). Federal Register. Regulator federalregister.gov — accessed 22 October 2026 ↩
  27. U.S. Food and Drug Administration (2026). List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period (FR Doc. 2026-12937). Federal Register. Regulator federalregister.gov — accessed 20 October 2026 ↩
  28. U.S. Food and Drug Administration (2026). FDA proposes to exclude semaglutide, tirzepatide, and liraglutide on 503B bulks list. Regulator fda.gov — accessed 20 October 2026 ↩
  29. Legal Information Institute, Cornell Law School (text of the United States Code) (2026). 21 U.S. Code § 381 – Imports and exports (FD&C Act § 801). United States Code. Law law.cornell.edu — accessed 22 October 2026 ↩
  30. U.S. Food and Drug Administration (2026). MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Regulator fda.gov — accessed 22 October 2026 ↩

Further reading