Are peptides legal? Peptides Legal Status What’s Actually Legal and What Isn’t

Peptides exist in a complex legal gray area where some are FDA-approved prescription drugs, others are legal for cosmetic use, and many popular compounds remain unapproved for human consumption. The FDA has not approved BPC-157 or most other peptides for any use in humans, and beginning in October 2023 and culminating in February 2024, the FDA made it very difficult and risky for compounding pharmacies to continue compounding peptides. The regulatory status depends entirely on the specific peptide, its intended use, and how it’s manufactured and sold.

What Does the FDA Say About Peptides?

If a peptide meets the definition of a drug and does not otherwise meet the statutory definition of a “biological product” or a “device,” it would be regulated as a drug under the Federal Food, Drug, and Cosmetic Act. This classification subjects peptides to strict FDA approval requirements before they can be marketed in interstate commerce.

FDA defines peptides as having an amino acid chain made of 40 or less amino acids, therefore peptides are regulated as drugs, not biologics because of the small number of amino acids.

The Category 2 Crackdown

In October 2023, the FDA announced that several peptides would be added to Category 2, which are considered “Bulk Drug Substances that Raise Significant Safety Risks”. Popular peptides like BPC-157, Ipamorelin, CJC-1295, AOD-9604, Thymosin Alpha-1, and Thymosin Beta-4 were placed on this list, effectively banning compounding pharmacies from producing them.

When the FDA looked at the peptides submitted for bulk drug approval, many of those peptides were identified as Category 2 substances posing ‘significant safety risks’ as per the FDA, meaning there were not enough studies done as per the FDA to prove these peptides were safe.

Recent Regulatory Shifts

In September 2024, the FDA announced that five peptide bulk drug substances—including Thymosin Alpha-1, CJC-1295, Ipamorelin, Pentadecapeptide, and Selank Nasal—were removed from the Category 2 list. However, this doesn’t mean they’re fully legal yet. The FDA has decided to move forward to consult the Pharmacy Compounding Advisory Committee for potential future inclusion of some of these peptides.

Which Peptides Are Legal?

FDA-Approved Prescription Peptides

Semaglutide is an FDA-approved peptide for weight loss that helps control appetite and cravings. Other FDA-approved peptides include:

• Semaglutide (Ozempic, Wegovy) – Type 2 diabetes and weight management
• Tirzepatide (Mounjaro, Zepbound) – Type 2 diabetes and weight loss
• Tesamorelin – HIV-related lipodystrophy
• Sermorelin – Growth hormone deficiency (still available through some compounding pharmacies)

Even though semaglutide seems like it’s everywhere in Hollywood, it’s only available with a doctor’s prescription, meaning you can’t legally buy semaglutide as a supplement or over-the-counter.

Legal for Cosmetic Use

GHK-Cu (copper tripeptide-1) is legal for cosmetic use and commonly found in skin care products, as the FDA recognizes the benefits of copper peptide in formulations designed to support skin complexion.

When it comes to injectable GHK-Cu treatments, the situation becomes murky. The FDA hasn’t approved the use of copper peptides for injectables, though micro-needling with copper peptides is still considered a topical rather than an injection-based treatment.

Peptides with Restricted Availability

Peptides that can be compounded are either FDA-approved, have FDA GRAS (Generally Recognized as Safe) status, have a USP monograph, appear on the 503A Bulks List, or have been placed in Category 1 of the interim 503A Bulks List. Examples include NAD+ and certain formulations of sermorelin.

Which Peptides Are Illegal or Unapproved?

Research Chemicals and the “Not for Human Use” Loophole

Many unapproved peptides are sold online as “research chemicals” with disclaimers like “not for human consumption”, but this doesn’t make them legal for human use.

FDA has pursued enforcement action especially where it can be shown that the products were actually intended for human use, where for example, therapeutic claims were made or where the products were sold together with diluent and syringes.

Category 2 Peptides

BPC-157 and Thymosin Beta-4 are classified as research chemicals and are not FDA-approved for supplements or medications. The FDA has specifically placed BPC-157 in Category 2 on the 503A bulks list, citing safety risks, meaning traditional compounding pharmacies cannot legally compound it for human use.

Other banned or restricted peptides include:

• BPC-157 – Healing and tissue repair claims
• Thymosin Beta-4 (TB-500) – Tissue healing
• Ibutamoren (MK-677) – Growth hormone secretagogue
• DSIP (Delta Sleep-Inducing Peptide) – Sleep enhancement
• Epitalon – Anti-aging and telomere extension
• MOTs-C – Metabolic regulation

How Compounding Pharmacies Are Affected

The new FDA regulation does not explicitly prohibit compounding peptides, however the regulation also fails to explicitly approve the use of many of the most popular peptides in compounded products. This creates massive liability for compounding pharmacies.

Since peptides are now unapproved by the FDA, compounding pharmacies face serious regulatory exposure if they continue to compound peptide products, as the FDA has sent numerous warning letters to compounding pharmacies relative to the use of unapproved or inaccurately marketed peptide-based products.

The Shortage Exception

Some peptides, like semaglutide and tirzepatide, are free flowing, which is confusing to consumers and clinicians—there’s an exception for compounding that applies to FDA-approved drugs that are “currently in shortage”. This explains why compounded versions of these weight-loss drugs remain available when others have disappeared.

State-Level Restrictions on Peptides

Beyond federal regulations, states are implementing their own restrictions focused on protecting minors from performance-enhancing substances.

New York passed new laws in 2024 that ban the sale of muscle-building and weight-loss supplements to anyone under 18. New Jersey requires parental/guardian consent for minors to purchase such products.

California, Massachusetts, Illinois, Virginia, Texas and New Hampshire have introduced or reintroduced similar legislation targeting underage access to performance-enhancing supplements.

These laws don’t ban peptides outright but create compliance requirements for sellers, particularly regarding age verification and marketing claims.

What Are the Consequences of Using Illegal Peptides?

For Healthcare Providers

Using unapproved peptides can lead to state medical board disciplinary action for unprofessional conduct, FDA enforcement and potential criminal charges.

For Consumers

When you use an unapproved peptide, you have no guarantee of its identity, purity, potency, or safety. Products from some unregulated pharmacies may be tainted with heavy metals like mercury.

Safety concerns include untested products leading to side effects, no guarantee of effectiveness, and quality control issues leading to contamination or wrong dosing, plus legal issues from selling or using unapproved peptides for medical purposes.

It’s Not Criminal (Yet)

Peptides are not illegal, you cannot go to jail if you prescribe or use them, but regulatory enforcement targets manufacturers and sellers rather than individual users. The risk lies in purchasing contaminated products or facing future regulatory action as enforcement evolves.

Common Misconceptions About Peptide Legality

Misconception 1: Research peptides are legal if labeled “not for human consumption” This label is what the industry calls a “ruse.” FDA has stated such disclaimers were a ruse to avoid FDA scrutiny for selling misbranded and adulterated products in violation of the FD&C Act.

Misconception 2: All peptides are the same legally As you can see from the four peptides covered, this group of compounds can have widely varying applications, so it’s hard to lump their legal status under one umbrella. Legal status depends on the specific peptide, intended use, and delivery method.

Misconception 3: Compounded peptides are always legal Compounding pharmacies can only legally compound peptides that meet specific FDA criteria. It is critical that pharmacy compounders perform due diligence and consult legal counsel before they engage in compounding peptides.

Misconception 4: Oral peptides have different legal status than injectables Many oral versions of peptides (like BPC-157 and Thymosin Beta 4) are not banned—it’s just the injectables. However, this doesn’t make them FDA-approved; it simply means enforcement focuses on compounded injectables.

Misconception 5: If a peptide is banned, it’s because it’s dangerous Most peptides have few if any side effects, however large studies proving this have not been done. The FDA’s stance reflects lack of clinical evidence rather than proven harm in many cases.

How to Stay Compliant With Peptide Regulations

For Medical Practices

Work only with licensed compounding pharmacies that follow Section 503A and 503B regulations. Peptide compounding must adhere to USP 797/795 and always align with local, state and federal laws and regulatory considerations.

Verify that any peptide you prescribe either has FDA approval, appears on Category 1 of the bulks list, has a USP monograph, or has been granted GRAS status.

For Consumers

Consulting a specialized peptide therapy clinic ensures you get expert advice and safe treatment options with trained professionals who can evaluate your health needs, recommend the right peptides, and monitor your progress.

Only obtain peptides through legitimate medical prescriptions from licensed healthcare providers. Avoid online sellers marketing “research chemicals” or products with disclaimers like “not for human use.”

If purchasing peptides from compounding pharmacies, verify they’re properly licensed and request Certificates of Analysis showing purity testing.

What to Ask Your Provider

• Is this peptide FDA-approved or does it meet 503A compounding requirements?
• What is the source of this peptide and do you have testing documentation?
• Are there FDA-approved alternatives that could achieve similar results?
• What are the legal risks associated with this treatment?

The Future of Peptide Regulation

The current state of the law and peptide industry is in flux—that will mean some providers will contract and others will fill the void created by leaving the market, and it’s a short-lived situation that is expected to develop further during the next year or so.

The FDA continues releasing guidance documents addressing peptide manufacturing and quality control. While the draft guidance isn’t legally binding, it implies that there may be more regulations to come from the FDA around how peptides are manufactured, marketed, and used.

With the 2024 administration change, some speculate enforcement priorities may shift. On the highest level, this seems to imply a reversal of the policies pertaining to suppression of products which do not comply with all FDA regulations, though it remains to be seen if regulatory scrutiny for this class of products will remain high.

FAQ: Are Peptides Legal?

Are peptides legal in the United States?

The legality of peptides depends on the specific compound and intended use. FDA-approved peptides like semaglutide and tirzepatide are legal with a prescription. Cosmetic peptides like GHK-Cu are legal in skincare products. However, most popular peptides like BPC-157, Thymosin Beta-4, and Ipamorelin are not FDA-approved for human use and cannot be legally compounded by pharmacies following October 2023 regulations. “Research chemical” peptides sold with “not for human consumption” labels occupy a regulatory gray area where they’re technically not illegal to possess but are illegal to market for human use.

What does the FDA say about peptides?

The FDA regulates peptides as drugs under the Federal Food, Drug, and Cosmetic Act if they have 40 or fewer amino acids. In October 2023, the FDA placed popular peptides on the Category 2 list of “Bulk Drug Substances that Raise Significant Safety Risks,” effectively prohibiting compounding pharmacies from producing them. The FDA’s position is that most peptides lack sufficient clinical evidence to demonstrate safety and efficacy for human use. However, in September 2024, the FDA removed five peptides from Category 2 and announced they would consult the Pharmacy Compounding Advisory Committee about their future regulatory status.

Which peptides are legal to use?

Legal peptides with prescription include semaglutide (Ozempic, Wegovy), tirzepatide (Mounjaro), tesamorelin for HIV-related lipodystrophy, and sermorelin for growth hormone deficiency. GHK-Cu (copper peptides) are legal in cosmetic products for topical use. Peptides that appear on Category 1 of the 503A bulks list, have USP monographs, or have GRAS status can be legally compounded. Most other peptides marketed for muscle building, fat loss, tissue repair, or anti-aging lack FDA approval and cannot be legally sold or prescribed for human use.

What are the consequences of using illegal peptides?

For healthcare providers, prescribing unapproved peptides can result in state medical board disciplinary action, FDA enforcement, and potential criminal charges. For consumers, the primary risks are safety-related rather than criminal—unapproved peptides have no guarantee of identity, purity, potency, or safety, and products from unregulated sources may contain contaminants like heavy metals. While individuals typically don’t face criminal charges for personal use, you risk purchasing contaminated products with unknown side effects. Sellers and manufacturers face much stricter enforcement than individual users.

How do state laws affect peptide legality?

State laws increasingly focus on restricting sales to minors rather than banning peptides outright. New York banned the sale of muscle-building and weight-loss supplements to anyone under 18 in 2024. New Jersey requires parental consent for minors to purchase performance-enhancing products. California, Massachusetts, Illinois, Virginia, Texas, and New Hampshire have introduced similar legislation. These laws create compliance requirements for sellers regarding age verification and marketing claims. States don’t override federal FDA regulations but add additional restrictions on how peptides can be sold and marketed, particularly targeting products promoted for muscle building or weight loss.

What are common misconceptions about peptide legality?

Many believe “research chemicals” labeled “not for human consumption” are legal—false, as the FDA views these disclaimers as attempts to evade regulation. Another misconception is that all peptides have the same legal status, when in reality status varies dramatically by specific compound, intended use, and delivery method. Some think oral peptides are legal while injectables aren’t—while enforcement focuses on compounded injectables, oral forms still lack FDA approval. Many assume banned peptides are dangerous, but the FDA’s Category 2 designation often reflects insufficient clinical evidence rather than proven harm. Finally, people believe compounded peptides are automatically legal, but pharmacies can only compound peptides meeting specific FDA criteria.

What are the latest regulatory changes?

The most significant change was the October 2023 addition of popular peptides to the FDA’s Category 2 list, which prohibited compounding pharmacies from producing them. In September 2024, the FDA removed five peptides (Thymosin Alpha-1, CJC-1295, Ipamorelin, Pentadecapeptide, and Selank Nasal) from Category 2 and announced consultation with the Pharmacy Compounding Advisory Committee for potential future inclusion. These peptides are still undergoing evaluation and aren’t fully approved yet. The FDA continues publishing draft guidance on peptide manufacturing and quality control. State-level restrictions targeting underage access to performance-enhancing supplements emerged in 2024, with New York, New Jersey, and several other states implementing age verification requirements.

Disclaimer: This information is for educational purposes only and does not constitute legal advice. Peptide legality, regulatory status, and applications vary by individual circumstances, intended use, and applicable law. Consult official FDA resources or a qualified attorney for specific guidance regarding peptide legality or compliance.

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About the Author

Sarah Klein, JD, is a licensed attorney and legal content strategist with over 12 years of experience across civil, criminal, family, and regulatory law. At All About Lawyer, she covers a wide range of legal topics — from high-profile lawsuits and courtroom stories to state traffic laws and everyday legal questions — all with a focus on accuracy, clarity, and public understanding.
Her writing blends real legal insight with plain-English explanations, helping readers stay informed and legally aware.
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