Peptide and compounding law · Updated
Are peptides legal?
It depends on the peptide and on who is selling it. Peptides the FDA has approved, such as semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound), are legal with a prescription. A compounding pharmacy may make a peptide for an individual patient only from an ingredient federal law lets it use, and on October 30, 2026 HHS said it does not intend to take enforcement action against 503A pharmacies and physicians compounding with the peptides listed in a draft policy, under that policy's conditions. Peptides sold online "for research use only" to people who will inject or swallow them are, in the FDA's view, unapproved new drugs whatever the label says. Federal drug law is aimed mainly at the people who make, sell and ship them.
| Product or channel | Federal status | Who may lawfully supply it | Law or rule |
|---|---|---|---|
| FDA-approved peptide drugs: semaglutide, tirzepatide, bremelanotide (Vyleesi) | Approved; legal with a prescription, including off-label prescribing | Pharmacies, on a prescription | 21 U.S.C. 355 |
| Compounded peptide from an ingredient with a USP monograph, or one that is part of an approved drug | Lawful under section 503A for an identified patient's prescription | A state-licensed pharmacy or a licensed physician | 21 U.S.C. 353a(b)(1)(A) |
| Compounded peptide on FDA's Category 1 interim list (for example GHK-Cu, not injectable) | FDA does not intend to take action if the guidance conditions are met | A 503A pharmacy | FDA 503A category list, updated May 14, 2026 |
| BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500 (Appendix A of HHS's October 30, 2026 draft policy) | Not approved and not on the 503A bulks list. HHS does not intend to enforce against 503A compounding that meets the draft policy's conditions | A state-licensed pharmacy, federal facility or licensed physician compounding under section 503A. Not a 503B outsourcing facility | 91 FR 68526 (Oct. 30, 2026); HHS policy |
| Compounded semaglutide or tirzepatide | Both shortages are over. Copies of an approved drug may not be compounded regularly | Only where a prescriber documents a significant difference for the patient | 21 U.S.C. 353a(b)(1)(D) |
| Retatrutide and cagrilintide | "Cannot be used in compounding under federal law" (FDA) | No one, outside an authorized clinical trial | FDA GLP-1 page |
| Peptides labeled "research use only" and sold to consumers | Unapproved new drugs when the seller's site shows they are meant for people | No one, for human use | 21 U.S.C. 331(d); 21 CFR 201.128 |
| Peptides sold as dietary supplements | Only if the ingredient may lawfully be a dietary ingredient. FDA has called a peptide a new dietary ingredient lacking safety data (August 2026) | Supplement makers, within the supplement rules | 21 U.S.C. 321(ff) |
| Human growth hormone, outside an approved use | A federal felony to distribute | No one | 21 U.S.C. 333(e) |
Why the answer depends on the product, not the molecule
Federal law has no category called "peptides". A peptide is a drug when it is meant to treat a disease or to affect the structure or function of the body (21 U.S.C. 321(g)(1)). A drug that is not generally recognized as safe and effective is a "new drug", and no one may ship a new drug across state lines unless the FDA has approved it (21 U.S.C. 355(a)). Doing so is a prohibited act under 21 U.S.C. 331(d), punishable by up to a year in prison, or three years with intent to defraud or mislead (21 U.S.C. 333(a)).
So the same peptide can be lawful in one channel and unlawful in another. Semaglutide in a Wegovy pen is an approved drug. Semaglutide compounded by a pharmacy is lawful only within the compounding rules. Semaglutide sold in a vial marked "for research use only" is, in the FDA's view, an unapproved new drug.
One more line matters. Since March 23, 2020, a chain of more than 40 amino acids is a "protein" and is regulated as a biological product (21 CFR 600.3(h)(6)). Tesamorelin (Egrifta) and the hCG products were moved to biologics licenses that day. The FDA's position is that biologics cannot be made under the compounding exemptions at all.
Peptides the FDA has approved
Approved peptide drugs are legal with a prescription. Prescribing one for an unapproved use is a matter of medical practice, not drug approval. Current examples include semaglutide (Ozempic, Rybelsus, Wegovy, and since December 22, 2025, Wegovy tablets), tirzepatide (Mounjaro, Zepbound) and bremelanotide (Vyleesi, the drug sold on research sites as "PT-141"), according to the FDA's Drugs@FDA database.
Sermorelin is a special case. Its brand, Geref, was discontinued, but in 2013 the FDA found it was not withdrawn for safety or effectiveness reasons (78 FR 14095), and the FDA's 503B list marks sermorelin acetate as a component of an approved drug. Whether a given compounded sermorelin product qualifies depends on the facts, including the limits on copies.
Compounded peptides: three routes for an ingredient
Most peptides used in longevity and wellness clinics are compounded, not approved. Under section 503A a pharmacy compounds for an identified patient on a valid prescription, and each bulk ingredient must take one of three routes: it has a USP or National Formulary monograph; or it is a component of an FDA-approved drug; or it appears on the FDA's 503A bulks list (21 U.S.C. 353a(b)(1)(A)). That list, at 21 CFR 216.23, has six substances and no peptides.
While the list is being built, the FDA sorts nominated substances into categories. It does not intend to act against a pharmacy using a Category 1 substance under the guidance conditions; Category 2 substances raised significant safety concerns (FDA 503A page). The FDA stopped categorizing new nominations on January 7, 2025. The current list was updated May 14, 2026: GHK-Cu (other than injectable forms) is back in Category 1 (see Is GHK-Cu legal?), and kisspeptin-10 is still in Category 2.
On April 22, 2026, after the nominators withdrew them, the FDA moved twelve peptides, including BPC-157, TB-500 and Semax, out of Category 2 into a "nominated but withdrawn" table (FDA safety-risk page). It did not move them into Category 1. Outsourcing facilities under section 503B work from a different, shorter list; see 503A vs 503B.
The October 30, 2026 HHS peptide policy
On October 30, 2026 the Department of Health and Human Services published notice of a draft "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances" (91 FR 68526, Docket HHS-OASH-2026-0496). It says HHS "does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance found in Appendix A." The notice itself does not name the peptides. It points to the policy on the HHS website as "the most current version", and that policy's Appendix A lists six: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. The notice cites the FDA's Pharmacy Compounding Advisory Committee meetings, which in July 2026 reviewed those six and a seventh, emideltide, that is not on the list (91 FR 20465).
Three limits matter. It covers 503A compounding only, so 503B outsourcing facilities cannot rely on it. It is not FDA approval and does not add anything to the 503A bulks list; the notice says the FDA's future rulemakings "may propose" adding some or all of these peptides. And it is a draft that "is not binding on HHS or the public", open for comment for two weeks (regulations.gov shows the docket closing on November 13, 2026), which HHS says it may revisit "if, among other things, a safety signal or product quality issue arises".
The policy, which calls itself an interim policy, sets conditions for relying on it. Among them: a patient-specific prescription; one listed peptide per product, so no blends; for BPC-157 acetate, subcutaneous, intramuscular, oral or topical forms only; bulk ingredient from an FDA-registered facility with a valid certificate of analysis; reporting serious adverse events and product-quality problems to the FDA and to the states; documented oral bioavailability for oral forms; no device packaged with the drug except an FDA-cleared syringe; and a label reading "This is a compounded drug product. Not for resale." Every other requirement of section 503A still applies. Check the HHS website for a newer version before relying on it. More in Is BPC-157 legal? and Is TB-500 legal?
Compounded GLP-1s after the shortages
Pharmacies were allowed to compound semaglutide and tirzepatide while they were in shortage. The FDA declared the tirzepatide shortage resolved on December 19, 2024 and the semaglutide shortage resolved on February 21, 2025. Its grace periods for 503A pharmacies ended in early March and late April 2025, and for 503B outsourcing facilities on March 19 and May 22, 2025 (FDA). The Fifth Circuit upheld both decisions on August 27, 2026.
Today a 503A pharmacy may not regularly compound copies of an approved drug (21 U.S.C. 353a(b)(1)(D)); the FDA's policy is four or fewer such prescriptions a month, unless the prescriber documents a significant difference for the patient. On May 1, 2026 the FDA proposed keeping semaglutide, tirzepatide and liraglutide off the 503B bulks list (91 FR 23431); that proposal was not final as of October 30, 2026. The FDA also says retatrutide and cagrilintide cannot be compounded under federal law.
"Research use only" does not make a peptide legal
Intended use is judged by what the seller objectively intends, shown by its labeling, advertising, statements and "the circumstances surrounding the distribution" (21 CFR 201.128). The FDA's letters repeat the point: "Despite statements on your product labeling marketing your products 'for research use only' and 'not for human consumption,' evidence obtained from your website establishes that your products are intended to be drugs for human use" (warning letter, August 24, 2026).
Selling bacteriostatic water and a dosing calculator next to the vials is the evidence the FDA cites most. In July 2026 the owner of an Indiana research-peptide business was sentenced to 70 months in federal prison (DOJ). More in Research-use-only peptides.
Buying, possessing and bringing peptides into the country
The federal prohibited acts target introducing drugs into interstate commerce, receiving and delivering them "for pay or otherwise", and misbranding drugs held for sale (21 U.S.C. 331). No commonly sold peptide is on the federal controlled-substance schedules (21 CFR part 1308). One federal exception stands out: distributing human growth hormone for an unapproved use is a felony (21 U.S.C. 333(e)). State controlled-substance laws can reach further than the federal schedules, so check the state as well.
Importing a drug that is not approved in the US is generally illegal. The FDA's personal importation policy describes when its staff may allow a small personal supply, usually no more than three months, for a patient with a US doctor. It is discretion, not a right. Athletes should know that BPC-157 is on the World Anti-Doping Agency's prohibited list.
North Carolina
North Carolina's Board of Pharmacy lets a pharmacy dispense a compounded drug only on a valid prescription, bars offering compounded drugs to others for resale, and allows compounding for a practitioner's office use only as federal law permits (21 NCAC 46 .2801). A federal decision not to enforce does not change state law, and we have found no Board statement on the HHS policy as of November 2, 2026.
The FDA's August 2026 research-peptide letters included one to a seller in Cornelius, in Mecklenburg County. A clinic or pharmacy in North Carolina should check both layers before adding a peptide.
Common questions
Is BPC-157 legal?
BPC-157 is not FDA-approved, is not part of any approved drug, and is not on the 503A bulks list. In April 2026 the FDA moved it out of Category 2 into a "nominated but withdrawn" table, not into Category 1. On October 30, 2026, HHS published a draft policy saying it does not intend to take enforcement action against 503A compounding with six peptides, BPC-157 among them, under the policy's conditions. 503B outsourcing facilities are not covered, and selling a peptide as a research chemical for people is still unlawful.
Are research peptides legal to buy?
Selling a peptide labeled "research use only" to people who will use it is, in the FDA's view, selling an unapproved new drug, and the FDA and the Justice Department act against sellers. Federal drug law is aimed at the people who sell and ship them, but a buyer has no assurance of what is in the vial.
Can a doctor prescribe peptides?
A licensed prescriber may prescribe FDA-approved peptide drugs, including off-label. For compounded peptides, the question is whether a pharmacy may lawfully make the product: the ingredient must have a monograph, be part of an approved drug, be on the 503A bulks list, or fall under an FDA or HHS enforcement policy such as Category 1 or the October 30, 2026 HHS policy.
Is compounded semaglutide still legal?
Only narrowly. Both GLP-1 shortages ended in 2024 and 2025, and pharmacies may no longer regularly compound copies of the approved drugs. A 503A pharmacy may compound a version for a patient when the prescriber documents a significant difference, such as an allergy to an ingredient. The FDA has proposed keeping semaglutide off the 503B bulks list.
Are peptides controlled substances?
Not federally: no commonly sold peptide is on the DEA schedules. Distributing human growth hormone for an unapproved use is a federal felony, and state controlled-substance laws can list substances the federal schedules do not.
Does the HHS policy make any peptide FDA-approved?
No. It is an enforcement-discretion policy from HHS, published as a draft on October 30, 2026. It approves no peptide, adds nothing to the bulks list, binds no one, and can be revisited if a safety or quality problem arises.
Can I order peptides from another country?
Importing an unapproved drug is generally illegal. The FDA's personal importation policy lets its staff use discretion for a small personal supply in limited cases. Bulk GLP-1 ingredients from abroad are subject to an FDA import alert.
Are peptides in supplements legal?
Only if the ingredient may lawfully be used as a dietary ingredient. A substance first studied or approved as a drug generally cannot become a supplement ingredient afterward, and in August 2026 the FDA warned a company that its peptide was a new dietary ingredient without adequate safety information.
Update log
- November 2, 2026. Published. Federal statutes, FDA lists and letters checked October 30, 2026; FDA list dates, the Federal Register and the HHS docket re-checked November 2, 2026, and the HHS policy and its Appendix A read on hhs.gov the same day.
Sources
- 21 U.S.C. 321 (definitions: drug, dietary supplement)
- 21 U.S.C. 331 and 333 (prohibited acts, penalties, human growth hormone)
- 21 U.S.C. 353a (section 503A, pharmacy compounding)
- 21 CFR 201.128 (intended use)
- 21 CFR 600.3(h)(6) (proteins regulated as biologics)
- HHS, Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, 91 FR 68526 (Oct. 30, 2026)
- HHS, the policy with Appendix A (peptides covered) and Appendix B, hhs.gov PDF (read November 2, 2026)
- FDA, Pharmacy Compounding Advisory Committee meeting notice, 91 FR 20465 (Apr. 16, 2026)
- FDA, Bulk Drug Substances Used in Compounding Under Section 503A (category list updated May 14, 2026)
- FDA, Certain Bulk Drug Substances That May Present Significant Safety Risks (current as of April 22, 2026)
- FDA, Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (current as of October 1, 2026)
- FDA, Personal Importation
- 21 NCAC 46 .2801 (North Carolina compounding rule; Cornell LII copy of the NC Administrative Code)
Related
Adding peptides to a practice or a pharmacy?
DPS Law advises clinics, physicians, pharmacies and founders on North Carolina and federal drug and compounding law. For another state's pharmacy or medical board rules, talk to a lawyer licensed in that state.