Compound LawsREAL-TIME LEGAL INTELLIGENCE

Home / Peptides

Are Peptides Legal? Research Peptides and Federal Law (2026)

Drug rules apply

As of November 12, 2026, peptides are not illegal as a class. A peptide product sold to treat or prevent disease, or sold as a drug, is a drug under federal law and needs FDA approval, a compounding exemption under section 503A or 503B, or an investigational exemption; a "research use only" or “not for human consumption” label does not supply one. Peptides sold as foods, dietary supplements or cosmetics fall under other federal rules. Since October 30, 2026, HHS says it will not act against pharmacies and physicians that compound six peptides (BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500) for a patient's prescription on ten conditions; that is enforcement discretion, not a change in the law.

Verified November 12, 2026 · federal record (FD&C Act) · federal status: restricted

In plain terms: Some peptides are prescription drugs, some are supplement or skin-care ingredients, and many sold online are unapproved drugs. If a peptide is sold for people to inject or take as a treatment, federal drug law applies, and a “research only” label does not change that.

This page reports federal and state law as written and enforced. It is not medical or legal advice.

Peptides on file

Is compounded semaglutide legal?Prescription compounding onlyCompounded semaglutide is lawful only under the conditions of sections 503A and 503B; semaglutide has been off the shortage list since February 21, 2025 Is compounded tirzepatide banned?Prescription compounding onlyCompounded tirzepatide is lawful only under the conditions of sections 503A and 503B; tirzepatide has been off the shortage list since FDA's December 19, 2024 decision Is retatrutide legal?Not approved: no lawful saleRetatrutide is not FDA-approved and cannot be compounded; use in people is lawful only in FDA-regulated studies or FDA patient-access programs Is BPC-157 legal?Not approved: HHS discretion on compoundingBPC-157 is not FDA-approved or eligible for compounding by statute; since Oct. 30, 2026 HHS says it will not act against 503A compounding of it on ten conditions

How a peptide drug reaches people lawfully

FDA approval
Approved peptide drugs, such as the semaglutide and tirzepatide products, are sold by prescription under an approved application. A chain longer than 40 amino acids is regulated as a biological product and needs a license under 42 U.S.C. 262. (21 U.S.C. 355(a))
Pharmacy compounding (section 503A)
A licensed pharmacist or physician may compound for an identified patient on a prescription, using bulk substances that meet a USP or NF monograph, are components of an approved drug, or appear on FDA's 503A list. (21 U.S.C. 353a(b)(1))
HHS enforcement discretion for six peptides (since Oct. 30, 2026)
HHS says it does not intend to take action against a state-licensed pharmacy, federal facility or licensed physician that compounds a drug from BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500, which are not on the 503A list, when all ten circumstances in its policy are present: a valid prescription for an individual patient; the peptide is listed in Appendix A with the identity and route of administration in Appendix B; the bulk substance comes from an FDA-registered facility with a certificate of analysis meeting FDA's criteria, and its original manufacturer is FDA-registered and follows current good manufacturing practice; serious adverse events, quality problems and products compounded are reported to FDA's MedWatch program and to the states involved; the label says "This is a compounded drug product. Not for resale."; the product has a single active ingredient; oral forms are documented to be absorbed; the only delivery device is an FDA 510(k)-cleared syringe; and every other FD&C Act requirement is met. The notice calls the policy a draft and nonbinding; it lasts until a final rule decides each peptide’s place on the 503A bulks list and does not cover outsourcing facilities or research-use-only sales. (91 FR 68526; HHS policy, Appendices A and B)
Outsourcing facilities (section 503B)
A registered outsourcing facility may compound from bulk substances on FDA's clinical-need list, or drugs on the drug shortage list. (21 U.S.C. 353b(a)(2))
Clinical studies and FDA patient-access programs
An investigational new drug application allows use in clinical studies under 21 CFR part 312. FDA expanded access and the federal Right to Try Act can provide an investigational drug to individual patients with serious or life-threatening conditions, with the sponsor’s agreement; neither allows sale to the general public. (21 U.S.C. 355(i)(1), 360bbb, 360bbb-0a)

"Research use only" and “not for human consumption”

A "research use only" or “not for human consumption” label does not exempt a drug intended for people from the approval requirement. FDA reads intended use from objective evidence, including labeling claims, advertising, statements and the circumstances in which the product is sold (21 CFR 201.128, which defines intended use for FDA labeling rules; FDA applies the same objective test when deciding whether a product is a drug). FDA rules do allow a new drug to be shipped solely for tests in vitro or in laboratory research animals when it is labeled and shipped as 21 CFR 312.160 requires, including the statement “Not for use in humans” (21 CFR 312.2(b)(3)); that route does not cover products sold to the public or used in people. The phrase “For Research Use Only” itself comes from FDA's labeling rule for in vitro diagnostic devices (21 CFR 809.10(c)). A review of FDA's warning letter index for these pages found at least 17 letters from February 2024 to August 2026 that cite research-use-only style labeling of peptide drugs.

The words intended uses or words of similar import in §§ 201.5, 201.115, 201.117, 201.119, 201.120, 201.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives.

21 CFR 201.128, first three sentences

No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.

21 U.S.C. 355(a), subsection (a)

State law

1 of the 51 jurisdictions screened on November 7, 2026 has a statute or rule of its own that addresses peptides. Federal law, described above, applies in every state.

Louisiana · La. Acts 2026, No. 374 (SB 253), enacting La. R.S. 37:23.5 (effective August 1, 2026)
Bars Louisiana licensing boards from prohibiting prescribers from providing peptides shipped from a 503B outsourcing facility or 503A pharmacy that complies with federal compounding law, and from prohibiting Louisiana pharmacists from compounding and dispensing peptides in compliance with 21 U.S.C. 353a. It does not define peptides and does not change which substances federal law allows to be compounded.

Federal drug law applies nationwide; state pharmacy, medical practice and food and drug laws apply on top of it.

How the state screen was done: Each jurisdiction's statutes, administrative rules, enacted session laws and controlled-substance schedules were searched on official sites for semaglutide, tirzepatide, GLP-1, retatrutide, BPC-157, peptide and salt-form language on November 6 and 7, 2026. Board letters, FAQs and position statements were recorded but are not counted as law. Some official sources could not be searched in full by automated reading: Arizona and Missouri rule PDFs, Colorado schedules, the District of Columbia regulations search, Georgia board rules, the Illinois site search, Maine and Massachusetts rule pages, New York statute search, Oklahoma and Rhode Island bill text, Tennessee rules (read through a non-official copy), Texas medical board rules and the Virginia code search. For those, the screen relied on the official statutes it could read and on searches restricted to the official domains.

Terms used here

FDA-approved drug: A drug FDA has reviewed and approved for sale under an application, such as a new drug application (NDA).
Compounded drug: A drug mixed or altered by a pharmacy or outsourcing facility. Compounded drugs are not FDA-approved.
Section 503A: The federal rule for drugs compounded by a state-licensed pharmacist or physician for an identified patient on a prescription (21 U.S.C. 353a).
Section 503B: The federal rule for outsourcing facilities registered with FDA, which may compound without a prescription for each patient and must follow federal manufacturing quality rules (21 U.S.C. 353b).
Enforcement discretion: A statement by FDA or HHS that it does not intend to act against certain conduct, often on conditions. It does not change the law, binds no one, can be withdrawn, and does not stop states or private parties from acting.
Investigational new drug application (IND): FDA permission for a sponsor to ship an unapproved drug for clinical studies (21 CFR part 312).

Questions

Are peptides legal?

Peptides are not illegal as a class. A peptide is regulated by what it is sold to do. A peptide product intended to treat or prevent disease, or sold as a drug, is a drug under federal law and is lawful only as an FDA-approved product, a drug compounded under section 503A or 503B, or within an investigational exemption. Peptides sold as foods, dietary supplements or cosmetics fall under other federal rules.

Are peptides illegal?

No federal law bans peptides as a class, and none of the peptides with records here (semaglutide, tirzepatide, retatrutide, BPC-157) is a federally controlled substance. What federal drug law prohibits is introducing an unapproved new drug into interstate commerce (21 U.S.C. 331(d) and 355(a)), which reaches peptide drugs sold for human use without approval or an exemption.

Which peptides can pharmacies compound under the HHS policy?

Six, under HHS’s enforcement discretion policy of October 30, 2026: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. HHS says it will not act against 503A pharmacies, federal facilities and licensed physicians that compound one of them for a patient on a prescription when ten conditions are met, each limited to the forms in Appendix B. The peptides are still not on the 503A bulks list, and the policy is not binding.

Is it illegal to sell peptides?

Selling a peptide drug for use in people without FDA approval, a compounding exemption or an investigational exemption generally violates federal drug law. Introducing an unapproved new drug into interstate commerce is a prohibited act (21 U.S.C. 331(d) and 355(a)), and state drug laws reach sales within a state. A disclaimer label does not change the intended use FDA reads from a product’s marketing and sale (21 CFR 201.128).

What does research use only mean for peptides?

FDA rules allow a new drug to be shipped solely for laboratory tests or animal research when it is labeled and shipped as 21 CFR 312.160 requires, including the statement “Not for use in humans.” That route does not cover products sold to the public or used in people. The phrase “For Research Use Only” itself comes from FDA's labeling rule for in vitro diagnostic devices (21 CFR 809.10(c)).

Does any state have a law about peptides?

Louisiana Act 374 of 2026 (R.S. 37:23.5, effective August 1, 2026) bars Louisiana licensing boards from prohibiting prescribers from providing peptides shipped from 503A pharmacies or 503B outsourcing facilities that comply with federal law, and from prohibiting Louisiana pharmacists from compounding peptides in compliance with 21 U.S.C. 353a. It does not change which peptides federal law allows to be compounded. No other state statute or rule naming peptides was found in the November 2026 screen.

Federal law and HHS policy on file

Stored verbatim from the official publisher, with the retrieval date and a fingerprint that changes when the text does. The HHS policy is a statement of enforcement discretion, not a statute or rule.

21 CFR 201.128 · Meaning of "intended uses".OFFICIAL

Instrument: Meaning of "intended uses".
Source: https://www.ecfr.gov/current/title-21/part-201/section-201.128
Retrieved: 2026-11-07
Fingerprint: 9c6b0110950305c2

§ 201.128 Meaning of "intended uses".
The words intended uses or words of similar import in §§ 201.5, 201.115, 201.117, 201.119, 201.120, 201.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. Objective intent may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered or used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for an approved drug based solely on that firm's knowledge that such drug was being prescribed or used by health care providers for such use. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he or she received the article, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.

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.OFFICIAL

Instrument: Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act.
Source: https://www.ecfr.gov/current/title-21/part-216/section-216.23
Retrieved: 2026-11-07
Fingerprint: dc6d8e48d21e5eb0

§ 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.
(a) The following bulk drug substances can be used in compounding under section 503A(b)(1)(A)(i)(III) of the Federal Food, Drug, and Cosmetic Act.
(1) Brilliant Blue G, also known as Coomassie Brilliant Blue G-250.
(2) Cantharidin (for topical use only).
(3) Diphenylcyclopropenone (for topical use only).
(4) N-acetyl-D-glucosamine (for topical use only).
(5) Squaric acid dibutyl ester (for topical use only).
(6) Thymol iodide (for topical use only).
(b) After balancing the criteria set forth in paragraph (c) of this section, FDA has determined that the following bulk drug substances will not be included on the list of substances that can be used in compounding set forth in paragraph (a) of this section:
(1) Oxitriptan.
(2) Piracetam.
(3) Silver Protein Mild.
(4) Tranilast.
(c) FDA will use the following criteria in evaluating substances considered for inclusion on the list set forth in paragraph (a) of this section:
(1) The physical and chemical characterization of the substance;
(2) Any safety issues raised by the use of the substance in compounded drug products;
(3) The available evidence of the effectiveness or lack of effectiveness of a drug product compounded with the substance, if any such evidence exists; and
(4) Historical use of the substance in compounded drug products, including information about the medical condition(s) the substance has been used to treat and any references in peer-reviewed medical literature.
(d) Based on evidence currently available, there are inadequate data to demonstrate the safety or efficacy of any drug product compounded using any of the drug substances listed in paragraph (a) of this section, or to establish general recognition of the safety or effectiveness of any such drug product. Any person who represents that a compounded drug made with a bulk drug substance that appears on this list is FDA approved, or otherwise endorsed by FDA generally or for a particular indication, will cause the drug to be misbranded under section 502(a) and/or 502(bb) of the Federal Food, Drug, and Cosmetic Act.

21 CFR 216.24 · Drug products withdrawn or removed from the market for reasons of safety or effectiveness.OFFICIAL

Instrument: Drug products withdrawn or removed from the market for reasons of safety or effectiveness.
Source: https://www.ecfr.gov/current/title-21/part-216/section-216.24
Retrieved: 2026-11-07
Fingerprint: ded6eef857eecb39

§ 216.24 Drug products withdrawn or removed from the market for reasons of safety or effectiveness.
The following drug products were withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. The following drug products may not be compounded under the exemptions provided by section 503A(a) or section 503B(a) of the Federal Food, Drug, and Cosmetic Act:
Adenosine phosphate: All drug products containing adenosine phosphate.
Adrenal cortex: All drug products containing adrenal cortex.
Alatrofloxacin mesylate: All drug products containing alatrofloxacin mesylate.
Aminopyrine: All drug products containing aminopyrine.
Astemizole: All drug products containing astemizole.
Azaribine: All drug products containing azaribine.
Benoxaprofen: All drug products containing benoxaprofen.
Bithionol: All drug products containing bithionol.
Bromfenac sodium: All drug products containing bromfenac sodium (except ophthalmic solutions).
Bromocriptine mesylate: All drug products containing bromocriptine mesylate for prevention of physiological lactation.
Butamben: All parenteral drug products containing butamben.
Camphorated oil: All drug products containing camphorated oil.
Carbetapentane citrate: All oral gel drug products containing carbetapentane citrate.
Casein, iodinated: All drug products containing iodinated casein.
Cerivastatin sodium: All drug products containing cerivastatin sodium.
Chloramphenicol: All oral drug products containing chloramphenicol.
Chlorhexidine gluconate: All tinctures of chlorhexidine gluconate formulated for use as a patient preoperative skin preparation.
Chlormadinone acetate: All drug products containing chlormadinone acetate.
Chloroform: All drug products containing chloroform.
Cisapride: All drug products containing cisapride.
Cobalt: All drug products containing cobalt salts (except radioactive forms of cobalt and its salts and cobalamin and its derivatives).
Dexfenfluramine hydrochloride: All drug products containing dexfenfluramine hydrochloride.
Diamthazole dihydrochloride: All drug products containing diamthazole dihydrochloride.
Dibromsalan: All drug products containing dibromsalan.
Diethylstilbestrol: All oral and parenteral drug products containing 25 milligrams or more of diethylstilbestrol per unit dose.
Dihydrostreptomycin sulfate: All drug products containing dihydrostreptomycin sulfate.
Dipyrone: All drug products containing dipyrone.
Encainide hydrochloride: All drug products containing encainide hydrochloride.
Esmolol hydrochloride: All parenteral dosage form drug products containing esmolol hydrochloride that supply 250 milligrams/milliliter of concentrated esmolol per 10-milliliter ampule.
Etretinate: All drug products containing etretinate.
Fenfluramine hydrochloride: All drug products containing fenfluramine hydrochloride.
Flosequinan: All drug products containing flosequinan.
Gatifloxacin: All drug products containing gatifloxacin (except ophthalmic solutions).
Gelatin: All intravenous drug products containing gelatin.
Glycerol, iodinated: All drug products containing iodinated glycerol.
Gonadotropin, chorionic: All drug products containing chorionic gonadotropins of animal origin.
Grepafloxacin: All drug products containing grepafloxacin.
Mepazine: All drug products containing mepazine hydrochloride or mepazine acetate.
Metabromsalan: All drug products containing metabromsalan.
Methamphetamine hydrochloride: All parenteral drug products containing methamphetamine hydrochloride.
Methapyrilene: All drug products containing methapyrilene.
Methopholine: All drug products containing methopholine.
Methoxyflurane: All drug products containing methoxyflurane.
Mibefradil dihydrochloride: All drug products containing mibefradil dihydrochloride.
Nitrofurazone: All drug products containing nitrofurazone (except topical drug products formulated for dermatologic application).
Nomifensine maleate: All drug products containing nomifensine maleate.
Novobiocin sodium: All drug products containing novobiocin sodium.
Ondansetron hydrochloride: All intravenous drug products containing greater than a 16 milligram single dose of ondansetron hydrochloride.
Oxyphenisatin: All drug products containing oxyphenisatin.
Oxyphenisatin acetate: All drug products containing oxyphenisatin acetate.
Pemoline: All drug products containing pemoline.
Pergolide mesylate: All drug products containing pergolide mesylate.
Phenacetin: All drug products containing phenacetin.
Phenformin hydrochloride: All drug products containing phenformin hydrochloride.
Phenylpropanolamine: All drug products containing phenylpropanolamine.
Pipamazine: All drug products containing pipamazine.
Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride, and bisacodyl: All drug products containing polyethylene glycol 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution, and 10 milligrams or more of bisacodyl delayed-release tablets.
Potassium arsenite: All drug products containing potassium arsenite.
Potassium chloride: All solid oral dosage form drug products containing potassium chloride that supply 100 milligrams or more of potassium per dosage unit (except for controlled-release dosage forms and those products formulated for preparation of solution prior to ingestion).
Povidone: All intravenous drug products containing povidone.
Propoxyphene: All drug products containing propoxyphene.
Rapacuronium bromide: All drug products containing rapacuronium bromide.
Reserpine: All oral dosage form drug products containing more than 1 milligram of reserpine.
Rofecoxib: All drug products containing rofecoxib.
Sibutramine hydrochloride: All drug products containing sibutramine hydrochloride.
Sparteine sulfate: All drug products containing sparteine sulfate.
Sulfadimethoxine: All drug products containing sulfadimethoxine.
Sulfathiazole: All drug products containing sulfathiazole (except for those formulated for vaginal use).
Suprofen: All drug products containing suprofen (except ophthalmic solutions).
Sweet spirits of nitre: All drug products containing sweet spirits of nitre.
Tegaserod maleate: All drug products containing tegaserod maleate.
Temafloxacin hydrochloride: All drug products containing temafloxacin hydrochloride.
Terfenadine: All drug products containing terfenadine.
3,3′,4′,5-tetrachlorosalicylanilide: All drug products containing 3,3′,4′,5-tetrachlorosalicylanilide.
Tetracycline: All liquid oral drug products formulated for pediatric use containing tetracycline in a concentration greater than 25 milligrams/milliliter.
Ticrynafen: All drug products containing ticrynafen.
Tribromsalan: All drug products containing tribromsalan.
Trichloroethane: All aerosol drug products intended for inhalation containing trichloroethane.
Troglitazone: All drug products containing troglitazone.
Trovafloxacin mesylate: All drug products containing trovafloxacin mesylate.
Urethane: All drug products containing urethane.
Valdecoxib: All drug products containing valdecoxib.
Vinyl chloride: All aerosol drug products containing vinyl chloride.
Zirconium: All aerosol drug products containing zirconium.
Zomepirac sodium: All drug products containing zomepirac sodium.

Show 11 more laws on file

21 CFR 312.2 · Applicability.OFFICIAL

Instrument: Applicability.
Source: https://www.ecfr.gov/current/title-21/part-312/section-312.2
Retrieved: 2026-11-07
Fingerprint: 56cab3a35360b174

§ 312.2 Applicability.
(a) Applicability. Except as provided in this section, this part applies to all clinical investigations of products that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act (58 Stat. 632, as amended (42 U.S.C. 201 et seq.)).
(b) Exemptions. (1) The clinical investigation of a drug product that is lawfully marketed in the United States is exempt from the requirements of this part if all the following apply:
(i) The investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug;
(ii) If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant change in the advertising for the product;
(iii) The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product;
(iv) The investigation is conducted in compliance with the requirements for institutional review set forth in part 56 and with the requirements for informed consent set forth in part 50; and
(v) The investigation is conducted in compliance with the requirements of § 312.7.
(2)(i) A clinical investigation involving an in vitro diagnostic biological product listed in paragraph (b)(2)(ii) of this section is exempt from the requirements of this part if (a) it is intended to be used in a diagnostic procedure that confirms the diagnosis made by another, medically established, diagnostic product or procedure and (b) it is shipped in compliance with § 312.160.
(ii) In accordance with paragraph (b)(2)(i) of this section, the following products are exempt from the requirements of this part: (a) blood grouping serum; (b) reagent red blood cells; and (c) anti-human globulin.
(3) A drug intended solely for tests in vitro or in laboratory research animals is exempt from the requirements of this part if shipped in accordance with § 312.160.
(4) FDA will not accept an application for an investigation that is exempt under the provisions of paragraph (b)(1) of this section.
(5) A clinical investigation involving use of a placebo is exempt from the requirements of this part if the investigation does not otherwise require submission of an IND.
(6) A clinical investigation involving an exception from informed consent under § 50.24 of this chapter is not exempt from the requirements of this part.
(c) Bioavailability studies. The applicability of this part to in vivo bioavailability studies in humans is subject to the provisions of § 320.31.
(d) Unlabeled indication. This part does not apply to the use in the practice of medicine for an unlabeled indication of a new drug product approved under part 314 or of a licensed biological product.
(e) Guidance. FDA may, on its own initiative, issue guidance on the applicability of this part to particular investigational uses of drugs. On request, FDA will advise on the applicability of this part to a planned clinical investigation.

21 U.S.C. 321(g)(1) · Definitions; generallyOFFICIAL

Instrument: Definitions; generally
Source: https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321&num=0&edition=prelim
Retrieved: 2026-11-07
Fingerprint: 1a3c5e22231d61e9

(g)(1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.

21 U.S.C. 321(p) · Definitions; generallyOFFICIAL

Instrument: Definitions; generally
Source: https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321&num=0&edition=prelim
Retrieved: 2026-11-07
Fingerprint: e8b907ec9399556d

(p) The term "new drug" means—
(1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a "new drug" if at any time prior to June 25, 1938, it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or
(2) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

21 U.S.C. 331(d) · Prohibited actsOFFICIAL

Instrument: Prohibited acts
Source: https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section331&num=0&edition=prelim
Retrieved: 2026-11-07
Fingerprint: 8086d744c6dc17e7

(d) The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 350d, 355,, 360bbb–3, or 364c of this title.

21 U.S.C. 353a · Pharmacy compoundingOFFICIAL

Instrument: Pharmacy compounding
Source: https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353a&num=0&edition=prelim
Retrieved: 2026-11-07
Fingerprint: 5c4554300815ed3c

§ 353a. Pharmacy compounding
(a) In general
Sections 351(a)(2)(B), 352(f)(1), and 355 of this title shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient, if the drug product meets the requirements of this section, and if the compounding—
(1) is by—
(A) a licensed pharmacist in a State licensed pharmacy or a Federal facility, or
(B) a licensed physician,
on the prescription order for such individual patient made by a licensed physician or other licensed practitioner authorized by State law to prescribe drugs; or
(2)(A) is by a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patient; and
(B) is based on a history of the licensed pharmacist or licensed physician receiving valid prescription orders for the compounding of the drug product, which orders have been generated solely within an established relationship between—
(i) the licensed pharmacist or licensed physician; and
(ii)(I) such individual patient for whom the prescription order will be provided; or
(II) the physician or other licensed practitioner who will write such prescription order.
(b) Compounded drug
(1) Licensed pharmacist and licensed physician
A drug product may be compounded under subsection (a) if the licensed pharmacist or licensed physician—
(A) compounds the drug product using bulk drug substances, as defined in regulations of the Secretary published at section 207.3(a)(4) of title 21 of the Code of Federal Regulations—
(i) that—
(I) comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding;
(II) if such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary; or
(III) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, that appear on a list developed by the Secretary through regulations issued by the Secretary under subsection (c);
(ii) that are manufactured by an establishment that is registered under section 360 of this title (including a foreign establishment that is registered under section 360(i) of this title); and
(iii) that are accompanied by valid certificates of analysis for each bulk drug substance;
(B) compounds the drug product using ingredients (other than bulk drug substances) that comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding;
(C) does not compound a drug product that appears on a list published by the Secretary in the Federal Register of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective; and
(D) does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product.
(2) Definition
For purposes of paragraph (1)(D), the term “essentially a copy of a commercially available drug product” does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product.
(3) Drug product
A drug product may be compounded under subsection (a) only if—
(A) such drug product is not a drug product identified by the Secretary by regulation as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product; and
(B) such drug product is compounded in a State—
(i) that has entered into a memorandum of understanding with the Secretary which addresses the distribution of inordinate amounts of compounded drug products interstate and provides for appropriate investigation by a State agency of complaints relating to compounded drug products distributed outside such State; or
(ii) that has not entered into the memorandum of understanding described in clause (i) and the licensed pharmacist, licensed pharmacy, or licensed physician distributes (or causes to be distributed) compounded drug products out of the State in which they are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician.
The Secretary shall, in consultation with the National Association of Boards of Pharmacy, develop a standard memorandum of understanding for use by the States in complying with subparagraph (B)(i).
(c) Regulations
(1) In general
The Secretary shall issue regulations to implement this section. Before issuing regulations to implement subsections (b)(1)(A)(i)(III), (b)(1)(C), or (b)(3)(A), the Secretary shall convene and consult an advisory committee on compounding unless the Secretary determines that the issuance of such regulations before consultation is necessary to protect the public health. The advisory committee shall include representatives from the National Association of Boards of Pharmacy, the United States Pharmacopoeia, pharmacy, physician, and consumer organizations, and other experts selected by the Secretary.
(2) Limiting compounding
The Secretary, in consultation with the United States Pharmacopoeia Convention, Incorporated, shall promulgate regulations identifying drug substances that may be used in compounding under subsection (b)(1)(A)(i)(III) for which a monograph does not exist or which are not components of drug products approved by the Secretary. The Secretary shall include in the regulation the criteria for such substances, which shall include historical use, reports in peer reviewed medical literature, or other criteria the Secretary may identify.
(d) Application
This section shall not apply to—
(1) compounded positron emission tomography drugs as defined in section 321(ii) of this title; or
(2) radiopharmaceuticals.
(e) “Compounding” defined
As used in this section, the term “compounding” does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling.

21 U.S.C. 353b · Outsourcing facilitiesOFFICIAL

Instrument: Outsourcing facilities
Source: https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353b&num=0&edition=prelim
Retrieved: 2026-11-07
Fingerprint: 9d436e6b446a634b

§ 353b. Outsourcing facilities
(a) In general
Sections 352(f)(1), 355, and 360eee–1 of this title shall not apply to a drug compounded by or under the direct supervision of a licensed pharmacist in a facility that elects to register as an outsourcing facility if each of the following conditions is met:
(1) Registration and reporting
The drug is compounded in an outsourcing facility that is in compliance with the requirements of subsection (b).
(2) Bulk drug substances
The drug is compounded in an outsourcing facility that does not compound using bulk drug substances (as defined in section 207.3(a)(4) of title 21, Code of Federal Regulations (or any successor regulation)), unless—
(A)(i) the bulk drug substance appears on a list established by the Secretary identifying bulk drug substances for which there is a clinical need, by—
(I) publishing a notice in the Federal Register proposing bulk drug substances to be included on the list, including the rationale for such proposal;
(II) providing a period of not less than 60 calendar days for comment on the notice; and
(III) publishing a notice in the Federal Register designating bulk drug substances for inclusion on the list; or
(ii) the drug compounded from such bulk drug substance appears on the drug shortage list in effect under section 356e of this title at the time of compounding, distribution, and dispensing;
(B) if an applicable monograph exists under the United States Pharmacopeia, the National Formulary, or another compendium or pharmacopeia recognized by the Secretary for purposes of this paragraph, the bulk drug substances each comply with the monograph;
(C) the bulk drug substances are each manufactured by an establishment that is registered under section 360 of this title (including a foreign establishment that is registered under section 360(i) of this title); and
(D) the bulk drug substances are each accompanied by a valid certificate of analysis.
(3) Ingredients (other than bulk drug substances)
If any ingredients (other than bulk drug substances) are used in compounding the drug, such ingredients comply with the standards of the applicable United States Pharmacopeia or National Formulary monograph, if such monograph exists, or of another compendium or pharmacopeia recognized by the Secretary for purposes of this paragraph if any.
(4) Drugs withdrawn or removed because unsafe or not effective
The drug does not appear on a list published by the Secretary of drugs that have been withdrawn or removed from the market because such drugs or components of such drugs have been found to be unsafe or not effective.
(5) Essentially a copy of an approved drug
The drug is not essentially a copy of one or more approved drugs.
(6) Drugs presenting demonstrable difficulties for compounding
The drug—
(A) is not identified (directly or as part of a category of drugs) on a list published by the Secretary, through the process described in subsection (c), of drugs or categories of drugs that present demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug or category of drugs, taking into account the risks and benefits to patients; or
(B) is compounded in accordance with all applicable conditions identified on the list described in subparagraph (A) as conditions that are necessary to prevent the drug or category of drugs from presenting the demonstrable difficulties described in subparagraph (A).
(7) Elements to assure safe use
In the case of a drug that is compounded from a drug that is the subject of a risk evaluation and mitigation strategy approved with elements to assure safe use pursuant to section 355–1 of this title, or from a bulk drug substance that is a component of such drug, the outsourcing facility demonstrates to the Secretary prior to beginning compounding that such facility will utilize controls comparable to the controls applicable under the relevant risk evaluation and mitigation strategy.
(8) Prohibition on wholesaling
The drug will not be sold or transferred by an entity other than the outsourcing facility that compounded such drug. This paragraph does not prohibit administration of a drug in a health care setting or dispensing a drug pursuant to a prescription executed in accordance with section 353(b)(1) of this title.
(9) Fees
The drug is compounded in an outsourcing facility that has paid all fees owed by such facility pursuant to section 379j–62 of this title.
(10) Labeling of drugs
(A) Label
The label of the drug includes—
(i) the statement "This is a compounded drug." or a reasonable comparable alternative statement (as specified by the Secretary) that prominently identifies the drug as a compounded drug;
(ii) the name, address, and phone number of the applicable outsourcing facility; and
(iii) with respect to the drug—
(I) the lot or batch number;
(II) the established name of the drug;
(III) the dosage form and strength;
(IV) the statement of quantity or volume, as appropriate;
(V) the date that the drug was compounded;
(VI) the expiration date;
(VII) storage and handling instructions;
(VIII) the National Drug Code number, if available;
(IX) the statement "Not for resale", and, if the drug is dispensed or distributed other than pursuant to a prescription for an individual identified patient, the statement "Office Use Only"; and
(X) subject to subparagraph (B)(i), a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient.
(B) Container
The container from which the individual units of the drug are removed for dispensing or for administration (such as a plastic bag containing individual product syringes) shall include—
(i) the information described under subparagraph (A)(iii)(X), if there is not space on the label for such information;
(ii) the following information to facilitate adverse event reporting: www.fda.gov/medwatch and 1–800–FDA–1088 (or any successor Internet Web site or phone number); and
(iii) directions for use, including, as appropriate, dosage and administration.
(C) Additional information
The label and labeling of the drug shall include any other information as determined necessary and specified in regulations promulgated by the Secretary.
(11) Outsourcing facility requirement
The drug is compounded in an outsourcing facility in which the compounding of drugs occurs only in accordance with this section.
(b) Registration of outsourcing facilities and reporting of drugs
(1) Registration of outsourcing facilities
(A) Annual registration
Upon electing and in order to become an outsourcing facility, and during the period beginning on October 1 and ending on December 31 of each year thereafter, a facility—
(i) shall register with the Secretary its name, place of business, and unique facility identifier (which shall conform to the requirements for the unique facility identifier established under section 360 of this title), and a point of contact email address; and
(ii) shall indicate whether the outsourcing facility intends to compound a drug that appears on the list in effect under section 356e of this title during the subsequent calendar year.
(B) Availability of registration for inspection; list
(i) Registrations
The Secretary shall make available for inspection, to any person so requesting, any registration filed pursuant to this paragraph.
(ii) List
The Secretary shall make available on the public Internet Web site of the Food and Drug Administration a list of the name of each facility registered under this subsection as an outsourcing facility, the State in which each such facility is located, whether the facility compounds from bulk drug substances, and whether any such compounding from bulk drug substances is for sterile or nonsterile drugs.
(2) Drug reporting by outsourcing facilities
(A) In general
Upon initially registering as an outsourcing facility, once during the month of June of each year, and once during the month of December of each year, each outsourcing facility that registers with the Secretary under paragraph (1) shall submit to the Secretary a report—
(i) identifying the drugs compounded by such outsourcing facility during the previous 6-month period; and
(ii) with respect to each drug identified under clause (i), providing the active ingredient, the source of such active ingredient, the National Drug Code number of the source drug or bulk active ingredient, if available, the strength of the active ingredient per unit, the dosage form and route of administration, the package description, the number of individual units produced, and the National Drug Code number of the final product, if assigned.
(B) Form
Each report under subparagraph (A) shall be prepared in such form and manner as the Secretary may prescribe by regulation or guidance.
(C) Confidentiality
Reports submitted under this paragraph shall be exempt from inspection under paragraph (1)(B)(i), unless the Secretary finds that such an exemption would be inconsistent with the protection of the public health.
(3) Electronic registration and reporting
Registrations and drug reporting under this subsection (including the submission of updated information) shall be submitted to the Secretary by electronic means unless the Secretary grants a request for waiver of such requirement because use of electronic means is not reasonable for the person requesting waiver.
(4) Risk-based inspection frequency
(A) In general
Outsourcing facilities—
(i) shall be subject to inspection pursuant to section 374 of this title; and
(ii) shall not be eligible for the exemption under section 374(a)(2)(A) of this title.
(B) Risk-based schedule
The Secretary, acting through one or more officers or employees duly designated by the Secretary, shall inspect outsourcing facilities in accordance with a risk-based schedule established by the Secretary.
(C) Risk factors
In establishing the risk-based schedule, the Secretary shall inspect outsourcing facilities according to the known safety risks of such outsourcing facilities, which shall be based on the following factors:
(i) The compliance history of the outsourcing facility.
(ii) The record, history, and nature of recalls linked to the outsourcing facility.
(iii) The inherent risk of the drugs compounded at the outsourcing facility.
(iv) The inspection frequency and history of the outsourcing facility, including whether the outsourcing facility has been inspected pursuant to section 374 of this title within the last 4 years.
(v) Whether the outsourcing facility has registered under this paragraph as an entity that intends to compound a drug that appears on the list in effect under section 356e of this title.
(vi) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.
(5) Adverse event reporting
Outsourcing facilities shall submit adverse event reports to the Secretary in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations).
(c) Regulations
(1) In general
The Secretary shall implement the list described in subsection (a)(6) through regulations.
(2) Advisory committee on compounding
Before issuing regulations to implement subsection (a)(6), the Secretary shall convene and consult an advisory committee on compounding. The advisory committee shall include representatives from the National Association of Boards of Pharmacy, the United States Pharmacopeia, pharmacists with current experience and expertise in compounding, physicians with background and knowledge in compounding, and patient and public health advocacy organizations.
(3) Interim list
(A) In general
Before the effective date of the regulations finalized to implement subsection (a)(6), the Secretary may designate drugs, categories of drugs, or conditions as described such subsection by—
(i) publishing a notice of such substances, drugs, categories of drugs, or conditions proposed for designation, including the rationale for such designation, in the Federal Register;
(ii) providing a period of not less than 60 calendar days for comment on the notice; and
(iii) publishing a notice in the Federal Register designating such drugs, categories of drugs, or conditions.
(B) Sunset of notice
Any notice provided under subparagraph (A) shall not be effective after the earlier of—
(i) the date that is 5 years after November 27, 2013; or
(ii) the effective date of the final regulations issued to implement subsection (a)(6).
(4) Updates
The Secretary shall review, and update as necessary, the regulations containing the lists of drugs, categories of drugs, or conditions described in subsection (a)(6) regularly, but not less than once every 4 years. Nothing in the previous sentence prohibits submissions to the Secretary, before or during any 4-year period described in such sentence, requesting updates to such lists.
(d) Definitions
In this section:
(1) The term “compounding” includes the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug.
(2) The term “essentially a copy of an approved drug” means—
(A) a drug that is identical or nearly identical to an approved drug, or a marketed drug not subject to section 353(b) of this title and not subject to approval in an application submitted under section 355 of this title, unless, in the case of an approved drug, the drug appears on the drug shortage list in effect under section 356e of this title at the time of compounding, distribution, and dispensing; or
(B) a drug, a component of which is a bulk drug substance that is a component of an approved drug or a marketed drug that is not subject to section 353(b) of this title and not subject to approval in an application submitted under section 355 of this title, unless there is a change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug and the comparable approved drug.
(3) The term “approved drug” means a drug that is approved under section 355 of this title and does not appear on the list described in subsection (a)(4) of drugs that have been withdrawn or removed from the market because such drugs or components of such drugs have been found to be unsafe or not effective.
(4)(A) The term “outsourcing facility” means a facility at one geographic location or address that—
(i) is engaged in the compounding of sterile drugs;
(ii) has elected to register as an outsourcing facility; and
(iii) complies with all of the requirements of this section.
(B) An outsourcing facility is not required to be a licensed pharmacy.
(C) An outsourcing facility may or may not obtain prescriptions for identified individual patients.
(5) The term "sterile drug" means a drug that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug that is required to be sterile under Federal or State law.
(d) 2 Obligation to pay fees
Payment of the fee under section 379j–62 of this title, as described in subsection (a)(9), shall not relieve an outsourcing facility that is licensed as a pharmacy in any State that requires pharmacy licensing fees of its obligation to pay such State fees.

21 U.S.C. 355(a) · New drugs: Necessity of effective approval of applicationOFFICIAL

Instrument: New drugs: Necessity of effective approval of application
Source: https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim
Retrieved: 2026-11-07
Fingerprint: d2c06b365474727a

(a) Necessity of effective approval of application
No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.

21 U.S.C. 355(i)(1) · New drugsOFFICIAL

Instrument: New drugs
Source: https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim
Retrieved: 2026-11-07
Fingerprint: 1d445b64735a39b9

(i)(1) The Secretary shall promulgate regulations for exempting from the operation of the foregoing subsections of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs. Such regulations may, within the discretion of the Secretary, among other conditions relating to the protection of the public health, provide for conditioning such exemption upon—
(A) the submission to the Secretary, before any clinical testing of a new drug is undertaken, of reports, by the manufacturer or the sponsor of the investigation of such drug, of nonclinical tests of such drug adequate to justify the proposed clinical testing;
(B) the manufacturer or the sponsor of the investigation of a new drug proposed to be distributed to investigators for clinical testing obtaining a signed agreement from each of such investigators that patients to whom the drug is administered will be under his personal supervision, or under the supervision of investigators responsible to him, and that he will not supply such drug to any other investigator, or to clinics, for administration to human beings;
(C) the establishment and maintenance of such records, and the making of such reports to the Secretary, by the manufacturer or the sponsor of the investigation of such drug, of data (including but not limited to analytical reports by investigators) obtained as the result of such investigational use of such drug, as the Secretary finds will enable him to evaluate the safety and effectiveness of such drug in the event of the filing of an application pursuant to subsection (b); and
(D) the submission to the Secretary by the manufacturer or the sponsor of the investigation of a new drug of a statement of intent regarding whether the manufacturer or sponsor has plans for assessing pediatric safety and efficacy.

21 U.S.C. 356e · Drug shortage listOFFICIAL

Instrument: Drug shortage list
Source: https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356e&num=0&edition=prelim
Retrieved: 2026-11-07
Fingerprint: d250850112b10b7d

§ 356e. Drug shortage list
(a) Establishment
The Secretary shall maintain an up-to-date list of drugs that are determined by the Secretary to be in shortage in the United States.
(b) Contents
For each drug on such list, the Secretary shall include the following information:
(1) The name of the drug in shortage, including the National Drug Code number for such drug.
(2) The name of each manufacturer of such drug.
(3) The reason for the shortage, as determined by the Secretary, selecting from the following categories:
(A) Requirements related to complying with good manufacturing practices.
(B) Regulatory delay.
(C) Shortage of an active ingredient.
(D) Shortage of an inactive ingredient component.
(E) Discontinuance of the manufacture of the drug.
(F) Delay in shipping of the drug.
(G) Demand increase for the drug.
(4) The estimated duration of the shortage as determined by the Secretary.
(c) Public availability
(1) In general
Subject to paragraphs (2) and (3), the Secretary shall make the information in such list publicly available.
(2) Trade secrets and confidential information
Nothing in this section alters or amends section 1905 of title 18 or section 552(b)(4) of title 5.
(3) Public health exception
The Secretary may choose not to make information collected under this section publicly available under paragraph (1) or section 356c(c) of this title if the Secretary determines that disclosure of such information would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of drug products to patients).
(d) Interagency notification
Not later than 180 days after March 27, 2020, and every 90 days thereafter, the Secretary shall transmit a report regarding the drugs of the current drug shortage list under this section to the Administrator of the Centers for Medicare & Medicaid Services.

91 FR 68526 · Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances; notice of availability (HHS Office of the Secretary, Oct. 30, 2026)OFFICIAL

Instrument: Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances; notice of availability (HHS Office of the Secretary, Oct. 30, 2026)
Source: https://www.govinfo.gov/content/pkg/FR-2026-10-30/pdf/2026-22192.pdf
Retrieved: 2026-11-12
Fingerprint: 9cd2cc7884542632

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. HHS–OASH–2026–0496]
RIN 0910–ZD94
Enforcement Discretion Policy
Regarding 503A Compounding Using
Certain Peptide Bulk Drug Substances
AGENCY: Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice of availability.
SUMMARY: The Secretary of the
Department of Health and Human
Services (HHS) is announcing the
availability of an ‘‘Enforcement
Discretion Policy Regarding 503A
Compounding Using Certain Peptide
Bulk Drug Substances.’’ This document
describes the Secretary of HHS’s
enforcement policy regarding the use of
certain peptide bulk drug substances in
compounding pursuant to section 503A
of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) while the list of bulk
drug substances that can be used in
compounding under section 503A of the
FD&C Act (the 503A bulks list) is
developed through rulemaking.
DATES: This announcement is published
in the Federal Register as of October 30,
2026.
ADDRESSES: Written comments can be
submitted until 2 weeks after date of
publication in the Federal Register via
regulations.gov on Docket No. HHS–
OASH–2026–0496
FOR FURTHER INFORMATION CONTACT:
Victoria Marshall, Office of the
Assistant Secretary for Health, 200
Independence Avenue SW, Washington,
DC, 202–690–7694, OASH-RFI@hhs.gov
SUPPLEMENTARY INFORMATION:
I. Background
HHS is announcing the availability of
a draft ‘‘Enforcement Discretion Policy
Regarding 503A Compounding Using
Certain Peptide Bulk Drug Substances.’’
This document describes the HHS
Secretary’s enforcement policy
regarding the use of certain peptide bulk
drug substances in compounding
pursuant to section 503A of the FD&C
Act while the list of bulk drug
substances that can be used in
compounding under section 503A of the
FD&C Act (the 503A bulks list) is
developed through rulemaking (21
U.S.C. 353a).
Compounding is generally a practice
in which a licensed pharmacist, a
licensed physician or, in the case of an
outsourcing facility, a person under the
supervision of a licensed pharmacist,
combines, mixes or alters ingredients of
a drug to create a medication tailored to
the needs of an individual patient.
Compounded drugs are not FDA-
approved, which means FDA does not
review their safety, effectiveness, or
quality before they are marketed.
Although compounded drugs can serve
an important medical need for certain
patients, they also may pose risks to
patients. However, based on the
Pharmacy Compounding Advisory
Committee meetings and data regarding
utilization of peptides, HHS believes
that there is significant interest in the
use of these peptides in compounding
given the lack of availability of
approved products. Therefore, to
expand and improve patient access,
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. FDA's
future rulemakings may propose adding
some or all of these peptides to the
503A bulks list based on the available
evidence.
HHS may revisit application of this
interim policy (in whole or in part) if,
among other things, a safety signal or
product quality issue arises with a
compounded drug product within the
scope of this policy. The draft
Enforcement Discretion Policy
Regarding 503A Compounding Using
Certain Peptide Bulk Drug Substances
does not establish any rights for any
person and is not binding on HHS or the
public.
II. Paperwork Reduction Act of 1995
This policy contains no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3521) is not required.
III. Electronic Access
Persons with access to the internet
may obtain the document at https://
www.hhs.gov/sites/default/files/hhs-
503a-peptide-enforcement-discretion-
policy-appendix-b.pdf, or https://
www.regulations.gov. Use the HHS
website listed in the previous sentence
to find the most current version of the
policy.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human
Services.
[FR Doc. 2026–22192 Filed 10–28–26; 11:15 am]
BILLING CODE 4164–01–P

HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances · Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (HHS Office of the Secretary), policy text, Appendix A and Appendix B narrativeOFFICIAL

Instrument: Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (HHS Office of the Secretary), policy text, Appendix A and Appendix B narrative
Source: https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf
Retrieved: 2026-11-12
Fingerprint: 3c00bb06152d4ea5

HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide
Bulk Drug Substances
This document describes the Secretary of the Department of Health and Human Services’
(HHS) enforcement policy regarding the use of certain peptide bulk drug substances in
compounding while the list of bulk drug substances that can be used in compounding under
section 503A of the FD&C Act (the 503A bulks list) is developed through rulemaking (21 U.S.C.
§ 353a).
Compounding is generally a practice in which a licensed pharmacist, a licensed physician or, in
the case of an outsourcing facility, a person under the supervision of a licensed pharmacist,
combines, mixes or alters ingredients of a drug to create a medication tailored to the needs of
an individual patient.1 Compounded drugs are not FDA-approved, which means FDA does not
review their safety, effectiveness, or quality before they are marketed. Although compounded
drugs can serve an important medical need for certain patients, they also may pose risks to
patients. However, based on the Pharmacy Compounding Advisory Committee (PCAC) meeting
and data regarding utilization of peptides, HHS believes that there is significant interest in the
use of these peptides in compounding. HHS also believes based on the PCAC meeting that
public comments may provide additional evidence that FDA can consider in rulemaking to
address some or all of the substances. Therefore, to expand and improve patient access while
FDA reviews these substances, in the circumstances below, HHS does not intend to take
enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician
compounding a drug product using a bulk drug substance in Appendix A.
HHS may revisit application of this interim policy (in whole or in part) if, among other things, a
safety signal or product quality issue arises with a compounded drug product within the scope of
this policy.
BACKGROUND
Section 503A of the FD&C Act (21 U.S.C § 353a) describes the conditions that must be satisfied
for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy
or Federal facility, or by a licensed physician, to be exempt from the requirements under section
505 (FDA approval prior to marketing) (21 U.S.C § 355), section 502(f)(1) (labeling of drugs with
adequate directions for use) (21 U.S.C. § 352(f)(1)), and section 501(a)(2)(B) (current good
manufacturing practice (CGMP) requirements) (21 U.S.C. § 351(a)(2)(B)) .
One of the conditions that must be met for a compounded drug product to qualify for these
exemptions is that a licensed pharmacist or licensed physician compounds the drug product
using bulk drug substances that: (1) comply with the standards of an applicable United States
Pharmacopeia (USP) or National Formulary (NF) monograph, if a monograph exists, and the
USP chapter on pharmacy compounding; (2) if such a monograph does not exist, are drug
substances that are components of FDA-approved drugs; or (3) if such a monograph does not
exist and the drug substance is not a component of an FDA-approved drug, they appear on a
list developed by the Secretary through regulations issued by the Secretary under section
503A(c)(1) (21 U.S.C. § 353a (b)(1)(A)(i)). The Secretary convened and consulted the PCAC as
required by statute to issue regulations to implement the 503A bulk peptide list (21 U.S.C. §
353a(c)(1)). FDA must also consult with USP (21 U.S.C. § 353a(c)(2)).
To qualify for the exemptions under section 503A, a drug product must also be compounded
using bulk drug substances that are manufactured by an establishment that is registered under
section 510 and accompanied by valid certificates of analysis (COAs) for each bulk drug
substance (21 U.S.C. § 353a(b)(1)(A)(ii)-(iii)). Additionally, for a drug product to qualify for the
exemptions under section 503A, it must be compounded based on the receipt of a valid patient-
specific prescription ((21 U.S.C. § 353a(a)).
HHS Interim Enforcement Policy
The Secretary of HHS has determined that this limited enforcement-discretion policy will
discourage the continued, widespread use of certain research-use-only peptides supplied by
foreign manufacturers that pose a safety risk to US patients. By allowing limited compounding
of the substances addressed in this guidance under appropriate safeguards, the policy provides
patients with a more controlled alternative. Based on the available evidence, including the
recommendations of a recent Pharmacy Compounding Advisory Committee, the Secretary has
determined that the policy advances patient choice and freedom while appropriately protecting
patient safety. Until a peptide bulk drug substance is addressed in a final rule as being included
or not included on the 503A bulks list, HHS does not intend to take action against a State-
licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a
peptide bulk drug substance that is not a component of an FDA-approved drug product, the
subject of an applicable USP or NF monograph, or on the 503A bulks list codified at 21 CFR
216.23(a), when all of the following circumstances are present:
1. 503A Interim Access List. The peptide bulk drug substance appears in Appendix A to
this policy.
2. Identity of the Peptide Bulk Drug Substance. The peptide bulk drug substance has
the identity and limitations in route of administration described in Appendix B. The
identity includes but is not limited to amino acid sequence, chemical structure, molecular
weight, and molecular formula.
3. Characterization. The bulk drug substance is from a facility registered under section
510 (21 U.S.C. § 360) and characterized and identified in a valid certificate of analysis
(COA) that includes test results consistent with existing guidance-based criteria
described by FDA (see Appendix B). This helps provide assurance that what a
compounder receives from a supplier is what it claims to be and has been tested for
identity, purity, potency, and the absence of harmful contaminants such as endotoxins,
heavy metals, microbial contamination, and impurities.
4. The original manufacturer of the bulk drug substance (not a subsequent packer,
repacker, labeler, or distributor) is registered with FDA under section 510, is in
compliance with CGMP2 and other FD&C requirements and the physical location of the
facility is listed on the COA provided to the 503A compounder. If the peptide bulk drug
substance is obtained through an FDA-registered repacker, relabeler, or reseller, that
entity has itself performed and documented appropriate vendor validation of the bulk
drug substance manufacturer and validation of the manufacturer’s COA.
5. Report products compounded, serious adverse events, and product quality issues
to FDA and to the States where the products are compounded and sent (if
different). Compounders report serious adverse events3 associated with the use of the
compounded drug product in humans (regardless of whether or not considered drug
related) and product quality issues (e.g., information concerning any bacteriological
contamination, or any significant chemical, physical, or other change in the distributed
drug product, or any failure of a product to meet applicable specifications) to FDA's
MedWatch Safety Information and Adverse Event Reporting Program. This provides an
opportunity for FDA and States to act on emerging risks. In addition, the procedure for
reporting adverse events and issues with the identity, strength, purity, and/or quality of
the product should be detailed on the product labeling provided to the patient.
Product reporting for the compounder includes the following
a. Active ingredient and strength of active ingredient per unit;
b. Original manufacturer of the active ingredient, including unique facility identifier
for the manufacturing facility; and
c. Dosage form and route of administration.
6. Product labeling. Product labeling that includes the following statement: “This is a
compounded drug product. Not for resale.”
7. The compounded drug product contains only a single Active Pharmaceutical
Ingredient (API) listed in Appendix A. It will be easier to attribute adverse events or
clinical outcomes to a specific substance, which is essential for meaningful safety
surveillance and signal detection, if compounded peptide products include a single API.
8. Route of administration. Achieving adequate oral bioavailability of peptides is
inherently difficult and complex. Therefore, if a peptide is compounded in an oral dosage
form, the compounder is expected to maintain documentation confirming that the specific
formulation provided to a patient achieves an adequate level of oral bioavailability in
humans.
9. Drug delivery device. The only drug delivery device co-packaged or containing the
compounded drug is an FDA 510(k)-cleared syringe. More complex drug delivery
devices introduce additional patient risk.
10. The drug product is compounded in compliance with all other applicable
requirements of the FD&C Act including that the drug product not be compounded
under insanitary conditions (21 U.S.C. § 351(a)(2)(A)) and section 503A’s
(21 U.S.C. 353a) patient specific prescription requirement.
Appendix A. List of Peptide Bulk Drug Substances Addressed by HHS Interim
Enforcement Policy Regarding 503A Compounding
1. BPC-157
2. Epitalon
3. KPV
4. MOTS-c
5. Semax
6. TB-500
Appendix B: Peptide Identities and Justifications for
Placement of Peptide Bulk Drug Substances Under
the Enforcement Discretion Policy Regarding 503A
Compounding Using Certain Peptide Bulk Drug
Substances
BPC-157 Identity
BPC-157 Acetate has a molecular formula (MF) of C62H98N 16O22·xCH 3COOH and a
molecular weight (MW) of 1419.54 + x(60.05) g/mol. Its amino acid (AA) sequence is H-Gly-
Glu-Pro-Pro-Pro-Gly-Lys-Pro-Ala-Asp-Asp-Ala-Gly-Leu-Val-OH·xCH3 COOH and its
chemical structure is shown below:
BPC-157 (free base) and BPC-157 acetate were in Category 2 from September 2023 until
April 22, 2026, and neither the placement nor the removal changed their status under
section 503A; Center for Drug Evaluation and Research (CDER) recommended against
listing either form, and the Pharmacy Compounding Advisory Committee (PCAC) voted in
favor of inclusion. HHS’s justification for including BPC-157 on the interim policy is
threefold. First, historical use is now documented and quantified showing its use as well as
multiple human studies. Second, the characterization record now includes evidence that
was not before CDER, namely a lot-specific certificate from an FDA-registered facility
reporting the identity, impurity, endotoxin, microbial, and residual solvent results CDER
found lacking. Third, the conditions of this policy address the risks through lot-level testing,
single-active pharmaceutical ingredient (API) products, and MedWatch reporting. Based on
the identified updated information, enforcement discretion for BPC-157 acetate is
appropriate for subcutaneous, intramuscular, oral, and topical dosage forms that are
compounded from API accompanied by a certificate of analysis (CoA) meeting the
conditions of this policy.
TB-500 Identity
TB-500 Acetate has a MF of C38H 68N10 O14·CH 3 COOH and has a MW of 949.1 g/mol. Its AA
Sequence is Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH·CH3COOH and its chemical structure is
shown below:
TB-500 was in Category 2 from September 29, 2023, until April 22, 2026, and neither the
placement nor the removal changed its status under section 503A; CDER recommended
against listing either form, and the PCAC voted in favor of both forms. HHS’s justification
for including TB-500 on the interim policy is threefold. First, the characterization record has
materially changed since the memorandum, as lot-specific certificates from FDA-
registered manufacturers supply the identification, assay, impurity, endotoxin, microbial,
and residual solvent results CDER found missing. Second, historical use is now
documented and quantified, where CDER could not identify any pharmacy compounding
TB-500. Third, the safety concerns CDER identified are inferential rather than observed, the
parent protein has a controlled human safety record across several routes, and the
fragment is rapidly truncated in human serum. Based on the identified updated
information, enforcement discretion for TB-500 acetate appropriate for subcutaneous or
intramuscular injectable dosage forms that are compounded from API accompanied by a
CoA meeting the conditions of this policy.
Epitalon Identity
Epitalon Acetate has MF of C14H 22 N4O9·CH 3COOH and has a MW of 450.40 g/mol. Its AA
Sequence is H-Ala-Glu-Asp-Gly-OH·CH3COOH and its chemical structure is shown below:
Epitalon was in Category 2 from September 29, 2023, until April 22, 2026, and neither the
placement nor the removal changed its status under section 503A; CDER recommended
against listing either form, and the PCAC voted in favor of inclusion. HHS’s justification for
including epitalon on the interim policy is threefold. First, the characterization record has
materially changed since the memorandum, as lots from FDA-registered facilities report
the endotoxin, microbial, and residual solvent results CDER found missing, and a second
lot adds solubility and elemental impurity results that answer CDER’s remaining concerns.
Second, historical use is now documented and quantified, where CDER had found
compounding but could not characterize its extent. Third, CDER’s safety concerns are
mechanistic rather than based on observed harm, the limited controlled human exposure
reported no side effects, and the documented regimens are intermittent rather than
continuous. Based on the identified updated information, enforcement discretion for
epitalon acetate is appropriate subcutaneous or intramuscular injectable dosage forms
that are dispensed in intermittent courses that are compounded from API accompanied by
a CoA meeting the conditions of this policy.
Semax Identity
Semax (Free Base) has a MF of C37H51N9O10S and has a MW of 813.9 g/mol. Its AA sequence
is H-Met-Glu-His-Phe-Pro-Gly-Pro-OH and its chemical structure is shown below:
Semax was in Category 2 from September 29, 2023, until April 22, 2026, and neither the
placement nor the removal changed its status under section 503A; CDER recommended
against listing either form, and the PCAC voted in favor of both forms. HHS’s justification
for including semax on the interim policy is threefold. First, the characterization record has
materially changed since the memorandum, as certificates from FDA-registered sources
supply the endotoxin result CDER identified as the principal deficiency for injectable use,
together with identity, purity, quantified impurities, residual solvents, and a declared salt
form. Second, historical use is now documented and quantified, where CDER had found
the extent unclear. Third, the safety concerns CDER identified are mechanistic rather than
observed, as the intranasal human record CDER itself compiled covers several hundred
subjects with no reported adverse outcome and the bleeding and abuse-potential signals
have no clinical counterpart in that record. Based on the identified updated information,
enforcement discretion for semax free base is appropriate for intranasal use that is
compounded from API accompanied by a CoA meeting the conditions of this policy.
KPV Identity
KPV Acetate has a MF of C16H30N4O4·CH3COOH has a MW of 402.5 g/mol. Its AA sequence is
H- Lys-Pro-Val-OH . CH 3COOH and its chemical structure is shown below:
KPV (free base) and KPV acetate were in Category 2 from September 2023 until April 22,
2026, and neither the placement nor the removal changed their status under section 503A;
CDER recommended against listing either form, and the PCAC voted in favor of inclusion.
HHS’s justification for including KPV on the interim policy is threefold. First, historical use is
now documented and quantified, including substantial single-ingredient use of the kind
this policy covers, where CDER had found the extent of use unknown. Second, the
characterization record has materially changed for the acetate, as lots supplied to 503A
pharmacies confirm the active moiety by mass spectrometry, report the endotoxin and
microbial results CDER found missing, and are consistent with the form for which CDER
identified no solubility obstacle. Third, CDER’s safety conclusion reflects an absence of
information rather than an observed signal, and the conditions of this policy address it
through single-API products, lot-level testing, and MedWatch reporting. Based on the
identified updated information, enforcement discretion for KPV acetate is appropriate for
topical and oral dosage forms that are compounded from API accompanied by a CoA
meeting the conditions of this policy.
MOTS-c Identity
MOTS-c Acetate has a MF of C101 H 152N28O 22S2 ·CH3COOH and a MW of 2234.64 g/mol. Its AA
sequence is H-Met-Arg-Trp-Gln-Glu-Met-Gly-Tyr-Ile-Phe-Tyr-Pro-Arg-Lys-Leu-Arg-OH
·CH3COOH and its chemical structure is shown below:
MOTS-c was in Category 2 from September 29, 2023, until April 22, 2026, and neither the
placement nor the removal changed its status under section 503A; CDER recommended
against listing either form, and the PCAC voted in favor of both forms. HHS’s justification
for including MOTS-c on the interim policy is threefold. First, the characterization record
has materially changed since the memorandum, as lot-specific certificates from FDA-
registered manufacturers report the impurity, residual solvent, endotoxin, and microbial
results CDER found missing and declare the acetate salt form. Second, historical use is
now documented and quantified, with the great majority of documented use being single-
ingredient products. Third, the available safety evidence points in one direction, as a
randomized placebo-controlled trial of a MOTS-c analogue reported no serious adverse
events at an exposure well above the compounded regimen and the rodent studies
reported metabolic benefit without systemic toxicity. Based on the identified updated
information, enforcement discretion for MOTS-c acetate is appropriate subcutaneous or
intramuscular injectable dosage forms that are compounded from API accompanied by a
CoA meeting the conditions of this policy.

Sources

21 U.S.C. 355(a) PRIMARYOFFICIAL
21 U.S.C. 331(d) (prohibited act: unapproved new drug) (Office of the Law Revision Counsel, 2026-11-07)OFFICIAL
21 U.S.C. 321(g)(1) and 321(p) (drug and new drug definitions) (Office of the Law Revision Counsel, 2026-11-07)OFFICIAL
21 U.S.C. 355(i)(1) (investigational use exemption) (Office of the Law Revision Counsel, 2026-11-07)OFFICIAL
21 CFR 312.2 (IND applicability) (eCFR, 2026-11-07)OFFICIAL
21 CFR 201.128 (meaning of intended uses) (eCFR, 2026-11-07)OFFICIAL
21 U.S.C. 353a (FD&C Act sec. 503A, pharmacy compounding) (Office of the Law Revision Counsel, 2026-11-07)OFFICIAL
21 U.S.C. 353b (FD&C Act sec. 503B, outsourcing facilities) (Office of the Law Revision Counsel, 2026-11-07)OFFICIAL
21 CFR 216.23 (bulk drug substances usable under 503A) (eCFR, 2026-11-07)OFFICIAL
21 CFR 809.10 (labeling for in vitro diagnostic products) (eCFR, 2026-11-07)OFFICIAL
FDA's concerns with unapproved GLP-1 drugs used for weight loss (FDA, 2026-10-01)OFFICIAL
FDA warning letters index (FDA, 2026-11-07)OFFICIAL
La. Acts 2026, No. 374 (SB 253), enacting La. R.S. 37:23.5 (Louisiana Legislature, 2026-11-07)OFFICIAL
21 U.S.C. 333(e) (human growth hormone) (Office of the Law Revision Counsel, 2026-11-07)OFFICIAL
21 CFR 600.3(h)(6) (definition of protein) (eCFR, 2026-11-07)OFFICIAL
21 CFR 312.160 (eCFR, 2026-11-07)OFFICIAL
HHS, Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, with Appendices A and B (U.S. Department of Health and Human Services, 2026-11-12)OFFICIAL
Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances; notice of availability, 91 FR 68526 (Oct. 30, 2026) (Federal Register (govinfo), 2026-10-30)OFFICIAL
Docket No. HHS-OASH-2026-0496 (comments on the policy) (regulations.gov, 2026-11-12)OFFICIAL

Cite this page

Compound Analytics. "Are Peptides Legal? Research Peptides and Federal Law (2026)." Compound Laws, https://compoundlaws.com/peptides/. Accessed November 13, 2026.

Compound Laws, published by Compound Analytics, reports the record: statutes verbatim, official citations, enforcement facts and verification dates. Nothing here is legal advice and nothing here describes how to get around a law. A jurisdiction with no verified row is reported as not yet verified, never as legal. Found an error? Corrections policy.

About · Methodology · Glossary · Changes · RSS · Data licensing · llms.txt · Sitemap