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Is Compounded GLP-1 Legal? Semaglutide, Tirzepatide (2026)

Federal drug law

As of November 7, 2026, compounded semaglutide may be made only under section 503A or 503B conditions; its shortage ended February 21, 2025. Compounded tirzepatide is under the same conditions; its shortage ended December 19, 2024. Retatrutide is not FDA-approved and cannot be compounded.

Verified November 7, 2026 · federal records (FD&C Act)

In plain terms: Brand-name semaglutide and tirzepatide are prescription drugs. Pharmacies may make their own versions only on the conditions federal law sets, mainly for a specific patient's prescription. Retatrutide is still being tested and may not be sold to the public.

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

GLP-1 drugs 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

State law

None of the 51 jurisdictions screened on November 7, 2026 has a statute or rule of its own that names semaglutide, tirzepatide or retatrutide. State pharmacy and medical licensing laws apply to compounded GLP-1 drugs, including when a pharmacy ships across state lines. The retatrutide page lists a related Montana law.

Terms used here

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).
Drug shortage list: FDA's list of drugs in short supply (21 U.S.C. 356e). While a drug is on it, some compounding limits do not apply.
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.

Questions

Is compounded semaglutide still legal?

Only on narrow conditions. A state-licensed pharmacist or physician may compound semaglutide for an identified patient on a prescription under section 503A. Since the shortage ended on February 21, 2025, the pharmacy may not compound copies of a commercially available product regularly or in inordinate amounts. A drug changed for one patient in a way the prescriber determines makes a significant difference for that patient is not counted as a copy. Compounded drugs are not FDA-approved.

Is compounded semaglutide FDA-approved?

No. Compounded drugs are not FDA-approved, and FDA does not review them for safety, effectiveness or quality before they are sold. The FDA-approved semaglutide products are Ozempic, Rybelsus and Wegovy.

Is compounded tirzepatide banned?

No federal law bans it by name. Compounded tirzepatide is lawful only on the conditions of sections 503A and 503B. Since the shortage ended, a 503A pharmacy may not compound copies of a commercially available product regularly or in inordinate amounts, and an outsourcing facility may not compound it from bulk tirzepatide. Compounded drugs are not FDA-approved.

Is compounded tirzepatide still legal?

Only on narrow conditions. A state-licensed pharmacist or physician may compound tirzepatide for an identified patient on a prescription under section 503A, but may not compound copies of a commercially available product regularly or in inordinate amounts. A drug changed for one patient in a way the prescriber determines makes a significant difference for that patient is not counted as a copy.

Is retatrutide legal?

Retatrutide is not a controlled substance, but it is not an FDA-approved drug and cannot be compounded. Federal law bars introducing an unapproved new drug into interstate commerce; use in people is lawful only in FDA-regulated clinical studies or FDA patient-access programs that run through the drug's sponsor.

Is retatrutide FDA approved?

No. As of November 7, 2026 Drugs@FDA lists no application for retatrutide, and FDA's novel drug approval lists for 2025 and 2026 do not include it.

Federal law on file

Stored verbatim from the official publisher, with the retrieval date and a fingerprint that changes when the text does.

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 9 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
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(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
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(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
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§ 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.

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Compound Analytics. “Is Compounded GLP-1 Legal? Semaglutide, Tirzepatide (2026).” Compound Laws, https://compoundlaws.com/glp-1/. Accessed November 13, 2026.

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