Compounded GLP-1 Drugs: FDA Rules for Semaglutide, Tirzepatide

Compounded semaglutide and tirzepatide are not FDA-approved drugs. They are made under narrow exceptions in the Federal Food, Drug, and Cosmetic Act (FD&C Act), which a federal shortage listing widened until the listings ended in 2024 and 2025. This article covers the rules as written in FDA documents, statutes and court records. The company side is in our Hims & Hers article and brand pricing in GLP-1 pricing and direct-to-consumer 2026.

Key points

• Compounded drugs are not FDA-approved and are not reviewed for safety, effectiveness or quality before reaching patients [4][7].
• FDA’s rule against compounded “essentially copies” of approved drugs was suspended while a drug was on the shortage list. FDA declared the tirzepatide shortage resolved on 2024-12-19 (after a first decision on 2024-10-02) and the semaglutide shortage resolved on 2025-02-21 [1][4][6].
• Compounders sued FDA over both decisions and lost; the Fifth Circuit affirmed judgment for FDA in both cases on 2026-08-27 [4][5].
• As of 2026-10-01, FDA reported 990 adverse event reports tied to compounded semaglutide and more than 730 tied to compounded tirzepatide (counts as of 2026-05-31), likely underreported [7].
• “Research use only” peptides sold by chemical suppliers are a separate category from compounded drugs. They are not made under 503A or 503B at all [7][8].

What compounding is

The Fifth Circuit describes compounding as a process in which a pharmacist or doctor “combines, mixes, or alters ingredients to create a medication” [4]. The FD&C Act has two main routes.

	Section 503A	Section 503B
Who	State-licensed pharmacy, or a licensed physician [2]	A sterile-drug “outsourcing facility” registered with FDA; it need not be a pharmacy [3]
Prescription	Compounded for an identified patient on a prescription; a limited-quantity route exists for pharmacies with a history of valid orders [2]	May supply without patient-specific prescriptions; not sold by anyone other than the facility, with exceptions [3]
Bulk ingredients	Must meet a USP/NF monograph, be a component of an FDA-approved drug, or be on an FDA list; supplier must be registered and supply certificates of analysis [2]	Only if on FDA’s 503B bulks list, or the drug is on the shortage list when compounded, distributed and dispensed [3]
Copies of approved drugs	Not “regularly or in inordinate amounts” [2]	“Identical or nearly identical” products barred unless the approved drug is on the shortage list [3]
Oversight	State board of pharmacy; FDA for other violations [1][9]	FDA inspection and adverse event reporting [3]

Statutory text was read from the U.S. Code as published by Cornell’s Legal Information Institute.

Why shortage status mattered

The statute requires FDA to keep an up-to-date list of drugs in shortage, defined as demand or projected demand exceeding supply [4]. While a drug was listed, the ban on compounded copies was temporarily suspended [4]. FDA added Wegovy to the list on 2022-03-31 and Ozempic on 2022-08-23; the Fifth Circuit gives December 2022 for Mounjaro and April 2024 for Zepbound [4][5].

For semaglutide, FDA’s order of 2025-02-21 found that Novo Nordisk’s supply was “currently meeting or exceeding demand”[6]. For tirzepatide, FDA concluded in December 2024 that Lilly’s supply would “meet or exceed projected demand” [4].

Dates, as stated by FDA

Drug	Shortage resolved	503A enforcement discretion	503B enforcement discretion
Tirzepatide	2024-10-02; sent back to FDA by the court and again resolved 2024-12-19	60 days, to 2025-02-18 or the court’s ruling if later; ended after the injunction was denied on 2025-03-05	to 2025-03-19
Semaglutide	2025-02-21	60 days, to 2025-04-22 or the court’s ruling if later; ended after the injunction was denied on 2025-04-24	to 2025-05-22

Dates are from FDA’s page (current as of 2026-04-01) and the court records [1][4][5]. That page says neither drug appears on the 503B bulks list or the shortage list [1]. FDA’s shortage database returned an error when we tried it.

The “essentially a copy” rule

Under 503A, a compounded product is essentially a copy if it has the same active ingredient in a similar or easily substitutable strength and the commercial product can be used by the same route. The exception: a prescriber “determines and documents” a significant difference for an identified patient [1]. The statute puts the same idea as a change “for an identified individual patient” that produces a significant difference, as the prescriber determines [2]. FDA’s example: a semaglutide and vitamin B12 injectable may still be a copy if each ingredient is within 10% of the commercial strength [1].

FDA says that, “at this time”, it does not intend to act against a compounder that fills four or fewer prescriptions of a compounded product in a calendar month [1]. Kentucky’s pharmacy board notes that 503B facilities work without patient prescriptions and cannot rely on the patient-specific exception [9].

On “personalized” dosing: FDA’s compounding page and its 2026-02-06 statement do not use the word, and the page does not discuss dosing changes beyond the documented-difference exception [1][10].

FDA statements, warning letters and adverse events

• 2026-02-06 statement. FDA said it intends to restrict GLP-1 active pharmaceutical ingredients for non-approved compounded drugs, said it “cannot verify quality, safety, or efficacy” of those products, and said promotion cannot call them generic, identical or clinically proven [10].
• FDA’s concerns page (content current 2026-10-01). It lists adverse event reports received through 2026-05-31: 990 for compounded semaglutide and more than 730 for compounded tirzepatide. FDA notes many appear consistent with reactions to approved products and that causation is not always clear. Reported symptoms include nausea, vomiting and abdominal pain; some led to hospitalization. FDA also reports dosing errors by patients and clinicians [7].
• Bulks list proposal. On 2026-04-30 FDA proposed leaving semaglutide, tirzepatide and liraglutide off the 503B bulks list [11]. The Federal Register notice (91 FR 23431, 2026-05-01) had its comment period extended to 2026-07-30 [12]. We found no final decision.
• Other. FDA says retatrutide and cagrilintide cannot be used in compounding under federal law [7]. Its September 2025 warning letters to Hims & Hers are covered in the company article.

Court cases

Two suits under the Administrative Procedure Act challenged the shortage decisions. The plaintiffs were the Outsourcing Facilities Association and FarmaKeio Custom Compounding; Lilly and Novo Nordisk intervened [4][5].

Case	Decision challenged	Key rulings
OFA v. FDA, No. 4:24-cv-953 (N.D. Tex.); appeal No. 25-10600	Tirzepatide	Court sent the October 2024 decision back to FDA; FDA reconfirmed on 2024-12-19; injunction denied 2025-03-05; summary judgment for FDA and Lilly; Fifth Circuit affirmed 2026-08-27 [1][4]
OFA v. FDA, No. 4:25-cv-174 (N.D. Tex.); appeal No. 25-10758	Semaglutide	Injunction denied 2025-04-24; summary judgment for FDA and Novo; Fifth Circuit affirmed, opinion filed 2026-08-27 and revised 2026-09-01 [1][5]

The plaintiffs argued that FDA should have used notice-and-comment rulemaking and that the decisions were arbitrary and capricious [4]. The Fifth Circuit assumed without deciding that FDA erred on the first point, found no prejudice to the compounders, and held the shortage determination was not arbitrary or capricious [4][5]. Both opinions are unpublished [4][5]. We did not open the district court opinions.

State boards

Kentucky’s board, in an alert dated 2025-11-14, restated FDA’s dates and said pharmacies should obtain compounded products only from outsourcing facilities legally authorized to make them [9]. We opened only that alert. Other boards (Ohio, Nevada, Oregon, Kansas) appeared in search results; we did not open them. Rules differ by state.

Compounded drugs versus research-use-only peptides

A compounded drug is made by a licensed pharmacy or registered facility under 503A or 503B. A “research use only” product is sold by a chemical supplier with labels such as “not for human consumption”. It has no pharmacy license behind it.

FDA’s position is that the label does not decide the matter. In a letter dated 2024-12-10 to a company selling semaglutide and retatrutide as “peptides”, FDA accepted that the products were labeled “research purposes only”, then pointed to website, blog and social media statements about disease treatment as evidence they were intended as drugs for human use. It called them unapproved new drugs [8]. FDA’s concerns page says it has warned companies selling semaglutide, tirzepatide, retatrutide, survodutide or mazdutide labeled for research, and that such products are “of unknown quality” [7]. Peptilyze compares research-use-only products; this is FDA’s stated view, not a finding on any listing.

Neither category is an FDA-approved version of Ozempic, Wegovy, Mounjaro or Zepbound. The court records give approval dates of December 2017 (Ozempic), June 2021 (Wegovy), May 2022 (Mounjaro) and November 2023 (Zepbound) [4][5]. See also our pages on semaglutide and tirzepatide.

Regulatory status summary

United States, as of 2026-11-08: the approved brands are prescription drugs made by Novo Nordisk and Eli Lilly [4][5]. Compounded versions are lawful only within 503A or 503B conditions, the shortage-based allowances have ended, and no compounded product is FDA-approved [1][7].

United Kingdom: an MHRA release of 2024-10-24 says approved GLP-1 weight-management products are prescribed only by registered healthcare professionals, that the benefit-risk balance outside the licensed indication “has not been shown to be favourable”, and that falsified pens exist [13]. We did not check UK rules on compounding or unlicensed supply.

European Union and Germany: not checked.

Risks and unknowns

FDA’s adverse event counts cannot give a rate, because they have no denominator of how many people used compounded products, and some pharmacies need not report [7]. FDA also describes dosing errors and mislabeled products [7]. We did not search for trials comparing compounded products with the approved drugs. The bulks-list decision was still open in our sources.

Frequently asked questions

Is compounded semaglutide or tirzepatide illegal? Not in itself. Compounding is lawful under 503A and 503B conditions, but the shortage-based allowances ended in 2025 and FDA treats products that are essentially copies of approved drugs as outside those conditions unless a documented exception applies [1][2][3].

Did courts say FDA was right to end the shortages? The Fifth Circuit affirmed judgment for FDA and the drugmakers in both cases on 2026-08-27, finding the determinations not arbitrary or capricious. The opinions are unpublished [4][5].

What does “essentially a copy” mean? In FDA’s words, the same active ingredient in a similar or easily substitutable strength for the same route, unless a prescriber determines and documents a significant difference for an identified patient [1].

Are research-use-only peptides the same as compounded drugs? No. They are sold as chemicals without a pharmacy or prescriber. FDA has treated “research purposes” labels as not controlling where marketing shows intended human use [7][8].

Sources

1. FDA, “FDA’s Human Drug Compounding Policy for GLP-1 Drugs” (page titled “FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize”; content current 2026-04-01). https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
2. 21 U.S.C. § 353a (FD&C Act section 503A), Cornell Legal Information Institute. https://www.law.cornell.edu/uscode/text/21/353a
3. 21 U.S.C. § 353b (FD&C Act section 503B), Cornell Legal Information Institute. https://www.law.cornell.edu/uscode/text/21/353b
4. U.S. Court of Appeals for the Fifth Circuit, Outsourcing Facilities Association v. FDA (Eli Lilly, intervenor), No. 25-10600, unpublished per curiam opinion (2026-08-27). https://www.ca5.uscourts.gov/opinions/unpub/25/25-10600.0.pdf
5. U.S. Court of Appeals for the Fifth Circuit, Outsourcing Facilities Association v. FDA (Novo Nordisk, intervenor), No. 25-10758, unpublished per curiam opinion (filed 2026-08-27, revised 2026-09-01). https://www.ca5.uscourts.gov/opinions/unpub/25/25-10758.0.pdf
6. FDA, “Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy)” (2025-02-21). https://www.fda.gov/media/185526/download
7. FDA, “FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss” (content current 2026-10-01; adverse event counts as of 2026-05-31). https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
8. FDA, Warning Letter to Prime Vitality, Inc. dba Prime Peptides, MARCS-CMS 695156 (2024-12-10). https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024
9. Kentucky Board of Pharmacy, “Compounded Semaglutide and Tirzepatide Compliance Alert” (2025-11-14). https://pharmacy.ky.gov/Documents/Compound%20Compliance%20Alert%20GLP1_GIP%2011.14.2025%281%29.pdf
10. FDA, “FDA intends to take action against non-FDA-approved GLP-1 drugs” (2026-02-06). https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs
11. FDA, “FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List” (2026-04-30). https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list
12. FDA, “List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period,” Docket FDA-2018-N-3240, Federal Register public inspection copy, scheduled for publication 2026-06-26 (the original notice is 91 FR 23431, 2026-05-01; the Federal Register site blocked us, so the original notice was not opened). https://public-inspection.federalregister.gov/2026-12937.pdf
13. MHRA, “MHRA reminds healthcare professionals to advise patients of the side effects of GLP-1 agonists and to report misuse” (2024-10-24). https://www.gov.uk/government/news/mhra-reminds-healthcare-professionals-to-advise-patients-of-the-side-effects-of-glp-1-agonists-and-to-report-misuse

This article is information, not medical advice.