Ozempic is no longer just a prescription—it has become a cultural phenomenon. From Hollywood red carpets to TikTok feeds, Glucagon-Like Peptide-1 (“GLP-1”) drugs like Ozempic, Wegovy, and Mounjaro are hailed as “miracle” fixes for weight loss. Yet, behind the hype lies an uncomfortable truth: These drugs surged into widespread use quickly, and patients are now uncovering risks the Food and Drug Administration (“FDA”) did not fully anticipate. The cracks in the FDA’s oversight of compounded drugs have left millions of Americans caught in the middle.
The backbone of the FDA’s authority is the Federal Food, Drug, and Cosmetic Act (“FDCA”).[i] Before a drug can reach consumers, section 355 of the FDCA requires manufacturers to submit a new drug application demonstrating: safety, efficacy through well-controlled studies, accurate labeling, and compliant manufacturing practices.[ii] Brand GLP-1s such as Ozempic and Wegovy underwent this process. Compounded versions of these drugs, however, have not.
Under section 353(a), a licensed pharmacist or physician may distribute compounded versions of these drugs for an individual patient with a valid prescription.[iii] In this circumstance, the compounded drug would be exempt from the FDA’s approval process for new drugs.[iv] The conditions for exemptions include using compliant bulk substances, avoiding duplication of FDA-approved drugs unless those drugs are in shortage, excluding prohibited ingredients, and dispensing through a licensed pharmacy or federal facility.
From March 31, 2022, until February 21, 2025, Ozempic and Wegovy were on the FDA’s official drug shortage list.[v] When a drug is deemed “not commercially available,” restrictions on compounding “copies” are temporarily lifted.[vi] This allowed compounding pharmacies to prepare semaglutide and tirzepatide copies without patient-specific prescriptions, while outsourcing facilities were permitted to compound the active pharmaceutical ingredients.[vii] In practice, this opened the door to widespread access to compounded GLP-1 products that bypass FDA’s premarket approval and therefore, receive no federal safety screening. As a result, many Americans seeking quick weight-loss results turned to these compounded versions, which were fraudulent or unsafe, rather than FDA-approved originals.[viii]
Under the FDCA, compounded drugs fall outside the FDA’s direct approval process, unless they are adulterated, meaning the strength, purity, or ingredients are compromised.[ix] Drugs can also avoid the direct approval process if they are misbranded, being that the label is false or misleading, such as listing a fake pharmacy.[x] Due to the proof standards, FDA’s authority is reactive: It can only intervene after evidence of adulteration or misbranding emerges.[xi] This leaves unsafe or fraudulent compounded GLP-1s in circulation until harm is documented.
Evidence of harm is already mounting. The FDA has reported adverse events, some requiring hospitalization, linked to overdoses of compounded semaglutide caused by dosing errors. In several cases, providers administered five to ten times the intended dosage, leaving patients with severe gastrointestinal complications.[xii] The FDA has since urged patients to work with healthcare providers to ensure proper dosing, but its hands remain tied until more evidence accumulates.
Litigation provides another avenue for accountability. The Middle District of Florida’s decision in Novo Nordisk v. Brooksville confirmed that state-law claims which merely echo the FDCA are preempted.[xiii] However, cases like Jacob and Godelia, demonstrate that injured consumers can still pursue traditional state tort actions—such as negligence, failure to warn, or manufacturing defect—while using FDCA violations as supporting evidence.[xiv] In practice, while drug manufacturers, like Novo, cannot rely on Florida consumer protection statutes that directly mirror FDCA provisions, individual patients harmed by fraudulently compounded GLP-1 products may ground their claims in state common law duties and avoid preemption. As the Eleventh Circuit has explained, a plaintiff’s claim survives preemption “so long as she claims the breach of a well-recognized duty owed to her under state law and so long as she can show that she was harmed by a violation of applicable federal law.”[xv]
GLP-1 drugs have become symbols of modern medicine’s promise and peril: While their benefits for diabetes and weight loss are undeniable, the surge of compounded versions has exposed a dangerous gap in FDA oversight. Statutory exemptions for compounding, once intended to protect individualized patient care, now enable widespread distribution of unapproved copies without federal safety screening. The FDA’s limited ability to act—intervening only after proof of adulteration or misbranding—has left consumers vulnerable to fraudulent and unsafe products. Yet, Eleventh Circuit precedent makes clear that patients are not without recourse: traditional state tort law provides a path to accountability when harm occurs, even where FDCA-based claims are preempted.[xvi] Closing this regulatory gap will require more than case-by-case litigation; it demands that Congress and the FDA rethink how compounding exemptions apply to high-demand drugs like GLP-1s. Until then, consumers remain the test subjects of a system that reacts to harm instead of preventing it.
[i] Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301–399(i) (2018).
[ii] 21 U.S.C. § 355 (2018).
[iii] 21 U.S.C. § 353 (a) (2018).
[iv] Id.
[v] 21 U.S.C. § 356(e) (2018).
[vi] 21 U.S.C. §§ 353(a)(b)(1)(D), 353(b) (a)(2)(A)(ii).
[vii] 21 U.S.C. § 353(b).
[viii] See FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, Food & Drug Admin. (Jan. 12, 2025), https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss [https://perma.cc/G2PR-JBHU] (warning of fraudulent compounded products and their safety risks).
[ix] 21 U.S.C. §§ 351–352 (2018).
[x] Id.
[xi] Id.
[xii] Food & Drug Admin., supra note viii (expressing the agency’s concern that compounded semaglutide and tirzepatide products pose safety risks); see also Joseph E. Lambson, Samuel C. Flegal & Amberly R. Johnson, Administration Errors of Compounded Semaglutide Reported to a Regional Poison Control Center, 63 J. Am. Pharm. Ass’n 1643, 1643 (2023) (reporting three patients overdoses from compounded semaglutide due to dosing errors).
[xiii] See Novo Nordisk Inc. v. Brooksville Pharmaceuticals, Inc., No. 8:23-cv-1503-WFJ-TGW, 2025 U.S. Dist. LEXIS 89419, at *28 (M.D. Fla. May 12, 2025).
[xiv] See Jacob v. Mentor Worldwide, LLC, 40 F.4th 1329, 1331 (11th Cir. 2022) (allowing state law manufacturing defect claim to proceed where FDCA violations were used as evidence); see also Godelia v. Doe, 881 F.3d 1309, 1317 (11th Cir. 2018) (finding FDCA violations may support, but not substitute, for state tort claims).
[xv] See Godelia, 881 F.3d at 1317.
[xvi] Id.
