Nicole Polisar
Associate Editor
Loyola University Chicago School of Law, JD 2027
A viral weight-loss craze that promised to trim waistlines has become one of the most urgent compliance battles for the U.S. Food and Drug Administration (FDA). In early 2025, the FDA uncovered counterfeit Ozempic circulating through unauthorized distributors and compounding pharmacies, some containing unknown ingredients that put patients at serious risk. The discovery exposed the continued fragility of the nation’s pharmaceutical supply chain, even after years of reform under the Drug Supply Chain Security Act (DSCSA). As demand for GLP-1 drugs like Ozempic and Wegovy skyrockets, regulatory gaps in manufacturing, compounding, and distribution have created new avenues for fraud, forcing the FDA to tighten enforcement and redefine the rules of pharmaceutical oversight.
Drug compounding and counterfeits
Ozempic, and similar drugs, were originally developed for Type 2 diabetes, but their success in promoting weight loss has turned them into cultural phenomena. The GLP-1 boom has produced a convergence of market forces: astronomical consumer demand, aggressive online marketing, and inconsistent regulatory enforcement. As a result, manufacturer shortages arose for the drug’s delivery mechanism, but the active ingredient – semaglutide – was still plentiful. Under sections 503A and 503B of the Food Drug & Cosmetic Act (FD&C Act), companies can create compound drugs for medications that are not commercially available, such as when a medication is on the FDA’s drug shortages list. Drug compounding is the process of creating customized medications by mixing or altering the ingredients of a drug to meet the specific needs of an individual patient. Compounded drugs are not approved by the FDA, so their safety, effectiveness, and quality are not verified, which can put consumers at risk.
In 2022, the FDA put Ozempic and Wegovy on its drug shortages list. This temporarily allowed compounding pharmacies to create semaglutide formulations. In February 2025, the FDA announced that the shortage was resolved and required pharmacies to phase out compounded semaglutide injectables. Once supply stabilized, compounding these drugs without explicit FDA approval became illegal. However, many compounders continued doing so, either unaware of the policy shift or deliberately ignoring it to meet consumer demand. On April 3, Novo Nordisk, the makers of Ozempic and Wegovy, informed the FDA that hundreds of counterfeit GLP-1 injectables were in the U.S. drug supply chain. As with other compounded drugs, these counterfeit injectables are not properly regulated and can cause harm to patients due to incorrect dosing, inclusion of dangerous ingredients, or a complete lack of the active ingredient.
DSCSA was intended to prevent this scenario. DSCSA amended the FD&C Act by providing a framework for unit-level electronic tracking and tracing of prescription drugs. DSCSA’s purpose is to enhance the security of the pharmaceutical supply chain by authenticating products across every handoff in the supply chain and eliminating opportunities for counterfeit entry. Yet, the Ozempic episode revealed that many smaller distributors and pharmacies still lack compliant tracking systems, allowing illegitimate products to blend with legitimate ones.
FDA’s escalating response
The agency’s post-Ozempic strategy signals a tougher era of pharmaceutical enforcement. The FDA issued an import alert permitting detention without physical examination (DWPE) of suspect drug shipments at U.S. entry points. Under this authority, the agency may hold products that appear non-compliant with federal drug standards pending verification. Importers bear the burden of proving quality assurance and compliance before the products are cleared for distribution. Additionally, recent warning letters target clinics promoting “custom” GLP-1 cocktails and online pharmacies selling unverified vials. The FDA has also urged healthcare providers to verify all National Drug Codes (NDCs), confirm authorized distributors, and report suspect products immediately.
Beyond enforcement, the Ozempic case has prompted renewed focus on supply-chain interoperability, which is DSCSA’s final implementation stage and requires electronic tracing across manufacturers, wholesalers, and dispensers. According to the FDA, many entities missed the 2023 compliance deadline and continue to rely on fragmented or incompatible verification tools. For smaller distributors, the cost of upgrading software and harmonizing data standards has proven especially burdensome. The counterfeit incident may accelerate that transition, as liability for distributing falsified products increasingly falls on every participant in the chain.
Looking ahead
The FDA’s crackdown on counterfeit GLP-1s may mark the beginning of a broader shift in regulatory philosophy: from reactive enforcement to predictive compliance, where real-time data sharing and supply-chain analytics identify risk before harm occurs. But achieving that goal requires coordination across regulators, manufacturers, and technology providers — something DSCSA envisioned but has yet to fully deliver. Until then, Ozempic’s legacy may extend far beyond weight loss. It will be remembered as the drug that revealed the fragile boundary between scientific innovation and regulatory failure, and how the race for results can sometimes outpace the rules meant to protect us.