The market for GLP-1 products—such as Ozempic, Wegovy, and Mounjaro—has exploded, driven by demand for both weight management and diabetes treatment. With unprecedented popularity, frequent supply chain disruptions, and manufacturers struggling to keep up, a dangerous byproduct has emerged: a black market of counterfeit and diverted GLP-1 products making their way into pharmacy inventory.
Independent pharmacies, eager to meet patient needs and maintain reimbursement levels, have increasingly turned to alternative sourcing channels. Unfortunately, in doing so, some have unknowingly purchased counterfeit GLP-1 brand products from individuals posing as representatives of licensed and reputable wholesalers. These are not simple misunderstandings or minor regulatory missteps—these transactions can jeopardize patient safety, expose the pharmacy to civil and regulatory liability, and undermine the integrity of the profession.
A stark illustration of these risks emerged when FDA issued a warning on April 14, 2025, following a notification from Novo Nordisk. The company reported that several hundred units of counterfeit Ozempic (semaglutide) injection 1mg had entered the U.S. drug supply chain through unauthorized distributed channels. FDA seized these counterfeit products on April 9, 2025, and advised all stakeholders, including pharmacies, to check their Ozempic inventories for specific lot and serial numbers associated with the counterfeit products.
This situation underscores the critical importance of vigilance in sourcing practices for pharmacies. Even actions taken without bad intent can lead to severe consequences, highlighting the need for robust verification processes and a commitment to patient safety in the face of a growing threat from counterfeit GLP-1 products.
When Good Faith Isn't Enough
One of the most alarming developments in this trend is that counterfeit products are being sold through convincing, but fraudulent, representations. In a recent example, a pharmacy purchased what they believed to be legitimate GLP-1 medications from a secondary distributor claiming to have sourced product from a national wholesaler. The seller provided what appeared to be valid documentation, a convincing invoice, and even referenced licensing credentials of the wholesaler they claimed to be affiliated with. It wasn't until later—after red flags were raised and product analysis revealed inconsistencies—that the pharmacy realized it had dispensed counterfeit medication. The reputational harm alone was devastating. But equally troubling was the realization that basic due diligence protocols had not been followed.
Understanding the Legal and Regulatory Exposure
Pharmacies are not insulated from responsibility simply because they were deceived. Under both federal and state law, pharmacies are expected to ensure that the prescription drugs they dispense are safe, effective, and legitimately sourced. The DSCSA imposes clear obligations on pharmacies to receive and review transaction documentation (commonly referred to as "T3" data), including information on the source, ownership history, and verification of each drug package. Failure to comply can lead to citations or more serious enforcement actions by the FDA.
State Boards of Pharmacy, meanwhile, may initiate investigations, issue fines, or suspend a pharmacy's license for failing to properly verify the legitimacy of their drug sources. Most states view this responsibility as non-delegable. Pharmacies must demonstrate that they exercised reasonable care in all procurement activities—especially when dealing with high-cost or high-risk products like GLP-1s.
And from a civil liability standpoint, pharmacies that dispense counterfeit medications—even unknowingly—may face lawsuits from patients alleging injury, lack of therapeutic effect, or even economic damages due to receiving non-FDA approved drugs. While the fraudsters who introduce counterfeit products into the stream of commerce are undoubtedly at fault, the legal system often scrutinizes whether the pharmacy's procurement and verification procedures were sufficient under the circumstances.
Why Pharmacies Must Rethink Their Procurement Protocols
The takeaway is simple: intent is not enough. Pharmacies must implement formalized, consistent, and well-documented procedures when sourcing drugs—especially when purchasing outside of their usual authorized distributors.
Every transaction should begin with independent verification of the wholesaler's licensure status. This includes checking state licensure databases, confirming DEA registration, and reviewing whether the seller appears in the FDA's Drug Establishment Registration database. Pharmacies should not rely solely on the claims of a sales representative. Direct outreach to a wholesaler's compliance or licensing department should be standard practice when any uncertainty exists.
Even when sourcing from seemingly trustworthy parties,
pharmacies should never skip reviewing the transaction history,
transaction information, and transaction statement required under
DSCSA. These documents, while often taken for granted, are central
to establishing the product's pedigree. A missing or
inconsistent T3 package should immediately halt a
transaction.
Red flags—such as pricing far below wholesale acquisition
cost, email addresses that don't match corporate domains, or
requests for wire transfers—should not be dismissed as mere
anomalies. Pharmacies that rationalize these signs as "market
quirks" are gambling with their licenses and their
patients' safety.
Patient Harm, Public Trust, and Long-Term Repercussions
While regulatory and legal exposure is significant, the human cost of dispensing counterfeit medications cannot be ignored. Patients receiving fake or subtherapeutic GLP-1 products may suffer adverse health outcomes, delays in treatment, or complete loss of therapeutic benefit. These outcomes not only endanger patient health, but also erode trust in the pharmacist-patient relationship—a relationship built on the assurance that every dispensed medication meets the highest safety and efficacy standards.
Once a pharmacy is publicly linked to counterfeit drugs, the damage to its reputation is often irreversible. Even if the pharmacy avoids disciplinary action or litigation, rebuilding patient confidence takes years—if it happens at all.
Moreover, pharmacy benefit managers (PBMs) and health plans may terminate network contracts if they determine that the pharmacy failed to maintain adequate sourcing practices or violated contractual terms regarding product authenticity. In some cases, even a single episode can lead to network exclusion or suspension.
Lessons Learned—and a Path Forward
The proliferation of counterfeit GLP-1 drugs is a wake-up call. Pharmacies must elevate procurement diligence from an operational afterthought to a core compliance function. Pharmacists, owners, and compliance officers should work together to develop internal policies that define the criteria for acceptable wholesalers, the steps for licensure verification, and procedures for retaining and auditing transaction documentation. Staff should be trained to recognize and escalate red flags, and pharmacy counsel should be consulted before entering into unfamiliar purchasing relationships.
Ultimately, protecting the pharmacy begins with protecting the patient. Ensuring the authenticity of every product that crosses the counter isn't just a legal requirement—it's a professional obligation. In today's high-demand, high-risk environment, pharmacies must not allow urgency or economic pressure to cloud their judgment.
What happened to one pharmacy can happen to any pharmacy. Let this serve not only as a warning, but also as a call to action: verify, document, and never assume. The cost of doing business the right way may be higher—but the cost of doing it the wrong way can be catastrophic.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
