Food and Drug Administration’s (FDA’s) Office of Criminal Investigations has identified cases where wholesalers (licensed and unlicensed) are offering to sell Ozempic® with large discounts. In some instances, the investigation has revealed it to be a “No-Delivery Scheme,” where the purchaser would make payment and not receive the product. In other instances, the product offered for sale is diverted from foreign countries or counterfeit. In some of the transactions currently under investigation, it is suspected that the sellers are involved in account takeover, in which they obtain the licensing, management, and location information from licensed wholesalers and pretend to be employees of such companies. This information is easily accessible online.
The sellers offer sufficient information and documentation to give the appearance that the transaction is legitimate. These transactions often require full or partial payment up front via wire transfer, non-disclosure agreements, establishment of purchase accounts, and on occasion, have involved fraudulent transaction statements (old pedigree). In some cases, the offer comes from a company that doesn’t distribute temperature-controlled drug products. It is important to verify the legitimacy of the offer and that the company offering the product for sale and distribution actually distributes Ozempic or other semaglutide drug products.
FDA is also investigating the sale of semaglutide and tirzepatide online. It appears that most of the products offered for sale are counterfeits imported from China. These products, however, are not made to look like legitimate Ozempic pens; they are sold in the form of injectable vials and labeled as semaglutide.
Lastly, FDA has identified several companies importing a salt form of semaglutide (semaglutide sodium and acetate) for distribution and sale to compounding pharmacies. FDA issued guidance indicating the salt form of semaglutide is prohibited from use in compounding human drugs. This bulk active pharmaceutical ingredient is purchased and distributed to compounding pharmacies that then compound semaglutide pursuant to individual prescriptions and in bulk, which has resulted in patients suffering adverse events.
This illicit activity has been detected at both the distributor and pharmacy levels of our supply chains. Any pharmacy that has been approached about the purchase/distribution of Ozempic, semaglutide, tirzepatide, or the salt form of semaglutide (and they haven’t spoken to the Healthcare Distribution Alliance Pharmaceutical Cargo Security Coalition already) is advised to contact Chuck Forsaith at cforsaith@hda.org or 401/623-1344.