The Pharmaceutical Cargo Security Coalition (PCSC) of the Healthcare Distribution Alliance (HDA) is alerting drug distributors and pharmacists to fraudulent activity surrounding the distribution of the pharmaceutical products Ozempic, semaglutide, and tirzepatide that has been occurring within the industry.

The Food and Drug Administration (FDA) Office of Criminal Investigations (OCI) has identified cases where licensed and unlicensed wholesalers are offering to sell Ozempic at large discounts.  In some cases, the purchaser makes a payment and never receives the product. In others, the product is diverted from foreign countries or counterfeit. It is suspected that in some instances, the sellers obtain information accessible online and pretend to be employees of licensed wholesalers.

It is important to verify the legitimacy of such offers and that the company offering the product for sale and distribution actually distributes Ozempic or other semaglutide drug products.

FDA is also working on investigations involving the sale of semaglutide and tirzepatide online. It appears that most of the products offered for sale are counterfeit imported from China. These products are not made to look like Ozempic pens but instead are sold in the form of injectable vials and labeled as semaglutide. 

Lastly, the FDA has also found several companies importing a salt form of semaglutide (semaglutide sodium and acetate) for distribution and sale to compounding pharmacies.

The FDA issued a guidance indicating the salt form of semaglutide is prohibited from use in compounding human drugs.  Patients have suffered adverse events from medications compounded with these products.

If you are a compounding physician and have been approached about the purchase of Ozempic, semaglutide, tirzepatide, or the salt form of semaglutide, please contact our Investigations Department at (334) 242-4116.