DSCSA 2025 Ten Count: Number 6 - Rise of Counterfeit and Diverted GLP 1 Medications
Coming in at number 6 on our annual Ten Count, is the rise in cases of dangerous doses related to GLP1 medicines within the US.
While most of the instances happen outside the legitmate supply chain, there are growing cases of product making it into licensed pharmacies through various paths, further highlighting the importance of compliance to DSCSA to the industry.
The Importance of DSCSA Becomes Apparent As Bad Actors Move Into The High Demand GLP1 Area
2025 started off with a letter from 38 State Attorney Generals warning of the increase instances of counterfeits and asking the FDA to take steps to help address the problem. In June, members of congress echoed the concerns and additionally asked for steps to be taken.
The FDA highlighted the growing risk of counterfeit semaglutide in April and again in late 2025 through a public warning that showed examples of counterfeit Ozempic and pictures to show the differences from the authentic product. The notice explained that dozens of counterfeit product had been seized from the legitimate supply chain in an active investigation. A similar notice from NovoNordisk further explained the process report suspicious product to the organization or through the FDA Suspected Criminal Activity website.
While instances of these dangerous products entering the legitimate supply chain were limited, there were multiple reports of bad actors selling products outside the supply chain through online and social media channels. Several of these cases were covered by:
While counterfeit semaglutides are a problem that has recently come into the forefront, the pattern is one that has repeated across other products and was the driver behind passing of the Drug Supply Chain Security Act. Regulators are expressing encouragement that they seeing new tools based on the requirements and systems in place for trading partners to comply with DSCSA. In a high-profile example, several states were able to leverage Product Verification to confirm illegitimate product and add to evidence in holding bad actors accountable. You can read more about these examples at:
At Ten Count Consulting, our commitment is to be a trusted partner in safeguarding the pharmaceutical supply chain and advancing patient safety. If you would like to connect with us to share more about your DSCSA challenges reach out to us through LinkedIn or email us at info@tencountconsulting.com
