News
FDA Alert: Counterfeit Ozempic found in U.S. Supply Chain
The FDA and Novo Nordisk are warning the public about counterfeit Ozempic injections circulating in the U.S. drug supply chain. The falsified products, labeled with lot number PAR0362 and serial numbers beginning with 51746517, were seized by the FDA on April 9, 2025. Their contents and safety are unverified and pose serious health risks.
[...]New initiative: Best practices for online pharmacy-to-pharmacy marketplaces
PSM is seeking input on developing a set of best practices to reduce sales of counterfeit and diverted medicines on online pharmacy-to-pharmacy marketplaces.
[...]April 14, 2025: Regulators announce a third instance of counterfeit Ozempic injections in the U.S. drug supply
The FDA announced that it had seized counterfeit Ozempic injections on April 9. PSM testified at a congressional hearing.
[...]April 7, 2025: A study examines FDA-OCI’s enforcement actions over a five-year period
A study examined the 130 enforcement actions undertaken by the U.S. Food and Drug Administration’s Office of Criminal Investigations from 2016 through 2021.
[...]Colorado’s March 2025 Amended SIP Application
The state of Colorado submitted a revised application to the U.S. Food and Drug Administration to operation a Canadian drug importation plan in March. This blog post examines how the state’s application has changed over the years.
[...]Colorado Department of Regulatory Agencies updates Joint Budget Committee on litigation costs
A March 12, 2025 memo said the state had paid more than $150,000 defending itself in a lawsuit Amgen had filed over plans to set an upper payment limit on its rheumatoid arthritis treatment, Enbrel.
[...]March 31, 2025: Senator asks how FDA will be accountable for unregulated active pharmaceutical ingredient (API) imports
Senator Jim Banks asked pointed questions about how FDA will stem the tide of semaglutide and tirzepatide coming from unknown facilities.
[...]March 24, 2025: Cost-saving AFPs are exposing Americans to risky, unregulated medicine
“Alternative funding programs” are shifting expensive prescription coverage to illegal drug importation schemes.
[...]PSM submits comment on CBP’s proposed rules to improve screening of low-value shipments
On March 14, the Partnership for Safe Medicines submitted comment on Customs and Border Protection’s proposed update to regulations around low-value, “de minimus” shipments.
[...]March 17, 2025: A Texas Pharmacist gets 17 years for $145m skin cream billing fraud
A Texas man billed government programs millions for creams compounded by untrained teenagers. News about counterfeit medicine in six U.S. states.
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