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Prescription Drug Freight Fraud Report, June 2025

July 25, 2025

What if your tirzepatide shipment came from a Brazilian beauty clinic? Or a vial of semaglutide was manufactured, supposedly, at a Costco in Toronto? In April and May 2025, dozens of shipments of semaglutide, tirzepatide, apixaban, and antibiotics entered the U.S. from facilities that aren’t in the FDA’s drug manufacturing database. These aren’t low-volume personal-use shipments; we looked at freight-scale…

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Final publication of guidelines for online pharmacy-to-pharmacy medicine marketplaces.

July 24, 2025

We’ve published the final document of best practices for online pharmacy-to-pharmacy marketplaces.

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Partnership for Safe Medicines Applauds Reintroduction of the Cooper Davis Devin Norring Act

July 22, 2025

The Partnership for Safe Medicines (PSM) today announced its strong support for the reintroduction of the Cooper Davis Devin Norring Act, a bipartisan effort aimed at curbing the online sale of deadly counterfeit and illicit drugs.

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July 21, 2025: Inspection policy for all FDA-regulated products changed at ports of entry

July 21, 2025

A policy change announced by U.S. Customs and Border Protection means that all FDA-regulated products are now subject to inspection at ports of entry.

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What is a 503B outsourcing facility, and why are so many of them uninspected by FDA?

July 16, 2025

503B outsourcing facilities make our drug supply more resilient, but 81% of 503Bs newly registered since June 2021 have never been inspected by FDA staff. Learn why we recommend changes to this important program.

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Pill press update: January through June 2025

July 16, 2025

Pill presses and molds are used to make fake pills with deadly consequences thousands of people every year. The number of Americans that take fake pills annually without a fatal event is even higher. Read our January through June 2025 report covering pill press seizures, policy developments, and legislation.

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Prescription Drug Affordability Board Activity, June 2025

July 16, 2025

Prescription Drug Affordability Board Activity, June 2025 Activities Summary Colorado: Colorado’s next PDAB meeting will be held on August 22, 2025. Maryland: Maryland’s PDAB met on June 23 for updates about federal drug pricing and Maryland’s biotech and life sciences industry. Oregon: At its June 18 meeting, Oregon’s PDAB reviewed survey data and narrowed its list of drugs for affordability…

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Boxes labeled Keytruda 50mg stacked on a white surface

July 14, 2025: Counterfeit Keytruda peddlers sentenced in federal court

July 14, 2025

Avanish Kumar Jha and Rajnish Kumar Jha got 30-month sentences for selling counterfeit medicines—including vials of fake Keytruda—to U.S. buyers.

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An FDA inspection revealed significant problems at Empower’s new outsourcing facility

July 14, 2025

After a November 2024 inspection, the FDA issued a Form 483 to Empower Clinic Services highlighting violations related to compounded drug manufacturing practices at its East Windsor, New Jersey facility.

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Government sentencing memo, USA v Avanish Kumar Jha and Rajnish Kumar Jha, July 2024

July 14, 2025

United States District Court Western District of Washington USA v Avanish Kumar Jha and Rajnish Kumar Jha Indictment Filed July 2025 Read the document.

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