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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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Defense sentencing memo, USA v Avanish Kumar Jha, Julu 2025

July 14, 2025

United States District Court Western District of Washington USA v Avanish Kumar Jha Defense sentencing memo Filed July 2025 Read the document.

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Defense Sentencing Memo, USA v Rajnish Kumar Jha, July 2025

July 14, 2025

United States District Court Western District of Washington USA v Rajnish Kumar Jha Defense sentencing memo Filed July 2025 Read the document.

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Pill press listings on Google Shopping from July 2025

July 7, 2025: Google to block promotion of pill presses on ads and shopping platforms

July 8, 2025

The change will affect the Google Ads and Google Shopping platforms starting in September 2025.

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FDA announces changes to section 804 importation program proposals

July 7, 2025

A July 1, 2025 post clarifies that applicants can use “a static baseline approach for the cost-savings analysis” instead of trying to account for changes in unpredictable markets.

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