Overwhelming demand for transformative GLP-1 agonists like Ozempic and Mounjaro has led to widespread compounding and a boom in counterfeiting.

Several states are trying to reduce healthcare costs by importing medicine from countries where it costs less, but this is a deeply flawed policy proposal.

Pharmacy Benefit Managers' under-reimbursements make pharmacies perfect targets for counterfeiters—and make the U.S. drug supply less safe as a result.

State Prescription Drug Affordability Boards intend to control medicine costs — but some of their strategies will have unintended consequences.

After two decades of tracking counterfeit drugs, PSM is an expert on medicine safety issues and we often offer journalists our insight and perspective. 

FDA Alert: Compounding Pharmacy in California Warned After Particulates Found in Injections

November 5, 2024

On August 14, 2024, FDA received a complaint from a patient who noticed a black particulate in a vial of semaglutide distributed by Fullerton Wellness. On September 23, 2024, FDA received information from California regulatory authorities as part of ongoing collaboration between FDA and the state noting deficiencies found at Fullerton Wellness during a state inspection. After the state inspection, Fullerton Wellness voluntarily ceased operations.

FDA Alert: FDA Reminds Compounders to Use Appropriate and Sterile Ingredients

November 5, 2024

The agency urges manufacturers, including repackagers, to clearly identify any ingredients intended for use in foods or dietary supplements on the label. Providing this information on ingredient labels could help prevent compounders from using ingredients that are not appropriate for sterile drugs and may help prevent patient harm.

November 4, 2024: The FDA continues to work for patient safety

November 4, 2024

This week the agency warned about compounding safety and sterility issues and a newly posted document shows inspectors enforcing manufacturing standards.

October 28, 2024: DOJ hands down indictments and patients harmed by formulary change

October 28, 2024

Chinese companies and individuals indicted by the Department of Justice and a study examines how patients were harmed by the sudden removal of a medication from a drug formulary.

A DSCSA-newbies guide to the recent FDA DSCSA announcement

October 22, 2024

The FDA recently announced that “connected trading partners” that have made progress in transmitting electronic data that identifies and follow medicines made for the U.S. drug supply will not be penalized if they are still working out challenges in the process. Are you wondering what that means? We can explain.

October 21, 2024: PSM advisory board member leads petition for tariffs over fentanyl precursors from China

October 21, 2024
Andrea Thomas speaking at PSM's Fall 2019 Congressional Briefing

Family advocates petition the Office of U.S. Trade Representative to take trade action over Chinese fentanyl precursors. The New York Times tackles PBMs and pharmacy deserts.

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Watch to see the illegal medicines CBP and FDA are seizing in Ohio.

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Fake Ozempic is being sold at Mexican border pharmacies. Learn more.

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How did counterfeit Botox turn into a full-blown public health emergency? Watch

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