About PSM
Update on drug importation, October 2026
Well-meaning advocates continue to propose importing medicine from foreign countries to lower drug prices for Americans. Past efforts didn’t pay off financially and raised public health risks. Here’s the state of this issue today.
[...]Statement on FDA’s Warning Letter to Empower Pharmacy for producing drug products in violation of federal law
“Don’t overlook the most consequential finding in this letter. The FDA flagged prescriber determinations that appeared verbatim across hundreds of patient records – like copy-pasted language, pre-loaded for selection, never actually written for an individual patient. The FDA made clear that approach does not meet the bar for prescribing a compounded drug, which must be tailored to the needs of an individual patient.
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“The FDA must follow this letter with action – seizures and injunctions where warranted – and Congress should work quickly to close the policy gaps that have allowed this shadow drug supply to persist. Patients deserve medicines they can trust.”
Pill press update: February to July 2026
Between February and July, the media covered pill press seizures in 13 states and customs forfeiture records reported seizures of 16 pill presses, six capsule-filling machines, and over 300 pill press parts, dies, and molds. Learn more about the last six months in pill press news.
[...]Tens of thousands of units of retatrutide: May & June 2026 freight fraud report
May and June 2026 saw thousands of shipments of drugs imported into the US, including weight loss drugs and antibiotics. We studied these shipments to learn more about their manufacturers and contents.
[...]Statement from Partnership for Safe Medicines on new litigation alleging illegal distribution of retatrutide
Partnership for Safe Medicines Executive Director Shabbir Imber Safdar released the following statement on the six lawsuits Eli Lilly filed today against businesses it accuses of illegally distributing unapproved copies of its investigational drug, retatrutide. Lilly is suing these defendants for illegal distribution of retatrutide including, in one case, a licensed 503A compounding pharmacy.
[...]Statement from Partnership for Safe Medicines on the appeals court’s decision in Gilead Sciences v. Meritain Health
The appeals court’s decision in Gilead Sciences v. Meritain Health is unambiguous: you cannot import untraceable medicine with foreign-language labels, hand it to American patients, and call it equivalent to an FDA-approved medicine. Track-and-trace is a cornerstone of why the U.S. drug supply chain is the safest in the world, and it is not optional.
[...]Key takeaways from PSM’s Axios event: Examining risk and regulation in the compounded GLP-1 landscape
SAFE Drugs Act sponsor Rep. Rudy Yakym (R-IN), Rep. Nikki Budzinski (D-IL), leading obesity medicine specialist Dr. Scott Kahan, and PSM Executive Director Shabbir Imber Safdar. delivered a clear message: Compounded substances are not the same as FDA-approved medications, and treating them as such undermines patients’ safety.
[...]Statement from Partnership for Safe Medicines Executive Director Shabbir Imber Safdar on the FDA PCAC vote to advance peptide compounding
The advisory committee voted to advance substances that FDA’s own scientists flagged as lacking adequate evidence of safety, efficacy, or quality. Its recommendation will inevitably be interpreted as an endorsement of broader clinical use. It is not.
[...]Death of woman in New York from compounded drug shows the risk of allowing compounding of untested substances
Fatality reported as the FDA’s Pharmacy Compounding Advisory Committee weighs adding more untested peptides to the compounding list
[...]Partnership for Safe Medicines urges FDA advisory committee to reject compounding of unapproved peptides
On July 23-24, the FDA will evaluate seven peptides for custom pharmacy compounding. Citing a critical deficit in human safety data, widespread consumer confusion, and systemic supply chain vulnerabilities, PSM urges the committee to block mass compounding and protect patient safety.
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