Press Releases
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.”
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.
[...]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.
[...]Joint statement on warning to pharmacists about diverted HIV medicines being sold on online pharmacy-to-pharmacy platforms
ADAP Advocacy and the Partnership for Safe Medicines (PSM) issued the following joint statement as a warning to pharmacists that all discounted HIV products bought from online, pharmacy-to-pharmacy (P2P) marketplaces fit the definition of suspect product under U.S. Food and Drug Administration (FDA) guidelines and the Drug Supply Chain Security Act.
[...]PSM’s action plan to protect patients from unapproved compounded GLP-1s
Read our roadmap to uphold the gold standard system that protects Americans from untested and unsafe medicines.
[...]Partnership for Safe Medicines Applauds FDA Action to Curb Unsafe Compounding of GLP-1 Medications
The Partnership for Safe Medicines strongly supports the Food and Drug Administration’s proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. This action reflects sound science, sound law, and a clear-eyed commitment to patient safety. Full statement inside.
[...]PSM urges the House Energy & Commerce Committee to support the SAFE Drugs Act of 2025
PSM wrote the House Energy & Commerce Committee in support of the Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act, to help protect the American drug supply from unsafely compounded medication.
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