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PSM joins PSI, Rx360 and PDSA in letter urging FDA to protect the traceable drug supply
PSM joined three other organizations for a sign-on letter explaining our concerns that unrestricted mass compounding increases the untraceable drug supply. An explosion of 503B compounding of these three substances, semaglutide, tirzepatide, and liraglutide, would dramatically increase the compounded medicine supply which is not serialized, and therefore, not traceable.
[...]PSM submits comment supporting the continued exclusion of GLP-1s from the 503B Bulks List
PSM supports the FDA’s proposal, which will help protect patient safety and the integrity of the drug approval process.
[...]Live event on safety on compounded GLP-1s
Join us in person in Washington DC on Wednesday July 26, 2026 for Axios Live “Examining Risk and Regulation in the GLP-1 Landscape” Speakers include The Honorable Nikki Budzinski (IL-13), Scott Kahan, M.D., M.P.H., F.T.O.S., Shabbir Imber Safdar, CFE, The Honorable Rudy Yakym (IN-02)
[...]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.
[...]Pharmacists beware: Diverted HIV medicines are being sold on online pharmacy-to-pharmacy platforms
The Partnership for Safe Medicines and ADAP Advocacy are warning that discounted HIV products bought from online, pharmacy-to-pharmacy (P2P) marketplaces qualify as suspicious products under U.S. Food and Drug Administration guidelines and the Drug Supply Chain Security Act. Given the risks, we believe that it isn’t safe or cost-effective to purchase HIV products from these platforms.
[...]Peptide therapies — popular, unproven, dangerous
Americans have become accustomed to taking peptides for for improved health, but unless they’ve undergone clinical trials and received FDA approval, there’s no way to establish a peptide’s safety or effectiveness.
[...]Photo gallery, Gilead Sciences v Pain Relief Rx et al
Photo gallery, Gilead Sciences v Pain Relief Rx et al Examples of suspect product purchased from pharmacy-to-pharmacy online platforms in December 2025 and January 2026. Descovy sold to a pharmacy in Florida; later listed on RxPost A bottle dispensed in New Jersey; allegedly listed on RxPost. A bottle allegedly returned to Gilead with an altered…
[...]June 15, 2026: Colorado becomes the second state given federal approval for Canadian drug importation program
Similar importation programs have been plagued with logistical hurdles, despite extensive funding of the efforts.
[...]Partnership for Safe Medicines statement on FDA authorization of Colorado’s Section 804 Importation Program
“Colorado is now poised to repeat Florida’s failed attempt to implement Canadian drug importation,” said PSM Executive Director Shabbir Imber Safdar. “Since beginning their program in 2019, Florida has spent $132 million and still not imported a single unit of medicine, proving that these bulk importation programs are not reducing drug costs for Americans.”
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