Author: ASEM Admin
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FDA’s Updated Guidance on Compounded GLP-1 Products is Welcome, but Illegal Actions Merit Enforcement Actions
(Washington, D.C.) September 2, 2026 – Americans for Safe and Effective Medicines’ (ASEM) Chief Policy Officer, Fred Mills, PharmD, released the below statement following the U.S. Food and Drug Administration (FDA) updating its guidance on unapproved GLP-1 drugs used for weight loss: “As the compounded and counterfeit weight-loss drug market continues to boom and put patients at increasing risk, the FDA is once again updating its guidance around illegally marketed and distributed compounded GLP-1 medications. While…
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ASEM Statement: Protecting Young People from Illegal Retatrutide, Other Drugs on Social Media
Meta, the owner of social media platforms Facebook and Instagram, has announced it is putting new protections in place for young users. The company, which is taking these steps as part of an agreement with 52 attorneys general, is also calling on TikTok and YouTube to adopt the same protections. However, safety must extend beyond…
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Retatrutide Isn’t Approved. The Black Market Isn’t Waiting.
Criminals and illicit sellers have long exploited consumer demand for popular medicines. Today’s black market is increasingly sophisticated, using polished advertising, scientific-sounding language, and misleading health claims to make counterfeit and unapproved products appear legitimate. The consequences can be serious. Federal authorities have charged operators of fake pharmacies with allegedly selling counterfeit prescription pills to…
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ASEM Applauds Medical Board of California
Americans for Safe and Effective Medicines (ASEM) commends the Medical Board of California for taking action against a San Diego medical office accused of compounding and administering injectable semaglutide and tirzepatide in unsafe conditions. According to the Board, the facility lacked basic safeguards necessary for sterile drug production, including a certified cleanroom, appropriate air filtration,…
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The FDA Shouldn’t Let Peptides Get Ahead of the Science
By Fred H. Mills Jr., PharmD., Chief Policy Officer, Americans for Safe and Effective Medicines Peptides are generating breathless headlines, viral social media testimonials, and sweeping, unfounded promises—but the noise is moving far faster than the evidence. The truth is that the science behind many of these products remains limited, and more rigorous research is needed before potential can…
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A Statement on Needed Reforms to Protect Patient Safety from Fred H. Mills Jr., PharmD – ASEM Chief Policy Officer
“As a compounding pharmacist for nearly 50 years, I know the importance of legitimate, patient-specific compounding. I also know that there is a fundamental difference between the compounding that ensures a cancer patient has the right treatment dosage versus the mass compounding of GLP-1s today – unvetted additives, no batch consistency, telehealth distribution by faux-pharmacists,…
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Americans for Safe and Effective Medicines Launches
Americans for Safe and Effective Medicines (ASEM) today launched as a new national advocacy organization dedicated to protecting patients from illegal mass compounding, counterfeit products, and misleading marketing practices and holding bad actors accountable…
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Why We Created ASEM — And Why Now
Most people have never heard of pharmaceutical compounding. But if you’ve been following the surge in GLP-1 weight-loss medications, you’ve almost certainly encountered it — whether you knew it or not. Real compounding has a legitimate place in medicine: a licensed pharmacist, working from a valid prescription, prepares a customized medication for one patient when…