Posts Tagged ‘peptides’
Statement on the FDA and HHS enforcement discretion policy for 503a compounding with certain peptides
“Today’s decision leaves Americans in a grey area as to whether peptides are safe or not, even though the FDA’s own scientists recommended against voting in favor of these substances due to concerns with evidence.”
[...]PSM files Citizen Petition with FDA to stop unsafe compounding of untested peptides
Partnership for Safe Medicines filed a citizen petition (CP) with the FDA asking them to refrain from taking action to allow for compounding of drug products using seven peptide bulk drug substances (BPC-157, KPV, TB-500, MOTS-c, emideltide, semax, and epitalon). Learn why here.
[...]Remembering Alex Boutin: the hidden risks of performance enhancing drugs
Alex took the advice of older gym veterans about how he could bulk up fast, setting off more than a decade of steroid and, eventually, unregulated peptide use.
[...]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.
[...]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
[...]The five risks of taking unapproved peptides
The FDA is reconsidering adding a dozen peptides—seven in July; another four next February—to its Section 503A bulk drug substances list after excluding them over safety concerns in 2023. The review is happening at a time when Americans are turning to peptides at an unprecedented rate, driven by grifters in the online wellness space, who push these products for a profit without any clinical evidence they are either safe or effective.
[...]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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