FDA’s Pharmaceutical Compounding Advisory Committee voted to add six of seven peptides to the 503A Bulk Drug Substance List, despite FDA scientists recommending against all of them because of limited evidence of their safety and effectiveness.
PSM supports the FDA’s proposal, which will help protect patient safety and the integrity of the drug approval process.
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.
Fatality reported as the FDA’s Pharmacy Compounding Advisory Committee weighs adding more untested peptides to the compounding list
She was given a dramatic increase in her prescribed dose, a change she questioned, but was told to follow the doctor’s instructions. Despite injecting a smaller amount than directed, she began violently vomiting within hours.
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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.