The ProRx warning letter signals increased FDA scrutiny of compounded weight loss product that are not intended to be compounded in the US.
Criminal counterfeiters are exploiting Americans’ demand for blockbuster diabetes and weight loss drugs made with semaglutide and tirzepatide, while compounders, telehealth companies, and med spas strain and skirt public health measures to meet high demand.
In a major settlement, Made-in-China.com will stop selling research chemicals to U.S. buyers following an investigation by Connecticut’s Attorney General.
The FDA proposed restricting three GLP-1 drugs from the 503B bulks list, which would prevent outsourcing facilities from compounding them from raw ingredients without a clear clinical need.
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.
The former doctor admitted to buying tirzepatide from a lab in China and distributing it without medical evaluations, and is now being sued by a former hospital employee who alleges the drug caused life-threatening complications requiring major surgery.
What do FDA records of GLP-1 and antibiotic imports show about freight fraud patterns over the last six months?
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A recent FDA warning letter highlights upstream supply chain vulnerabilities.
Troubling practices alleged at a compounding pharmacy that supplied glp-1s. Learn more.
Congressman Krishnamoorthy is looking into GLP-1 drugs that may be entering the US unlawfully.
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