Online Pharmacy Stirs Ranitidine Controversy With Petition To Halt Sales
After its tests showed ranitidine forms a nitrosamine impurity that is a probable carcinogen, Valisure asks FDA to suspend sales of antacid products containing the API. In citizen petition firm, online pharmacy also advises FDA to publish regulations requiring independent chemical testing, verification of drugs.
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“I think one of the big issues of how the FDA regulatory framework works is that it's very rare that the FDA actually tests anything. It's all self-reported testing, by manufacturers that are also selling the product,” says Valisure CEO David Light.
FDA should recall dozens of hand sanitizers found to contain benzene, a known human carcinogen, says Valisure, the compounding pharmacy that raised initial alarm about ranitidine in OTC heartburn drugs, leading eventually to withdrawals of the products.
Sedgwick reported US OTC drug recalls in 2020 doubled to 61 driven by methanol contamination and GMP deviations in hand sanitizers. Once FDA resumes full inspection schedule, enforcement will be “more frequent, penalties will be harsher and cross-agency collaboration” will be welcome.