Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, October 15, 2020
FDA decision to stop quick review of lab developed tests raises payment concerns for labs |
The agency's decision raises questions around reimbursement and liability protections. It could also impact the ability of new lab-developed tests to compete. That's because an emergency use authorization, which the new tests won't have, are often seen as a mark of quality. |
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Tuesday, October 13, 2020
FDA Warns Dietary Supplement Companies Illegally Selling Products Containing Cesium Chloride
The U.S. Food and Drug Administration today posted five warning letters issued to companies marketing dietary supplements containing cesium chloride. In a February 2020 public health alert, the FDA warned consumers and health care professionals to avoid using dietary supplements containing cesium salts, primarily cesium chloride. In July 2018, the FDA alerted health care professionals of significant safety risks associated with cesium chloride in compounded drugs. Cesium chloride is sometimes promoted as an alternative treatment for cancer; however, no cesium-chloride-containing products have been approved by the FDA to treat cancer or any other disease.
Cesium chloride is a new dietary ingredient that has not previously been present in the food supply in a non-chemically altered form. Therefore, firms must provide certain safety-related information about the ingredient to...