FDA addresses bulk drug substances used for compounding – APhA submits compounding comments to FDA. – (866) 348-2889.
FDA on Monday issued a compounding risk alert to warn health care providers, compounders, and patients of the dangers of using the bulk drug substance cesium chloride. Cesium chloride is sometimes used by cancer patients despite never having been proven safe and effective for any use. Serious adverse events associated with the use of cesium chloride and other cesium salts include abnormal heart rhythms, low potassium, seizures, fainting, cardiac arrest, and death. FDA also announced that it intends to move cesium chloride to category 2 under the agency’s interim policy on compounding with bulk drug substances under section 503A. Under the interim policy, a bulk drug substance placed in category 2 raises significant safety risks in compounding and is not subject to FDA’s enforcement policy on compounding with the bulk drug substance while the agency is formally evaluating that substance for use in compounding through the rulemaking process.