FDA Details When Repackaged Drugs, Biologics Exempt From Certain Reqs

FDA unveiled five draft guidances related to drug compounding Friday (Feb. 13), including guides pertaining to repackaging of drug products, which one drug safety expert notes was not a topic addressed under the federal compounding law, the Drug Quality and Security Act (DQSA). "When a drug product is repackaged, its characteristics may change in ways that have not been evaluated during the FDA approval process and that could affect the safety and efficacy of the drug product," says FDA in...