Posted 21 December 2011

FDA Issues Interim Rule on Drug Production Discontinuance

The US Food and Drug Administration (FDA) issued an interim final rule last week that clarifies what a 'discontinuance' of production of a drug is and what 'sole manufacturer' means when it comes to a pharmaceutical company's duty to inform federal officials about a potential shortage. The new regulation defines a 'discontinuance' as either a permanent or temporary disruption in the supply of a product. Previously, companies had to inform FDA only when they permanently stopped making a particular medicine. The initiative would increase visibility about shortages between industry and the FDA, according to the trade group. It would also require acceptance by the Federal Trade Commission and Health and Human Services. (California Healthline)