FDA Issues Interim Final Rule To Avert Drug Shortages
On Thursday, FDA issued an interim final rule requiring drug companies that are the sole manufacturers of certain critical medicines to report a potential shortage to federal officials. Previously, companies were required only to report permanent disruptions to drug supplies. However, the new rule states that "[s]ubsequent experience has showed that even temporary discontinuance of manufacturing can have a significant impact on patient access to drug products."
- "Rule Aims at Averting Drug Shortages" (Lee, Modern Healthcare, 12/15).
- "FDA Rule Addresses Drug Shortages" (Goedert, Health Data Management, 12/15).
- "Generic Drugmakers To Build Warning System on Shortages" (Yukhananov, Reuters, 12/15).