Updated Policy on CDER Drug Shortage Management

CDER has posted a Manual of Policies and Procedures updated policy on Drug Shortage Management. The manual establishes the Center’s policy and procedures for notification, evaluation, and management of drug shortage situations for all CDER products. It also outlines the responsibilities of the CDER drug shortage staff that are designated to receive reports from all sources (including industry, other FDA offices, and other external entities, health care professionals, and patients) related to drug shortages and discontinuations. The agency says manufacturers must provide notice at least six months in advance, or as soon as practicable, but in no case later than five business days after a permanent discontinuance or interruption in manufacturing occurs. Shortages and discontinuances also should be reported to the review office or division that regulates the application.