FDAnews
www.fdanews.com/articles/159846-fda-to-require-advanced-notice-of-potential-manufacturing-stoppages

FDA to Require Advanced Notice of Potential Manufacturing Stoppages

November 4, 2013
Certain drug and biologic manufacturers must notify the FDA at least six months before they believe a product may be permanently discontinued or experience an interruption in manufacturing, according to a new proposed rule published Thursday. The agency says if six months’ notice is not possible, drugmakers should notify the agency about a potential stoppage “as soon as practicable thereafter, but in no case later than five business days after the permanent discontinuance or interruption in manufacturing occurs.”
Drug Industry Daily