[Federal Register: January 8, 2010 (Volume 75, Number 5)] [Notices][Page 1060-1062] – Draft Guidance for Industry on Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products; Availability – The draft guidance encourages manufacturers of medically necessary drug products (MNPs)
and components to develop contingency production plans in the event of an emergency that results in high absenteeism at one or more production facilities. In particular, the draft guidance provides recommendations regarding considerations for the development and implementation of a contingency production plan, including specific elements to include in such a plan. The draft guidance is intended for manufacturers of finished drug products as well as manufacturers of the raw materials necessary for manufacturing an MNP.”