Order Permitting Emergency Dispensing of Oral Formulations of Doxycycline and Waiver of CGMP (Current Good Manufacturing Practice) Requirements During an Anthrax Emergency

U.S. Food and Drug Administration. 04/13/2016This six-page document is the order to permit emergency dispensing of Food and Drug Administration-approved oral dosage forms of doxycycline products ("eligible doxycycline products") for the post-exposure prophylaxis of inhalational anthrax during an emergency involving Bacillus (B.) anthracis, the biological agent that causes anthrax disease. It will allow stakeholders to implement plans for emergency dispensing of eligible doxycycline products without individual prescriptions in the future if they reasonably believe there is a need to do so because of their constituents' known, suspected, or likely imminent exposure to B. anthracis. (PDF)

Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health - April 15, 2016 Category: Global & Universal Authors: The U.S. National Library of Medicine Source Type: news