Emergency Preparedness and Response
Emergency Use Authorization
OVERVIEW
The emergency use authorization (EUA) authority allows the FDA Commissioner to strengthen the public health protections against biological, chemical, radiological, and nuclear agents that may be used to attack the American people or the U.S. armed forces. Under section 564 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3), which was amended by the Project Bioshield Act of 2004 (public Law 108-276), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by such agents, when there are no adequate, approved and available alternatives.
GUIDANCE
FDA developed guidance explaining the Agency's policies for authorizing the emergency use of medical products under section 564 of the Federal Food, Drug, and Cosmetic Act. The guidance is intended to inform industry, government agencies, and FDA staff of FDA's general recommendation and procedures for issuance of EUAs.
CURRENT AND PREVIOUS EMERGENCY USE AUTHORIZATIONS
The lists below provide information on current Emergency Use Authorizations.
Doxycycline Mass Dispensing EUA Information
Doxycycline Mass Dispensing EUA Information
- Letter of Authorization (PDF - 9MB)
Letter of authorization in Word (DOC - 296KB)- Federal Register Notice: 7/2012 Renewal of Declaration on Emergency Use of Doxycycline
- Federal Register Notice: 7/2011 Renewal of Declaration on Emergency Use of Doxycycline
- Doxycycline EUA Fact Sheet for Health Care Professionals (PDF - 140KB)
- Doxycycline EUA Fact Sheet for Recipients (PDF - 137KB)
Doxycycline--Home Preparation Instructions for Children or Adults Who Cannot Swallow Pills (PDF - 189KB)- In an Emergency: How to Prepare Doxycycline for Children and Adults Who Cannot Swallow Pills (PDF - 1.1MB)
Interim Questions and Answers: Emergency Use Authorization for Oral Formulations of Doxycycline for Post-Exposure Prophylaxis of Inhalational Anthrax
National Postal Model/Cities Readiness Initiative Anthrax EUA Information
Natonal Postal Model/Cities Readiness Initiative Anthrax EUA Documentation
- 10/2011 Amendment to Letter of Authorization. In addition to other important changes, changes references to the USPS Cities Readiness Initiative to National Postal Model (PDF - 7MB)
10/2011 Amendment to the Letter of Authorization (Word Version) (DOC - 306KB)- 8/2010 Amendment to the Letter of Authorization (PDF - 2.3MB)
10/2008 Federal Register Notice Announcing EUA for Pre-event Provision of Potential Use of Doxycycline for Inhalation Anthrax (PDF - 86KB)10/2008 Federal Register Notice of Public Health Determination and Declaration (PDF - 53KB)- 11/2011 Federal Register Notice on amended EUA for doxycycline hyclate tablet for USPS as part of the National Postal Model
- 7/2012 Federal Register Notice of Renewal of Declaration on Emergency Use of Doxycycline
7/2011 Federal Register Notice of Renewal of Declaration on Emergency Use of Doxycyline (PDF - 180KB)10/2010 Federal Register Notice of Renewal of Public Health Determination and Declaration (PDF - 46KB)10/2009 Federal Register Notice of Renewal of Public Health Determination and Declaration (PDF - 41KB)
