Emergency Use Authorization Toolkit
The Emergency Use Authorization (EUA) Toolkit addresses key concepts and issues regarding the federal law allowing special uses for drugs, biologics, and devices during specified emergencies. The EUA Toolkit also addresses programs and issues related to the storage, dispensing, and use of medical countermeasures. The toolkit’s component documents are designed to be used in education, training, and planning activities to prepare for emergencies, as well as to serve as a quick reference resource during an emergency response to an event. The EUA Toolkit is one of six toolkits in ASTHO’s Legal Preparedness Series. Please see the Introduction document for additional background on the project and the other toolkits.
Intended Audiences
These documents are specifically designed to address the different needs of discrete audiences within a state health agency:
- State health officers, agency directors, or other senior governmental officials may find the executive overviews and fact sheets of particular interest.
- Preparedness directors and other programmatic staff will find the fact sheets, issue briefs, state analysis guides, and resource materials useful in understanding and gaining more in-depth knowledge about particular concepts and legal issues.
- Legal counsel will find the fact sheets about particular federal laws and regulations, issue briefs, state analysis guides, and citations within the resource materials a good basis from which to conduct additional research and analyze their particular state’s authorities on these issues.
- The current issue updates are a good resource for all audiences to learn the latest developments on issues related to the toolkit topic.
Emergency Use Authorization Toolkit Contents
All documents are listed alphabetically within each document category
Executive Overviews
One-page snapshots of key concepts and issues
Fact Sheets
Short documents addressing fundamental issues or legal authorities
- Emergency Use Authorization: §564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
- Comparing Emergency Use Authorization to Investigational New Drug & Investigational Device Exemption Protocols
- Federal Shelf Life Extension Program (SLEP)
- Project BioShield Act
- Public Readiness and Emergency Preparedness Act (PREP Act)
- Strategic National Stockpile (SNS)
Issue Briefs
In-depth information and analyses of fundamental issues
- No issue briefs in the toolkit currently
State Analysis Guides
Aids to assist states in identifying and analyzing their own statutes, regulations, and policies
- State Pharmaceutical and Dispensing Authorities (Word document will download)