Emergency Dispensing Orders and Emergency Use Instructions (EUI)
Emergency Dispensing Orders | Current Emergency Dispensing Orders | Emergency Use Instructions (EUI) | Current CDC-Issued Emergency Use Information | Guidance
Emergency Dispensing Orders
The emergency dispensing order authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of eligible, approved MCMs needed during public health emergencies without FDA needing to issue an Emergency Use Authorization.
Under section 564A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA may allow emergency dispensing (including mass dispensing at a point of dispensing (POD)) of approved MCMs during an actual CBRN emergency, without requiring an individual prescription for each recipient of the MCM, if (1) permitted by state law or (2) in accordance with an order issued by FDA.
Emergency dispensing orders issued by FDA also may include waivers of Current Good Manufacturing Practice (CGMP) requirements, when appropriate. Section 564A(c) of the FD&C Act permits FDA to waive otherwise applicable CGMP requirements, such as storage or handling, to accommodate emergency response needs. In addition, when feasible, FDA and the Centers for Disease Control and Prevention (CDC) will coordinate issuance of an emergency dispensing order and Emergency Use Instructions (EUI) for an MCM.
Current Emergency Dispensing Orders
Doxycycline Emergency Dispensing Information
Note: The issuance of the Doxycycline Emergency Dispensing Order and Doxycycline Emergency Use Instructions (EUI) replace the need for an Emergency Use Authorization (EUA) for doxycycline mass dispensing for post-exposure prophylaxis (PEP) of inhalational anthrax.
|
Medical Product |
Date of Emergency Dispensing Order Issuance |
Emergency Dispensing Order |
CGMP Waiver |
EUI (CDC) |
Determination(s)
|
PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
|
FDA-approved oral dosage forms of doxycycline products (“eligible doxycycline products”) for the post-exposure prophylaxis (PEP) of inhalational anthrax during an anthrax emergency |
April 13, 2016 |
Doxycycline Emergency Dispensing Order (PDF, 53 KB) |
Included in the doxycycline emergency dispensing order |
CDC-issued EUI for doxycycline and ciprofloxacin are available on the CDC website.
|
(2004) DHS Secretary Material Threat Determination indicating that B. anthracis presents a material threat against the population of the U.S. sufficient to affect national security. |
Anthrax Medical Countermeasures-Amendment (December 9, 2015) |
Ciprofloxacin Emergency Dispensing Information
Note: The issuance of the Ciprofloxacin Emergency Dispensing Order and Ciprofloxacin EUI replace the need for an EUA for ciprofloxacin mass dispensing for post-exposure prophylaxis (PEP) of inhalational anthrax.
|
Medical Product |
Date of Emergency Dispensing Order Issuance |
Emergency Dispensing Order |
CGMP Waiver |
EUI (CDC) |
Determination(s)
|
PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
|
FDA-approved oral dosage forms of ciprofloxacin products (“eligible ciprofloxacin products”) for the post-exposure prophylaxis (PEP) of inhalational anthrax during an anthrax emergency |
April 13, 2016 |
Ciprofloxacin Emergency Dispensing Order (PDF, 51 KB) |
Included in the ciprofloxacin emergency dispensing order |
CDC-issued EUI for doxycycline and ciprofloxacin are available on the CDC website. |
(2004) DHS Secretary Material Threat Determination indicating that B. anthracis presents a material threat against the population of the U.S. sufficient to affect national security. |
Anthrax Medical Countermeasures-Amendment (December 9, 2015) |
Emergency Use Instructions (EUI)
The EUI authority allows CDC to facilitate the availability of streamlined information about the use of eligible, approved MCMs needed during public health emergencies without FDA needing to issue an Emergency Use Authorization.
Under section 564A(e) of the FD&C Act, CDC may create and issue, and government stakeholders may disseminate, EUI (also referred to as fact sheets for recipients of an MCM and for health care professionals) about the FDA-approved conditions of use for such MCMs before or during a CBRN event. When feasible, FDA and CDC will coordinate issuance of an emergency dispensing order and EUI for an MCM. To facilitate creation of EUI, FDA and CDC entered into a Memorandum of Understanding. The HHS Secretary delegated the EUI authority to the Director of CDC in 2013.
Current CDC-Issued Emergency Use Information
- Emergency Use Instructions (EUI) for Oseltamivir - On July 19, 2024, CDC issued EUI for an antiviral called oseltamivir, generic for brand name drug Tamiflu, for treatment or post-exposure prophylaxis (PEP) of pandemic influenza A viruses and novel influenza A viruses with pandemic potential.
- COVID-19 Vaccine EUI Resources
- Instructions for Using Antibiotics to Prevent Anthrax After Exposure (also available as a printable PDF: Anthrax Emergency: How to Take Doxycycline to Prevent Anthrax - EUI Instructions for Recipients)
Guidance
In January 2017, FDA finalized the guidance: Emergency Use Authorization of Medical Products and Related Authorities. For more information, please see the January 13, 2017 Federal Register notice.