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  1. MCM Legal, Regulatory and Policy Framework

Emergency Dispensing Orders

Emergency Dispensing Order | Emergency Use Instructions | Guidance | Current Emergency Dispensing Orders

Emergency Dispensing Order

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.

Section 564A of the FD&C Act was established by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), which was enacted in March 2013.

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.

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.

Printable PDF (288 KB)

 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. Therefore, the doxycycline mass dispensing EUA that FDA issued in 2011 will be terminated by FDA, and notice of such termination will be published in the Federal Register.
 

 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.

 

(2008) DHS Secretary determination pursuant to section 564(b)(1)(A) of the FD&C Act that there is a significant potential for a domestic emergency involving a heightened risk of attack with B. anthracis. 

 

(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.

  (2008) DHS Secretary determination pursuant to section 564(b)(1)(A) of the FD&C Act that there is a significant potential for a domestic emergency involving a heightened risk of attack with B. anthracis 

 

(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) 

 

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