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 In this section:

                MCM Legal, Regulatory and Policy Framework

MCM Legal, Regulatory and Policy Framework

                        Emergency Use Authorization
          Expiration Dating Extension
          MCM Emergency Use Authorities
          MCM-Related Counterterrorism Legislation
          MCM-Related Legal and Policy Presentations, Publications and Q&As
          State, Tribal, Local, and Territorial Public Health Preparedness
          Guidance and Other Information of Special Interest to MCM Stakeholders
          MCM-Related Cooperative Arrangements
          Availability of Regulatory Management Plans
          Vaccine EUA Questions and Answers for Stakeholders
          FAQs: What happens to EUAs when a public health emergency ends? Home
          Emergency Preparedness and Response
          Counterterrorism and Emerging Threats
          Medical Countermeasures Initiative (MCMi)
          MCM Legal, Regulatory and Policy Framework
          Emergency Dispensing Orders and Emergency Use Instructions (EUI)MCM Legal, Regulatory and Policy Framework Emergency Dispensing Orders and Emergency Use Instructions (EUI)
  
  	
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    PrintEmergency 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.
			(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)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

**COVID-19 Vaccine Emergency Use Instructions (EUI) Resources**
	**Instructions for Using Antibiotics to Prevent Anthrax After Exposure**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)

Related Links

Summary of PAHPRA's MCM Provisions
	Memorandum of Understanding between FDA and CDC for coordination regarding EUI for MCMs

                                                                                  Content current as of:
      11/17/2021
              
              
Regulated Product(s)
		 Biologics
			  			     			  			     Drugs
			     			  						              
			
			 
			  VaccinesTopic(s)
			  Emergency ResponseHealth Topic(s)
			  CoronavirusLaw(s) & Regulation(s)
			  Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
			    			       			    			       Federal Food, Drug & Cosmetic ActMCM Legal, Regulatory and Policy Framework

          
                        Emergency Use Authorization
          Expiration Dating Extension
          MCM Emergency Use Authorities
          MCM-Related Counterterrorism Legislation
          MCM-Related Legal and Policy Presentations, Publications and Q&As
          State, Tribal, Local, and Territorial Public Health Preparedness
          Guidance and Other Information of Special Interest to MCM Stakeholders
          MCM-Related Cooperative Arrangements
          Availability of Regulatory Management Plans
          Vaccine EUA Questions and Answers for Stakeholders
          FAQs: What happens to EUAs when a public health emergency ends?
 
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