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.
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.
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
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