Emergency Use Authorization Declaration

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. On July 15, 2026, the Secretary of War determined under the FD&C that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces of an attack with a chemical, biological, radiological, or nuclear agent or agents; or an attack by an agent or agents that may cause, or are otherwise associated with an imminently life-threatening and specific risk to those forces. Injuries arising from these attacks may cause those forces to experience moderate to severe acute pain and place them at risk of developing life-threatening hemodynamic instability, including shock or respiratory distress. On the basis of this determination, the Secretary of HHS declared on August 31, 2026, pursuant to the FD&C Act, that circumstances exist justifying the authorization of emergency use of drugs identified and supported by the Department of War (DOW) as addressing an unmet military operations- related medical need for use to manage moderate to severe acute pain in casualties caused by, or associated with, an emergency involving biological, chemical, radiological, or nuclear agent or agents, or agents of military combat, including firearms, projectiles, and explosive devices, that may cause, or may otherwise be associated with, an imminently life-threatening and specific risk to U.S. military forces, subject to the terms of any authorization issued under that section.

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https://www.federalregister.gov/documents/full_text/text/2026/09/03/2026-18008.txt
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government, policy, regulation
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https://www.federalregister.gov/documents/2026/09/03/2026-18008/emergency-use-authorization-declaration
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United States
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Government
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