DECLARATION THAT CIRCUMSTANCES EXIST JUSTIFYING AN AUTHORIZATION PURSUANT TO SECTION 564 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT, 21 U.S.C. § 360bbb-3(b)

On July 15, 2026, and pursuant to section 564(b)(1)(B) of the of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1)(B), Secretary Hegseth determined 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 U.S. military forces (including, but not limited to agents of military combat such as firearms, projectiles, and explosive devices). Injuries arising from these attacks may cause U.S. military 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, I hereby declare, pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 United States Code 360bbb-3(b), that circumstances exist justifying the authorization of emergency use of drugs identified and supported by the Department of War 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 chemical, biological, 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.