scope:

Applicability.

This regulation applies to the Active Army, the Army National Guard/Army National Guard of the United States, and the U.S. Army Reserve, unless otherwise stated. It also applies to all personnel involved in clinical investigation programs, as well as to all Army Medical Department organizations involved in the use of investigational products in humans. During mobilization, the proponent may modify chapters and policies contained in this regulation.

Purpose

This regulation prescribes Department of the Army (DA) policies, procedures, and responsibilities for the use of U.S. Food and Drug Administration (FDA)-regulated investigational products, the use of FDA-approved drugs for unapproved indications in humans, and the use of U.S. Drug Enforcement Administration (DEA) Schedule I controlled substances in humans and animals where DA facilities, personnel, or financial support are used. This regulation implements, and is intended to be consistent with, FDA and DOD regulations. If these FDA or DOD regulations are changed to be more restrictive, there must be compliance with the more restrictive provisions.