This regulation prescribes Department of the Army policies, procedures, and responsibilities for the use of U.S. Food and Drug Administration regulated investigational products, the use of FDA-approved drugs for unapproved indications in humans, and the use of U.S. Drug Enforcement Administration 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. It includes citations for the use of International Conference on Harmonisation Guidelines for Good Clinical Practice in the use of investigational products; adds procedures for the control of investigational drugs used to treat patients moving among U. S. Army Medical Centers and U. S. Army Medical Department Activities; and updates office symbols and addresses.
