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ARMY - AR 40-7

Use of U.S. Food and Drug Administration-Regulated Investigational Products in Humans Including Schedule I Controlled Substances

active, Most Current
Organization: ARMY
Publication Date: 19 October 2009
Status: active
Page Count: 38
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.

Document History

AR 40-7
October 19, 2009
Use of U.S. Food and Drug Administration-Regulated Investigational Products in Humans Including Schedule I Controlled Substances
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...
January 4, 1991
USE OF INVESTIGATIONAL DRUGS AND DEVICES IN HUMANS AND THE USE OF SCHEDULE I CONTROLLED DRUG SUBSTANCES
A description is not available for this item.

References

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