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Drug Unapproved for Its Applied Use

Date of Publication

2/27/2008

Definition

As provided in section 1107 of Title 10, United States Code, an FDA-approved drug or biological product administered for a use not described in the approved labeling of the drug or biological product (referred to in subsection (g)(2)) and for which requirements of use authorization (referred to in subsection (d)(4)) and prior informed consent (referred to in subsection (f)(1)) are applicable by reason of a determination (referred to in subsection (f)(2)) by the Commissioner of Food and Drugs that such use is subject to the investigational new drug requirements of section 505(i) of the Federal Food Drug and Cosmetic Act (FFDCA) (21 U.S.C. 301, et seq.).

Source of Definition

DoD Instruction 6200.02: Application of FDA Rules to Department of Defense Force Health Protection Programs

Related Glossary Terms

Drug Unapproved for Its Applied Use

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