OTC monograph drug
Defined in 2 places of the United States Code.
The term "OTC monograph drug" has the meaning given such term in section 379j–71 of this title.
Source
- 2022–present21 U.S.C. § 353Food and Drugs · Exemptions and consideration for certain drugs, devices, and biological products · in this section
The term “OTC monograph drug” means a nonprescription drug without an approved new drug application which is governed by the provisions of section 355h of this title.
Source
- 2020–present21 U.S.C. § 379j-71Food and Drugs · Definitions · in this subpart