OTC monograph drug
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 353 — in this section
The term "OTC monograph drug" has the meaning given such term in section 379j–71 of this title.
21 U.S.C. § 379j-71 — in this subpart (2 versions over time)
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.