### Question
What is the definition of OTC monograph drug?


### Answer
The definition of **OTC monograph drug** is as follows in *21 U.S.C. § 379j*:

> a nonprescription drug without an approved new drug application which is governed by the provisions of section 355h of this title

#### Citation:
  - *21 U.S.C. § 379j*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 10-fees relating to over-the-counter drugs**

