### Question
How does the law define OTC monograph drug facility?


### Answer
Under *21 U.S.C. § 379j*, **OTC monograph drug facility** is defined as:

> a foreign or domestic business or other entity that—


(i) is—


(I) under one management, either direct or indirect

#### 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**

