### Question
What does affiliate mean?


### Answer
**Affiliate** has the following meaning in *21 U.S.C. § 379j*:

> a business entity that has a relationship with a second business entity if, directly or indirectly—


(A) one business entity controls, or has the power to control, the other business entity

#### Citation:
  - *21 U.S.C. § 379j*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 7-fees relating to generic drugs**

