### Question
How does GENERAL AUTHORITY define gross annual sales?


### Answer
Under *21 U.S.C. § 379j*, **gross annual sales** is defined as:

> the total worldwide gross annual sales, in United States dollars, for an outsourcing facility, including the sales of all the affiliates of the outsourcing facility

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

