### Question
What does small business mean?


### Answer
**Small business** has the following meaning in *21 U.S.C. § 379h*:

> an entity that has fewer than 500 employees, including employees of affiliates, and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce

#### Citation:
  - *21 U.S.C. § 379h*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 2-fees relating to drugs**

