### Question
How is the term regulated person defined?


### Answer
The term **regulated person** is defined in *21 CFR § 1300.02* as the following:

> any individual, corporation, partnership, association, or other legal entity who manufactures, distributes, imports, or exports a listed chemical, a tableting machine, or an encapsulating machine, or who acts as a broker or trader for an international transaction involving a listed chemical, tableting machine, or encapsulating machine.

#### Citation:
  - *21 CFR § 1300.02*
  - Heading: **Title 21-Food and Drugs > PART 1300—DEFINITIONS**

