### Question
How is the term drug product defined?


### Answer
The term **drug product** is defined in *21 U.S.C. § 830* as the following:

> an active ingredient in dosage form that has been approved or otherwise may be lawfully marketed under the Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] for distribution in the United States

#### Citation:
  - *21 U.S.C. § 830*
  - Heading: **CHAPTER 13-DRUG ABUSE PREVENTION AND CONTROL > SUBCHAPTER I-CONTROL AND ENFORCEMENT > Part C-Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances**

