### Question
How is the "prescription drug product" defined?


### Answer
The term **prescription drug product** is defined in *21 U.S.C. § 379g* as follows -

> a specific strength or potency of a drug in final dosage form—


(A) for which a human drug application has been approved,


(B) which may be dispensed only under prescription pursuant to section 353(b) of this title, and


(C) which is on the list of products described in section 355(j)(7)(A) of this title or is on a list created and maintained by the Secretary of products approved under human drug applications under section 262 of title 42

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

