### Question
How does the law define prescription drug product?


### Answer
Under *21 U.S.C. § 379g*, **prescription drug product** is defined as:

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


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


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

#### 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**

