### Question
What does prescription drug product mean?


### Answer
**Prescription drug product** has the following meaning in *21 U.S.C. § 379g*:

> 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 8-NARCOTIC FARMS > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 2-fees relating to drugs**

