### Question
How is the term Type II active pharmaceutical ingredient drug master file defined?


### Answer
The term **Type II active pharmaceutical ingredient drug master file** is defined in *21 U.S.C. § 379j* as the following:

> a submission of information to the Secretary by a person that intends to authorize the Food and Drug Administration to reference the information to support approval of a generic drug submission without the submitter having to disclose the information to the generic drug submission applicant

#### Citation:
  - *21 U.S.C. § 379j*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 7-fees relating to generic drugs**

