### Question
How is the "Tier 1 OTC monograph order request" defined?


### Answer
The term **Tier 1 OTC monograph order request** is defined in *21 U.S.C. § 379j* as follows -

> any OTC monograph order request not determined to be a Tier 2 OTC monograph order request

#### Citation:
  - *21 U.S.C. § 379j*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 10-fees relating to over-the-counter drugs**

