### Question
What does sterile drug mean?


### Answer
**Sterile drug** has the following meaning in *21 U.S.C. § 353b*:

> a drug that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug that is required to be sterile under Federal or State law

#### Citation:
  - *21 U.S.C. § 353b*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part A-Drugs and Devices**

