### Question
How is the term rare disease or condition defined?


### Answer
The term **rare disease or condition** is defined in *21 U.S.C. § 360bb* as the following:

> any disease or condition which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug

#### Citation:
  - *21 U.S.C. § 360bb*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part B-Drugs for Rare Diseases or Conditions**

