rare disease or condition
Defined in 2 places of the United States Code.
For purposes of this section, the term "rare disease or condition" means any disease or condition which—
(A) affects less than 200,000 persons in the United States, or
(B) affects more than 200,000 persons in the United States but 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.
Determinations under the preceding sentence with respect to any drug shall be made on the basis of the facts and circumstances as of the date such drug is designated under section 526 of the Federal Food, Drug, and Cosmetic Act.
Same definition in 2 sections
- 1994–present26 U.S.C. § 28Internal Revenue Code · Renumbered 45C] · for purposes of this section
- 1996–present26 U.S.C. § 45CInternal Revenue Code · Clinical testing expenses for certain drugs for rare diseases or conditions · for purposes of this section
For purposes of this section, the term “rare disease or condition” means any disease or condition which—
(A) affects less than 200,000 persons in the United States, or
(B) affects more than 200,000 persons in the United States but 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.
Source
- 2013–201826 U.S.C. § 45CInternal Revenue Code · Clinical testing expenses for certain drugs for rare diseases or conditions · for purposes of this section