covered product
Defined in 3 places across 3 titles of the United States Code.
the term “covered product”—
(A) means—
(i) any drug approved under subsection (c) or (j) of section 355 of this title or biological product licensed under subsection (a) or (k) of section 262 of title 42;
(ii) any combination of a drug or biological product described in clause (i); or
(iii) when reasonably necessary to support approval of an application under section 355 of this title, or section 262 of title 42, as applicable, or otherwise meet the requirements for approval under either such section, any product, including any device, that is marketed or intended for use with such a drug or biological product; and
(B) does not include any drug or biological product that appears on the drug shortage list in effect under section 356e of this title, unless—
(i) the drug or biological product has been on the drug shortage list in effect under such section 356e of this title continuously for more than 6 months; or
(ii) the Secretary determines that inclusion of the drug or biological product as a covered product is likely to contribute to alleviating or preventing a shortage.
Source
- 2019–present21 U.S.C. § 355-2Food and Drugs · Actions for delays of generic drugs and biosimilar biological products · in this section
the term “covered product” means a consumer product manufactured by a small batch manufacturer where no more than 7,500 units of the same product were manufactured in the previous calendar year; and
Source
- 2011–present15 U.S.C. § 2063Commerce and Trade · Product certification and labeling · under this chapter
The term “covered product” means a consumer product of a type specified in section 6292 of this title.
Source
- 1994–present42 U.S.C. § 6291The Public Health and Welfare · Definitions · for purposes of this part