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covered product

Defined in 1 dictionary — U.S. Code

United States Code

15 U.S.C. § 2063 — under this chapter

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

21 U.S.C. § 355-2 — in this section (2 versions over time)

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.

42 U.S.C. § 6291 — for purposes of this part (6 versions over time)

The term “covered product” means a consumer product of a type specified in section 6292 of this title.

Show all 3 definitions and how they changed over time