Sec. 3. Safe drug and device importation
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Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by adding at the end the following: The importation of a drug or device that was manufactured or processed at a banned foreign facility for which an order is in effect under section 810. . The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 809 of such Act ( 21 U.S.C. 384e ) the following new section: The Secretary shall issue an order determining a facility to be a banned foreign facility if— the facility manufactures or processes any drug or device that is imported into the United States; and a Class I or Class II recall is issued by the Food and Drug Administration for any drug or device that is manufactured or processed at such facility.
For a banned facility for which a Class I recall is issued as described in subsection (a)(2): The designation of the banned facility pursuant to an order under subsection (a), based on an initial Class I recall of a drug or device manufactured or processed at the facility, shall be in effect for the 10-year period beginning on the date that is one year after the issuance of the order. The designation of the banned facility pursuant to an order under subsection (a), based on a subsequent Class I recall of a drug or device manufactured or processed at the facility, shall be in effect permanently beginning on the date that is one year after the issuance of such order.
For a banned facility for which a class II recall is issued as described in subsection (a)(2): The designation of the banned facility pursuant to an order under subsection (a), based on an initial Class II recall of a drug or device manufactured or processed at the facility, shall be in effect for the 5-year period beginning on the date that is one year after the issuance of the order. The designation of the banned facility pursuant to an order under subsection (a), based on a first subsequent Class II recall of a drug or device manufactured or processed at the facility, may be renewed to be in effect for a period of 5 years beginning— if the initial 5-year period under subparagraph
(A)has concluded, one year from the date of the first subsequent recall; or if the initial 5-year period under subparagraph
(A)has not concluded, at the conclusion of such initial 5-year period. The designation of the banned facility pursuant to an order under subsection (a), based on a second subsequent Class II recall of a drug or device manufactured or processed at the facility, shall be in effect permanently beginning— if the first subsequent 5-year period under subparagraph
(B)has concluded, one year after the issuance of the order; or if the first subsequent 5-year period under subparagraph
(B)has not concluded, immediately. In this section: The term banned facility means a banned foreign facility for which an order is in effect under subsection (a). The terms Class I and Class II , in connection with a recall, mean classified as Class I or Class II, respectively, by the Food and Drug Administration pursuant to section 7.41 of title 21, Code of Federal Regulations (or any successor regulations). . Section 810 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b), applies only with respect to recalls issued or reissued on or after the date of enactment of this Act. Subsection
(f)of section 303 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333 ) is amended by adding at the end the following new paragraph: Any person who violates section 301(fff) shall be subject to a civil money penalty not to exceed— if the violation involves a Class I recall, as described in section 810(a)(2)— $25,000,000 if the violation is the first violation of section 301(fff) by such person; and $100,000,000 if the violation is a subsequent violation of section 301(fff) by such person; and if the violation involves a Class II recall, as described in section 810(a)(2)— $10,000,000 if the violation is the first violation of section 301(fff) by such person; and $50,000,000 if the violation is a subsequent violation of section 301(fff) by such person. .
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