Sec. 708. DESTRUCTION OF ADULTERATED, MISBRANDED, OR COUNTERFEIT DRUGS OFFERED FOR IMPORT
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## SEC. 708 DESTRUCTION OF ADULTERATED, MISBRANDED, OR COUNTERFEIT DRUGS OFFERED FOR IMPORT ###
(a)In General The sixth sentence of section 801(a) (21 U.S.C. 381(a)) is amended by inserting before the period at the end the following: “, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug refused admission under this section, if such drug is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 498(a)(1) of the Tariff Act of 1930 (19 U.S.C. 1498(a)(1)) and was not brought into compliance as described under subsection (b).”. ###
(b)Notice Subsection
(a)of section 801 (21 U.S.C. 381), as amended by subsection (a), is further amended by inserting after the sixth sentence the following: “The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug under the sixth sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c). Such process may be combined with the notice and opportunity to appear before the Secretary and introduce testimony, as described in the first sentence of this subsection, as long as appropriate notice is provided to the owner or consignee.”. ###
(c)Applicability **[**[21 U.S.C. 381 note](/us/usc/t21/s381)**]** The amendment made by subsection
(a)shall apply beginning on the effective date of the regulations promulgated pursuant to the amendment made by subsection (b). ###
(d)Regulations **[**[21 U.S.C. 381 note](/us/usc/t21/s381)**]** ####
(1)In general Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall adopt final regulations implementing the amendments made this section. ####
(2)Procedure In promulgating a regulation implementing the amendments made by this section, the Secretary of Health and Human Services shall— #####
(A)issue a notice of proposed rulemaking that includes a copy of the proposed regulation; #####
(B)provide a period of not less than 60 days for comments on the proposed regulation; and #####
(C)publish the final regulation not less than 30 days before the effective date of the regulation. ####
(3)Restrictions Notwithstanding any other provision of law, the Secretary of Health and Human Services shall promulgate regulations implementing the amendments made by this section only as described in paragraph (2).
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Sec. 708
DESTRUCTION OF ADULTERATED, MISBRANDED, OR COUNTERFEIT DRUGS OFFERED FOR IMPORT
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