Sec. 2
Destruction of certain refused articles
(a)
changed
In general— Section 801(a) 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) 381) is amended—amended by adding at the end the following:
added
“(v) Destruction of refused articles presenting significant public health concerns
added
“(1) In general—If the Secretary of Health and Human Services finds that an article that has been refused admission under subsection (a) presents a significant public health concern, the Secretary may issue to the owner or consignee of the article an order to destroy the article, without the opportunity for export.
added
“(2) Deadline; costs—Not later than 90 days after the issuance of an order under paragraph (1), the owner or consignee of the article shall destroy the article. The owner or consignee shall be responsible for the costs of such destruction.
added
“(3) Due process—The Secretary of Health and Human Services shall provide to the owner or consignee of an article subject to an order under paragraph (1) appropriate due process prior to the destruction of the article. Such due process shall be specified in regulations and include notice and an opportunity to appear before the Secretary and introduce testimony on the destruction—
added
“(A) in combination with the notice and opportunity to appear and introduce testimony on the refusal of admission of the article under subsection (a); or
added
“(B) separately.”
(1)
removed
in the seventh sentence, by striking “as described under subsection (b).” and inserting “as described under subsection (b), or any article refused admission under this section, if the Secretary of Health and Human Services determines that such article presents a significant public health concern.”; and
(2)
removed
in the eighth, ninth, and tenth sentences, by striking “drug or device” each place it appears and inserting “drug, device, or other article”.
(b)
Prohibited acts— Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:
changed
“(jjj) The unauthorized movement, or introduction or delivery for introduction into interstate commerce, including export, of an article that the Secretary has decided is subject to destroy an order for destruction under the seventh sentence of section 801(a).”801(v).”
(c)
changed
Applicability— The amendments made by subsections (a) and (b) shall apply to articles beginning on the date that is 180 30 days after the date on which the Secretary of enactment Health and Human Services, acting through the Commissioner of this Act.Food and Drugs, promulgates final regulations under subsection (d).
(1)
added
Proposed— Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue proposed regulations to implement the amendment made by subsection (a), allowing for notice and comment on such proposed regulations.
(d)
removed
Regulations— The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall—
(2)
changed
Final— not Not later than 90 days 1 year after the date issuance of enactment the proposed regulations under paragraph (1), the Secretary of this Act, finalize such revisions to Health and Human Services, acting through the Commissioner of Food and Drugs, shall promulgate final regulations as may be necessary to implement the amendments amendment made by subsections (a) and (b); andsubsection (a).
(2)
removed
ensure that such regulations are consistent with any applicable international agreements.