Destruction of certain refused articles

Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the following: (v) Order To destroy certain refused articles (1) In general For any article that has been refused admission and is in violation of this Act, the Secretary of Health and Human Services may issue to the owner or consignee an order that the article shall be destroyed, without the opportunity to export, if the Secretary of Health and Human Services finds that the article presents a significant public health concern. Before issuing an order to destroy an article under this subsection, the Secretary of Health and Human Services shall issue regulations providing provide for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony on the order to destroy. The Secretary of Health and Human Services may combine the opportunity to appear before the Secretary and the opportunity to introduce testimony into a single proceeding with respect to an article. The regulations under paragraph (2) shall provide that prior to the destruction of any such article, appropriate due process is available to the owner or consignee seeking to challenge the decision of the Secretary of Health and Human Service’s decision Services to order destruction. Such process may be combined with the notice and opportunity to appear before the Secretary and introduce testimony on the refusal as long as appropriate notice is provided to the owner or consignee about the potential order to destroy. The Secretary of the Treasury shall cause the owner or consignee to complete the destruction of any such article within 90 days of the order for destruction and the owner or consignee shall be responsible for the costs of such destruction..destruction. (2) Regulations (A) Proposed Not later than 18 months after the date of enactment of the Making America's Food Safer Act, the Secretary of Health and Human Services shall issue proposed regulations to implement paragraph (1), including a framework for due process, allowing for notice and comment on such proposed regulations. (B) Final Not later than 1 year after the issuance of the proposed regulations under subparagraph (A), the Secretary of Health and Human Services shall promulgate final regulations to implement paragraph (1). (3) Exceptions With respect to importation by an individual of a prescription drug that is not a controlled substance pursuant to section 804(j) and in a manner that is consistent with personal or household use, the authority provided under paragraph (1) shall not apply. (4) Clarification For purposes of this section, a prescription drug described in paragraph (3) that is imported as described in such paragraph shall not be considered a significant public health concern..