REGISTRATION OF COMMERCIAL IMPORTERS.

SEC. 714. REGISTRATION OF COMMERCIAL IMPORTERS. (a) Prohibitions.—Section 301 (21 U.S.C. 331) is amended by adding at the end the following: “(aaa) The failure to register in accordance with section 801(s).” . (b) Registration.—Section 801 (21 U.S.C. 381), as amended by section 713 of this Act, is further amended by adding at the end the following: “(s) Registration of Commercial Importers. “(1) Registration. The Secretary shall require a commercial importer of drugs— “(A) to be registered with the Secretary in a form and manner specified by the Secretary; and “(B) subject to paragraph (4), to submit, at the time of registration, a unique identifier for the principal place of business for which the importer is required to register under this subsection. “(2) Regulations. “(A) In general. The Secretary, in consultation with the Secretary of Homeland Security acting through U.S. Customs and Border Protection, shall promulgate regulations to establish good importer practices that specify the measures an importer shall take to ensure imported drugs are in compliance with the requirements of this Act and the Public Health Service Act. “(B) Procedure. In promulgating a regulation under subparagraph (A), the Secretary shall— “(i) issue a notice of proposed rulemaking that includes the proposed regulation; “(ii) provide a period of not less than 60 days for comments on the proposed regulation; and “(iii) publish the final regulation not less than 30 days before the regulation’s effective date. “(C) Restrictions. Notwithstanding any other provision of Federal law, in implementing this subsection, the Secretary shall only promulgate regulations as described in subparagraph (B). “(3) Discontinuance of registration. The Secretary shall discontinue the registration of any commercial importer of drugs that fails to comply with the regulations promulgated under this subsection. “(4) Unique facility identifier. The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1). The requirement to include a unique facility identifier in a registration under paragraph (1) shall not apply until the date that the identifier system is specified by the Secretary under the preceding sentence. “(5) Exemptions. The Secretary, by notice in the Federal Register, may establish exemptions from the requirements of this subsection.” . (c) Misbranding.—Section 502(o) (21 U.S.C. 352) is amended by inserting “if it is a drug and was imported or offered for import by a commercial importer of drugs not duly registered under section 801(s),” after “not duly registered under section 510,”.