Sec. 7. Uniform national policy
342 words·~2 min read·
/bill/113/hr/1919/eh/section-7A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Subchapter H of chapter V of the Federal Food, Drug, and Cosmetic Act, as amended by section 5, is further amended by adding at the end the following: Beginning on the date of the enactment of the Safeguarding America’s Pharmaceuticals Act of 2013 , no State or political subdivision of a State may establish or continue in effect any requirements for tracing drugs through the distribution system (including any requirements with respect to paper or electronic pedigrees, track and trace, statements of distribution history, transaction history, or transaction statements, or verification, investigation, disposition, alerts, or recordkeeping relating to the pharmaceutical distribution supply chain system) that— are inconsistent with, more stringent than, or in addition to any requirements applicable under this Act; or are inconsistent with any applicable waiver, exception, or exemption issued by the Secretary under section 582(a).
Beginning on the date of the enactment of Safeguarding America’s Pharmaceuticals Act of 2013 , no State or political subdivision of a State may establish or continue any standards, requirements, or regulations with respect to wholesale drug distributor or third-party logistics provider licensure which are inconsistent with, less stringent than, in addition to, or more stringent than, the standards and requirements under this Act. Paragraph
(1)does not affect the authority of a State to collect fees from wholesale drug distributors or third-party logistics providers in connection with State licensing under section 583 or 584 pursuant to a licensing program meeting the requirements of such sections. Notwithstanding paragraph (1), a State— may take administrative action, including fines, to enforce a licensure requirement promulgated by the State in accordance with this Act; may provide for the suspension or revocation of licenses issued by the State for violations of the laws of such State; upon conviction of a person for a violation of Federal, State, or local controlled substance laws or regulations, may provide for fines, imprisonment, or civil penalties; and may regulate activities of entities licensed pursuant to section 583 or 584 in a manner that is consistent with the provisions of this subchapter. .