UNIFORM NATIONAL POLICY.

SEC. 585. [21 U.S.C. 360eee–4] UNIFORM NATIONAL POLICY. (a) Product Tracing and Other Requirements.—Beginning on the date of enactment of the Drug Supply Chain Security Act, no State or political subdivision of a State may establish or continue in effect any requirements for tracing products through the distribution system (including any requirements with respect to statements of distribution history, transaction history, transaction information, or transaction statement of a product as such product changes ownership in the supply chain, or verification, investigation, disposition, notification, or recordkeeping relating to such systems, including paper or electronic pedigree systems or for tracking and tracing drugs throughout the distribution system) which are inconsistent with, more stringent than, or in addition to, any requirements applicable under section 503(e) (as amended by such Act) or this subchapter (or regulations issued thereunder), or which are inconsistent with— (1) any waiver, exception, or exemption pursuant to section 581 or 582; or (2) any restrictions specified in section 582. (b) Wholesale Distributor and Third-Party Logistics Provider Standards.— (1) In general.—Beginning on the date of enactment of the Drug Supply Chain Security Act, no State or political subdivision of a State may establish or continue any standards, requirements, or regulations with respect to wholesale prescription drug distributor or third-party logistics provider licensure that are inconsistent with, less stringent than, directly related to, or covered by the standards and requirements applicable under section 503(e) (as amended by such Act), in the case of a wholesale distributor, or section 584, in the case of a third-party logistics provider. (2) State regulation of third-party logistics providers.—No State shall regulate third-party logistics providers as wholesale distributors. (3) Administration fees.—Notwithstanding paragraph (1), a State may administer fee collections for effectuating the wholesale drug distributor and third-party logistics provider licensure requirements under sections 503(e) (as amended by the Drug Supply Chain Security Act), 583, and 584. (4) Enforcement, suspension, and revocation.—Notwithstanding paragraph (1), a State— (A) may take administrative action, including fines, to enforce a requirement promulgated by the State in accordance with section 503(e) (as amended by the Drug Supply Chain Security Act) or this subchapter; (B) may provide for the suspension or revocation of licenses issued by the State for violations of the laws of such State; (C) upon conviction of violations of Federal, State, or local drug laws or regulations, may provide for fines, imprisonment, or civil penalties; and (D) may regulate activities of licensed entities in a manner that is consistent with product tracing requirements under section 582. (c) Exception.—Nothing in this section shall be construed to preempt State requirements related to the distribution of prescription drugs if such requirements are not related to product tracing as described in subsection (a) or wholesale distributor and third-party logistics provider licensure as described in subsection (b) applicable under section 503(e) (as amended by the Drug Supply Chain Security Act) or this subchapter (or regulations issued thereunder).