21 U.S.C. § 360eee–4 — Uniform national policy

(a) Product tracing and other requirements Starting November 27, 2013, no state or local government may create or keep any requirement for tracing products through the distribution system — including rules about distribution history, transaction history, transaction information, or transaction statements as a drug changes hands, or about verification, investigation, disposition, notification, or recordkeeping tied to those systems, including paper or electronic "pedigree" systems for tracking drugs — if that state requirement is inconsistent with, more strict than, or in addition to the federal requirements under section 353(e) or this part (or their regulations). States also can't keep requirements that are inconsistent with any waiver, exception, or exemption granted under section 360eee or 360eee–1, or with the restrictions listed in section 360eee–1. (b) Wholesale distributor and third-party logistics provider standards Starting the same date, no state may create or keep standards, requirements, or regulations for licensing wholesale prescription drug distributors or third-party logistics providers that are inconsistent with, less strict than, directly related to, or already covered by the federal standards in section 353(e) (for distributors) or section 360eee–3 (for third-party logistics providers). States also may not regulate third-party logistics providers as if they were wholesale distributors. Even so, a state may still: administer fee collection to help carry out the federal wholesale-distributor and logistics-provider licensing requirements under sections 353(e), 360eee–2, and 360eee–3; take administrative action, including fines, to enforce a state requirement that matches section 353(e) or this part; suspend or revoke state-issued licenses for violations of that state's own laws; impose fines, imprisonment, or civil penalties for convicted violations of federal, state, or local drug laws or regulations; and otherwise regulate licensed entities in ways consistent with the product-tracing requirements in section 360eee–1. (c) Exception Nothing in this section stops a state from regulating other aspects of prescription drug distribution, as long as those state requirements are not actually about product tracing, as described in subsection (a), or about wholesale-distributor or third-party-logistics-provider licensing, as described in subsection (b), to the extent those topics are covered by section 353(e) or this part (or their regulations).