--- kind: "section" citation: "21 U.S.C. § 360eee–4" title: "21" title_heading: "Food and Drugs" number: "360eee–4" heading: "Uniform national policy" release: "119-102" date: "2026-07-12" url: "https://uscodex.org/usc/21/360eee-4" units: - "Chapter 9 — Federal Food, Drug, and Cosmetic Act" - "Subchapter V — Drugs and Devices" - "Part H — Pharmaceutical Distribution Supply Chain" --- # §360eee–4. Uniform national policy - (a) **Product tracing and other requirements—** Beginning on November 27, 2013, no [State](/usc/21/321.md?p=a-1) or political subdivision of a [State](/usc/21/321.md?p=a-1) may establish or continue in effect any requirements for tracing [products](/usc/21/360eee.md?p=13) through the [distribution](/usc/21/360eee.md?p=5) system (including any requirements with respect to statements of [distribution](/usc/21/360eee.md?p=5) history, [transaction history](/usc/21/360eee.md?p=25), [transaction information](/usc/21/360eee.md?p=26), or [transaction](/usc/21/360eee.md?p=24-A) statement of a [product](/usc/21/360eee.md?p=13) as such [product](/usc/21/360eee.md?p=13) changes ownership in the supply chain, or [verification](/usc/21/360eee.md?p=28), investigation, [disposition](/usc/21/360eee.md?p=4), notification, or recordkeeping relating to such systems, including paper or electronic pedigree systems or for tracking and tracing [drugs](/usc/21/321.md?p=g-1) throughout the [distribution](/usc/21/360eee.md?p=5) system) which are inconsistent with, more stringent than, or in addition to, any requirements applicable under [section 353(e) of this title](/usc/21/353.md?p=e) or this part (or regulations issued thereunder), or which are inconsistent with— - (1) any waiver, exception, or exemption pursuant to section [360eee](/usc/21/360eee.md) or [360eee–1](/usc/21/360eee–1.md) of this title; or - (2) any restrictions specified in [section 360eee–1 of this title](/usc/21/360eee–1.md). - (b) **Wholesale distributor and third-party logistics provider standards—** - (1) **In general—** Beginning on November 27, 2013, no [State](/usc/21/321.md?p=a-1) or political subdivision of a [State](/usc/21/321.md?p=a-1) may establish or continue any standards, requirements, or regulations with respect to wholesale [prescription drug](/usc/21/360eee.md?p=12) distributor or [third-party logistics provider](/usc/21/360eee.md?p=22) licensure that are inconsistent with, less stringent than, directly related to, or covered by the standards and requirements applicable under [section 353(e) of this title](/usc/21/353.md?p=e), in the case of a [wholesale distributor](/usc/21/360eee.md?p=29), or [section 360eee–3 of this title](/usc/21/360eee–3.md), in the case of a [third-party logistics provider](/usc/21/360eee.md?p=22). - (2) **State regulation of third-party logistics providers—** No [State](/usc/21/321.md?p=a-1) shall regulate [third-party logistics providers](/usc/21/360eee.md?p=22) as [wholesale distributors](/usc/21/360eee.md?p=29). - (3) **Administration fees—** Notwithstanding [paragraph (1)](#b-1), a [State](/usc/21/321.md?p=a-1) may administer fee collections for effectuating the wholesale [drug](/usc/21/321.md?p=g-1) distributor and [third-party logistics provider](/usc/21/360eee.md?p=22) licensure requirements under sections [353(e)](/usc/21/353.md?p=e), [360eee–2](/usc/21/360eee–2.md), and [360eee–3](/usc/21/360eee–3.md) of this title. - (4) **Enforcement, suspension, and revocation—** Notwithstanding [paragraph (1)](#b-1), a [State](/usc/21/321.md?p=a-1)— - (A) may take administrative action, including fines, to enforce a requirement promulgated by the [State](/usc/21/321.md?p=a-1) in accordance with [section 353(e) of this title](/usc/21/353.md?p=e) or this part; - (B) may provide for the suspension or revocation of licenses issued by the [State](/usc/21/321.md?p=a-1) for violations of the laws of such [State](/usc/21/321.md?p=a-1); - (C) upon conviction of violations of Federal, [State](/usc/21/321.md?p=a-1), or local [drug](/usc/21/321.md?p=g-1) laws or regulations, may provide for fines, imprisonment, or civil penalties; and - (D) may regulate activities of [licensed](/usc/21/360eee.md?p=9) entities in a manner that is consistent with [product](/usc/21/360eee.md?p=13) tracing requirements under [section 360eee–1 of this title](/usc/21/360eee–1.md). - (c) **Exception—** Nothing in this section shall be construed to preempt [State](/usc/21/321.md?p=a-1) requirements related to the [distribution](/usc/21/360eee.md?p=5) of [prescription drugs](/usc/21/360eee.md?p=12) if such requirements are not related to [product](/usc/21/360eee.md?p=13) tracing as described in [subsection (a)](#a) or [wholesale distributor](/usc/21/360eee.md?p=29) and [third-party logistics provider](/usc/21/360eee.md?p=22) licensure as described in [subsection (b)](#b) applicable under [section 353(e) of this title](/usc/21/353.md?p=e) or this part (or regulations issued thereunder). ## Source credit (June 25, 1938, ch. 675, § 585, as added Pub. L. 113–54, title II, § 205, Nov. 27, 2013, 127 Stat. 638.)