Title 21, Food and DrugsRelease 119-73not60

§360eee–4 Uniform National Policy

Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part H— Pharmaceutical Distribution Supply Chain › § 360eee–4

Last updated Apr 5, 2026|Official source

Summary

Starting November 27, 2013, states and local governments must not make or keep rules about tracking drugs through the supply chain that conflict with or add to federal tracking rules. They also may not set different or weaker licensing rules for wholesale drug distributors (companies that buy and sell drugs in bulk) or third‑party logistics providers (companies that store or ship drugs for others). States may not treat those logistics companies as wholesale distributors, and state rules must also respect any federal waivers or limits. States may collect fees to help carry out the federal licensing program. They can still enforce state law in ways that fit the federal rules: they may fine businesses, suspend or revoke state licenses, impose penalties after convictions, and regulate licensed activities so long as those steps do not clash with the federal tracking and licensing rules. Rules that do not deal with tracking or these specific licenses are not affected.

Full Legal Text

Title 21, §360eee–4

Food and Drugs, Source: USLM XML via OLRC

(a)Beginning on November 27, 2013, 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 353(e) of this title or this part (or regulations issued thereunder), or which are inconsistent with—
(1)any waiver, exception, or exemption pursuant to section 360eee or 360eee–1 of this title; or
(2)any restrictions specified in section 360eee–1 of this title.
(b)(1)Beginning on November 27, 2013, 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 353(e) of this title, in the case of a wholesale distributor, or section 360eee–3 of this title, in the case of a third-party logistics provider.
(2)No State shall regulate third-party logistics providers as wholesale distributors.
(3)Notwithstanding paragraph (1), a State may administer fee collections for effectuating the wholesale drug distributor and third-party logistics provider licensure requirements under section 353(e), 360eee–2, and 360eee–3 of this title.
(4)Notwithstanding paragraph (1), a State—
(A)may take administrative action, including fines, to enforce a requirement promulgated by the State in accordance with section 353(e) of this title or this part;
(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 360eee–1 of this title.
(c)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 353(e) of this title or this part (or regulations issued thereunder).

Reference

Citations & Metadata

Citation

21 U.S.C. § 360eee–4

Title 21, Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60