Us Code § 360eee - –4. Uniform national policy
Full text of Us Code United States Code § 360eee — –4. Uniform national policy, with citation guidance and answers to common questions.
§ 360eee. –4. Uniform national policy
(a) Product tracing and other requirements
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) Wholesale distributor and third-party logistics provider standards
(1) In general
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) 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 353(e), 360eee–2, and 360eee–3 of this title.
(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 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) 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 353(e) of this title or this part (or regulations issued thereunder).
(June 25, 1938, ch. 675, §585, as added Pub. L. 113–54, title II, §205, Nov. 27, 2013, 127 Stat. 638.)
Part I—Nonprescription Sunscreen and Other Active Ingredients
Termination of Part
This part ceased to be effective at the end of fiscal year 2022, see section 360fff–8 of this title.
About This Section
21 U.S.C. § 360eee is part of Title 21 of the United States Code. The United States Code is the official codification of federal statutes maintained by the Office of the Law Revision Counsel of the U.S. House of Representatives. Congress amends the Code through new public laws, which are eventually incorporated into the relevant title.
This section may be cited in legal writing as 21 U.S.C. § 360eee. For the most current official text, including any recent amendments, use the official source links below. Do not rely on this page as the sole authority for legal citation or litigation.
How to Read This Statute
Statutes are organized by title, chapter, section, and subsection. Pay attention to words like "shall," "may," "and," and "or," because they determine whether a requirement is mandatory or permissive and whether multiple conditions must all be met. Historical notes and amendments often appear at the end of a section.
Using This Page
This page is intended for research and educational use. Lawyers, students, journalists, and compliance professionals can use it as a starting point, but should always verify the current text through an official government source before relying on it for legal advice, filings, or compliance decisions.