21 U.S.C. § 360eee-4

Current through P.L. 118-107 (published on www.congress.gov on 11/21/2024)

Section 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).

21 U.S.C. § 360eee-4

June 25, 1938, ch. 675, §585, as added Pub. L. 113-54, title II, §205, Nov. 27, 2013, 127 Stat. 638.