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–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
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.
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).
The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.
The most recent Classification Table update that we have noticed was Tuesday, August 13, 2013
An empty table indicates that we see no relevant changes listed in the classification tables. If you suspect that our system may be missing something, please double-check with the Office of the Law Revision Counsel.