Federal · Title 21 — Food and Drugs

21 U.S.C. § 360eee: Uniform national policy

Civil

What this law says, in plain English

Federal law establishes uniform standards for state regulation of wholesale prescription drug distributors and third-party logistics providers, effective November 27, 2013. States must enforce consistent licensure requirements and may collect fees and impose administrative penalties for violations.

Read the full statutory text
any waiver, exception, or exemption pursuant to section 360eee or 360eee–1 of this title; or any restrictions specified in section 360eee–1 of this title . 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. No State shall regulate third-party logistics providers as wholesale distributors. 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. 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; may provide for the suspension or revocation of licenses issued by the State for violations of the laws of such State; upon conviction of violations of Federal, State, or local drug laws or regulations, may provide for fines, imprisonment, or civil penalties; and 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).

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