21 U.S.C. § 360eee–3
National standards for third-party logistics providers
United States · Title 21 — FOOD AND DRUGS · Status: effective
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- Citation
- 21 U.S.C. § 360eee–3, National standards for third-party logistics providers, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454348
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Full text
No third-party logistics provider in any State may conduct activities in any State unless each facility of such third-party logistics provider—
Beginning 1 year after November 27, 2013, a facility of a third-party logistics provider shall report to the Secretary, on an annual basis pursuant to a schedule determined by the Secretary—
If a State does not establish a licensing program for a third-party logistics provider, the Secretary shall license the third-party logistics provider located in such State and may collect a reasonable fee in such amount necessary to reimburse the Secretary for costs associated with establishing and administering the licensure program and conducting periodic inspections under this section. The Secretary shall adjust fee rates as needed on an annual basis to generate only the amount of revenue needed to perform this service. Fees authorized under this paragraph shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation.
Nothing in this chapter shall prohibit a State that has established a program to license a third-party logistics provider from collecting fees from a third-party logistics provider for such a license.
A State that does not establish a program to license a third-party logistics provider in accordance with this section shall be prohibited from collecting a State licensing fee from a third-party logistics provider.
Not later than 2 years after November 27, 2013, the Secretary shall issue regulations regarding the standards for licensing under subsection (a), including the revocation and reissuance of such license, to third-party logistics providers under this section.
Such regulations shall—
require that the entity complies with storage practices, as determined by the Secretary for such facility, including—
having written policies and procedures to—
include procedures under which any third-party logistics provider license—
In promulgating the regulations under this subsection, the Secretary shall, notwithstanding section 553 of title 5—
A license issued under this section shall remain valid as long as such third-party logistics provider remains licensed consistent with this section. If the Secretary finds that the third-party accreditation program demonstrates that all applicable requirements for licensure under this section are met, the Secretary shall issue a license under this section to a third-party logistics provider receiving accreditation, pursuant to subsection (d)(2)(A).
Legislative history
The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone.
- Drug Quality and Security ActHouse: no recorded tallySenate: no recorded tally