---
kind: "section"
citation: "21 U.S.C. § 360eee–3"
title: "21"
title_heading: "Food and Drugs"
number: "360eee–3"
heading: "National standards for third-party logistics providers"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360eee-3"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part H — Pharmaceutical Distribution Supply Chain"
---

# §360eee–3. National standards for third-party logistics providers

- (a) **Requirements—** No [third-party logistics provider](/usc/21/360eee.md?p=22) in any [State](/usc/21/321.md?p=a-1) may conduct activities in any [State](/usc/21/321.md?p=a-1) unless each facility of such [third-party logistics provider](/usc/21/360eee.md?p=22)—
  - (1)
    - (A) is [licensed](/usc/21/360eee.md?p=9) by the [State](/usc/21/321.md?p=a-1) from which the [drug](/usc/21/321.md?p=g-1) is distributed by the [third-party logistics provider](/usc/21/360eee.md?p=22), in accordance with the regulations promulgated under [subsection (d)](#d); or
    - (B) if the [State](/usc/21/321.md?p=a-1) from which the [drug](/usc/21/321.md?p=g-1) distributed by the [third-party logistics provider](/usc/21/360eee.md?p=22) has not established a licensure requirement, is [licensed](/usc/21/360eee.md?p=9) by the [Secretary](/usc/21/321.md?p=d), in accordance with the regulations promulgated under [subsection (d)](#d); and
  - (2) if the [drug](/usc/21/321.md?p=g-1) is distributed interstate, is [licensed](/usc/21/360eee.md?p=9) by the [State](/usc/21/321.md?p=a-1) into which the [drug](/usc/21/321.md?p=g-1) is distributed by the [third-party logistics provider](/usc/21/360eee.md?p=22) if such [State](/usc/21/321.md?p=a-1) licenses [third-party logistics providers](/usc/21/360eee.md?p=22) that [distribute](/usc/21/360eee.md?p=5) [drugs](/usc/21/321.md?p=g-1) into the [State](/usc/21/321.md?p=a-1) and the [third-party logistics provider](/usc/21/360eee.md?p=22) is not [licensed](/usc/21/360eee.md?p=9) by the [Secretary](/usc/21/321.md?p=d) as described in [paragraph (1)(B)](#a-1-B).
- (b) **Reporting—** Beginning 1 year after November 27, 2013, a facility of a [third-party logistics provider](/usc/21/360eee.md?p=22) shall report to the [Secretary](/usc/21/321.md?p=d), on an annual basis pursuant to a schedule determined by the [Secretary](/usc/21/321.md?p=d)—
  - (1) the [State](/usc/21/321.md?p=a-1) by which the facility is [licensed](/usc/21/360eee.md?p=9) and the appropriate identification number of such license; and
  - (2) the name and address of the facility and all trade names under which such facility conducts business.
- (c) **Costs—**
  - (1) **Authorized fees of Secretary—** If a [State](/usc/21/321.md?p=a-1) does not establish a licensing program for a [third-party logistics provider](/usc/21/360eee.md?p=22), the [Secretary](/usc/21/321.md?p=d) shall license the [third-party logistics provider](/usc/21/360eee.md?p=22) located in such [State](/usc/21/321.md?p=a-1) and may collect a reasonable fee in such amount necessary to reimburse the [Secretary](/usc/21/321.md?p=d) for costs associated with establishing and administering the licensure program and conducting periodic inspections under this section. The [Secretary](/usc/21/321.md?p=d) shall adjust fee rates as needed on an annual basis to generate only the amount of revenue needed to perform this service. Fees [authorized](/usc/21/360eee.md?p=2) 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](/usc/21/360eee.md?p=2) to remain available until expended. Such sums as may be necessary may be transferred from the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation.
  - (2) **State licensing fees—**
    - (A) **State established program—** Nothing in this chapter shall prohibit a [State](/usc/21/321.md?p=a-1) that has established a program to license a [third-party logistics provider](/usc/21/360eee.md?p=22) from collecting fees from a [third-party logistics provider](/usc/21/360eee.md?p=22) for such a license.
    - (B) **No State established program—** A [State](/usc/21/321.md?p=a-1) that does not establish a program to license a [third-party logistics provider](/usc/21/360eee.md?p=22) in accordance with this section shall be prohibited from collecting a [State](/usc/21/321.md?p=a-1) licensing fee from a [third-party logistics provider](/usc/21/360eee.md?p=22).
- (d) **Regulations—**
  - (1) **In general—** Not later than 2 years after November 27, 2013, the [Secretary](/usc/21/321.md?p=d) shall issue regulations regarding the standards for licensing under [subsection (a)](#a), including the revocation and reissuance of such license, to [third-party logistics providers](/usc/21/360eee.md?p=22) under this section.
  - (2) **Content—** Such regulations shall—
    - (A) establish a process by which a third-party accreditation program approved by the [Secretary](/usc/21/321.md?p=d) shall, upon request by a [third-party logistics provider](/usc/21/360eee.md?p=22), issue a license to each [third-party logistics provider](/usc/21/360eee.md?p=22) that meets the requirements set forth in this section;
    - (B) establish a process by which the [Secretary](/usc/21/321.md?p=d) shall issue a license to each [third-party logistics provider](/usc/21/360eee.md?p=22) that meets the requirements set forth in this section if the [Secretary](/usc/21/321.md?p=d) is not able to approve a third-party accreditation program because no such program meets the [Secretary](/usc/21/321.md?p=d)’s requirements necessary for approval of such a third-party accreditation program;
    - (C) require that the entity complies with storage practices, as determined by the [Secretary](/usc/21/321.md?p=d) for such facility, including—
      - (i) maintaining access to warehouse space of suitable size to facilitate [safe](/usc/21/321.md?p=u) operations, including a suitable area to [quarantine](/usc/21/360eee.md?p=15) [suspect product](/usc/21/360eee.md?p=21);
      - (ii) maintaining adequate security; and
      - (iii) having written policies and procedures to—
        - (I) address receipt, security, storage, inventory, shipment, and [distribution](/usc/21/360eee.md?p=5) of a [product](/usc/21/360eee.md?p=13);
        - (II) identify, record, and report confirmed losses or thefts in the United States;
        - (III) correct errors and inaccuracies in inventories;
        - (IV) provide support for [manufacturer](/usc/21/360hh.md?p=3) recalls;
        - (V) prepare for, protect against, and address any reasonably foreseeable crisis that affects security or operation at the facility, such as a strike, fire, or flood;
        - (VI) ensure that any expired [product](/usc/21/360eee.md?p=13) is segregated from other [products](/usc/21/360eee.md?p=13) and returned to the [manufacturer](/usc/21/360hh.md?p=3) or [repackager](/usc/21/360eee.md?p=16) or destroyed;
        - (VII) maintain the capability to trace the receipt and outbound [distribution](/usc/21/360eee.md?p=5) of a [product](/usc/21/360eee.md?p=13), and supplies and records of inventory; and
        - (VIII) [quarantine](/usc/21/360eee.md?p=15) or destroy a [suspect product](/usc/21/360eee.md?p=21) if directed to do so by the respective [manufacturer](/usc/21/360hh.md?p=3), [wholesale distributor](/usc/21/360eee.md?p=29), [dispenser](/usc/21/360eee.md?p=3), or an [authorized](/usc/21/360eee.md?p=2) government agency;
    - (D) provide for periodic inspection by the licensing authority, as determined by the [Secretary](/usc/21/321.md?p=d), of such facility warehouse space to ensure compliance with this section;
    - (E) prohibit a facility from having as a manager or designated representative anyone convicted of any felony violation of subsection (i) or (k) of [section 331 of this title](/usc/21/331.md) or any violation of [section 1365 of title 18](/usc/18/1365.md), relating to [product](/usc/21/360eee.md?p=13) tampering;
    - (F) provide for mandatory background checks of a facility manager or a designated representative of such manager;
    - (G) require a [third-party logistics provider](/usc/21/360eee.md?p=22) to provide the applicable licensing authority, upon a request by such authority, a list of all [product](/usc/21/360eee.md?p=13) [manufacturers](/usc/21/360hh.md?p=3), [wholesale distributors](/usc/21/360eee.md?p=29), and [dispensers](/usc/21/360eee.md?p=3) for whom the [third-party logistics provider](/usc/21/360eee.md?p=22) provides services at such facility; and
    - (H) include procedures under which any [third-party logistics provider](/usc/21/360eee.md?p=22) license—
      - (i) expires on the date that is 3 years after issuance of the license; and
      - (ii) may be renewed for additional 3-year periods.
  - (3) **Procedure—** In promulgating the regulations under this subsection, the [Secretary](/usc/21/321.md?p=d) shall, notwithstanding [section 553 of title 5](/usc/5/553.md)—
    - (A) issue a notice of proposed rulemaking that includes a copy of the proposed regulation;
    - (B) provide a period of not less than 60 days for comments on the proposed regulation; and
    - (C) provide that the final regulation takes effect upon the expiration of 1 year after the date that such final regulation is issued.
- (e) **Validity—** A license issued under this section shall remain valid as long as such [third-party logistics provider](/usc/21/360eee.md?p=22) remains [licensed](/usc/21/360eee.md?p=9) consistent with this section. If the [Secretary](/usc/21/321.md?p=d) finds that the third-party accreditation program demonstrates that all applicable requirements for licensure under this section are met, the [Secretary](/usc/21/321.md?p=d) shall issue a license under this section to a [third-party logistics provider](/usc/21/360eee.md?p=22) receiving accreditation, pursuant to [subsection (d)(2)(A)](#d-2-A).

## Source credit

(June 25, 1938, ch. 675, § 584, as added Pub. L. 113–54, title II, § 205, Nov. 27, 2013, 127 Stat. 636.)