---
kind: "section"
citation: "21 U.S.C. § 360eee–2"
title: "21"
title_heading: "Food and Drugs"
number: "360eee–2"
heading: "National standards for prescription drug wholesale distributors"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360eee-2"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part H — Pharmaceutical Distribution Supply Chain"
---

# §360eee–2. National standards for prescription drug wholesale distributors

- (a) **In general—** The [Secretary](/usc/21/321.md?p=d) shall, not later than 2 years after November 27, 2013, establish by regulation standards for the licensing of [persons](/usc/21/321.md?p=e) under [section 353(e)(1) of this title](/usc/21/353.md?p=e-1), including the revocation, reissuance, and renewal of such license.
- (b) **Content—** For the purpose of ensuring uniformity with respect to standards set forth in this section, the standards established under [subsection (a)](#a) shall apply to all [State](/usc/21/321.md?p=a-1) and Federal licenses described under [section 353(e)(1) of this title](/usc/21/353.md?p=e-1) and shall include standards for the following:
  - (1) The storage and handling of [prescription drugs](/usc/21/360eee.md?p=12), including facility requirements.
  - (2) The establishment and maintenance of records of the [distributions](/usc/21/360eee.md?p=5) of such [drugs](/usc/21/321.md?p=g-1).
  - (3) The furnishing of a bond or other equivalent means of security, as follows:
    - (A)
      - (i) For the issuance or renewal of a [wholesale distributor](/usc/21/360eee.md?p=29) license, an applicant that is not a government owned and operated [wholesale distributor](/usc/21/360eee.md?p=29) shall submit a surety bond of $100,000 or other equivalent means of security acceptable to the [State](/usc/21/321.md?p=a-1).
      - (ii) For purposes of [clause (i)](#b-3-A-i), the [State](/usc/21/321.md?p=a-1) or other applicable authority may accept a surety bond in the amount of $25,000 if the annual gross receipts of the previous tax year for the wholesaler is $10,000,000 or less.
    - (B) If a [wholesale distributor](/usc/21/360eee.md?p=29) can provide evidence that it possesses the required bond in a [State](/usc/21/321.md?p=a-1), the requirement for a bond in another [State](/usc/21/321.md?p=a-1) shall be waived.
  - (4) Mandatory background checks and fingerprinting of facility managers or designated representatives.
  - (5) The establishment and implementation of qualifications for key personnel.
  - (6) The mandatory physical inspection of any facility to be used in wholesale [distribution](/usc/21/360eee.md?p=5) within a reasonable time frame from the initial application of the facility and to be conducted by the licensing authority or by the [State](/usc/21/321.md?p=a-1), consistent with [subsection (c)](#c).
  - (7) In accordance with [subsection (d)](#d), the prohibition of certain [persons](/usc/21/321.md?p=e) from receiving or maintaining licensure for wholesale [distribution](/usc/21/360eee.md?p=5).
- (c) **Inspections—** To satisfy the inspection requirement under [subsection (b)(6)](#b-6), the Federal or [State](/usc/21/321.md?p=a-1) licensing authority may conduct the inspection or may accept an inspection by the [State](/usc/21/321.md?p=a-1) in which the facility is located, or by a third-party accreditation or inspection service approved by the [Secretary](/usc/21/321.md?p=d) or the [State](/usc/21/321.md?p=a-1) licensing such [wholesale distributor](/usc/21/360eee.md?p=29).
- (d) **Prohibited persons—** The standards established under [subsection (a)](#a) shall include requirements to prohibit a [person](/usc/21/321.md?p=e) from receiving or maintaining licensure for wholesale [distribution](/usc/21/360eee.md?p=5) if the [person](/usc/21/321.md?p=e)—
  - (1) has been convicted of any felony for conduct relating to wholesale [distribution](/usc/21/360eee.md?p=5), any felony violation of subsection (i) or (k) of [section 331 of this title](/usc/21/331.md), or any felony violation of [section 1365 of title 18](/usc/18/1365.md) relating to [product](/usc/21/360eee.md?p=13) tampering; or
  - (2) has engaged in a pattern of violating the requirements of this section, or [State](/usc/21/321.md?p=a-1) requirements for licensure, that presents a threat of serious adverse health consequences or death to humans.
- (e) **Requirements—** The [Secretary](/usc/21/321.md?p=d), in promulgating any regulation pursuant to this section, shall, notwithstanding [section 553 of title 5](/usc/5/553.md)—
  - (1) issue a notice of proposed rulemaking that includes a copy of the proposed regulation;
  - (2) provide a period of not less than 60 days for comments on the proposed regulation; and
  - (3) provide that the final regulation take effect on the date that is 2 years after the date such final regulation is published.

## Source credit

(June 25, 1938, ch. 675, § 583, as added Pub. L. 113–54, title II, § 204(a)(5), Nov. 27, 2013, 127 Stat. 634.)

## Notes

### Statutory Notes and Related Subsidiaries

### Effective Date

Section effective Jan. 1, 2015, see section 204(c) of Pub. L. 113–54, set out as an Effective Date of 2013 Amendment note under section 353 of this title.