---
kind: "section"
citation: "21 U.S.C. § 355e"
title: "21"
title_heading: "Food and Drugs"
number: "355e"
heading: "Pharmaceutical security"
release: "119-102"
url: "https://uscodex.org/usc/21/355e"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §355e. Pharmaceutical security

- (a) **In general—** The [Secretary](/usc/21/321.md?p=d) shall develop standards and identify and validate effective technologies for the purpose of securing the [drug](/usc/21/321.md?p=g-1) supply chain against counterfeit, diverted, subpotent, substandard, adulterated, [misbranded](/usc/21/1033.md?p=l), or expired [drugs](/usc/21/321.md?p=g-1).
- (b) **Standards development—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) shall, in consultation with the agencies specified in [paragraph (4)](#b-4), manufacturers, distributors, pharmacies, and other supply chain stakeholders, prioritize and develop standards for the identification, validation, authentication, and tracking and tracing of [prescription drugs](#d).
  - (2) **Standardized numeral identifier—** Not later than 30 months after September 27, 2007, the [Secretary](/usc/21/321.md?p=d) shall develop a standardized numerical identifier (which, to the extent practicable, shall be harmonized with international consensus standards for such an identifier) to be applied to a [prescription drug](#d) at the point of manufacturing and repackaging (in which case the numerical identifier shall be linked to the numerical identifier applied at the point of manufacturing) at the package or pallet level, sufficient to facilitate the identification, validation, authentication, and tracking and tracing of the [prescription drug](#d).
  - (3) **Promising technologies—** The standards developed under this subsection shall address promising technologies, which may include—
    - (A) radio frequency identification technology;
    - (B) nanotechnology;
    - (C) encryption technologies; and
    - (D) other track-and-trace or authentication technologies.
  - (4) **Interagency collaboration—** In carrying out this subsection, the [Secretary](/usc/21/321.md?p=d) shall consult with Federal health and security agencies, including—
    - (A) the [Department](/usc/21/321.md?p=c) of Justice;
    - (B) the [Department](/usc/21/321.md?p=c) of Homeland Security;
    - (C) the [Department](/usc/21/321.md?p=c) of Commerce; and
    - (D) other appropriate Federal and [State](/usc/21/321.md?p=a-1) agencies.
- (c) **Inspection and enforcement—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) shall expand and enhance the resources and [facilities](/usc/21/350g.md?p=o-2) of agency components of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration involved with regulatory and criminal enforcement of this chapter to secure the [drug](/usc/21/321.md?p=g-1) supply chain against counterfeit, diverted, subpotent, substandard, adulterated, [misbranded](/usc/21/1033.md?p=l), or expired [drugs](/usc/21/321.md?p=g-1) including biological [products](/usc/21/360eee.md?p=13) and active pharmaceutical ingredients from domestic and foreign sources.
  - (2) **Activities—** The [Secretary](/usc/21/321.md?p=d) shall undertake enhanced and joint enforcement activities with other Federal and [State](/usc/21/321.md?p=a-1) agencies, and establish regional capacities for the validation of [prescription drugs](#d) and the inspection of the [prescription drug](#d) supply chain.
- (d) **Definition—** In this section, the term “prescription drug” means a [drug](/usc/21/321.md?p=g-1) subject to [section 353(b)(1) of this title](/usc/21/353.md?p=b-1).

## Source credit

(June 25, 1938, ch. 675, § 505D, as added Pub. L. 110–85, title IX, § 913, Sept. 27, 2007, 121 Stat. 952.)