---
kind: "section"
citation: "21 U.S.C. § 355e"
title: "21"
title_heading: "Food and Drugs"
number: "355e"
heading: "Pharmaceutical security"
release: "119-102"
date: "2026-07-12"
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, 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](/usc/21/360hh.md?p=3), distributors, pharmacies, and other supply chain stakeholders, prioritize and develop standards for the identification, validation, authentication, and tracking and tracing of [prescription drugs](/usc/21/360eee.md?p=12).
  - (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](/usc/21/360eee.md?p=20) (which, to the extent practicable, shall be harmonized with international consensus standards for such an identifier) to be applied to a [prescription drug](/usc/21/360eee.md?p=12) 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](/usc/21/360eee.md?p=11-A) or pallet level, sufficient to facilitate the identification, validation, authentication, and tracking and tracing of the [prescription drug](/usc/21/360eee.md?p=12).
  - (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](/usc/21/360hh.md?p=4); 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 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, 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](/usc/21/360eee.md?p=12) and the inspection of the [prescription drug](/usc/21/360eee.md?p=12) supply chain.
- (d) **Definition—** In this section, the term “[prescription drug](/usc/21/360eee.md?p=12)” 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.)