21 U.S.C.
United States Code, 2010 Edition
Title 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
Sec. 355e - Pharmaceutical security
From the U.S. Government Printing Office, www.gpo.gov

§355e. Pharmaceutical security

(a) In general

The Secretary shall develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.

(b) Standards development

(1) In general

The Secretary shall, in consultation with the agencies specified in paragraph (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.

(2) Standardized numeral identifier

Not later than 30 months after September 27, 2007, the Secretary 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 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.

(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 shall consult with Federal health and security agencies, including—

(A) the Department of Justice;

(B) the Department of Homeland Security;

(C) the Department of Commerce; and

(D) other appropriate Federal and State agencies.

(c) Inspection and enforcement

(1) In general

The Secretary shall expand and enhance the resources and facilities of agency components of the Food and Drug Administration involved with regulatory and criminal enforcement of this chapter to secure the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs including biological products and active pharmaceutical ingredients from domestic and foreign sources.

(2) Activities

The Secretary shall undertake enhanced and joint enforcement activities with other Federal and State agencies, and establish regional capacities for the validation of prescription drugs and the inspection of the prescription drug supply chain.

(d) Definition

In this section, the term “prescription drug” means a drug subject to section 353(b)(1) of this title.

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