§ 355e. Pharmaceutical security

382 words·~2 min read·/usc/title-21/section-355e

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(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.)

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Public Law 110–85
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes

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U.S. Code

Exemptions and consideration for certain drugs, devices, and biological products
§ 353

3 references not yet in our index

June 25, 1938, ch. 675, § 505D
Pub. L. 110–85, title IX, § 913
121 Stat. 952

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§ 355e

Pharmaceutical security

Fed. Reg.×7

Stat.×1

U.S.C.§ 353

ActJune 25, 1938, ch. 675, § 505D

Pub. L.Pub. L. 110–85, title IX, § 913

Stat.121 Stat. 952

Cites 4Cited by 8 across 2 sources