What does Preamble of Combating Counterfeit Pharmaceuticals Act of 2025 do?

This bill is formally titled 'To amend the Fentanyl Sanctions Act to address trafficking of copy-cat and counterfeit drugs and active pharmaceutical ingredients, and for other purposes.'

What does SHORT TITLE. of Combating Counterfeit Pharmaceuticals Act of 2025 do?

This bill is formally titled Combating Counterfeit Pharmaceuticals Act of 2025.

What does DEFINITIONS. of Combating Counterfeit Pharmaceuticals Act of 2025 do?

This section amends Section 7203 of the Fentanyl Sanctions Act. It redesignates paragraphs (4) through (10) as paragraphs (5) through (11). A new definition of 'copy-cat ingredient' is added, referring to an ingredient intended to mimic a prescription drug component but manufactured differently or with lower purity. The definition of 'counterfeit drug' is adopted from Section 201(g)(2) of the Federal Food, Drug, and Cosmetic Act. Paragraph (6) is redesignated and its heading and text are modified to use 'illicit drug' instead of 'opioid'. Paragraph (9) is redesignated, its heading and text are modified to use 'illicit drug' instead of 'Opioid', and counterfeit drugs and copy-cat ingredients are added to its list.

What does MODIFICATION OF REQUIREMENTS FOR DIRECTOR OF NATIONAL of Combating Counterfeit Pharmaceuticals Act of 2025 do?

This section modifies the Fentanyl Sanctions Act. It allows the Director of National Intelligence to delegate authority in sections 7211 and 7216. Section 7231 of the Fentanyl Sanctions Act is amended to change the program title from 'Opioid' to 'Illicit Drug'. Subsection (a) of section 7231 is revised to remove consultation requirements and modify language. Subsections (b) and (c) of section 7231 are struck, and subsection (d) is redesignated as (b).

What does WAIVER FOR ACCESS TO PRESCRIPTION MEDICATIONS. of Combating Counterfeit Pharmaceuticals Act of 2025 do?

This section amends Section 7214(b)(1)(B) of the Fentanyl Sanctions Act. The amendment inserts language referencing the drug shortage list maintained by the Secretary of Health and Human Services. This list is under section 506E of the Federal Food, Drug, and Cosmetic Act.

What does TECHNICAL AND CONFORMING AMENDMENTS. of Combating Counterfeit Pharmaceuticals Act of 2025 do?

This section amends the Fentanyl Sanctions Act to replace references to 'fentanyl' and 'opioids' with 'illicit drugs'. The subtitle heading for subtitle A of the Fentanyl Sanctions Act is changed from 'Opioid' to 'Illicit Drug'. Section 7211 of the Fentanyl Sanctions Act has its heading updated to reflect 'illicit drug' instead of 'opioid'. Various subsections within Section 7214 of the Fentanyl Sanctions Act are modified to substitute 'illicit opioids' with 'illicit drugs'. Section 7217(a) of the Fentanyl Sanctions Act is amended to replace 'illicit opioids' with 'illicit drugs'. Section 7233 of the Fentanyl Sanctions Act is amended to change a reference from 'section 7203(8)' to 'section 7203(9)'. Throughout the Fentanyl Sanctions Act, 'opioid trafficking' is replaced with 'illicit drug trafficking', and 'foreign opioid traffickers' and 'foreign opioid trafficker' are replaced with 'foreign illicit drug traffickers' and 'foreign illicit drug trafficker', respectively. Section 489(a)(9) of the Foreign Assistance Act of 1961 is amended to include '(or a designee of the Director)' after 'Director of National Intelligence'. The Foreign Assistance Act of 1961 is also amended to replace 'illicit opioids' with 'illicit drugs'.

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Combating Counterfeit Pharmaceuticals Act of 2025

Last updated: 11/6/2025 · Introduced: 11/6/2025

Author: Tom Cotton (R-AR)

TL;DR (AI)

This bill expands the Fentanyl Sanctions Act to address the trafficking of counterfeit drugs and copy-cat ingredients, defining these terms within the Act.
The Director of National Intelligence is now authorized to delegate authority and the program title related to illicit drug activities is updated throughout the Fentanyl Sanctions Act.
When granting waivers for access to prescription medications, the Act now considers the drug shortage list maintained by the Secretary of Health and Human Services.

119th Congressin committeeOfficial page

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Includes provisions on preamble, short title., and 4 more.

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