S. 3134 — Combating Counterfeit Pharmaceuticals Act of 2025

This section amends the definitions in the Fentanyl Sanctions Act (21 U.S.C. 2302)—which authorizes sanctions against foreign persons who play a significant role in specified drug trafficking—by (1) adding a definition of "copy-cat ingredient" as an ingredient intended to mimic a drug substance in an FDA-approved prescription drug or licensed biological product but manufactured by a different process or with lower purity or quality; (2) adding a definition of "counterfeit drug" as defined in the Federal Food, Drug, and Cosmetic Act; (3) revising "foreign opioid trafficker" to "foreign illicit drug trafficker"; and (4) expanding "opioid trafficking" to "illicit drug trafficking" to include, in addition to synthetic opioids and related precursors, counterfeit drugs and copy-cat ingredients. (Thus, the President's determinations of sanctionable foreign traffickers and related activities may now encompass a broader array of substandard, fake, and synthetic drugs beyond synthetic opioids.)

This section authorizes the Director of National Intelligence to delegate specified identification and briefing duties under the Fentanyl Sanctions Act (i.e., in 21 U.S.C. 2311(d) and (e) regarding foreign drug traffickers and in 21 U.S.C. 2316 regarding implementation briefings). The section further revises the program on use of intelligence resources (21 U.S.C. 2331) by (1) changing the section heading and certain terms from "opioid" or "narcotics" to "illicit drug"; (2) removing the consultation requirement with the Director of National Drug Control Policy in subsection (a)(1); and (3) striking subsections (b) and (c) and redesignating subsection (d) as subsection (b).

This section limits the presidential waiver of sanctions under the Fentanyl Sanctions Act (i.e., sanctions on foreign persons involved in fentanyl trafficking) to protect U.S. persons' access to prescription medications on the current drug shortage list maintained by the Secretary of Health and Human Services (from any prescription medications).

This section makes technical and conforming amendments to the Fentanyl Sanctions Act to broaden its scope from fentanyl and opioids to illicit drugs, including (1) inserting "and other illicit drugs" after "fentanyl" in the definition under section 7202(3); (2) replacing "opioid" with "illicit drug" in the subtitle A heading and section 7211 heading; (3) replacing specified terms throughout, such as "opioid trafficking" with "illicit drug trafficking," "illicit opioids" with "illicit drugs," "foreign opioid traffickers" with "foreign illicit drug traffickers," and "foreign opioid trafficker" with "foreign illicit drug trafficker"; (4) making conforming replacements of "opioids" and "illicit opioids" with "illicit drugs" in sections 7214 and 7217; and (5) updating a cross-reference in section 7233 from "section 7203(8)" to "section 7203(9)." It further amends reporting requirements under the International Narcotics Control Strategy Report (22 U.S.C. 2291h(a)(9)) to authorize a designee of the Director of National Intelligence and replace "illicit opioids" with "illicit drugs."