To amend the Controlled Substances Act to prevent the misuse of a tableting machine, encapsulating machine, or critical part of a tableting and encapsulating machine for the illicit manufacture of a controlled substance or listed chemical, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. Short title.

SEC. 2. Regulation of certain machines.

(a) Definitions.—Section 102 of the Controlled Substances Act (21 U.S.C. 802) is amended—

(1) by striking paragraph (38) and inserting the following:

“(38) The term ‘regulated person’ means a person who—

“(A) manufactures, distributes, imports, or exports a listed chemical;

“(B) manufactures, distributes, delivers, sells, imports, or exports a tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine; or

“(C) acts as a broker or trader for a regulated transaction involving a listed chemical, tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine.”;

(2) by striking paragraph (39)(B) and inserting the following:

“(B) a distribution, delivery, sale, importation, exportation, or international transaction of a tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine.”;

(3) in paragraph (42), by inserting “, tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine” after “listed chemical”;

(4) in paragraph (43), in the matter preceding subparagraph (A)—

(A) by striking “an international” and inserting “a regulated”; and

(B) by inserting “, tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine” after “listed chemical”; and

(5) by adding at the end the following:

“(61) The term ‘critical part’, when used in reference to a tableting or encapsulating machine, means any of the following integral parts of a tableting or encapsulating machine:

“(A) An upper punch.

“(B) A lower punch.

“(C) A die.

“(D) Any additional parts that the Attorney General has determined to be integral to the operation of a tableting or encapsulating machine, provided that such determination—

“(i) is made through rulemaking; and

“(ii) does not go into effect until the rulemaking process has been completed.

“(62) The term ‘die’ means a tool that serves as the mold in which a product is compressed to form the desired size and shape of a tablet or capsule.

“(63) The term ‘lower punch’ means the punch inserted into the turret below the die.

“(64) The term ‘punch’ means a rod-shaped tool used in producing tablets and other products.

“(65) The term ‘upper punch’ means the punch inserted into the turret above the die.”.

(b) Regulation.—

(1) RECORDS OF REGULATED TRANSACTIONS.—Section 310(a) of the Controlled Substances Act (21 U.S.C. 830(a)) is amended—

(A) in paragraph (1), by striking “or an encapsulating machine” and inserting “, encapsulating machine, or critical part of a tableting or encapsulating machine”; and

(B) in paragraph (2)—

(i) by striking “or encapsulating machine” and inserting “, encapsulating machine, or critical part of a tableting or encapsulating machine”; and

(ii) by inserting before the period at the end the following: “and shall identify the tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine by means of a serial number that is engraved, cast, or otherwise permanently affixed to a nonremovable part of the tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine”.

(2) REPORTS TO ATTORNEY GENERAL.—Section 310(b)(1) of the Controlled Substances Act (21 U.S.C. 830(b)(1)) is amended by striking subparagraph (D) and inserting the following:

“(D) any regulated transaction in a tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine, including the serial number affixed to the tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine.”.

(3) REGULATIONS.—

(A) IN GENERAL.—Not later than 180 days after the date of enactment of this Act, the Attorney General shall promulgate regulations carrying out the amendments made by paragraphs (1) and (2).

(B) INCLUSION.—The regulations required under subparagraph (A) shall include requirements regarding serial numbers affixed to tableting machines, encapsulating machines, or critical parts of tableting or encapsulating machines manufactured on or before the date of enactment of this Act.

(4) APPLICABILITY.—

(A) IN GENERAL.—Except as specified in subparagraph (B), the amendments made by paragraphs (1) and (2) shall apply only to any tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine manufactured, distributed, delivered, sold, imported, exported, or included in an international transaction after the effective date of the regulations promulgated under paragraph (3).

(B) EXCEPTION.—Beginning on the date that is 180 days after the date of the enactment of this Act, the amendments made by paragraph (1) of this subsection to paragraphs (1) and (2) of section 310(a) of the Controlled Substances Act (21 U.S.C. 830(a)) shall apply with respect to a tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine manufactured on or before the date of enactment of this Act.

(c) Prohibited acts.—Section 403(a) of the Controlled Substances Act (21 U.S.C. 843(a)) is amended—

(1) in paragraph (8), by striking “or” at the end;

(2) in paragraph (9), by striking the period at the end and inserting a semicolon; and

(3) by adding at the end the following:

“(10) to remove, alter, or obliterate any serial number affixed to a tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine, that is required to have a serial number and with reasonable cause to believe the serial number is so required; or

“(11) to transport, ship, receive, possess, distribute, deliver, sell, import, or export a tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine that is required to have a serial number, knowing that the serial number has been removed, altered, or obliterated, and with reasonable cause to believe the serial number is so required.”.

SEC. 3. Providing for extraterritorial jurisdiction.

(a) Possession, manufacture, or distribution for purposes of unlawful importation.—Section 1009 of the Controlled Substances Act (21 U.S.C. 959) is amended—

(1) by redesignating subsections (c) and (d) as subsections (d) and (e), respectively;

(2) by inserting after subsection (b) the following:

“(c) It shall be unlawful for any person to manufacture or distribute a tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine—

“(1) intending or knowing that the tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine will be used to illicitly manufacture a controlled substance or listed chemical; and

“(2) intending, knowing, or having reasonable cause to believe that the tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine will be unlawfully imported into the United States.”; and

(3) in subsection (d), as so redesignated—

(A) in paragraph (1), by striking “or” at the end;

(B) in paragraph (2), by striking the period at the end and inserting “; or”; and

(C) by adding at the end the following:

“(3) manufacture or distribute a tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine—

“(A) intending or knowing that the tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine will be used to illicitly manufacture a controlled substance or listed chemical; and

“(B) intending, knowing, or having reasonable cause to believe that the tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine will be unlawfully imported into the United States.”.

(b) Prohibited acts.—Section 1010 of the Controlled Substances Act (21 U.S.C. 960) is amended—

(1) in subsection (d)—

(A) in paragraph (6), by striking “or” at the end;

(B) in paragraph (7)—

(i) by striking “section 959 of this title” and inserting “section 1009”; and

(ii) by striking the period at the end and inserting “; or”;

(C) by inserting after paragraph (7) the following:

“(8) manufactures or distributes a tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine in violation of section 1009,”; and

(D) in the matter following paragraph (8), as so inserted, by striking “shall be fined” and all that follows through “or both” and inserting the following: “shall be fined in accordance with title 18, United States Code, imprisoned for the applicable period described in subsection (e), or both”; and

(2) by adding at the end the following:

“(e) The applicable period described in this subsection is the following:

“(1) In the case of a violation of paragraph (1) or (3) of subsection (d) involving a list I chemical, not more than 20 years.

“(2) Subject to paragraph (4), in the case of a violation of paragraph (7) of subsection (d), not more than 10 years.

“(3) Subject to paragraph (4), in the case of a violation of paragraph (8) of subsection (d), not more than 8 years.

“(4) In the case of a violation of paragraph (7) or (8) of subsection (d) that involves more than 1,000 kilograms of a chemical or product or more than 100 machines that are tableting machines or encapsulating machines, not more than 15 years.

“(5) In the case of any other violation of subsection (d), not more than 10 years.”.

(c) United States Sentencing Commission.—Pursuant to its authority under section 994(p) of title 28, United States Code, the United States Sentencing Commission shall review and amend the Federal sentencing guidelines and policy statements of the Commission in accordance with this Act and the amendments made by this Act.

SEC. 4. Counterfeit pills containing an illicit synthetic substance.

(a) Definition.—In this Act, the term “counterfeit pill containing an illicit synthetic substance” means a substance in pill or tablet form that—

(1) is a counterfeit substance, as defined in section 102(7) of the Controlled Substances Act (21 U.S.C. 802(7)); and

(2) contains fentanyl, an analogue of fentanyl, a fentanyl-related substance, methamphetamine, an illicit depressant or stimulant substance, an illicit narcotic, or an illicit synthetic opioid.

(b) Prohibited acts.—Section 403(d)(2) of the Controlled Substances Act (21 U.S.C. 843(d)(2)) is amended, in the matter preceding subparagraph (A), by inserting “, fentanyl, an analogue of fentanyl, or a fentanyl-related substance” after “methamphetamine”.

(c) Comprehensive plan.—

(1) IN GENERAL.—Not later than 180 days after the date of enactment of this Act, the Administrator of the Drug Enforcement Administration shall establish and implement an operation and response plan to address counterfeit pills containing an illicit synthetic substance.

(2) CONTENTS.—The plan required under paragraph (1) shall include—

(A) strategies to enable and empower Federal law enforcement efforts to investigate and seize counterfeit pills containing an illicit synthetic substance;

(B) specific ways that education and prevention efforts to stop the use of counterfeit pills containing an illicit synthetic substance will be increased, including—

(i) how ongoing efforts, such as Operation Engage, are effective in increasing education and prevention; and

(ii) how such ongoing efforts are tailored to youth and teen access; and

(C) an audit of current campaigns on counterfeit pills containing an illicit synthetic substance, including a review of data and other available information on how the campaigns can be tailored, adjusted, or improved to better address the flow of such counterfeit pills.

(3) REPORT TO CONGRESS.—

(A) REPORT.—Not later than 1 year after the date of enactment of this Act, and every year thereafter through fiscal year 2031, the Attorney General, in consultation with the Administrator of the Drug Enforcement Administration and the Director of the Office of National Drug Control Policy, shall submit to Congress a report containing information regarding the collection of counterfeit pills containing an illicit synthetic substance and prosecutions undertaken in connection with such counterfeit pills.

(B) CONTENTS.—The report required under subparagraph (A) shall include the following:

(i) Data on the aggregate number of counterfeit pills containing an illicit synthetic substance that have been seized and collected by Federal law enforcement agencies.

(ii) A description of pharmaceutical markings used for counterfeit pills containing an illicit synthetic substance, including how the markings compare to required labeling for products approved by the Food and Drug Administration.

(iii) A breakdown of which illicit substances are present in counterfeit pills containing an illicit synthetic substance.

(iv) Data outlining the geographic origin and points of seizure of counterfeit pills containing an illicit synthetic substance.

(v) Data on the charges filed pursuant to paragraph (1) or (2) of section 401(a) of the Controlled Substances Act (21 U.S.C. 841(a)) in relation to counterfeit pills containing an illicit synthetic substance, unless disclosure of the data would—

(I) require unsealing an indictment; or

(II) undermine investigations and charges brought by the Department of Justice.

(vi) Data on the convictions and sentences against those who are found guilty under paragraph (1) or (2) of section 401(a) of the Controlled Substances Act (21 U.S.C. 841(a)) as it pertains to counterfeit pills containing an illicit synthetic substance.

(vii) Any prevention measures that the Department of Justice, the Drug Enforcement Administration, or the Office of National Drug Control Policy are undertaking to limit and reduce the spread of counterfeit pills containing an illicit synthetic substance, including ongoing public awareness campaigns.

Passed the House of Representatives September 15, 2026.

Clerk.