Disrupt Fentanyl Pill Production Act

Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:

(jjj) The intentional introduction or delivery for introduction into interstate commerce of a drug that was manufactured using a pill press mold in violation of section 524C.

Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the end the following:

The Secretary shall require each pill press mold that is used to manufacture a drug intended for introduction into interstate commerce to bear a unique serial number.

The Secretary shall require each manufacturer that uses a pill press mold to manufacture drugs intended for introduction into interstate commerce—

(1) to register with the Food and Drug Administration; and

(2) to include in such registration—

(A) the serial number required under subsection (a) for each pill press mold so used; and

(B) such other information regarding such pill press molds as the Secretary may require.

The Secretary and the Attorney General shall ensure coordination and information-sharing in the regulation of pill press molds.

In this section and section 301(jjj), the term pill press mold means any punch, die, plate, stone, or other object designed to print, imprint, or reproduce on a drug (or the container or labeling thereof) the trademark, trade name, or other identifying mark, imprint, number, or device, or any likeness thereof, of a manufacturer, distributor, or dispenser other than the person or persons who in fact manufactured, distributed, or dispensed such product.

Not later than1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall promulgate a final regulation to carry out sections 301(jjj) and 524C of the Federal Food, Drug, and Cosmetic Act, as added by this section.

Sections 301(jjj) and 524C of the Federal Food, Drug, and Cosmetic Act, as added by this section, apply beginning on the date that is 2 years after the date on which the final regulation required by subsection (c) is promulgated.

Section 401 of the Controlled Substances Act (21 U.S.C. 841) is amended by adding at the end the following:

Whoever, with intent to manufacture in violation of this title a counterfeit substance in schedule I or II in a capsule, tablet, or other form for distribution, knowingly possesses a pill press mold, shall be imprisoned not more than 20 years and fined in accordance with title 18, United States Code.

In this subsection, the term pill press mold means any punch, die, plate, stone, or other object designed to print, imprint, or reproduce on a controlled substance (or the container or labeling thereof) the trademark, trade name, or other identifying mark, imprint, number, or device, or any likeness thereof, of a manufacturer, distributor, or dispenser other than the person or persons who in fact manufactured, distributed, or dispensed such product, thereby rendering it a counterfeit substance.

Pursuant to its authority under section 994 of title 28, United States Code, and in accordance with this section, the United States Sentencing Commission shall review and amend, as appropriate, the Federal sentencing guidelines and policy statements to ensure that the guidelines provide for a penalty enhancement of not less than 2 offense levels above the offense level otherwise applicable for a violation of section 401(a) of the Controlled Substances Act (21 U.S.C. 841(a)) if the defendant is found, in connection with such violation of section 401(a), to be in violation of section 401(i) of the Controlled Substances Act, as added by subsection (a).