[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9258 Introduced in House (IH)]

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118th CONGRESS
  2d Session
                                H. R. 9258

To amend the Federal Food, Drug, and Cosmetic Act to require pill press 
     molds to bear a unique serial number, to amend the Controlled 
Substances Act to prohibit the knowing possession of a pill press mold 
  with intent to manufacture certain counterfeit substances, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             August 2, 2024

Mr. Harder of California (for himself and Mr. Crenshaw) introduced the 
   following bill; which was referred to the Committee on Energy and 
  Commerce, and in addition to the Committee on the Judiciary, for a 
 period to be subsequently determined by the Speaker, in each case for 
consideration of such provisions as fall within the jurisdiction of the 
                          committee concerned

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to require pill press 
     molds to bear a unique serial number, to amend the Controlled 
Substances Act to prohibit the knowing possession of a pill press mold 
  with intent to manufacture certain counterfeit substances, 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.

    This Act may be cited as the ``Disrupt Fentanyl Pill Production 
Act''.

SEC. 2. FDA REGULATION OF LAWFUL USE OF PILL PRESS MOLDS.

    (a) Prohibited 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.''.
    (b) Requirements.--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:

``SEC. 524C. PILL PRESS MOLDS.

    ``(a) Serial Numbers.--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.
    ``(b) Registration.--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.
    ``(c) Coordination.--The Secretary and the Attorney General shall 
ensure coordination and information-sharing in the regulation of pill 
press molds.
    ``(d) Definition.--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.''.
    (c) Regulations.--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.
    (d) Delayed Applicability.--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.

SEC. 3. UNLAWFUL POSSESSION OF PILL PRESS MOLDS.

    (a) Prohibition.--Section 401 of the Controlled Substances Act (21 
U.S.C. 841) is amended by adding at the end the following:
    ``(i) Offense Regarding Unlawful Possession of Pill Press Molds.--
            ``(1) In general.--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.
            ``(2) Definitions.--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.''.
    (b) Sentencing Guidelines.--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).
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