[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.
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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
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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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