I 
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 Sub-
stances 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 Com-
merce, and in addition to the Committee on the Judiciary, for a period 
to be subsequently determined by the Speaker, in each case for consider-
ation 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 Representa-
tives of the United States of America in Congress assembled, 
VerDate Sep 11 2014 
03:46 Sep 05, 2024
Jkt 049200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H9258.IH
H9258
kjohnson on DSK7ZCZBW3PROD with $$_JOB
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Disrupt Fentanyl Pill 
Production Act’’. 
SEC. 2. FDA REGULATION OF LAWFUL USE OF PILL PRESS 
MOLDS. 
(a) PROHIBITED ACT.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
‘‘(jjj) The intentional introduction or delivery for in-
troduction into interstate commerce of a drug that was 
manufactured using a pill press mold in violation of sec-
tion 524C.’’. 
(b) REQUIREMENTS.—Subchapter A of chapter V of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
et seq.) is amended by adding at the end the following: 
‘‘SEC. 524C. PILL PRESS MOLDS. 
‘‘(a) SERIAL NUMBERS.—The Secretary shall require 
each pill press mold that is used to manufacture a drug 
intended for introduction into interstate commerce to bear 
a unique serial number. 
‘‘(b) REGISTRATION.—The Secretary shall require 
each manufacturer that uses a pill press mold to manufac-
ture drugs intended for introduction into interstate com-
merce— 
‘‘(1) to register with the Food and Drug Ad-
ministration; and 
VerDate Sep 11 2014 
03:46 Sep 05, 2024
Jkt 049200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H9258.IH
H9258
kjohnson on DSK7ZCZBW3PROD with $$_JOB
‘‘(2) to include in such registration— 
‘‘(A) the serial number required under sub-
section (a) for each pill press mold so used; and 
‘‘(B) such other information regarding 
such pill press molds as the Secretary may re-
quire. 
‘‘(c) COORDINATION.—The Secretary and the Attor-
ney 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, im-
print, number, or device, or any likeness thereof, of a man-
ufacturer, distributor, or dispenser other than the person 
or persons who in fact manufactured, distributed, or dis-
pensed 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. 
VerDate Sep 11 2014 
03:46 Sep 05, 2024
Jkt 049200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H9258.IH
H9258
kjohnson on DSK7ZCZBW3PROD with $$_JOB
(d) DELAYED APPLICABILITY.—Sections 301(jjj) and 
524C of the Federal Food, Drug, and Cosmetic Act, as 
added by this section, apply beginning on the date that 
is 2 years after the date on which the final regulation re-
quired by subsection (c) is promulgated. 
SEC. 3. UNLAWFUL POSSESSION OF PILL PRESS MOLDS. 
(a) PROHIBITION.—Section 401 of the Controlled 
Substances Act (21 U.S.C. 841) is amended by adding at 
the end the following: 
‘‘(i) OFFENSE REGARDING UNLAWFUL POSSESSION 
OF PILL PRESS MOLDS.— 
‘‘(1) IN
GENERAL.—Whoever, with intent to 
manufacture in violation of this title a counterfeit 
substance in schedule I or II in a capsule, tablet, or 
other form for distribution, knowingly possesses a 
pill press mold, shall be imprisoned not more than 
20 years and fined in accordance with title 18, 
United States Code. 
‘‘(2) DEFINITIONS.—In this subsection, the 
term ‘pill press mold’ means any punch, die, plate, 
stone, or other object designed to print, imprint, or 
reproduce on a controlled substance (or the con-
tainer or labeling thereof) the trademark, trade 
name, or other identifying mark, imprint, number, 
or device, or any likeness thereof, of a manufacturer, 
VerDate Sep 11 2014 
03:46 Sep 05, 2024
Jkt 049200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H9258.IH
H9258
kjohnson on DSK7ZCZBW3PROD with $$_JOB
distributor, or dispenser other than the person or 
persons who in fact manufactured, distributed, or 
dispensed such product, thereby rendering it a coun-
terfeit substance.’’. 
(b) SENTENCING GUIDELINES.—Pursuant to its au-
thority 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 appro-
priate, the Federal sentencing guidelines and policy state-
ments 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 sub-
section (a). 
Æ 
VerDate Sep 11 2014 
03:46 Sep 05, 2024
Jkt 049200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6301
E:\BILLS\H9258.IH
H9258
kjohnson on DSK7ZCZBW3PROD with $$_JOB