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 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
2 

•HR 9258 IH

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Disrupt Fentanyl Pill 

3 Production Act’’. 

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

5 MOLDS. 

6 (a) PROHIBITED ACT.—Section 301 of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend8 ed by adding at the end the following: 

9 ‘‘(jjj) The intentional introduction or delivery for in10 troduction into interstate commerce of a drug that was 

11 manufactured using a pill press mold in violation of sec12 tion 524C.’’. 

13 (b) REQUIREMENTS.—Subchapter A of chapter V of 

14 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 

15 et seq.) is amended by adding at the end the following: 

16 ‘‘SEC. 524C. PILL PRESS MOLDS. 

17 ‘‘(a) SERIAL NUMBERS.—The Secretary shall require 

18 each pill press mold that is used to manufacture a drug 

19 intended for introduction into interstate commerce to bear 

20 a unique serial number. 

21 ‘‘(b) REGISTRATION.—The Secretary shall require 

22 each manufacturer that uses a pill press mold to manufac23 ture drugs intended for introduction into interstate com24 merce— 

25 ‘‘(1) to register with the Food and Drug Ad26 ministration; and 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
3 

•HR 9258 IH

1 ‘‘(2) to include in such registration— 

2 ‘‘(A) the serial number required under sub3 section (a) for each pill press mold so used; and 

4 ‘‘(B) such other information regarding 

5 such pill press molds as the Secretary may re6 quire. 

7 ‘‘(c) COORDINATION.—The Secretary and the Attor8 ney General shall ensure coordination and information9 sharing in the regulation of pill press molds. 

10 ‘‘(d) DEFINITION.—In this section and section 

11 301(jjj), the term ‘pill press mold’ means any punch, die, 

12 plate, stone, or other object designed to print, imprint, or 

13 reproduce on a drug (or the container or labeling thereof) 

14 the trademark, trade name, or other identifying mark, im15 print, number, or device, or any likeness thereof, of a man16 ufacturer, distributor, or dispenser other than the person 

17 or persons who in fact manufactured, distributed, or dis18 pensed such product.’’. 

19 (c) REGULATIONS.—Not later than1 year after the 

20 date of enactment of this Act, the Secretary of Health and 

21 Human Services, acting through the Commissioner of 

22 Food and Drugs, shall promulgate a final regulation to 

23 carry out sections 301(jjj) and 524C of the Federal Food, 

24 Drug, and Cosmetic Act, as added by this section. 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
4 

•HR 9258 IH

1 (d) DELAYED APPLICABILITY.—Sections 301(jjj) and 

2 524C of the Federal Food, Drug, and Cosmetic Act, as 

3 added by this section, apply beginning on the date that 

4 is 2 years after the date on which the final regulation re5 quired by subsection (c) is promulgated. 

6 SEC. 3. UNLAWFUL POSSESSION OF PILL PRESS MOLDS. 

7 (a) PROHIBITION.—Section 401 of the Controlled 

8 Substances Act (21 U.S.C. 841) is amended by adding at 

9 the end the following: 

10 ‘‘(i) OFFENSE REGARDING UNLAWFUL POSSESSION

11 OF PILL PRESS MOLDS.— 

12 ‘‘(1) IN GENERAL.—Whoever, with intent to 

13 manufacture in violation of this title a counterfeit 

14 substance in schedule I or II in a capsule, tablet, or 

15 other form for distribution, knowingly possesses a 

16 pill press mold, shall be imprisoned not more than 

17 20 years and fined in accordance with title 18, 

18 United States Code. 

19 ‘‘(2) DEFINITIONS.—In this subsection, the 

20 term ‘pill press mold’ means any punch, die, plate, 

21 stone, or other object designed to print, imprint, or 

22 reproduce on a controlled substance (or the con23 tainer or labeling thereof) the trademark, trade 

24 name, or other identifying mark, imprint, number, 

25 or device, or any likeness thereof, of a manufacturer, 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
5 

•HR 9258 IH

1 distributor, or dispenser other than the person or 

2 persons who in fact manufactured, distributed, or 

3 dispensed such product, thereby rendering it a coun4 terfeit substance.’’. 

5 (b) SENTENCING GUIDELINES.—Pursuant to its au6 thority under section 994 of title 28, United States Code, 

7 and in accordance with this section, the United States 

8 Sentencing Commission shall review and amend, as appro9 priate, the Federal sentencing guidelines and policy state10 ments to ensure that the guidelines provide for a penalty 

11 enhancement of not less than 2 offense levels above the 

12 offense level otherwise applicable for a violation of section 

13 401(a) of the Controlled Substances Act (21 U.S.C. 

14 841(a)) if the defendant is found, in connection with such 

15 violation of section 401(a), to be in violation of section 

16 401(i) of the Controlled Substances Act, as added by sub17 section (a). 

Æ 


kjohnson on DSK7ZCZBW3PROD with $$_JOB