I 119THCONGRESS 1 STSESSION H. R. 1100 To amend the Controlled Substances Act to provide for the regulation of critical parts of tableting machines and encapsulating machines, and for other purposes. IN THE HOUSE OF REPRESENTATIVES FEBRUARY6, 2025 Ms. S TANSBURY(for herself, Mr. GRIJALVA, Ms. PETTERSEN, Ms. SALINAS, and Mr. H ORSFORD) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Com- mittee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall with- in the jurisdiction of the committee concerned A BILL To amend the Controlled Substances Act to provide for the regulation of critical parts of tableting machines and encapsulating machines, and for other purposes. Be it enacted by the Senate and House of Representa-1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Stop the Opioid Pill 4 Presser and Fentanyl Act’’ or the ‘‘STOPP Act’’. 5 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 2 •HR 1100 IH SEC. 2. DEFINITIONS. 1 Section 102 of the Controlled Substances Act (21 2 U.S.C. 802) is amended— 3 (1) in paragraph (38), by striking ‘‘or an en-4 capsulating machine’’ and inserting ‘‘an encap-5 sulating machine, a critical part of a tableting ma-6 chine, or a critical part of an encapsulating ma-7 chine’’; 8 (2) in paragraph (39)(B)— 9 (A) by striking ‘‘distribution, importation, 10 or exportation of’’ and inserting ‘‘distribution, 11 receipt, sale, importation, or exportation of, or 12 an international transaction involving shipment 13 of’’; and 14 (B) by striking ‘‘or encapsulating ma-15 chine’’ and inserting ‘‘, encapsulating machine, 16 critical part of a tableting machine, or critical 17 part of an encapsulating machine’’; 18 (3) in paragraph (42), by striking ‘‘a listed 19 chemical’’ and inserting ‘‘a listed chemical, a 20 tableting machine, an encapsulating machine, a crit-21 ical part of a tableting machine, or a critical part of 22 an encapsulating machine’’; 23 (4) in paragraph (43), by striking ‘‘a listed 24 chemical’’ and inserting ‘‘a listed chemical, a 25 tableting machine, an encapsulating machine, a crit-26 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 3 •HR 1100 IH ical part of a tableting machine, or a critical part of 1 an encapsulating machine’’; and 2 (5) by adding at the end the following: 3 ‘‘(60) The term ‘critical part’, when used in reference 4 to a tableting machine or encapsulating machine, means 5 any of the following integral parts when designed pri-6 marily for use in a tableting or encapsulating machine: 7 ‘‘(A) Press punch. 8 ‘‘(B) Die system. 9 ‘‘(C) Press turret. 10 ‘‘(D) Hopper. 11 ‘‘(E) Compression roller. 12 ‘‘(F) Discharge chute. 13 ‘‘(G) Vacuum system. 14 ‘‘(H) Capsule feeding unit. 15 ‘‘(I) Automatic feeding unit. 16 ‘‘(J) Any other item identified in a regulation 17 published by the Attorney General used in the oper-18 ating of tableting or encapsulating machines.’’. 19 SEC. 3. REGULATED TRANSACTIONS OF CRITICAL PARTS. 20 (a) R ECORD OFREGULATEDTRANSACTIONS.—Sec-21 tion 310 of the Controlled Substances Act (21 U.S.C. 830) 22 is amended— 23 (1) in subsection (a)(1)— 24 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 4 •HR 1100 IH (A) by striking ‘‘or an encapsulating ma-1 chine’’ and inserting ‘‘an encapsulating ma-2 chine, a critical part of a tableting machine, or 3 a critical part of an encapsulating machine’’; 4 and 5 (B) by inserting ‘‘, in such form and man-6 ner as the Attorney General shall prescribe by 7 regulation,’’ after ‘‘record of the transaction’’; 8 and 9 (2) in paragraph (a)(2), by striking ‘‘or encap-10 sulating machine’’ and inserting ‘‘, encapsulating 11 machine, critical part of a tableting machine, or crit-12 ical part of an encapsulating machine’’. 13 (b) R EPORTS TOATTORNEYGENERAL ANDRECORD-14 KEEPING.—Section 310(b)(1) of the Controlled Sub-15 stances Act (21 U.S.C. 830) is amended— 16 (1) in subparagraph (A)— 17 (A) by striking ‘‘payment or delivery’’ and 18 inserting ‘‘payment or delivery of a listed chem-19 ical, tableting machine, encapsulating machine, 20 a critical part of a tableting machine, or a crit-21 ical part of an encapsulating machine’’; and 22 (B) by striking ‘‘any other circumstance 23 that the regulated person believes may indicate 24 that the listed chemical’’ and inserting ‘‘any 25 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 5 •HR 1100 IH other circumstance that the regulated person 1 believes may indicate that the listed chemical, 2 tableting machine, encapsulating machine, crit-3 ical part of a tableting machine, or critical part 4 of an encapsulating machine’’; 5 (2) in subparagraph (C), by striking ‘‘listed 6 chemical’’ and inserting ‘‘listed chemical, tableting 7 machine, encapsulating machine, critical part of a 8 tableting machine, or critical part of an encap-9 sulating machine’’; and 10 (3) in subparagraph (D), by striking ‘‘or an en-11 capsulating machine’’ and inserting ‘‘, an encap-12 sulating machine, critical part of a tableting ma-13 chine, or critical part of an encapsulating machine’’. 14 (c) E FFECTIVEDATE.—The amendments made by 15 this section shall apply beginning on the date that is 120 16 days after the date of enactment of this Act, except that 17 the Attorney General may, by order published in the Fed-18 eral Register, postpone such date of application for such 19 period as the Attorney General may determine to be nec-20 essary for the efficient administration of the Controlled 21 Substances Act (21 U.S.C. 801 et seq.). 22 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 6 •HR 1100 IH SEC. 4. SERIALIZATION OF CERTAIN MACHINES AND 1 PARTS. 2 The Controlled Substances Act (21 U.S.C. 801 et 3 seq.) is amended by inserting after section 310 (21 U.S.C. 4 830) the following: 5 ‘‘SEC. 310A SERIALIZATION OF CERTAIN MACHINES AND 6 PARTS. 7 ‘‘(a) S ERIALNUMBER.—Each manufacturer, dis-8 tributor, importer, or exporter of a tableting machine, en-9 capsulating machine, a critical part of a tableting ma-10 chine, or a critical part of an encapsulating machine shall, 11 when and as required by regulation of the Attorney Gen-12 eral, identify the tableting machine, encapsulating ma-13 chine, critical part of a tableting machine, or critical part 14 of an encapsulating machine by a serial number which 15 shall be engraved, cast, or otherwise permanently affixed 16 to a non-removable part of the tableting machine, encap-17 sulating machine, critical part of a tableting machine, or 18 critical part of an encapsulating machine in accordance 19 with such regulations. 20 ‘‘(b) R EPORTING.—Any regulated person who manu-21 factures, distributes, receives, sells, imports, or exports a 22 tableting machine, encapsulating machine, critical part of 23 a tableting machine, or critical part of an encapsulating 24 machine that is subject to the serialization requirement 25 set forth in subsection (a), shall report the transaction to 26 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 7 •HR 1100 IH the Attorney General and maintain records of such trans-1 action, in such form and manner as the Attorney General 2 shall prescribe by regulation.’’. 3 SEC. 5. REGISTRATION OF CERTAIN MACHINES AND PARTS. 4 The Controlled Substances Act (21 U.S.C. 801 et 5 seq.), as amended by section 4, is further amended by in-6 serting after section 310A the following: 7 ‘‘SEC. 310B. REGISTRATION OF CERTAIN MACHINES AND 8 PARTS. 9 ‘‘(a) R EGISTRATION OF CERTAINMACHINES AND 10 P ARTS.—Each manufacturer, distributor, importer, or ex-11 porter of a tableting machine, encapsulating machine, crit-12 ical part of a tableting machine, or critical part of an en-13 capsulating machine shall, when and as required by regu-14 lation of the Attorney General, register the tableting ma-15 chine, encapsulating machine, critical part of a tableting 16 machine, or critical part of an encapsulating machine with 17 the Attorney General in accordance with such regulation. 18 ‘‘(b) R EPORTING.—Any regulated person who manu-19 factures, distributes, receives, sells, imports, exports, or 20 destroys a tableting machine, encapsulating machine, crit-21 ical part of a tableting machine, or critical part of an en-22 capsulating machine that is required to be registered pur-23 suant to subsection (a), shall report that act to the Attor-24 ney General and maintain records of such act as required 25 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 8 •HR 1100 IH in section 310, in such form and manner as the Attorney 1 General shall prescribe by regulation. 2 ‘‘(c) R EGULATIONS.—The Attorney General is au-3 thorized to promulgate rules and regulations relating to 4 tableting machines and encapsulating machines. The At-5 torney General shall by regulation establish which 6 tableting machines, encapsulating machines, critical parts 7 of tableting machines, and critical parts of encapsulating 8 machines are subject to the registration and reporting re-9 quirements of subsections (a) and (b) and the information 10 to be provided pursuant to subsections (a) and (b), which 11 shall include the location of the tableting machine, encap-12 sulating machine, critical part of a tableting machine, or 13 critical part of an encapsulating machine. 14 ‘‘(d) N ATIONALPILLPRESSREGISTRY.—The Attor-15 ney General shall maintain a central registry of all 16 tableting machines, encapsulating machines, critical parts 17 of a tableting machine, or critical parts of an encap-18 sulating machine that are subject to the registration re-19 quirement set forth in subsection (a), which shall be 20 known and referred to as the National Pill Press Registry. 21 ‘‘(e) D EFINITIONS.—For the purposes of this section: 22 ‘‘(1) M ANUFACTURE.—The term ‘manufacture’ 23 means the production or assembly of a tableting ma-24 chine, encapsulating machine, critical part of a 25 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 9 •HR 1100 IH tableting machine, or critical part of an encap-1 sulating machine. 2 ‘‘(2) D ISTRIBUTE.—The term ‘distribute’ 3 means to deliver a tableting machine, encapsulating 4 machine, critical part of a tableting machine, or crit-5 ical part of an encapsulating machine. 6 ‘‘(3) D ELIVER.—The term ‘deliver’ means the 7 actual, constructive, or attempted transfer of a 8 tableting machine, encapsulating machine, critical 9 part of a tableting machine, or critical part of an en-10 capsulating machine, whether or not there exists an 11 agency relationship. 12 ‘‘(4) D ESTROY.—The term ‘destroy’ means to 13 cause such serious damage to a tableting machine, 14 encapsulating machine, critical part of a tableting 15 machine, or critical part of an encapsulating ma-16 chine so that it can no longer be used for its in-17 tended purpose.’’. 18 SEC. 6. REGISTRATION OF MANUFACTURERS, IMPORTERS, 19 EXPORTERS, AND DEALERS OF TABLETING 20 MACHINES, ENCAPSULATING MACHINES, AND 21 CRITICAL PARTS. 22 The Controlled Substances Act (21 U.S.C. 801 et 23 seq.), as amended by sections 4 and 5, is further amended 24 by inserting after section 310B the following: 25 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 10 •HR 1100 IH ‘‘SEC. 310C. REGISTRATION OF MANUFACTURERS, IMPORT-1 ERS, EXPORTERS, AND DEALERS OF 2 TABLETING MACHINES, ENCAPSULATING MA-3 CHINES, AND CRITICAL PARTS. 4 ‘‘(a) R EGISTRATION.— 5 ‘‘(1) I N GENERAL.—Every person who manu-6 factures, imports, exports, or deals, or proposes to 7 engage in the manufacture, importation, exportation, 8 or dealing of any tableting machine, encapsulating 9 machine, critical part of a tableting machine, or crit-10 ical part of an encapsulating machine, shall obtain, 11 on an annual basis, a registration issued by the At-12 torney General. 13 ‘‘(2) W AIVER.—The Attorney General may, by 14 regulation, waive the requirement for registration of 15 certain manufacturers, importers, exporters, and dis-16 tributors of any tableting machine, encapsulating 17 machine, critical part of a tableting machine, or crit-18 ical part of an encapsulating machine if the Attor-19 ney General finds that issuing such a waiver would 20 be consistent with public health and safety. 21 ‘‘(3) S EPARATE REGISTRATIONS REQUIRED .—A 22 separate registration shall be required for each prin-23 cipal place of business where the applicant manufac-24 tures, imports, exports, or deals a tableting machine, 25 encapsulating machine, critical part of a tableting 26 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 11 •HR 1100 IH machine, or critical part of an encapsulating ma-1 chine. 2 ‘‘(4) T ERMINATION.— 3 ‘‘(A) I N GENERAL.—A registration to man-4 ufacture, import, export, or deal a tableting ma-5 chine, encapsulating machine, critical part of a 6 tableting machine, or critical part of an encap-7 sulating machine terminates if and when such 8 registrant— 9 ‘‘(i) ceases legal existence; 10 ‘‘(ii) ceases to engage in the manufac-11 ture, importation, exportation, or dealing 12 of such a machine or critical part thereof; 13 or 14 ‘‘(iii) surrenders such registration. 15 ‘‘(B) N OTIFICATION.—In the case of such 16 a registrant who ceases legal existence or ceases 17 to engage in the manufacture, importation, ex-18 portation, or dealing, such registrant, or agent 19 or successor in interest of such registrant, shall 20 promptly notify the Attorney General in writing 21 of such fact. 22 ‘‘(5) R E-ASSIGNMENT.—A registration to manu-23 facture, import, export, or deal a tableting machine, 24 encapsulating machine, critical part of a tableting 25 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 12 •HR 1100 IH machine, or critical part of an encapsulating ma-1 chine may only be assigned to another entity with 2 the written consent of, and upon such conditions as, 3 the Attorney General may specify. 4 ‘‘(b) R EGISTRATIONCONSIDERATIONS.—The Attor-5 ney General shall register an applicant to manufacture, 6 import, export, or deal a tableting machine, encapsulating 7 machine, critical part of a tableting machine, or critical 8 part of an encapsulating machine, unless the Attorney 9 General determines that registration of the applicant is 10 inconsistent with the public interest. 11 ‘‘(c) C ONSIDERATIONS.—In determining the public 12 interest for the purposes of subsection (b), the Attorney 13 General shall consider— 14 ‘‘(1) development and maintenance of effective 15 controls against diversion of tableting machines, en-16 capsulating machines, and critical parts thereof into 17 other than legitimate channels; 18 ‘‘(2) compliance with applicable Federal, State, 19 and local law; 20 ‘‘(3) prior conviction record of the applicant; 21 ‘‘(4) past experience in the manufacture, im-22 port, export, and dealing of tableting machines, en-23 capsulating machines, or critical parts thereof; and 24 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 13 •HR 1100 IH ‘‘(5) such other factors as may be relevant to 1 and consistent with the public health and safety. 2 ‘‘(d) A UTHORIZED ACTIVITIES.—No person may 3 manufacture, import, export, or deal any tableting ma-4 chine, encapsulating machine, critical part of a tableting 5 machine, or critical part of an encapsulating machine un-6 less such person has an active registration to do so issued 7 by the Attorney General, unless— 8 ‘‘(1) such person is an agent or employee of any 9 registrant acting in the usual course of his business 10 or employment; or 11 ‘‘(2) a common or contract carrier or ware-12 houseman, or an employee thereof, whose possession 13 of the tableting machine, encapsulating machine, or 14 critical part thereof is in the lawful and usual course 15 of his business or employment. 16 ‘‘(e) I NSPECTION.—The Attorney General is author-17 ized to inspect the establishment of a registrant or appli-18 cant for registration in accordance with the rules and reg-19 ulations promulgated by the Attorney General. 20 ‘‘(f) D ENIAL, REVOCATION, ORSUSPENSION OFREG-21 ISTRATION.— 22 ‘‘(1) S USPENSION OR REVOCATION .—A reg-23 istration pursuant to subsection (b) of this section to 24 manufacture, import, export, or deal a tableting ma-25 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 14 •HR 1100 IH chine, encapsulating machine, critical part of a 1 tableting machine, or critical part of an encap-2 sulating machine may be suspended or revoked by 3 the Attorney General upon a finding that the reg-4 istrant— 5 ‘‘(A) has materially falsified any applica-6 tion filed pursuant to or required by this sub-7 chapter or subchapter II; 8 ‘‘(B) has been convicted in any court of an 9 offense involving a tableting machine, encap-10 sulating machine, a critical part of a tableting 11 machine, or a critical part of an encapsulating 12 machine; or 13 ‘‘(C) has committed such acts as would 14 render his registration inconsistent with the 15 public interest. 16 ‘‘(2) O RDER.— 17 ‘‘(A) I N GENERAL.—Before suspending or 18 revoking a registration to manufacture, import, 19 export, or deal tableting machines, encap-20 sulating machines, critical parts of tableting 21 machines, or critical parts of encapsulating ma-22 chines, or pursuant to a denial of registration, 23 the Attorney General shall serve upon the appli-24 cant or registrant an order to show cause why 25 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 15 •HR 1100 IH registration should not be denied, revoked, or 1 suspended. 2 ‘‘(B) C ONTENTS.—An order to show cause 3 shall contain a statement of the basis for the 4 denial, revocation, or suspension, including spe-5 cific citations to any laws or regulations alleged 6 to be violated by the applicant or registrant, di-7 rect the applicant or registrant to appear before 8 the Attorney General at a time and place stated 9 in the order, and notify the applicant or reg-10 istrant of the opportunity to submit a corrective 11 action plan on or before the date of appearance. 12 ‘‘(C) C ORRECTIVE ACTION PLAN RE -13 VIEW.—Upon review of any corrective action 14 plan submitted by an applicant or registrant 15 pursuant to subparagraph (B), the Attorney 16 General shall determine whether denial, revoca-17 tion, or suspension proceedings should be dis-18 continued, or deferred for the purposes of modi-19 fication, amendment, or clarification to such 20 plan. 21 ‘‘(D) A PPLICABLE LAW.—Proceedings to 22 deny, revoke, or suspend shall be conducted in 23 accordance with subchapter II of chapter 5 of 24 title 5. Such proceedings shall be independent 25 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 16 •HR 1100 IH of, and not in lieu of, criminal prosecutions or 1 other proceedings under this subchapter or any 2 other law of the United States. 3 ‘‘(E) R ELATIONSHIP TO IMMEDIATE SUS -4 PENSION ORDER.—The requirements of this 5 subsection shall not apply to the issuance of an 6 immediate suspension order under paragraph 7 (3). 8 ‘‘(3) S USPENSION OF REGISTRATION IN CASES 9 OF IMMINENT DANGER .— 10 ‘‘(A) I N GENERAL.—The Attorney General 11 may, in the discretion of the Attorney General, 12 suspend any registration simultaneously with 13 the institution of proceedings under this sec-14 tion, in cases where he finds that there is an 15 imminent danger to the public health or safety. 16 A suspension under this subsection shall con-17 tinue in effect until the conclusion of such pro-18 ceedings, including judicial review thereof, un-19 less sooner withdrawn by the Attorney General 20 or dissolved by a court of competent jurisdic-21 tion. 22 ‘‘(B) I MMINENT DANGER TO THE PUBLIC 23 SAFETY DEFINED .—In this subsection, the 24 phrase ‘imminent danger to the public health or 25 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 17 •HR 1100 IH safety’ means that, due to the failure of the 1 registrant to maintain effective controls against 2 diversion or otherwise comply with the obliga-3 tions of a registrant under this Act, there is a 4 substantial likelihood that a tableting machine, 5 encapsulating machine, critical part of a 6 tableting machine, or critical part of an encap-7 sulating machine will be used in the illicit man-8 ufacture of controlled substances and cause 9 death, serious bodily harm, or abuse of a con-10 trolled substance in the absence of an imme-11 diate suspension of the registration. 12 ‘‘(g) D ISPOSITION OFTABLETINGMACHINES, EN-13 CAPSULATINGMACHINES, ANDCRITICALPART.— 14 ‘‘(1) I N GENERAL.—Upon termination, suspen-15 sion, or revocation of registration of a registrant, the 16 former registrant may, within 30 days or such addi-17 tional period designated by the Attorney General for 18 good cause, liquidate any remaining tableting ma-19 chines, encapsulating machines, critical parts of 20 tableting machines, or critical parts of encapsulating 21 machines by lawfully selling, transferring, or other-22 wise disposing of the tableting machines, encap-23 sulating machines, critical parts of a tableting ma-24 chines, or critical parts of encapsulating machines to 25 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 18 •HR 1100 IH a registered manufacturer, importer, exporter, or 1 dealer of tableting machines, encapsulating ma-2 chines, critical parts of tableting machines, or crit-3 ical parts of encapsulating machines. 4 ‘‘(2) E XCEPTION.—Except for the liquidation of 5 remaining inventory to a registrant within 30 days 6 (or approved period) in accordance with paragraph 7 (1), a former registrant may no longer deal tableting 8 machines, encapsulating machines, critical parts of 9 tableting machines, or critical parts of encapsulating 10 machines. 11 ‘‘(h) R ECORDS ANDREPORTS.— 12 ‘‘(1) Every registrant shall maintain, on a cur-13 rent basis, a complete and accurate record of each 14 tableting machine, encapsulating machine, critical 15 part of a tableting machine, or critical part of an en-16 capsulating machine possessed, manufactured, re-17 ceived, imported, exported, sold, distributed, deliv-18 ered, or destroyed, with such information, and in 19 such form and manner as the Attorney General may 20 by regulations require. 21 ‘‘(2) Every registrant shall, at such time or 22 times, with such information, and in such form and 23 manner as the Attorney General may by regulations 24 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 19 •HR 1100 IH require, make periodic reports to the Attorney Gen-1 eral. 2 ‘‘(3) Every record required under this section 3 shall be kept and be readily retrievable, for at least 4 10 years, for inspection and copying by officers or 5 employees of the United States authorized by the 6 Attorney General. 7 ‘‘(i) R EGULATIONS AND FEES.—The Attorney Gen-8 eral is authorized to promulgate rules and regulations and 9 charge reasonable fees relating to the registration and con-10 trol of the manufacture, importation, exportation, and 11 dealing of tableting machines, encapsulating machines, 12 critical parts of tableting machines, and critical parts of 13 encapsulating machines. The Attorney General shall by 14 regulation establish which tableting machines, encap-15 sulating machines, critical parts of tableting machines, 16 and critical parts of encapsulating machines are subject 17 to the registration, recordkeeping, and reporting require-18 ments under this section, and the form, manner, and in-19 formation to be maintained and furnished under such re-20 quirements. 21 ‘‘(j) D EFINITIONS.—For the purposes of this section: 22 ‘‘(1) D EAL.—The term ‘deal’ means to engage 23 in the business of selling or distributing tableting 24 machines, encapsulating machines, critical parts of 25 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 20 •HR 1100 IH tableting machines, or critical parts of encapsulating 1 machines at wholesale or retail. 2 ‘‘(2) D ELIVERY, DISTRIBUTE, DESTROY, MANU-3 FACTURE.—The terms ‘deliver’, ‘distribute’, ‘de-4 stroy’, and ‘manufacture’ have the meanings given 5 such terms in section 310B. 6 ‘‘(3) E NGAGED IN THE BUSINESS .—The term 7 ‘engaged in the business’ means devoting time, at-8 tention, and labor to dealing tableting machines, en-9 capsulating machines, critical parts of tableting ma-10 chines, or critical parts of an encapsulating machine 11 as a regular trade or business to predominantly earn 12 a profit through the repetitive purchase and resale. 13 ‘‘(k) E FFECTIVEDATE.—This section shall apply be-14 ginning 120 days after the date of enactment of this sec-15 tion, except that the Attorney General may by order pub-16 lished in the Federal Register postpone the effective date 17 of this section for such period as the Attorney General 18 may determine to be necessary for the efficient adminis-19 tration of this Act.’’. 20 SEC. 7. OFFENSES; PENALTIES. 21 (a) S ERIALNUMBERS.— 22 (1) P ROHIBITED ACTS B—PENALTIES.—Section 23 402(a) of the Controlled Substances Act (21 U.S.C. 24 842(a)) is amended— 25 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 21 •HR 1100 IH (A) in paragraph (16), by striking ‘‘or’’ at 1 the end; 2 (B) in paragraph (17), by striking the pe-3 riod at the end and inserting a semicolon; and 4 (C) by inserting after paragraph (17) the 5 following: 6 ‘‘(18) to violate subsection (a) of section 310A; 7 ‘‘(19) to refuse or negligently fail to make a re-8 port under subsection (b) of section 310A;’’. 9 (2) P ROHIBITED ACTS C—PENALTIES.—Section 10 403 of the Controlled Substances Act (21 U.S.C. 11 843) is amended— 12 (A) in subsection (a), in each of para-13 graphs (6) and (7), by inserting ‘‘critical part 14 of a tableting machine, critical part of an en-15 capsulating machine,’’ after ‘‘encapsulating ma-16 chine,’’; and 17 (B) by adding at the end the following: 18 ‘‘(g) It shall be unlawful to— 19 ‘‘(1) intentionally remove, alter, or obliterate 20 any serial number affixed to any tableting machine, 21 encapsulating machine, critical part of a tableting 22 machine, or critical part of an encapsulating ma-23 chine that is required to have a serial number pursu-24 ant to subsection (a) of section 310A, if the person 25 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 22 •HR 1100 IH removing, altering, or obliterating such serial num-1 ber knows or has reasonable cause to believe the se-2 rial number is so required; 3 ‘‘(2) transport, ship, receive, or possess any 4 tableting machine, encapsulating machine, critical 5 part of a tableting machine, or critical part of an en-6 capsulating machine that is required to have a serial 7 number pursuant to subsection (a) of section 310A, 8 if the person transporting, shipping, receiving, or 9 possessing such a machine or critical part thereof 10 knows that the serial number has been removed, ob-11 literated, or altered, and has reasonable cause to be-12 lieve the serial number is required pursuant to sub-13 section (a) of section 310A; or 14 ‘‘(3) possess a tableting machine or an encap-15 sulating machine that is required to have a serial 16 number pursuant to subsection (a) of section 310A, 17 if the person in possession of such machine knows 18 that the machine does not have a serial number, and 19 has reasonable cause to believe the serial number is 20 required pursuant to subsection (a) of section 310A. 21 ‘‘(h) In a prosecution for an offense under subsection 22 (g)(3), it is an affirmative defense, as to which the defend-23 ant has the burden of proof by a preponderance of the 24 evidence, that the person possessed the tableting machine 25 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 23 •HR 1100 IH or encapsulating machine on the day before the effective 1 date of this subsection and, not later than 180 days after 2 that date, or for such additional period designated by the 3 Attorney General for good cause, the person— 4 ‘‘(1) sold or otherwise transferred the tableting 5 machine or encapsulating machine to a manufac-6 turer, importer, exporter, or dealer of tableting ma-7 chines or encapsulating machines that is registered 8 under section 310C(a); 9 ‘‘(2) had a serial number engraved, cast, or oth-10 erwise affixed to a non-removable part of the 11 tableting machine or encapsulating machine by a 12 manufacturer, importer, exporter, or dealer of 13 tableting machines or encapsulating machines that is 14 registered under section 310C(a); or 15 ‘‘(3) destroyed the tableting machine or encap-16 sulating machine. 17 ‘‘(i) For purposes of this subsection, the term ‘de-18 stroy’ has the meaning given such term in section 310B. 19 ‘‘(j) Subsection (g) does not apply to a manufacturer, 20 importer, exporter, or dealer of tableting machines or en-21 capsulating machines that is registered under section 22 310C(a)(1) or exempt from registration pursuant to sec-23 tion 310C(a)(2). Subsection (g) shall become effective 2 24 years after the date of enactment, except that the Attor-25 VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB 24 •HR 1100 IH ney General may by order published in the Federal Reg-1 ister postpone the effective date of subsection (g) for such 2 period as he may determine to be necessary for the effi-3 cient administration of this Act.’’. 4 (b) R EGISTRATION OF CERTAINMACHINES AND 5 P ARTS.—Section 402(a) of the Controlled Substances Act 6 (21 U.S.C. 842(a)), as amended by subsection (a), is fur-7 ther amended by inserting after paragraph (19) the fol-8 lowing: 9 ‘‘(20) to violate subsection (a) or (b) of section 10 310B; or’’. 11 (c) R EGISTRATION OF MANUFACTURERS, IMPORT-12 ERS, EXPORTERS, ANDDEALERS.—Section 402(a) of the 13 Controlled Substances Act (21 U.S.C. 842(a)), as amend-14 ed by subsections (a) and (b), is further amended by in-15 serting after paragraph (20) the following: 16 ‘‘(21) to manufacture, import, export, or deal a 17 tableting machine, encapsulating machine, critical 18 part of a tableting machine, or critical part of an en-19 capsulating machine without a registration required 20 by section 310C, except as specified in subsection 21 (g)(1) of such section.’’. 22 Æ VerDate Sep 11 2014 00:08 Mar 06, 2025 Jkt 059200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6301 E:\BILLS\H1100.IH H1100 kjohnson on DSK7ZCZBW3PROD with $$_JOB