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Us Congress House Bill HB1100

Us Congress 2025-2026 Regular Session

Us Congress House Bill HB1100 Compare Versions

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11 I
22 119THCONGRESS
33 1
44 STSESSION H. R. 1100
55 To amend the Controlled Substances Act to provide for the regulation of
66 critical parts of tableting machines and encapsulating machines, and
77 for other purposes.
88 IN THE HOUSE OF REPRESENTATIVES
99 FEBRUARY6, 2025
1010 Ms. S
1111 TANSBURY(for herself, Mr. GRIJALVA, Ms. PETTERSEN, Ms. SALINAS,
1212 and Mr. H
1313 ORSFORD) introduced the following bill; which was referred to
1414 the Committee on Energy and Commerce, and in addition to the Com-
1515 mittee on the Judiciary, for a period to be subsequently determined by
1616 the Speaker, in each case for consideration of such provisions as fall with-
1717 in the jurisdiction of the committee concerned
1818 A BILL
1919 To amend the Controlled Substances Act to provide for the
2020 regulation of critical parts of tableting machines and
2121 encapsulating machines, and for other purposes.
2222 Be it enacted by the Senate and House of Representa-1
2323 tives of the United States of America in Congress assembled, 2
2424 SECTION 1. SHORT TITLE. 3
2525 This Act may be cited as the ‘‘Stop the Opioid Pill 4
2626 Presser and Fentanyl Act’’ or the ‘‘STOPP Act’’. 5
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3030 SEC. 2. DEFINITIONS. 1
3131 Section 102 of the Controlled Substances Act (21 2
3232 U.S.C. 802) is amended— 3
3333 (1) in paragraph (38), by striking ‘‘or an en-4
3434 capsulating machine’’ and inserting ‘‘an encap-5
3535 sulating machine, a critical part of a tableting ma-6
3636 chine, or a critical part of an encapsulating ma-7
3737 chine’’; 8
3838 (2) in paragraph (39)(B)— 9
3939 (A) by striking ‘‘distribution, importation, 10
4040 or exportation of’’ and inserting ‘‘distribution, 11
4141 receipt, sale, importation, or exportation of, or 12
4242 an international transaction involving shipment 13
4343 of’’; and 14
4444 (B) by striking ‘‘or encapsulating ma-15
4545 chine’’ and inserting ‘‘, encapsulating machine, 16
4646 critical part of a tableting machine, or critical 17
4747 part of an encapsulating machine’’; 18
4848 (3) in paragraph (42), by striking ‘‘a listed 19
4949 chemical’’ and inserting ‘‘a listed chemical, a 20
5050 tableting machine, an encapsulating machine, a crit-21
5151 ical part of a tableting machine, or a critical part of 22
5252 an encapsulating machine’’; 23
5353 (4) in paragraph (43), by striking ‘‘a listed 24
5454 chemical’’ and inserting ‘‘a listed chemical, a 25
5555 tableting machine, an encapsulating machine, a crit-26
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5959 ical part of a tableting machine, or a critical part of 1
6060 an encapsulating machine’’; and 2
6161 (5) by adding at the end the following: 3
6262 ‘‘(60) The term ‘critical part’, when used in reference 4
6363 to a tableting machine or encapsulating machine, means 5
6464 any of the following integral parts when designed pri-6
6565 marily for use in a tableting or encapsulating machine: 7
6666 ‘‘(A) Press punch. 8
6767 ‘‘(B) Die system. 9
6868 ‘‘(C) Press turret. 10
6969 ‘‘(D) Hopper. 11
7070 ‘‘(E) Compression roller. 12
7171 ‘‘(F) Discharge chute. 13
7272 ‘‘(G) Vacuum system. 14
7373 ‘‘(H) Capsule feeding unit. 15
7474 ‘‘(I) Automatic feeding unit. 16
7575 ‘‘(J) Any other item identified in a regulation 17
7676 published by the Attorney General used in the oper-18
7777 ating of tableting or encapsulating machines.’’. 19
7878 SEC. 3. REGULATED TRANSACTIONS OF CRITICAL PARTS. 20
7979 (a) R
8080 ECORD OFREGULATEDTRANSACTIONS.—Sec-21
8181 tion 310 of the Controlled Substances Act (21 U.S.C. 830) 22
8282 is amended— 23
8383 (1) in subsection (a)(1)— 24
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8787 (A) by striking ‘‘or an encapsulating ma-1
8888 chine’’ and inserting ‘‘an encapsulating ma-2
8989 chine, a critical part of a tableting machine, or 3
9090 a critical part of an encapsulating machine’’; 4
9191 and 5
9292 (B) by inserting ‘‘, in such form and man-6
9393 ner as the Attorney General shall prescribe by 7
9494 regulation,’’ after ‘‘record of the transaction’’; 8
9595 and 9
9696 (2) in paragraph (a)(2), by striking ‘‘or encap-10
9797 sulating machine’’ and inserting ‘‘, encapsulating 11
9898 machine, critical part of a tableting machine, or crit-12
9999 ical part of an encapsulating machine’’. 13
100100 (b) R
101101 EPORTS TOATTORNEYGENERAL ANDRECORD-14
102102 KEEPING.—Section 310(b)(1) of the Controlled Sub-15
103103 stances Act (21 U.S.C. 830) is amended— 16
104104 (1) in subparagraph (A)— 17
105105 (A) by striking ‘‘payment or delivery’’ and 18
106106 inserting ‘‘payment or delivery of a listed chem-19
107107 ical, tableting machine, encapsulating machine, 20
108108 a critical part of a tableting machine, or a crit-21
109109 ical part of an encapsulating machine’’; and 22
110110 (B) by striking ‘‘any other circumstance 23
111111 that the regulated person believes may indicate 24
112112 that the listed chemical’’ and inserting ‘‘any 25
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116116 other circumstance that the regulated person 1
117117 believes may indicate that the listed chemical, 2
118118 tableting machine, encapsulating machine, crit-3
119119 ical part of a tableting machine, or critical part 4
120120 of an encapsulating machine’’; 5
121121 (2) in subparagraph (C), by striking ‘‘listed 6
122122 chemical’’ and inserting ‘‘listed chemical, tableting 7
123123 machine, encapsulating machine, critical part of a 8
124124 tableting machine, or critical part of an encap-9
125125 sulating machine’’; and 10
126126 (3) in subparagraph (D), by striking ‘‘or an en-11
127127 capsulating machine’’ and inserting ‘‘, an encap-12
128128 sulating machine, critical part of a tableting ma-13
129129 chine, or critical part of an encapsulating machine’’. 14
130130 (c) E
131131 FFECTIVEDATE.—The amendments made by 15
132132 this section shall apply beginning on the date that is 120 16
133133 days after the date of enactment of this Act, except that 17
134134 the Attorney General may, by order published in the Fed-18
135135 eral Register, postpone such date of application for such 19
136136 period as the Attorney General may determine to be nec-20
137137 essary for the efficient administration of the Controlled 21
138138 Substances Act (21 U.S.C. 801 et seq.). 22
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142142 SEC. 4. SERIALIZATION OF CERTAIN MACHINES AND 1
143143 PARTS. 2
144144 The Controlled Substances Act (21 U.S.C. 801 et 3
145145 seq.) is amended by inserting after section 310 (21 U.S.C. 4
146146 830) the following: 5
147147 ‘‘SEC. 310A SERIALIZATION OF CERTAIN MACHINES AND 6
148148 PARTS. 7
149149 ‘‘(a) S
150150 ERIALNUMBER.—Each manufacturer, dis-8
151151 tributor, importer, or exporter of a tableting machine, en-9
152152 capsulating machine, a critical part of a tableting ma-10
153153 chine, or a critical part of an encapsulating machine shall, 11
154154 when and as required by regulation of the Attorney Gen-12
155155 eral, identify the tableting machine, encapsulating ma-13
156156 chine, critical part of a tableting machine, or critical part 14
157157 of an encapsulating machine by a serial number which 15
158158 shall be engraved, cast, or otherwise permanently affixed 16
159159 to a non-removable part of the tableting machine, encap-17
160160 sulating machine, critical part of a tableting machine, or 18
161161 critical part of an encapsulating machine in accordance 19
162162 with such regulations. 20
163163 ‘‘(b) R
164164 EPORTING.—Any regulated person who manu-21
165165 factures, distributes, receives, sells, imports, or exports a 22
166166 tableting machine, encapsulating machine, critical part of 23
167167 a tableting machine, or critical part of an encapsulating 24
168168 machine that is subject to the serialization requirement 25
169169 set forth in subsection (a), shall report the transaction to 26
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173173 the Attorney General and maintain records of such trans-1
174174 action, in such form and manner as the Attorney General 2
175175 shall prescribe by regulation.’’. 3
176176 SEC. 5. REGISTRATION OF CERTAIN MACHINES AND PARTS. 4
177177 The Controlled Substances Act (21 U.S.C. 801 et 5
178178 seq.), as amended by section 4, is further amended by in-6
179179 serting after section 310A the following: 7
180180 ‘‘SEC. 310B. REGISTRATION OF CERTAIN MACHINES AND 8
181181 PARTS. 9
182182 ‘‘(a) R
183183 EGISTRATION OF CERTAINMACHINES AND 10
184184 P
185185 ARTS.—Each manufacturer, distributor, importer, or ex-11
186186 porter of a tableting machine, encapsulating machine, crit-12
187187 ical part of a tableting machine, or critical part of an en-13
188188 capsulating machine shall, when and as required by regu-14
189189 lation of the Attorney General, register the tableting ma-15
190190 chine, encapsulating machine, critical part of a tableting 16
191191 machine, or critical part of an encapsulating machine with 17
192192 the Attorney General in accordance with such regulation. 18
193193 ‘‘(b) R
194194 EPORTING.—Any regulated person who manu-19
195195 factures, distributes, receives, sells, imports, exports, or 20
196196 destroys a tableting machine, encapsulating machine, crit-21
197197 ical part of a tableting machine, or critical part of an en-22
198198 capsulating machine that is required to be registered pur-23
199199 suant to subsection (a), shall report that act to the Attor-24
200200 ney General and maintain records of such act as required 25
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204204 in section 310, in such form and manner as the Attorney 1
205205 General shall prescribe by regulation. 2
206206 ‘‘(c) R
207207 EGULATIONS.—The Attorney General is au-3
208208 thorized to promulgate rules and regulations relating to 4
209209 tableting machines and encapsulating machines. The At-5
210210 torney General shall by regulation establish which 6
211211 tableting machines, encapsulating machines, critical parts 7
212212 of tableting machines, and critical parts of encapsulating 8
213213 machines are subject to the registration and reporting re-9
214214 quirements of subsections (a) and (b) and the information 10
215215 to be provided pursuant to subsections (a) and (b), which 11
216216 shall include the location of the tableting machine, encap-12
217217 sulating machine, critical part of a tableting machine, or 13
218218 critical part of an encapsulating machine. 14
219219 ‘‘(d) N
220220 ATIONALPILLPRESSREGISTRY.—The Attor-15
221221 ney General shall maintain a central registry of all 16
222222 tableting machines, encapsulating machines, critical parts 17
223223 of a tableting machine, or critical parts of an encap-18
224224 sulating machine that are subject to the registration re-19
225225 quirement set forth in subsection (a), which shall be 20
226226 known and referred to as the National Pill Press Registry. 21
227227 ‘‘(e) D
228228 EFINITIONS.—For the purposes of this section: 22
229229 ‘‘(1) M
230230 ANUFACTURE.—The term ‘manufacture’ 23
231231 means the production or assembly of a tableting ma-24
232232 chine, encapsulating machine, critical part of a 25
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236236 tableting machine, or critical part of an encap-1
237237 sulating machine. 2
238238 ‘‘(2) D
239239 ISTRIBUTE.—The term ‘distribute’ 3
240240 means to deliver a tableting machine, encapsulating 4
241241 machine, critical part of a tableting machine, or crit-5
242242 ical part of an encapsulating machine. 6
243243 ‘‘(3) D
244244 ELIVER.—The term ‘deliver’ means the 7
245245 actual, constructive, or attempted transfer of a 8
246246 tableting machine, encapsulating machine, critical 9
247247 part of a tableting machine, or critical part of an en-10
248248 capsulating machine, whether or not there exists an 11
249249 agency relationship. 12
250250 ‘‘(4) D
251251 ESTROY.—The term ‘destroy’ means to 13
252252 cause such serious damage to a tableting machine, 14
253253 encapsulating machine, critical part of a tableting 15
254254 machine, or critical part of an encapsulating ma-16
255255 chine so that it can no longer be used for its in-17
256256 tended purpose.’’. 18
257257 SEC. 6. REGISTRATION OF MANUFACTURERS, IMPORTERS, 19
258258 EXPORTERS, AND DEALERS OF TABLETING 20
259259 MACHINES, ENCAPSULATING MACHINES, AND 21
260260 CRITICAL PARTS. 22
261261 The Controlled Substances Act (21 U.S.C. 801 et 23
262262 seq.), as amended by sections 4 and 5, is further amended 24
263263 by inserting after section 310B the following: 25
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267267 ‘‘SEC. 310C. REGISTRATION OF MANUFACTURERS, IMPORT-1
268268 ERS, EXPORTERS, AND DEALERS OF 2
269269 TABLETING MACHINES, ENCAPSULATING MA-3
270270 CHINES, AND CRITICAL PARTS. 4
271271 ‘‘(a) R
272272 EGISTRATION.— 5
273273 ‘‘(1) I
274274 N GENERAL.—Every person who manu-6
275275 factures, imports, exports, or deals, or proposes to 7
276276 engage in the manufacture, importation, exportation, 8
277277 or dealing of any tableting machine, encapsulating 9
278278 machine, critical part of a tableting machine, or crit-10
279279 ical part of an encapsulating machine, shall obtain, 11
280280 on an annual basis, a registration issued by the At-12
281281 torney General. 13
282282 ‘‘(2) W
283283 AIVER.—The Attorney General may, by 14
284284 regulation, waive the requirement for registration of 15
285285 certain manufacturers, importers, exporters, and dis-16
286286 tributors of any tableting machine, encapsulating 17
287287 machine, critical part of a tableting machine, or crit-18
288288 ical part of an encapsulating machine if the Attor-19
289289 ney General finds that issuing such a waiver would 20
290290 be consistent with public health and safety. 21
291291 ‘‘(3) S
292292 EPARATE REGISTRATIONS REQUIRED .—A 22
293293 separate registration shall be required for each prin-23
294294 cipal place of business where the applicant manufac-24
295295 tures, imports, exports, or deals a tableting machine, 25
296296 encapsulating machine, critical part of a tableting 26
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300300 machine, or critical part of an encapsulating ma-1
301301 chine. 2
302302 ‘‘(4) T
303303 ERMINATION.— 3
304304 ‘‘(A) I
305305 N GENERAL.—A registration to man-4
306306 ufacture, import, export, or deal a tableting ma-5
307307 chine, encapsulating machine, critical part of a 6
308308 tableting machine, or critical part of an encap-7
309309 sulating machine terminates if and when such 8
310310 registrant— 9
311311 ‘‘(i) ceases legal existence; 10
312312 ‘‘(ii) ceases to engage in the manufac-11
313313 ture, importation, exportation, or dealing 12
314314 of such a machine or critical part thereof; 13
315315 or 14
316316 ‘‘(iii) surrenders such registration. 15
317317 ‘‘(B) N
318318 OTIFICATION.—In the case of such 16
319319 a registrant who ceases legal existence or ceases 17
320320 to engage in the manufacture, importation, ex-18
321321 portation, or dealing, such registrant, or agent 19
322322 or successor in interest of such registrant, shall 20
323323 promptly notify the Attorney General in writing 21
324324 of such fact. 22
325325 ‘‘(5) R
326326 E-ASSIGNMENT.—A registration to manu-23
327327 facture, import, export, or deal a tableting machine, 24
328328 encapsulating machine, critical part of a tableting 25
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332332 machine, or critical part of an encapsulating ma-1
333333 chine may only be assigned to another entity with 2
334334 the written consent of, and upon such conditions as, 3
335335 the Attorney General may specify. 4
336336 ‘‘(b) R
337337 EGISTRATIONCONSIDERATIONS.—The Attor-5
338338 ney General shall register an applicant to manufacture, 6
339339 import, export, or deal a tableting machine, encapsulating 7
340340 machine, critical part of a tableting machine, or critical 8
341341 part of an encapsulating machine, unless the Attorney 9
342342 General determines that registration of the applicant is 10
343343 inconsistent with the public interest. 11
344344 ‘‘(c) C
345345 ONSIDERATIONS.—In determining the public 12
346346 interest for the purposes of subsection (b), the Attorney 13
347347 General shall consider— 14
348348 ‘‘(1) development and maintenance of effective 15
349349 controls against diversion of tableting machines, en-16
350350 capsulating machines, and critical parts thereof into 17
351351 other than legitimate channels; 18
352352 ‘‘(2) compliance with applicable Federal, State, 19
353353 and local law; 20
354354 ‘‘(3) prior conviction record of the applicant; 21
355355 ‘‘(4) past experience in the manufacture, im-22
356356 port, export, and dealing of tableting machines, en-23
357357 capsulating machines, or critical parts thereof; and 24
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361361 ‘‘(5) such other factors as may be relevant to 1
362362 and consistent with the public health and safety. 2
363363 ‘‘(d) A
364364 UTHORIZED ACTIVITIES.—No person may 3
365365 manufacture, import, export, or deal any tableting ma-4
366366 chine, encapsulating machine, critical part of a tableting 5
367367 machine, or critical part of an encapsulating machine un-6
368368 less such person has an active registration to do so issued 7
369369 by the Attorney General, unless— 8
370370 ‘‘(1) such person is an agent or employee of any 9
371371 registrant acting in the usual course of his business 10
372372 or employment; or 11
373373 ‘‘(2) a common or contract carrier or ware-12
374374 houseman, or an employee thereof, whose possession 13
375375 of the tableting machine, encapsulating machine, or 14
376376 critical part thereof is in the lawful and usual course 15
377377 of his business or employment. 16
378378 ‘‘(e) I
379379 NSPECTION.—The Attorney General is author-17
380380 ized to inspect the establishment of a registrant or appli-18
381381 cant for registration in accordance with the rules and reg-19
382382 ulations promulgated by the Attorney General. 20
383383 ‘‘(f) D
384384 ENIAL, REVOCATION, ORSUSPENSION OFREG-21
385385 ISTRATION.— 22
386386 ‘‘(1) S
387387 USPENSION OR REVOCATION .—A reg-23
388388 istration pursuant to subsection (b) of this section to 24
389389 manufacture, import, export, or deal a tableting ma-25
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393393 chine, encapsulating machine, critical part of a 1
394394 tableting machine, or critical part of an encap-2
395395 sulating machine may be suspended or revoked by 3
396396 the Attorney General upon a finding that the reg-4
397397 istrant— 5
398398 ‘‘(A) has materially falsified any applica-6
399399 tion filed pursuant to or required by this sub-7
400400 chapter or subchapter II; 8
401401 ‘‘(B) has been convicted in any court of an 9
402402 offense involving a tableting machine, encap-10
403403 sulating machine, a critical part of a tableting 11
404404 machine, or a critical part of an encapsulating 12
405405 machine; or 13
406406 ‘‘(C) has committed such acts as would 14
407407 render his registration inconsistent with the 15
408408 public interest. 16
409409 ‘‘(2) O
410410 RDER.— 17
411411 ‘‘(A) I
412412 N GENERAL.—Before suspending or 18
413413 revoking a registration to manufacture, import, 19
414414 export, or deal tableting machines, encap-20
415415 sulating machines, critical parts of tableting 21
416416 machines, or critical parts of encapsulating ma-22
417417 chines, or pursuant to a denial of registration, 23
418418 the Attorney General shall serve upon the appli-24
419419 cant or registrant an order to show cause why 25
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423423 registration should not be denied, revoked, or 1
424424 suspended. 2
425425 ‘‘(B) C
426426 ONTENTS.—An order to show cause 3
427427 shall contain a statement of the basis for the 4
428428 denial, revocation, or suspension, including spe-5
429429 cific citations to any laws or regulations alleged 6
430430 to be violated by the applicant or registrant, di-7
431431 rect the applicant or registrant to appear before 8
432432 the Attorney General at a time and place stated 9
433433 in the order, and notify the applicant or reg-10
434434 istrant of the opportunity to submit a corrective 11
435435 action plan on or before the date of appearance. 12
436436 ‘‘(C) C
437437 ORRECTIVE ACTION PLAN RE -13
438438 VIEW.—Upon review of any corrective action 14
439439 plan submitted by an applicant or registrant 15
440440 pursuant to subparagraph (B), the Attorney 16
441441 General shall determine whether denial, revoca-17
442442 tion, or suspension proceedings should be dis-18
443443 continued, or deferred for the purposes of modi-19
444444 fication, amendment, or clarification to such 20
445445 plan. 21
446446 ‘‘(D) A
447447 PPLICABLE LAW.—Proceedings to 22
448448 deny, revoke, or suspend shall be conducted in 23
449449 accordance with subchapter II of chapter 5 of 24
450450 title 5. Such proceedings shall be independent 25
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454454 of, and not in lieu of, criminal prosecutions or 1
455455 other proceedings under this subchapter or any 2
456456 other law of the United States. 3
457457 ‘‘(E) R
458458 ELATIONSHIP TO IMMEDIATE SUS -4
459459 PENSION ORDER.—The requirements of this 5
460460 subsection shall not apply to the issuance of an 6
461461 immediate suspension order under paragraph 7
462462 (3). 8
463463 ‘‘(3) S
464464 USPENSION OF REGISTRATION IN CASES 9
465465 OF IMMINENT DANGER .— 10
466466 ‘‘(A) I
467467 N GENERAL.—The Attorney General 11
468468 may, in the discretion of the Attorney General, 12
469469 suspend any registration simultaneously with 13
470470 the institution of proceedings under this sec-14
471471 tion, in cases where he finds that there is an 15
472472 imminent danger to the public health or safety. 16
473473 A suspension under this subsection shall con-17
474474 tinue in effect until the conclusion of such pro-18
475475 ceedings, including judicial review thereof, un-19
476476 less sooner withdrawn by the Attorney General 20
477477 or dissolved by a court of competent jurisdic-21
478478 tion. 22
479479 ‘‘(B) I
480480 MMINENT DANGER TO THE PUBLIC 23
481481 SAFETY DEFINED .—In this subsection, the 24
482482 phrase ‘imminent danger to the public health or 25
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486486 safety’ means that, due to the failure of the 1
487487 registrant to maintain effective controls against 2
488488 diversion or otherwise comply with the obliga-3
489489 tions of a registrant under this Act, there is a 4
490490 substantial likelihood that a tableting machine, 5
491491 encapsulating machine, critical part of a 6
492492 tableting machine, or critical part of an encap-7
493493 sulating machine will be used in the illicit man-8
494494 ufacture of controlled substances and cause 9
495495 death, serious bodily harm, or abuse of a con-10
496496 trolled substance in the absence of an imme-11
497497 diate suspension of the registration. 12
498498 ‘‘(g) D
499499 ISPOSITION OFTABLETINGMACHINES, EN-13
500500 CAPSULATINGMACHINES, ANDCRITICALPART.— 14
501501 ‘‘(1) I
502502 N GENERAL.—Upon termination, suspen-15
503503 sion, or revocation of registration of a registrant, the 16
504504 former registrant may, within 30 days or such addi-17
505505 tional period designated by the Attorney General for 18
506506 good cause, liquidate any remaining tableting ma-19
507507 chines, encapsulating machines, critical parts of 20
508508 tableting machines, or critical parts of encapsulating 21
509509 machines by lawfully selling, transferring, or other-22
510510 wise disposing of the tableting machines, encap-23
511511 sulating machines, critical parts of a tableting ma-24
512512 chines, or critical parts of encapsulating machines to 25
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515515 •HR 1100 IH
516516 a registered manufacturer, importer, exporter, or 1
517517 dealer of tableting machines, encapsulating ma-2
518518 chines, critical parts of tableting machines, or crit-3
519519 ical parts of encapsulating machines. 4
520520 ‘‘(2) E
521521 XCEPTION.—Except for the liquidation of 5
522522 remaining inventory to a registrant within 30 days 6
523523 (or approved period) in accordance with paragraph 7
524524 (1), a former registrant may no longer deal tableting 8
525525 machines, encapsulating machines, critical parts of 9
526526 tableting machines, or critical parts of encapsulating 10
527527 machines. 11
528528 ‘‘(h) R
529529 ECORDS ANDREPORTS.— 12
530530 ‘‘(1) Every registrant shall maintain, on a cur-13
531531 rent basis, a complete and accurate record of each 14
532532 tableting machine, encapsulating machine, critical 15
533533 part of a tableting machine, or critical part of an en-16
534534 capsulating machine possessed, manufactured, re-17
535535 ceived, imported, exported, sold, distributed, deliv-18
536536 ered, or destroyed, with such information, and in 19
537537 such form and manner as the Attorney General may 20
538538 by regulations require. 21
539539 ‘‘(2) Every registrant shall, at such time or 22
540540 times, with such information, and in such form and 23
541541 manner as the Attorney General may by regulations 24
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545545 require, make periodic reports to the Attorney Gen-1
546546 eral. 2
547547 ‘‘(3) Every record required under this section 3
548548 shall be kept and be readily retrievable, for at least 4
549549 10 years, for inspection and copying by officers or 5
550550 employees of the United States authorized by the 6
551551 Attorney General. 7
552552 ‘‘(i) R
553553 EGULATIONS AND FEES.—The Attorney Gen-8
554554 eral is authorized to promulgate rules and regulations and 9
555555 charge reasonable fees relating to the registration and con-10
556556 trol of the manufacture, importation, exportation, and 11
557557 dealing of tableting machines, encapsulating machines, 12
558558 critical parts of tableting machines, and critical parts of 13
559559 encapsulating machines. The Attorney General shall by 14
560560 regulation establish which tableting machines, encap-15
561561 sulating machines, critical parts of tableting machines, 16
562562 and critical parts of encapsulating machines are subject 17
563563 to the registration, recordkeeping, and reporting require-18
564564 ments under this section, and the form, manner, and in-19
565565 formation to be maintained and furnished under such re-20
566566 quirements. 21
567567 ‘‘(j) D
568568 EFINITIONS.—For the purposes of this section: 22
569569 ‘‘(1) D
570570 EAL.—The term ‘deal’ means to engage 23
571571 in the business of selling or distributing tableting 24
572572 machines, encapsulating machines, critical parts of 25
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575575 •HR 1100 IH
576576 tableting machines, or critical parts of encapsulating 1
577577 machines at wholesale or retail. 2
578578 ‘‘(2) D
579579 ELIVERY, DISTRIBUTE, DESTROY, MANU-3
580580 FACTURE.—The terms ‘deliver’, ‘distribute’, ‘de-4
581581 stroy’, and ‘manufacture’ have the meanings given 5
582582 such terms in section 310B. 6
583583 ‘‘(3) E
584584 NGAGED IN THE BUSINESS .—The term 7
585585 ‘engaged in the business’ means devoting time, at-8
586586 tention, and labor to dealing tableting machines, en-9
587587 capsulating machines, critical parts of tableting ma-10
588588 chines, or critical parts of an encapsulating machine 11
589589 as a regular trade or business to predominantly earn 12
590590 a profit through the repetitive purchase and resale. 13
591591 ‘‘(k) E
592592 FFECTIVEDATE.—This section shall apply be-14
593593 ginning 120 days after the date of enactment of this sec-15
594594 tion, except that the Attorney General may by order pub-16
595595 lished in the Federal Register postpone the effective date 17
596596 of this section for such period as the Attorney General 18
597597 may determine to be necessary for the efficient adminis-19
598598 tration of this Act.’’. 20
599599 SEC. 7. OFFENSES; PENALTIES. 21
600600 (a) S
601601 ERIALNUMBERS.— 22
602602 (1) P
603603 ROHIBITED ACTS B—PENALTIES.—Section 23
604604 402(a) of the Controlled Substances Act (21 U.S.C. 24
605605 842(a)) is amended— 25
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609609 (A) in paragraph (16), by striking ‘‘or’’ at 1
610610 the end; 2
611611 (B) in paragraph (17), by striking the pe-3
612612 riod at the end and inserting a semicolon; and 4
613613 (C) by inserting after paragraph (17) the 5
614614 following: 6
615615 ‘‘(18) to violate subsection (a) of section 310A; 7
616616 ‘‘(19) to refuse or negligently fail to make a re-8
617617 port under subsection (b) of section 310A;’’. 9
618618 (2) P
619619 ROHIBITED ACTS C—PENALTIES.—Section 10
620620 403 of the Controlled Substances Act (21 U.S.C. 11
621621 843) is amended— 12
622622 (A) in subsection (a), in each of para-13
623623 graphs (6) and (7), by inserting ‘‘critical part 14
624624 of a tableting machine, critical part of an en-15
625625 capsulating machine,’’ after ‘‘encapsulating ma-16
626626 chine,’’; and 17
627627 (B) by adding at the end the following: 18
628628 ‘‘(g) It shall be unlawful to— 19
629629 ‘‘(1) intentionally remove, alter, or obliterate 20
630630 any serial number affixed to any tableting machine, 21
631631 encapsulating machine, critical part of a tableting 22
632632 machine, or critical part of an encapsulating ma-23
633633 chine that is required to have a serial number pursu-24
634634 ant to subsection (a) of section 310A, if the person 25
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638638 removing, altering, or obliterating such serial num-1
639639 ber knows or has reasonable cause to believe the se-2
640640 rial number is so required; 3
641641 ‘‘(2) transport, ship, receive, or possess any 4
642642 tableting machine, encapsulating machine, critical 5
643643 part of a tableting machine, or critical part of an en-6
644644 capsulating machine that is required to have a serial 7
645645 number pursuant to subsection (a) of section 310A, 8
646646 if the person transporting, shipping, receiving, or 9
647647 possessing such a machine or critical part thereof 10
648648 knows that the serial number has been removed, ob-11
649649 literated, or altered, and has reasonable cause to be-12
650650 lieve the serial number is required pursuant to sub-13
651651 section (a) of section 310A; or 14
652652 ‘‘(3) possess a tableting machine or an encap-15
653653 sulating machine that is required to have a serial 16
654654 number pursuant to subsection (a) of section 310A, 17
655655 if the person in possession of such machine knows 18
656656 that the machine does not have a serial number, and 19
657657 has reasonable cause to believe the serial number is 20
658658 required pursuant to subsection (a) of section 310A. 21
659659 ‘‘(h) In a prosecution for an offense under subsection 22
660660 (g)(3), it is an affirmative defense, as to which the defend-23
661661 ant has the burden of proof by a preponderance of the 24
662662 evidence, that the person possessed the tableting machine 25
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666666 or encapsulating machine on the day before the effective 1
667667 date of this subsection and, not later than 180 days after 2
668668 that date, or for such additional period designated by the 3
669669 Attorney General for good cause, the person— 4
670670 ‘‘(1) sold or otherwise transferred the tableting 5
671671 machine or encapsulating machine to a manufac-6
672672 turer, importer, exporter, or dealer of tableting ma-7
673673 chines or encapsulating machines that is registered 8
674674 under section 310C(a); 9
675675 ‘‘(2) had a serial number engraved, cast, or oth-10
676676 erwise affixed to a non-removable part of the 11
677677 tableting machine or encapsulating machine by a 12
678678 manufacturer, importer, exporter, or dealer of 13
679679 tableting machines or encapsulating machines that is 14
680680 registered under section 310C(a); or 15
681681 ‘‘(3) destroyed the tableting machine or encap-16
682682 sulating machine. 17
683683 ‘‘(i) For purposes of this subsection, the term ‘de-18
684684 stroy’ has the meaning given such term in section 310B. 19
685685 ‘‘(j) Subsection (g) does not apply to a manufacturer, 20
686686 importer, exporter, or dealer of tableting machines or en-21
687687 capsulating machines that is registered under section 22
688688 310C(a)(1) or exempt from registration pursuant to sec-23
689689 tion 310C(a)(2). Subsection (g) shall become effective 2 24
690690 years after the date of enactment, except that the Attor-25
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694694 ney General may by order published in the Federal Reg-1
695695 ister postpone the effective date of subsection (g) for such 2
696696 period as he may determine to be necessary for the effi-3
697697 cient administration of this Act.’’. 4
698698 (b) R
699699 EGISTRATION OF CERTAINMACHINES AND 5
700700 P
701701 ARTS.—Section 402(a) of the Controlled Substances Act 6
702702 (21 U.S.C. 842(a)), as amended by subsection (a), is fur-7
703703 ther amended by inserting after paragraph (19) the fol-8
704704 lowing: 9
705705 ‘‘(20) to violate subsection (a) or (b) of section 10
706706 310B; or’’. 11
707707 (c) R
708708 EGISTRATION OF MANUFACTURERS, IMPORT-12
709709 ERS, EXPORTERS, ANDDEALERS.—Section 402(a) of the 13
710710 Controlled Substances Act (21 U.S.C. 842(a)), as amend-14
711711 ed by subsections (a) and (b), is further amended by in-15
712712 serting after paragraph (20) the following: 16
713713 ‘‘(21) to manufacture, import, export, or deal a 17
714714 tableting machine, encapsulating machine, critical 18
715715 part of a tableting machine, or critical part of an en-19
716716 capsulating machine without a registration required 20
717717 by section 310C, except as specified in subsection 21
718718 (g)(1) of such section.’’. 22
719719 Æ
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