US
Us Congress Senate Bill SB331

Us Congress 2025-2026 Regular Session

Us Congress Senate Bill SB331 Compare Versions

OldNewDifferences
1+II
2+Calendar No. 18
13 119THCONGRESS
24 1
35 STSESSION S. 331
4-AN ACT
6+To amend the Controlled Substances Act with respect to the scheduling
7+of fentanyl-related substances, and for other purposes.
8+IN THE SENATE OF THE UNITED STATES
9+JANUARY30, 2025
10+Mr. C
11+ASSIDY(for himself, Mr. HEINRICH, Mr. GRASSLEY, Mr. MARSHALL,
12+Mr. Y
13+OUNG, Mr. DAINES, Mr. ROUNDS, Mrs. CAPITO, Mr. SCHMITT, Mr.
14+K
15+ENNEDY, Mr. GALLEGO, Ms. HASSAN, Ms. CORTEZMASTO, Mrs. SHA-
16+HEEN, Mr. KING, Mr. KELLY, Mr. CORNYN, Mr. HAWLEY, Mr. TILLIS,
17+Mr. G
18+RAHAM, Mr. CRUZ, Mrs. BRITT, Mrs. BLACKBURN, Mr. LEE, and
19+Mrs. M
20+OODY) introduced the following bill; which was read twice and re-
21+ferred to the Committee on the Judiciary
22+M
23+ARCH3, 2025
24+Reported by Mr. G
25+RASSLEY, with an amendment
26+[Strike out all after the enacting clause and insert the part printed in italic]
27+A BILL
528 To amend the Controlled Substances Act with respect to
629 the scheduling of fentanyl-related substances, and for
730 other purposes.
831 Be it enacted by the Senate and House of Representa-1
9-tives of the United States of America in Congress assembled, 2 2
10-†S 331 ES
32+tives of the United States of America in Congress assembled, 2
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35+•S 331 RS
1136 SECTION1.SHORTTITLE. 1
1237 ThisActmaybecitedasthe‘‘HaltAllLethalTraf-2
1338 fickingofFentanylAct’’orthe‘‘HALTFentanylAct’’. 3
1439 SEC.2.CLASSSCHEDULING OFFENTANYL-RELATED SUB-4
1540 STANCES. 5
1641 Section202(c)oftheControlledSubstancesAct(21 6
1742 U.S.C.812(c))isamendedbyaddingattheendofsched-7
1843 uleIthefollowing: 8
1944 ‘‘(e)(1)Unlessspecificallyexemptedorunlesslisted 9
2045 inanotherschedule,anymaterial,compound,mixture,or 10
2146 preparationwhichcontainsanyquantityofafentanyl-re-11
2247 latedsubstance,orwhichcontainsthesalts,isomers,and 12
2348 saltsofisomersofafentanyl-relatedsubstancewhenever 13
2449 theexistenceofsuchsalts,isomers,andsaltsofisomers 14
2550 ispossiblewithinthespecificchemicaldesignation. 15
2651 ‘‘(2)Forpurposesofparagraph(1),exceptaspro-16
2752 videdinparagraph(3),theterm‘fentanyl-relatedsub-17
2853 stance’meansanysubstancethatisstructurallyrelated 18
2954 tofentanylby1ormoreofthefollowingmodifications: 19
3055 ‘‘(A)Byreplacementofthephenylportionof 20
3156 thephenethylgroupbyanymonocycle,whetheror 21
3257 notfurthersubstitutedinoronthemonocycle. 22
3358 ‘‘(B)Bysubstitutioninoronthephenethyl 23
3459 groupwithalkyl,alkenyl,alkoxyl,hydroxyl,halo, 24
35-haloalkyl, amino, or nitro groups. 25 3
36-†S 331 ES
60+haloalkyl,amino,ornitrogroups. 25
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3764 ‘‘(C)Bysubstitutioninoronthepiperidine 1
3865 ringwithalkyl,alkenyl,alkoxyl,ester,ether, 2
3966 hydroxyl,halo,haloalkyl,amino,ornitrogroups. 3
4067 ‘‘(D)Byreplacementoftheanilineringwith 4
4168 anyaromaticmonocyclewhetherornotfurthersub-5
4269 stitutedinoronthearomaticmonocycle. 6
43-‘‘(E) By replacement of the N-propionyl group 7
70+‘‘(E)ByreplacementoftheN–propionylgroup 7
4471 withanotheracylgroup. 8
4572 ‘‘(3)Asubstancethatsatisfiesthedefinitionofthe 9
4673 term‘fentanyl-relatedsubstance’inparagraph(2)shall 10
4774 nonethelessnotbetreatedasafentanyl-relatedsubstance 11
4875 subjecttothisscheduleifthesubstance— 12
4976 ‘‘(A)iscontrolledbyactionoftheAttorney 13
5077 Generalundersection201;or 14
5178 ‘‘(B)isotherwiseexpresslylistedinaschedule 15
5279 otherthanthisschedule. 16
5380 ‘‘(4)(A)TheAttorneyGeneralmaybyorderpublish 17
5481 intheFederalRegisteralistofsubstancesthatsatisfy 18
5582 thedefinitionoftheterm‘fentanyl-relatedsubstance’in 19
5683 paragraph(2). 20
5784 ‘‘(B)Theabsenceofasubstancefromalistpublished 21
5885 undersubparagraph(A)doesnotnegatethecontrolstatus 22
5986 ofthesubstanceunderthisscheduleifthesubstancesatis-23
6087 fiesthedefinitionoftheterm‘fentanyl-relatedsubstance’ 24
61-in paragraph (2).’’. 25 4
62-†S 331 ES
88+inparagraph(2).’’. 25
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6392 SEC.3.REGISTRATION REQUIREMENTS RELATED TORE-1
6493 SEARCH. 2
65-(a) A
66-LTERNATIVE REGISTRATIONPROCESS FOR 3
67-S
68-CHEDULEI RESEARCH.—Section 303 of the Controlled 4
94+(a)ALTERNATIVE REGISTRATIONPROCESSFOR 3
95+SCHEDULEIRESEARCH.—Section303oftheControlled 4
6996 SubstancesAct(21U.S.C.823)isamended— 5
7097 (1)byredesignatingthesecondsubsection(l) 6
7198 (relatingtorequiredtrainingforprescribers)assub-7
7299 section(m);and 8
73100 (2)byaddingattheendthefollowing: 9
74-‘‘(n) S
75-PECIALPROVISIONS FOR PRACTITIONERS 10
76-C
77-ONDUCTINGCERTAINRESEARCHWITHSCHEDULEI 11
78-C
79-ONTROLLEDSUBSTANCES.— 12
80-‘‘(1) I
81-N GENERAL.—Notwithstanding subsection 13
101+‘‘(n)SPECIALPROVISIONSFORPRACTITIONERS 10
102+CONDUCTINGCERTAINRESEARCHWITHSCHEDULEI 11
103+CONTROLLEDSUBSTANCES.— 12
104+‘‘(1)INGENERAL.—Notwithstandingsubsection 13
82105 (g),apractitionermayconductresearchdescribedin 14
83106 paragraph(2)ofthissubsectionwith1ormore 15
84107 scheduleIsubstancesinaccordancewithsubpara-16
85108 graph(A)or(B)ofparagraph(3)ofthissub-17
86109 section. 18
87-‘‘(2) R
88-ESEARCH SUBJECT TO EXPEDITED PRO -19
110+‘‘(2)RESEARCHSUBJECTTOEXPEDITED PRO-19
89111 CEDURES.—Researchdescribedinthisparagraphis 20
90112 researchthat— 21
91113 ‘‘(A)iswithrespecttoadrugthatisthe 22
92114 subjectofaninvestigationaluseexemption 23
93115 undersection505(i)oftheFederalFood,Drug, 24
94116 andCosmeticAct(21U.S.C.355(i));or 25
95-‘‘(B) is— 26 5
96-†S 331 ES
117+‘‘(B)is— 26
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97121 ‘‘(i)conductedbytheDepartmentof 1
98122 HealthandHumanServices,theDepart-2
99123 mentofDefense,ortheDepartmentof 3
100124 VeteransAffairs;or 4
101125 ‘‘(ii)fundedpartlyorentirelybya 5
102126 grant,contract,cooperativeagreement,or 6
103127 othertransactionfromtheDepartmentof 7
104128 HealthandHumanServices,theDepart-8
105129 mentofDefense,ortheDepartmentof 9
106130 VeteransAffairs. 10
107-‘‘(3) E
108-XPEDITED PROCEDURES .— 11
109-‘‘(A) R
110-ESEARCHER WITH A CURRENT 12
131+‘‘(3)EXPEDITEDPROCEDURES.— 11
132+‘‘(A)RESEARCHER WITHACURRENT 12
111133 SCHEDULE IORIIRESEARCHREGISTRATION.— 13
112-‘‘(i) I
113-N GENERAL.—If a practitioner is 14
134+‘‘(i)INGENERAL.—Ifapractitioneris 14
114135 registeredtoconductresearchwithacon-15
115136 trolledsubstanceinscheduleIorII,the 16
116137 practitionermayconductresearchunder 17
117138 thissubsectiononandafterthedatethat 18
118139 is30daysafterthedateonwhichthe 19
119140 practitionersendsanoticetotheAttorney 20
120141 Generalcontainingthefollowinginforma-21
121142 tion,withrespecttoeachsubstancewith 22
122143 whichthepractitionerwillconductthere-23
123-search: 24 6
124-†S 331 ES
144+search: 24
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125148 ‘‘(I)Thechemicalnameofthe 1
126149 substance. 2
127150 ‘‘(II)Thequantityofthesub-3
128151 stancetobeusedintheresearch. 4
129152 ‘‘(III)Demonstrationthatthere-5
130153 searchisinthecategorydescribedin 6
131154 paragraph(2),whichdemonstration 7
132155 maybesatisfied— 8
133156 ‘‘(aa)inthecaseofagrant, 9
134157 contract,cooperativeagreement, 10
135158 orothertransaction,orintra-11
136159 muralresearchproject,byidenti-12
137160 fyingthesponsoringagencyand 13
138161 supplyingthenumberofthe 14
139162 grant,contract,cooperative 15
140163 agreement,othertransaction,or 16
141164 project;or 17
142165 ‘‘(bb)inthecaseofanap-18
143166 plicationundersection505(i)of 19
144167 theFederalFood,Drug,and 20
145168 CosmeticAct(21U.S.C.355(i)), 21
146169 bysupplyingtheapplication 22
147170 numberandthesponsorof 23
148-record on the application. 24 7
149-†S 331 ES
171+recordontheapplication. 24
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150175 ‘‘(IV)Demonstrationthatthere-1
151176 searcherisauthorizedtoconductre-2
152177 searchwithrespecttothesubstance 3
153178 underthelawsoftheStateinwhich 4
154179 theresearchwilltakeplace. 5
155-‘‘(ii) V
156-ERIFICATION OF INFORMATION 6
180+‘‘(ii)VERIFICATIONOFINFORMATION 6
157181 BYHHSORVA.—Uponrequestfromthe 7
158182 AttorneyGeneral,theSecretaryofHealth 8
159183 andHumanServices,theDepartmentof 9
160184 Defense,ortheSecretaryofVeteransAf-10
161185 fairs,asappropriate,shallverifyinforma-11
162186 tionsubmittedbyanapplicantunder 12
163187 clause(i)(III). 13
164-‘‘(B) R
165-ESEARCHER WITHOUT A CURRENT 14
188+‘‘(B)RESEARCHER WITHOUT ACURRENT 14
166189 SCHEDULE IORIIRESEARCHREGISTRATION.— 15
167-‘‘(i) I
168-N GENERAL.—If a practitioner is 16
190+‘‘(i)INGENERAL.—Ifapractitioneris 16
169191 notregisteredtoconductresearchwitha 17
170192 controlledsubstanceinscheduleIorII, 18
171193 thepractitionermaysendanoticetothe 19
172194 AttorneyGeneralcontainingtheinforma-20
173195 tionlistedinsubparagraph(A)(i),withre-21
174196 specttoeachsubstancewithwhichthe 22
175197 practitionerwillconducttheresearch. 23
176-‘‘(ii) A
177-TTORNEY GENERAL ACTION .— 24
178-The Attorney General shall— 25 8
179-†S 331 ES
198+‘‘(ii)ATTORNEYGENERALACTION.— 24
199+TheAttorneyGeneralshall— 25
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202+•S 331 RS
180203 ‘‘(I)treatnoticereceivedunder 1
181204 clause(i)asasufficientapplication 2
182205 foraresearchregistration;and 3
183206 ‘‘(II)notlaterthan45daysof 4
184207 receivingsuchanoticethatcontains 5
185208 allinformationrequiredundersub-6
186209 paragraph(A)(i)— 7
187210 ‘‘(aa)registertheapplicant; 8
188211 or 9
189212 ‘‘(bb)serveanordertoshow 10
190213 causeupontheapplicantinac-11
191214 cordancewithsection304(c). 12
192-‘‘(4) E
193-LECTRONIC SUBMISSIONS .—The Attorney 13
215+‘‘(4)ELECTRONICSUBMISSIONS.—TheAttorney 13
194216 Generalshallprovideameanstopermitapracti-14
195217 tionertosubmitanotificationunderparagraph(3) 15
196218 electronically. 16
197-‘‘(5) L
198-IMITATION ON AMOUNTS .—A practitioner 17
219+‘‘(5)LIMITATIONONAMOUNTS.—Apractitioner 17
199220 conductingresearchwithascheduleIsubstance 18
200221 underthissubsectionmayonlypossesstheamounts 19
201222 ofscheduleIsubstanceidentifiedin— 20
202223 ‘‘(A)thenotificationtotheAttorneyGen-21
203224 eralunderparagraph(3);or 22
204225 ‘‘(B)asupplementalnotificationthatthe 23
205-practitioner may send if the practitioner needs 24 9
206-†S 331 ES
226+practitionermaysendifthepractitionerneeds 24
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207230 additionalamountsfortheresearch,whichsup-1
208231 plementalnotificationshallinclude— 2
209232 ‘‘(i)thenameofthepractitioner; 3
210233 ‘‘(ii)theadditionalquantityneededof 4
211234 thesubstance;and 5
212235 ‘‘(iii)anattestationthattheresearch 6
213236 tobeconductedwiththesubstanceiscon-7
214237 sistentwiththescopeoftheresearchthat 8
215238 wasthesubjectofthenotificationunder 9
216239 paragraph(3). 10
217-‘‘(6) I
218-MPORTATION AND EXPORTATION RE -11
240+‘‘(6)IMPORTATION ANDEXPORTATION RE-11
219241 QUIREMENTS NOTAFFECTED.—Nothinginthissub-12
220242 sectionalterstherequirementsofpartAoftitleIII, 13
221243 regardingtheimportationandexportationofcon-14
222244 trolledsubstances. 15
223-‘‘(7) I
224-NSPECTOR GENERAL REPORT .—Not later 16
245+‘‘(7)INSPECTORGENERALREPORT.—Notlater 16
225246 than1yearafterthedateofenactmentoftheHalt 17
226247 AllLethalTraffickingofFentanylAct,theInspec-18
227248 torGeneraloftheDepartmentofJusticeshallcom-19
228249 pleteastudy,andsubmittoCongressareport 20
229250 thereon,aboutresearchdescribedinparagraph(2) 21
230251 ofthissubsectionwithfentanyl.’’. 22
231-(b) S
232-EPARATEREGISTRATIONSNOTREQUIRED FOR 23
233-A
234-DDITIONALRESEARCHER INSAMEINSTITUTION.— 24 10
235-†S 331 ES
252+(b)SEPARATEREGISTRATIONSNOTREQUIREDFOR 23
253+ADDITIONALRESEARCHERINSAMEINSTITUTION.— 24
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256+•S 331 RS
236257 (1)INGENERAL.—Section302(c)oftheCon-1
237258 trolledSubstancesAct(21U.S.C.822(c))isamend-2
238259 edbyaddingattheendthefollowing: 3
239260 ‘‘(4)Anagentoremployeeofaresearchinsti-4
240261 tutionthatisconductingresearchwithacontrolled 5
241262 substanceif— 6
242263 ‘‘(A)theagentoremployeeisactingwith-7
243264 inthescopeoftheprofessionalpracticeofthe 8
244265 agentoremployee; 9
245266 ‘‘(B)anotheragentoremployeeofthein-10
246267 stitutionisregisteredtoconductresearchwith 11
247268 acontrolledsubstanceinthesameschedule; 12
248269 ‘‘(C)theresearcherwhoissoregistered— 13
249270 ‘‘(i)informstheAttorneyGeneralof 14
250271 thename,positiontitle,andemployingin-15
251272 stitutionoftheagentoremployeewhois 16
252273 notseparatelyregistered; 17
253274 ‘‘(ii)authorizesthatagentorem-18
254275 ployeetoperformresearchunderthereg-19
255276 istrationoftheregisteredresearcher;and 20
256277 ‘‘(iii)affirmsthatanyacttakenby 21
257278 thatagentoremployeeinvolvingacon-22
258279 trolledsubstanceshallbeattributableto 23
259280 theregisteredresearcher,asifthere-24
260-searcher had directly committed the act, 25 11
261-†S 331 ES
281+searcherhaddirectlycommittedtheact, 25
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284+•S 331 RS
262285 forpurposesofanyproceedingundersec-1
263286 tion304(a)tosuspendorrevokethereg-2
264287 istrationoftheregisteredresearcher;and 3
265288 ‘‘(D)theAttorneyGeneraldoesnot,within 4
266289 30daysofreceivingtheinformation,authoriza-5
267290 tion,andaffirmationdescribedinsubparagraph 6
268291 (C),refuse,forareasonlistedinsection 7
269292 304(a),toallowtheagentoremployeetopos-8
270293 sessthesubstancewithoutaseparateregistra-9
271294 tion.’’. 10
272-(2) T
273-ECHNICAL CORRECTION .—Section 11
295+(2)TECHNICAL CORRECTION.—Section 11
274296 302(c)(3)oftheControlledSubstancesAct(21 12
275297 U.S.C.822(c)(3))isamendedbystriking‘‘(25)’’ 13
276298 andinserting‘‘(27)’’. 14
277-(c) S
278-INGLEREGISTRATION FORRELATEDRESEARCH 15
279-S
280-ITES.—Section 302(e) of the Controlled Substances Act 16
299+(c)SINGLEREGISTRATIONFORRELATEDRESEARCH 15
300+SITES.—Section302(e)oftheControlledSubstancesAct 16
281301 (21U.S.C.822(e))isamendedbyaddingattheendthe 17
282302 following: 18
283303 ‘‘(4)(A)Notwithstandingparagraph(1),aperson 19
284304 registeredtoconductresearchwithacontrolledsubstance 20
285305 undersection303(g)mayconducttheresearchundera 21
286306 singleregistrationif— 22
287307 ‘‘(i)theresearchoccursexclusivelyonsitesall 23
288308 ofwhichare— 24
289-‘‘(I) within the same city or county; and 25 12
290-†S 331 ES
309+‘‘(I)withinthesamecityorcounty;and 25
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291313 ‘‘(II)underthecontrolofthesameinstitu-1
292314 tion,organization,oragency;and 2
293315 ‘‘(ii)beforecommencingtheresearch,there-3
294316 searchernotifiestheAttorneyGeneralofeachsite 4
295317 where— 5
296318 ‘‘(I)theresearchwillbeconducted;or 6
297319 ‘‘(II)thecontrolledsubstancewillbe 7
298320 storedoradministered. 8
299321 ‘‘(B)Asitedescribedinsubparagraph(A)shallbe 9
300322 includedinaregistrationdescribedinthatsubparagraph 10
301323 onlyiftheresearcherhasnotifiedtheAttorneyGeneral 11
302324 ofthesite— 12
303325 ‘‘(i)intheapplicationfortheregistration;or 13
304326 ‘‘(ii)beforetheresearchisconducted,orbefore 14
305327 thecontrolledsubstanceisstoredoradministered,at 15
306328 thesite. 16
307329 ‘‘(C)TheAttorneyGeneralmay,inconsultationwith 17
308330 theSecretary,issueregulationsaddressing,withrespect 18
309331 toresearchsitesdescribedinsubparagraph(A)— 19
310332 ‘‘(i)themannerinwhichcontrolledsubstances 20
311333 maybedeliveredtotheresearchsites; 21
312334 ‘‘(ii)thestorageandsecurityofcontrolledsub-22
313335 stancesattheresearchsites; 23
314336 ‘‘(iii)themaintenanceofrecordsforthere-24
315-search sites; and 25 13
316-†S 331 ES
337+searchsites;and 25
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340+•S 331 RS
317341 ‘‘(iv)anyothermattersnecessarytoensureef-1
318342 fectivecontrolsagainstdiversionattheresearch 2
319343 sites.’’. 3
320-(d) N
321-EWINSPECTIONNOTREQUIRED INCERTAIN 4
322-S
323-ITUATIONS.—Section 302(f) of the Controlled Sub-5
344+(d)NEWINSPECTIONNOTREQUIREDINCERTAIN 4
345+SITUATIONS.—Section302(f)oftheControlledSub-5
324346 stancesAct(21U.S.C.822(f))isamended— 6
325347 (1)bystriking‘‘(f)The’’andinserting‘‘(f)(1) 7
326348 The’’;and 8
327349 (2)byaddingattheendthefollowing: 9
328350 ‘‘(2)(A)Ifapersonisregisteredtoconductresearch 10
329351 withacontrolledsubstanceandappliesforaregistration, 11
330352 orforamodificationofaregistration,toconductresearch 12
331353 withasecondcontrolledsubstancethatisinthesame 13
332354 scheduleasthefirstcontrolledsubstance,orisinasched-14
333355 ulewithahighernumericaldesignationthantheschedule 15
334356 ofthefirstcontrolledsubstance,anewinspectionbythe 16
335357 AttorneyGeneraloftheregisteredlocationisnotrequired. 17
336358 ‘‘(B)Nothinginsubparagraph(A)shallprohibitthe 18
337359 AttorneyGeneralfromconductinganinspectionthatthe 19
338360 AttorneyGeneraldeterminesnecessarytoensurethata 20
339361 registrantmaintainseffectivecontrolsagainstdiversion.’’. 21
340-(e) C
341-ONTINUATION OF RESEARCH ONSUBSTANCES 22
342-N
343-EWLYADDED TOSCHEDULEI.—Section 302 of the 23
362+(e)CONTINUATION OFRESEARCHONSUBSTANCES 22
363+NEWLYADDEDTOSCHEDULEI.—Section302ofthe 23
344364 ControlledSubstancesAct(21U.S.C.822)isamended 24
345-by adding at the end the following: 25 14
346-†S 331 ES
365+byaddingattheendthefollowing: 25
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347369 ‘‘(h)CONTINUATION OFRESEARCHONSUBSTANCES 1
348-N
349-EWLYADDED TOSCHEDULEI.—If a person is con-2
370+NEWLYADDEDTOSCHEDULEI.—Ifapersoniscon-2
350371 ductingresearchonasubstancewhenthesubstanceis 3
351372 addedtoscheduleI,andthepersonisalreadyregistered 4
352373 toconductresearchwithacontrolledsubstanceinsched-5
353374 uleI— 6
354375 ‘‘(1)notlaterthan90daysafterthescheduling 7
355376 ofthenewlyscheduledsubstance,thepersonshall 8
356377 submitacompletedapplicationforregistrationor 9
357378 modificationofexistingregistration,toconductre-10
358379 searchonthesubstance,inaccordancewithregula-11
359380 tionsissuedbytheAttorneyGeneralforpurposesof 12
360381 thisparagraph; 13
361382 ‘‘(2)thepersonmay,notwithstandingsub-14
362383 sections(a)and(b),continuetoconductthere-15
363384 searchonthesubstanceuntil— 16
364385 ‘‘(A)thepersonwithdrawstheapplication 17
365386 describedinparagraph(1)ofthissubsection; 18
366387 or 19
367388 ‘‘(B)theAttorneyGeneralservesonthe 20
368389 personanordertoshowcauseproposingthe 21
369390 denialoftheapplicationundersection304(c); 22
370391 ‘‘(3)iftheAttorneyGeneralservesanorderto 23
371392 showcauseasdescribedinparagraph(2)(B)and 24
372-the person requests a hearing, the hearing shall be 25 15
373-†S 331 ES
393+thepersonrequestsahearing,thehearingshallbe 25
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374397 heldonanexpeditedbasisandnotlaterthan45 1
375398 daysaftertherequestismade,exceptthatthehear-2
376399 ingmaybeheldatalatertimeifsorequestedby 3
377400 theperson;and 4
378401 ‘‘(4)ifthepersonsendsacopyoftheapplica-5
379402 tiondescribedinparagraph(1)toamanufactureror 6
380403 distributorofthesubstance,receiptofthecopyby 7
381404 themanufacturerordistributorshallconstitutesuf-8
382405 ficientevidencethatthepersonisauthorizedtore-9
383406 ceivethesubstance.’’. 10
384-(f) T
385-REATMENT OF CERTAINMANUFACTURING AC-11
407+(f)TREATMENT OFCERTAINMANUFACTURING AC-11
386408 TIVITIESASCOINCIDENTTORESEARCH.—Section302of 12
387409 theControlledSubstancesAct(21U.S.C.822),asamend-13
388410 edbysubsection(e),isamendedbyaddingattheend 14
389411 thefollowing: 15
390-‘‘(i) T
391-REATMENT OFCERTAINMANUFACTURINGAC-16
412+‘‘(i)TREATMENT OFCERTAINMANUFACTURINGAC-16
392413 TIVITIESASCOINCIDENTTORESEARCH.— 17
393-‘‘(1) I
394-N GENERAL.—Except as provided in para-18
414+‘‘(1)INGENERAL.—Exceptasprovidedinpara-18
395415 graph(3),apersonwhoisregisteredtoperformre-19
396416 searchonacontrolledsubstancemayperformmanu-20
397417 facturingactivitieswithsmallquantitiesofthatsub-21
398418 stance,includingactivitiesdescribedinparagraph 22
399419 (2),withoutbeingrequiredtoobtainamanufac-23
400-turing registration, if— 24 16
401-†S 331 ES
420+turingregistration,if— 24
421+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6401 E:\BILLS\S331.RS S331
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423+•S 331 RS
402424 ‘‘(A)theactivitiesareperformedforthe 1
403425 purposeoftheresearch;and 2
404426 ‘‘(B)theactivitiesandthequantitiesof 3
405427 thesubstanceinvolvedintheactivitiesarestat-4
406428 edin— 5
407429 ‘‘(i)anotificationsubmittedtothe 6
408430 AttorneyGeneralundersection303(n); 7
409431 ‘‘(ii)aresearchprotocolfiledwithan 8
410432 applicationforregistrationapprovalunder 9
411433 section303(g);or 10
412434 ‘‘(iii)anotificationtotheAttorney 11
413435 Generalthatincludes— 12
414436 ‘‘(I)thenameoftheregistrant; 13
415437 and 14
416438 ‘‘(II)anattestationthatthere-15
417439 searchtobeconductedwiththesmall 16
418440 quantitiesofmanufacturedsubstance 17
419441 isconsistentwiththescopeofthere-18
420442 searchthatisthebasisforthereg-19
421443 istration. 20
422-‘‘(2) A
423-CTIVITIES INCLUDED.—Activities per-21
444+‘‘(2)ACTIVITIESINCLUDED.—Activitiesper-21
424445 mittedunderparagraph(1)include— 22
425446 ‘‘(A)processingthesubstancetocreateex-23
426447 tracts,tinctures,oils,solutions,derivatives,or 24
427-other forms of the substance consistent with— 25 17
428-†S 331 ES
448+otherformsofthesubstanceconsistentwith— 25
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451+•S 331 RS
429452 ‘‘(i)theinformationprovidedaspart 1
430453 ofanotificationsubmittedtotheAttorney 2
431454 Generalundersection303(n);or 3
432455 ‘‘(ii)aresearchprotocolfiledwithan 4
433456 applicationforregistrationapprovalunder 5
434457 section303(g);and 6
435458 ‘‘(B)dosageformdevelopmentstudiesper-7
436459 formedforthepurposeofrequestinganinves-8
437460 tigationalnewdrugexemptionundersection 9
438461 505(i)oftheFederalFood,Drug,andCos-10
439462 meticAct(21U.S.C.355(i)). 11
440-‘‘(3) E
441-XCEPTION REGARDING MARIHUANA .— 12
463+‘‘(3)EXCEPTION REGARDING MARIHUANA.— 12
442464 Theauthorityunderparagraph(1)tomanufacture 13
443465 substancesdoesnotincludetheauthoritytogrow 14
444466 marihuana.’’. 15
445-(g) T
446-RANSPARENCY REGARDINGSPECIALPROCE-16
467+(g)TRANSPARENCY REGARDINGSPECIALPROCE-16
447468 DURES.—Section303oftheControlledSubstancesAct 17
448469 (21U.S.C.823),asamendedbysubsection(a),isamend-18
449470 edbyaddingattheendthefollowing: 19
450-‘‘(o) T
451-RANSPARENCY REGARDINGSPECIALPROCE-20
471+‘‘(o)TRANSPARENCY REGARDINGSPECIALPROCE-20
452472 DURES.— 21
453-‘‘(1) I
454-N GENERAL.—If the Attorney General de-22
473+‘‘(1)INGENERAL.—IftheAttorneyGeneralde-22
455474 termines,withrespecttoacontrolledsubstance,that 23
456475 anapplicationbyapractitionertoconductresearch 24
457-with the substance should be considered under a 25 18
458-†S 331 ES
476+withthesubstanceshouldbeconsideredundera 25
477+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6401 E:\BILLS\S331.RS S331
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479+•S 331 RS
459480 process,orsubjecttocriteria,differentfromthe 1
460481 processorcriteriaapplicabletoapplicationstocon-2
461482 ductresearchwithothercontrolledsubstancesinthe 3
462483 sameschedule,theAttorneyGeneralshallmake 4
463484 public,includingbypostingonthewebsiteofthe 5
464485 DrugEnforcementAdministration— 6
465486 ‘‘(A)theidentitiesofallsubstancesfor 7
466487 whichsuchdeterminationshavebeenmade; 8
467488 ‘‘(B)theprocessandcriteriathatshallbe 9
468489 appliedtoapplicationstoconductresearchwith 10
469490 thosesubstances;and 11
470491 ‘‘(C)howtheprocessandcriteriadescribed 12
471492 insubparagraph(B)differfromtheprocess 13
472493 andcriteriaapplicabletoapplicationstocon-14
473494 ductresearchwithothercontrolledsubstances 15
474495 inthesameschedule. 16
475-‘‘(2) T
476-IMING OF POSTING.—The Attorney Gen-17
496+‘‘(2)TIMINGOFPOSTING.—TheAttorneyGen-17
477497 eralshallmakeinformationdescribedinparagraph 18
478498 (1)publicuponmakingadeterminationdescribedin 19
479499 thatparagraph,regardlessofwhetherapractitioner 20
480500 hassubmittedsuchanapplicationatthattime.’’. 21
481501 SEC.4.TECHNICAL CORRECTION ONCONTROLLED SUB-22
482502 STANCES DISPENSING. 23
483503 EffectiveasifincludedintheenactmentofPublic 24
484-Law 117–328— 25 19
485-†S 331 ES
504+Law117–328— 25
505+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6401 E:\BILLS\S331.RS S331
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507+•S 331 RS
486508 (1)section1252(a)ofdivisionFFofPublic 1
487509 Law117–328(136Stat.5681)isamended,inthe 2
488510 matterbeinginsertedintosection302(e)oftheCon-3
489511 trolledSubstancesAct,bystriking‘‘303(g)’’andin-4
490512 serting‘‘303(h)’’; 5
491513 (2)section1262ofdivisionFFofPublicLaw 6
492514 117–328(136Stat.5681)isamended— 7
493515 (A)insubsection(a)— 8
494516 (i)inthematterprecedingparagraph 9
495517 (1),bystriking‘‘303(g)’’andinserting 10
496518 ‘‘303(h)’’; 11
497519 (ii)inthematterbeingstrickenby 12
498520 subsection(a)(2),bystriking‘‘(g)(1)’’and 13
499521 inserting‘‘(h)(1)’’;and 14
500522 (iii)inthematterbeinginsertedby 15
501523 subsection(a)(2),bystriking‘‘(g)Practi-16
502524 tioners’’andinserting‘‘(h)Practitioners’’; 17
503525 and 18
504526 (B)insubsection(b)— 19
505527 (i)inthematterbeingstrickenby 20
506528 paragraph(1),bystriking‘‘303(g)(1)’’ 21
507529 andinserting‘‘303(h)(1)’’; 22
508530 (ii)inthematterbeinginsertedby 23
509531 paragraph(1),bystriking‘‘303(g)’’and 24
510-inserting ‘‘303(h)’’; 25 20
511-†S 331 ES
532+inserting‘‘303(h)’’; 25
533+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6401 E:\BILLS\S331.RS S331
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535+•S 331 RS
512536 (iii)inthematterbeingstrickenby 1
513537 paragraph(2)(A),bystriking‘‘303(g)(2)’’ 2
514538 andinserting‘‘303(h)(2)’’; 3
515539 (iv)inthematterbeingstrickenby 4
516540 paragraph(3),bystriking‘‘303(g)(2)(B)’’ 5
517541 andinserting‘‘303(h)(2)(B)’’; 6
518542 (v)inthematterbeingstrickenby 7
519543 paragraph(5),bystriking‘‘303(g)’’and 8
520544 inserting‘‘303(h)’’;and 9
521545 (vi)inthematterbeingstrickenby 10
522546 paragraph(6),bystriking‘‘303(g)’’and 11
523547 inserting‘‘303(h)’’;and 12
524548 (3)section1263(b)ofdivisionFFofPublic 13
525549 Law117–328(136Stat.5685)isamended— 14
526550 (A)bystriking‘‘303(g)(2)’’andinserting 15
527551 ‘‘303(h)(2)’’;and 16
528552 (B)bystriking‘‘(21U.S.C.823(g)(2))’’ 17
529553 andinserting‘‘(21U.S.C.823(h)(2))’’. 18
530554 SEC.5.RULEMAKING. 19
531-(a) I
532-NTERIMFINALRULES.—The Attorney Gen-20
555+(a)INTERIMFINALRULES.—TheAttorneyGen-20
533556 eral— 21
534557 (1)shall,notlaterthan6monthsafterthedate 22
535558 ofenactmentofthisAct,issuerulestoimplement 23
536-this Act and the amendments made by this Act; and 24 21
537-†S 331 ES
559+thisActandtheamendmentsmadebythisAct;and 24
560+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6401 E:\BILLS\S331.RS S331
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562+•S 331 RS
538563 (2)mayissuetherulesunderparagraph(1)as 1
539564 interimfinalrules. 2
540-(b) P
541-ROCEDURE FORFINALRULE.— 3
542-(1) E
543-FFECTIVENESS OF INTERIM FINAL 4
565+(b)PROCEDUREFORFINALRULE.— 3
566+(1)EFFECTIVENESS OFINTERIM FINAL 4
544567 RULES.—AruleissuedbytheAttorneyGeneralas 5
545568 aninterimfinalruleundersubsection(a)shallbe-6
546569 comeimmediatelyeffectiveasaninterimfinalrule 7
547570 withoutrequiringtheAttorneyGeneraltodem-8
548571 onstrategoodcausetherefor,notwithstandingsub-9
549-paragraph (B) of the undesignated matter following 10
550-paragraph (4) of section 553(b) of title 5, United 11
551-States Code. 12
552-(2) O
553-PPORTUNITY FOR COMMENT AND HEAR -13
554-ING.—An interim final rule issued under subsection 14
555-(a) shall give interested persons the opportunity to 15
556-comment and to request a hearing. 16
557-(3) F
558-INAL RULE.—After the conclusion of such 17
559-proceedings, the Attorney General shall issue a final 18
560-rule to implement this Act and the amendments 19
561-made by this Act in accordance with section 553 of 20
562-title 5, United States Code. 21
563-SEC. 6. PENALTIES. 22
564-(a) I
565-NGENERAL.—Section 401(b)(1) of the Con-23
566-trolled Substances Act (21 U.S.C. 841(b)(1)) is amend-24
567-ed— 25 22
568-†S 331 ES
572+paragraph(B)ofsection553(b)oftitle5,United 10
573+StatesCode. 11
574+(2)OPPORTUNITY FORCOMMENT ANDHEAR-12
575+ING.—Aninterimfinalruleissuedundersubsection 13
576+(a)shallgiveinterestedpersonstheopportunityto 14
577+commentandtorequestahearing. 15
578+(3)FINALRULE.—Aftertheconclusionofsuch 16
579+proceedings,theAttorneyGeneralshallissueafinal 17
580+ruletoimplementthisActandtheamendments 18
581+madebythisActinaccordancewithsection553of 19
582+title5,UnitedStatesCode. 20
583+SEC.6.PENALTIES. 21
584+(a)INGENERAL.—Section401(b)(1)oftheCon-22
585+trolledSubstancesAct(21U.S.C.841(b)(1))isamend-23
586+ed— 24
587+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6401 E:\BILLS\S331.RS S331
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589+•S 331 RS
569590 (1)insubparagraph(A)(vi),byinserting‘‘ora 1
570591 fentanyl-relatedsubstance’’after‘‘anyanalogueof 2
571592 N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 3
572593 propanamide’’;and 4
573594 (2)insubparagraph(B)(vi),byinserting‘‘ora 5
574595 fentanyl-relatedsubstance’’after‘‘anyanalogueof 6
575596 N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 7
576597 propanamide’’. 8
577-(b) I
578-MPORTATION AND EXPORTATION.—Section 9
598+(b)IMPORTATION ANDEXPORTATION.—Section 9
579599 1010(b)oftheControlledSubstancesImportandExport 10
580600 Act(21U.S.C.960(b))isamended— 11
581601 (1)inparagraph(1)(F),byinserting‘‘ora 12
582602 fentanyl-relatedsubstance’’after‘‘anyanalogueof 13
583603 N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 14
584604 propanamide’’;and 15
585605 (2)inparagraph(2)(F),byinserting‘‘ora 16
586606 fentanyl-relatedsubstance’’after‘‘anyanalogueof 17
587607 N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 18
588608 propanamide’’. 19
589-(c) D
590-EFINITION OF FENTANYL-RELATED SUB-20
609+(c)DEFINITION OFFENTANYL-RELATEDSUB-20
591610 STANCE.—Section102oftheControlledSubstancesAct 21
592611 (21U.S.C.802)isamendedbyaddingattheendthefol-22
593-lowing: 23 23
594-†S 331 ES
612+lowing: 23
613+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6401 E:\BILLS\S331.RS S331
614+kjohnson on DSK7ZCZBW3PROD with $$_JOB 23
615+•S 331 RS
595616 ‘‘(60)Theterm‘fentanyl-relatedsubstance’hasthe 1
596617 meaninggiventheterminsubsection(e)(2)ofschedule 2
597618 Iofsection202(c).’’. 3
598619 SEC.7.APPLICABILITY; OTHERMATTERS. 4
599-(a) I
600-NGENERAL.—Irrespective of the date on which 5
601-the rules required by section 5 are finalized, the amend-6
620+(a)INGENERAL.—Irrespectiveofthedateonwhich 5
621+therulesrequiredbysection4arefinalized,theamend-6
602622 mentsmadebythisActapplybeginningasofthedate 7
603623 ofenactmentofthisAct. 8
604-(b) R
605-ULE OF CONSTRUCTION.—Nothing in the 9
624+(b)RULEOFCONSTRUCTION.—Nothinginthe 9
606625 amendmentsmadebythisActmaybeconstruedasevi-10
607-dence that, in applying sections 401(b)(1) of the Con-11
608-trolled Substances Act (21 U.S.C. 841(b)(1)) and 1010(b) 12
609-of the Controlled Substances Import and Export Act (21 13
610-U.S.C. 960(b)) with respect to conduct occurring before 14
611-the date of the enactment of this Act, a fentanyl-related 15
612-substance (as defined by such amendments) is not an ana-16
613-logue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 17
614-propanamide. 18
626+dencethat,inapplyingsections401(b)(1)and1010(b)of 11
627+theControlledSubstancesAct(21U.S.C.841(b)(1), 12
628+960(b))withrespecttoconductoccurringbeforethedate 13
629+oftheenactmentofthisAct,afentanyl-relatedsubstance 14
630+(asdefinedbysuchamendments)isnotananalogueof 15
631+N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 16
632+propanamide. 17
633+(c)SENSEOFCONGRESS.—Congressagreeswiththe 18
634+interpretationoftheControlledSubstancesAct(21 19
635+U.S.C.801etseq.)inUnitedStatesv.McCray,346F. 20
636+Supp.3d363(W.D.N.Y.2018). 21
637+SECTION 1. SHORT TITLE. 22
638+This Act may be cited as the ‘‘Halt All Lethal Traf-23
639+ficking of Fentanyl Act’’ or the ‘‘HALT Fentanyl Act’’. 24
640+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
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642+•S 331 RS
643+SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB-1
644+STANCES. 2
645+Section 202(c) of the Controlled Substances Act (21 3
646+U.S.C. 812(c)) is amended by adding at the end of schedule 4
647+I the following: 5
648+‘‘(e)(1) Unless specifically exempted or unless listed in 6
649+another schedule, any material, compound, mixture, or 7
650+preparation which contains any quantity of a fentanyl-re-8
651+lated substance, or which contains the salts, isomers, and 9
652+salts of isomers of a fentanyl-related substance whenever the 10
653+existence of such salts, isomers, and salts of isomers is pos-11
654+sible within the specific chemical designation. 12
655+‘‘(2) For purposes of paragraph (1), except as provided 13
656+in paragraph (3), the term ‘fentanyl-related substance’ 14
657+means any substance that is structurally related to fentanyl 15
658+by 1 or more of the following modifications: 16
659+‘‘(A) By replacement of the phenyl portion of the 17
660+phenethyl group by any monocycle, whether or not 18
661+further substituted in or on the monocycle. 19
662+‘‘(B) By substitution in or on the phenethyl 20
663+group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 21
664+haloalkyl, amino, or nitro groups. 22
665+‘‘(C) By substitution in or on the piperidine 23
666+ring with alkyl, alkenyl, alkoxyl, ester, ether, 24
667+hydroxyl, halo, haloalkyl, amino, or nitro groups. 25
668+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
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670+•S 331 RS
671+‘‘(D) By replacement of the aniline ring with 1
672+any aromatic monocycle whether or not further sub-2
673+stituted in or on the aromatic monocycle. 3
674+‘‘(E) By replacement of the N–propionyl group 4
675+with another acyl group. 5
676+‘‘(3) A substance that satisfies the definition of the 6
677+term ‘fentanyl-related substance’ in paragraph (2) shall 7
678+nonetheless not be treated as a fentanyl-related substance 8
679+subject to this schedule if the substance— 9
680+‘‘(A) is controlled by action of the Attorney Gen-10
681+eral under section 201; or 11
682+‘‘(B) is otherwise expressly listed in a schedule 12
683+other than this schedule. 13
684+‘‘(4)(A) The Attorney General may by order publish 14
685+in the Federal Register a list of substances that satisfy the 15
686+definition of the term ‘fentanyl-related substance’ in para-16
687+graph (2). 17
688+‘‘(B) The absence of a substance from a list published 18
689+under subparagraph (A) does not negate the control status 19
690+of the substance under this schedule if the substance satisfies 20
691+the definition of the term ‘fentanyl-related substance’ in 21
692+paragraph (2).’’. 22
693+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
694+kjohnson on DSK7ZCZBW3PROD with $$_JOB 26
695+•S 331 RS
696+SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RE-1
697+SEARCH. 2
698+(a) A
699+LTERNATIVEREGISTRATIONPROCESS FOR 3
700+S
701+CHEDULEI RESEARCH.—Section 303 of the Controlled 4
702+Substances Act (21 U.S.C. 823) is amended— 5
703+(1) by redesignating the second subsection (l) (re-6
704+lating to required training for prescribers) as sub-7
705+section (m); and 8
706+(2) by adding at the end the following: 9
707+‘‘(n) S
708+PECIALPROVISIONS FORPRACTITIONERSCON-10
709+DUCTINGCERTAINRESEARCHWITHSCHEDULEI CON-11
710+TROLLEDSUBSTANCES.— 12
711+‘‘(1) I
712+N GENERAL.—Notwithstanding subsection 13
713+(g), a practitioner may conduct research described in 14
714+paragraph (2) of this subsection with 1 or more 15
715+schedule I substances in accordance with subpara-16
716+graph (A) or (B) of paragraph (3) of this subsection. 17
717+‘‘(2) R
718+ESEARCH SUBJECT TO EXPEDITED PROCE -18
719+DURES.—Research described in this paragraph is re-19
720+search that— 20
721+‘‘(A) is with respect to a drug that is the 21
722+subject of an investigational use exemption under 22
723+section 505(i) of the Federal Food, Drug, and 23
724+Cosmetic Act (21 U.S.C. 355(i)); or 24
725+‘‘(B) is— 25
726+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
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728+•S 331 RS
729+‘‘(i) conducted by the Department of 1
730+Health and Human Services, the Depart-2
731+ment of Defense, or the Department of Vet-3
732+erans Affairs; or 4
733+‘‘(ii) funded partly or entirely by a 5
734+grant, contract, cooperative agreement, or 6
735+other transaction from the Department of 7
736+Health and Human Services, the Depart-8
737+ment of Defense, or the Department of Vet-9
738+erans Affairs. 10
739+‘‘(3) E
740+XPEDITED PROCEDURES .— 11
741+‘‘(A) R
742+ESEARCHER WITH A CURRENT 12
743+SCHEDULE I OR II RESEARCH REGISTRATION .— 13
744+‘‘(i) I
745+N GENERAL.—If a practitioner is 14
746+registered to conduct research with a con-15
747+trolled substance in schedule I or II, the 16
748+practitioner may conduct research under 17
749+this subsection on and after the date that is 18
750+30 days after the date on which the practi-19
751+tioner sends a notice to the Attorney Gen-20
752+eral containing the following information, 21
753+with respect to each substance with which 22
754+the practitioner will conduct the research: 23
755+‘‘(I) The chemical name of the 24
756+substance. 25
757+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00027 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
758+kjohnson on DSK7ZCZBW3PROD with $$_JOB 28
759+•S 331 RS
760+‘‘(II) The quantity of the sub-1
761+stance to be used in the research. 2
762+‘‘(III) Demonstration that the re-3
763+search is in the category described in 4
764+paragraph (2), which demonstration 5
765+may be satisfied— 6
766+‘‘(aa) in the case of a grant, 7
767+contract, cooperative agreement, 8
768+or other transaction, or intra-9
769+mural research project, by identi-10
770+fying the sponsoring agency and 11
771+supplying the number of the 12
772+grant, contract, cooperative agree-13
773+ment, other transaction, or 14
774+project; or 15
775+‘‘(bb) in the case of an appli-16
776+cation under section 505(i) of the 17
777+Federal Food, Drug, and Cosmetic 18
778+Act (21 U.S.C. 355(i)), by sup-19
779+plying the application number 20
780+and the sponsor of record on the 21
781+application. 22
782+‘‘(IV) Demonstration that the re-23
783+searcher is authorized to conduct re-24
784+search with respect to the substance 25
785+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
786+kjohnson on DSK7ZCZBW3PROD with $$_JOB 29
787+•S 331 RS
788+under the laws of the State in which 1
789+the research will take place. 2
790+‘‘(ii) V
791+ERIFICATION OF INFORMATION 3
792+BY HHS OR VA.—Upon request from the At-4
793+torney General, the Secretary of Health and 5
794+Human Services, the Department of De-6
795+fense, or the Secretary of Veterans Affairs, 7
796+as appropriate, shall verify information 8
797+submitted by an applicant under clause 9
798+(i)(III). 10
799+‘‘(B) R
800+ESEARCHER WITHOUT A CURRENT 11
801+SCHEDULE I OR II RESEARCH REGISTRATION .— 12
802+‘‘(i) I
803+N GENERAL.—If a practitioner is 13
804+not registered to conduct research with a 14
805+controlled substance in schedule I or II, the 15
806+practitioner may send a notice to the Attor-16
807+ney General containing the information 17
808+listed in subparagraph (A)(i), with respect 18
809+to each substance with which the practi-19
810+tioner will conduct the research. 20
811+‘‘(ii) A
812+TTORNEY GENERAL ACTION .— 21
813+The Attorney General shall— 22
814+‘‘(I) treat notice received under 23
815+clause (i) as a sufficient application 24
816+for a research registration; and 25
817+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
818+kjohnson on DSK7ZCZBW3PROD with $$_JOB 30
819+•S 331 RS
820+‘‘(II) not later than 45 days of re-1
821+ceiving such a notice that contains all 2
822+information required under subpara-3
823+graph (A)(i)— 4
824+‘‘(aa) register the applicant; 5
825+or 6
826+‘‘(bb) serve an order to show 7
827+cause upon the applicant in ac-8
828+cordance with section 304(c). 9
829+‘‘(4) E
830+LECTRONIC SUBMISSIONS.—The Attorney 10
831+General shall provide a means to permit a practi-11
832+tioner to submit a notification under paragraph (3) 12
833+electronically. 13
834+‘‘(5) L
835+IMITATION ON AMOUNTS .—A practitioner 14
836+conducting research with a schedule I substance under 15
837+this subsection may only possess the amounts of 16
838+schedule I substance identified in— 17
839+‘‘(A) the notification to the Attorney Gen-18
840+eral under paragraph (3); or 19
841+‘‘(B) a supplemental notification that the 20
842+practitioner may send if the practitioner needs 21
843+additional amounts for the research, which sup-22
844+plemental notification shall include— 23
845+‘‘(i) the name of the practitioner; 24
846+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00030 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
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848+•S 331 RS
849+‘‘(ii) the additional quantity needed of 1
850+the substance; and 2
851+‘‘(iii) an attestation that the research 3
852+to be conducted with the substance is con-4
853+sistent with the scope of the research that 5
854+was the subject of the notification under 6
855+paragraph (3). 7
856+‘‘(6) I
857+MPORTATION AND EXPORTATION REQUIRE -8
858+MENTS NOT AFFECTED .—Nothing in this subsection 9
859+alters the requirements of part A of title III, regard-10
860+ing the importation and exportation of controlled sub-11
861+stances. 12
862+‘‘(7) I
863+NSPECTOR GENERAL REPORT .—Not later 13
864+than 1 year after the date of enactment of the Halt 14
865+All Lethal Trafficking of Fentanyl Act, the Inspector 15
866+General of the Department of Justice shall complete 16
867+a study, and submit to Congress a report thereon, 17
868+about research described in paragraph (2) of this sub-18
869+section with fentanyl.’’. 19
870+(b) S
871+EPARATEREGISTRATIONSNOTREQUIRED FOR 20
872+A
873+DDITIONALRESEARCHER INSAMEINSTITUTION.— 21
874+(1) I
875+N GENERAL.—Section 302(c) of the Con-22
876+trolled Substances Act (21 U.S.C. 822(c)) is amended 23
877+by adding at the end the following: 24
878+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00031 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
879+kjohnson on DSK7ZCZBW3PROD with $$_JOB 32
880+•S 331 RS
881+‘‘(4) An agent or employee of a research institu-1
882+tion that is conducting research with a controlled sub-2
883+stance if— 3
884+‘‘(A) the agent or employee is acting within 4
885+the scope of the professional practice of the agent 5
886+or employee; 6
887+‘‘(B) another agent or employee of the insti-7
888+tution is registered to conduct research with a 8
889+controlled substance in the same schedule; 9
890+‘‘(C) the researcher who is so registered— 10
891+‘‘(i) informs the Attorney General of 11
892+the name, position title, and employing in-12
893+stitution of the agent or employee who is 13
894+not separately registered; 14
895+‘‘(ii) authorizes that agent or employee 15
896+to perform research under the registration of 16
897+the registered researcher; and 17
898+‘‘(iii) affirms that any act taken by 18
899+that agent or employee involving a con-19
900+trolled substance shall be attributable to the 20
901+registered researcher, as if the researcher 21
902+had directly committed the act, for purposes 22
903+of any proceeding under section 304(a) to 23
904+suspend or revoke the registration of the reg-24
905+istered researcher; and 25
906+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00032 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
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908+•S 331 RS
909+‘‘(D) the Attorney General does not, within 1
910+30 days of receiving the information, authoriza-2
911+tion, and affirmation described in subparagraph 3
912+(C), refuse, for a reason listed in section 304(a), 4
913+to allow the agent or employee to possess the sub-5
914+stance without a separate registration.’’. 6
915+(2) T
916+ECHNICAL CORRECTION.—Section 302(c)(3) 7
917+of the Controlled Substances Act (21 U.S.C. 822(c)(3)) 8
918+is amended by striking ‘‘(25)’’ and inserting ‘‘(27)’’. 9
615919 (c) S
616-ENSE OFCONGRESS.—Congress agrees with the 19
617-interpretation of the Controlled Substances Act (21 20 24
618-†S 331 ES
619-U.S.C. 801 et seq.) in United States v. McCray, 346 F. 1
620-Supp. 3d 363 (W.D.N.Y. 2018). 2
621-Passed the Senate March 14, 2025.
622-Attest:
623-Secretary. 119
920+INGLEREGISTRATION FORRELATEDRESEARCH 10
921+S
922+ITES.—Section 302(e) of the Controlled Substances Act (21 11
923+U.S.C. 822(e)) is amended by adding at the end the fol-12
924+lowing: 13
925+‘‘(4)(A) Notwithstanding paragraph (1), a person reg-14
926+istered to conduct research with a controlled substance 15
927+under section 303(g) may conduct the research under a sin-16
928+gle registration if— 17
929+‘‘(i) the research occurs exclusively on sites all of 18
930+which are— 19
931+‘‘(I) within the same city or county; and 20
932+‘‘(II) under the control of the same institu-21
933+tion, organization, or agency; and 22
934+‘‘(ii) before commencing the research, the re-23
935+searcher notifies the Attorney General of each site 24
936+where— 25
937+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00033 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
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939+•S 331 RS
940+‘‘(I) the research will be conducted; or 1
941+‘‘(II) the controlled substance will be stored 2
942+or administered. 3
943+‘‘(B) A site described in subparagraph (A) shall be in-4
944+cluded in a registration described in that subparagraph 5
945+only if the researcher has notified the Attorney General of 6
946+the site— 7
947+‘‘(i) in the application for the registration; or 8
948+‘‘(ii) before the research is conducted, or before 9
949+the controlled substance is stored or administered, at 10
950+the site. 11
951+‘‘(C) The Attorney General may, in consultation with 12
952+the Secretary, issue regulations addressing, with respect to 13
953+research sites described in subparagraph (A)— 14
954+‘‘(i) the manner in which controlled substances 15
955+may be delivered to the research sites; 16
956+‘‘(ii) the storage and security of controlled sub-17
957+stances at the research sites; 18
958+‘‘(iii) the maintenance of records for the research 19
959+sites; and 20
960+‘‘(iv) any other matters necessary to ensure effec-21
961+tive controls against diversion at the research sites.’’. 22
962+(d) N
963+EWINSPECTIONNOTREQUIRED INCERTAINSIT-23
964+UATIONS.—Section 302(f) of the Controlled Substances Act 24
965+(21 U.S.C. 822(f)) is amended— 25
966+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00034 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
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968+•S 331 RS
969+(1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 1
970+The’’; and 2
971+(2) by adding at the end the following: 3
972+‘‘(2)(A) If a person is registered to conduct research 4
973+with a controlled substance and applies for a registration, 5
974+or for a modification of a registration, to conduct research 6
975+with a second controlled substance that is in the same sched-7
976+ule as the first controlled substance, or is in a schedule with 8
977+a higher numerical designation than the schedule of the first 9
978+controlled substance, a new inspection by the Attorney Gen-10
979+eral of the registered location is not required. 11
980+‘‘(B) Nothing in subparagraph (A) shall prohibit the 12
981+Attorney General from conducting an inspection that the 13
982+Attorney General determines necessary to ensure that a reg-14
983+istrant maintains effective controls against diversion.’’. 15
984+(e) C
985+ONTINUATION OF RESEARCH ON SUBSTANCES 16
986+N
987+EWLYADDED TOSCHEDULEI.—Section 302 of the Con-17
988+trolled Substances Act (21 U.S.C. 822) is amended by add-18
989+ing at the end the following: 19
990+‘‘(h) C
991+ONTINUATION OFRESEARCH ONSUBSTANCES 20
992+N
993+EWLYADDED TOSCHEDULEI.—If a person is conducting 21
994+research on a substance when the substance is added to 22
995+schedule I, and the person is already registered to conduct 23
996+research with a controlled substance in schedule I— 24
997+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00035 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
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999+•S 331 RS
1000+‘‘(1) not later than 90 days after the scheduling 1
1001+of the newly scheduled substance, the person shall sub-2
1002+mit a completed application for registration or modi-3
1003+fication of existing registration, to conduct research 4
1004+on the substance, in accordance with regulations 5
1005+issued by the Attorney General for purposes of this 6
1006+paragraph; 7
1007+‘‘(2) the person may, notwithstanding sub-8
1008+sections (a) and (b), continue to conduct the research 9
1009+on the substance until— 10
1010+‘‘(A) the person withdraws the application 11
1011+described in paragraph (1) of this subsection; or 12
1012+‘‘(B) the Attorney General serves on the per-13
1013+son an order to show cause proposing the denial 14
1014+of the application under section 304(c); 15
1015+‘‘(3) if the Attorney General serves an order to 16
1016+show cause as described in paragraph (2)(B) and the 17
1017+person requests a hearing, the hearing shall be held on 18
1018+an expedited basis and not later than 45 days after 19
1019+the request is made, except that the hearing may be 20
1020+held at a later time if so requested by the person; and 21
1021+‘‘(4) if the person sends a copy of the application 22
1022+described in paragraph (1) to a manufacturer or dis-23
1023+tributor of the substance, receipt of the copy by the 24
1024+manufacturer or distributor shall constitute sufficient 25
1025+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00036 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
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1027+•S 331 RS
1028+evidence that the person is authorized to receive the 1
1029+substance.’’. 2
1030+(f) T
1031+REATMENT OFCERTAINMANUFACTURINGACTIVI-3
1032+TIES ASCOINCIDENT TORESEARCH.—Section 302 of the 4
1033+Controlled Substances Act (21 U.S.C. 822), as amended by 5
1034+subsection (e), is amended by adding at the end the fol-6
1035+lowing: 7
1036+‘‘(i) T
1037+REATMENT OFCERTAINMANUFACTURINGAC-8
1038+TIVITIES ASCOINCIDENT TORESEARCH.— 9
1039+‘‘(1) I
1040+N GENERAL.—Except as provided in para-10
1041+graph (3), a person who is registered to perform re-11
1042+search on a controlled substance may perform manu-12
1043+facturing activities with small quantities of that sub-13
1044+stance, including activities described in paragraph 14
1045+(2), without being required to obtain a manufac-15
1046+turing registration, if— 16
1047+‘‘(A) the activities are performed for the 17
1048+purpose of the research; and 18
1049+‘‘(B) the activities and the quantities of the 19
1050+substance involved in the activities are stated 20
1051+in— 21
1052+‘‘(i) a notification submitted to the At-22
1053+torney General under section 303(n); 23
1054+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00037 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
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1056+•S 331 RS
1057+‘‘(ii) a research protocol filed with an 1
1058+application for registration approval under 2
1059+section 303(g); or 3
1060+‘‘(iii) a notification to the Attorney 4
1061+General that includes— 5
1062+‘‘(I) the name of the registrant; 6
1063+and 7
1064+‘‘(II) an attestation that the re-8
1065+search to be conducted with the small 9
1066+quantities of manufactured substance 10
1067+is consistent with the scope of the re-11
1068+search that is the basis for the registra-12
1069+tion. 13
1070+‘‘(2) A
1071+CTIVITIES INCLUDED.—Activities per-14
1072+mitted under paragraph (1) include— 15
1073+‘‘(A) processing the substance to create ex-16
1074+tracts, tinctures, oils, solutions, derivatives, or 17
1075+other forms of the substance consistent with— 18
1076+‘‘(i) the information provided as part 19
1077+of a notification submitted to the Attorney 20
1078+General under section 303(n); or 21
1079+‘‘(ii) a research protocol filed with an 22
1080+application for registration approval under 23
1081+section 303(g); and 24
1082+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00038 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
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1084+•S 331 RS
1085+‘‘(B) dosage form development studies per-1
1086+formed for the purpose of requesting an inves-2
1087+tigational new drug exemption under section 3
1088+505(i) of the Federal Food, Drug, and Cosmetic 4
1089+Act (21 U.S.C. 355(i)). 5
1090+‘‘(3) E
1091+XCEPTION REGARDING MARIHUANA .—The 6
1092+authority under paragraph (1) to manufacture sub-7
1093+stances does not include the authority to grow mari-8
1094+huana.’’. 9
1095+(g) T
1096+RANSPARENCY REGARDINGSPECIALPROCE-10
1097+DURES.—Section 303 of the Controlled Substances Act (21 11
1098+U.S.C. 823), as amended by subsection (a), is amended by 12
1099+adding at the end the following: 13
1100+‘‘(o) T
1101+RANSPARENCYREGARDINGSPECIALPROCE-14
1102+DURES.— 15
1103+‘‘(1) I
1104+N GENERAL.—If the Attorney General de-16
1105+termines, with respect to a controlled substance, that 17
1106+an application by a practitioner to conduct research 18
1107+with the substance should be considered under a proc-19
1108+ess, or subject to criteria, different from the process or 20
1109+criteria applicable to applications to conduct research 21
1110+with other controlled substances in the same schedule, 22
1111+the Attorney General shall make public, including by 23
1112+posting on the website of the Drug Enforcement Ad-24
1113+ministration— 25
1114+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00039 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
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1116+•S 331 RS
1117+‘‘(A) the identities of all substances for 1
1118+which such determinations have been made; 2
1119+‘‘(B) the process and criteria that shall be 3
1120+applied to applications to conduct research with 4
1121+those substances; and 5
1122+‘‘(C) how the process and criteria described 6
1123+in subparagraph (B) differ from the process and 7
1124+criteria applicable to applications to conduct re-8
1125+search with other controlled substances in the 9
1126+same schedule. 10
1127+‘‘(2) T
1128+IMING OF POSTING.—The Attorney General 11
1129+shall make information described in paragraph (1) 12
1130+public upon making a determination described in 13
1131+that paragraph, regardless of whether a practitioner 14
1132+has submitted such an application at that time.’’. 15
1133+SEC. 4. TECHNICAL CORRECTION ON CONTROLLED SUB-16
1134+STANCES DISPENSING. 17
1135+Effective as if included in the enactment of Public Law 18
1136+117–328— 19
1137+(1) section 1252(a) of division FF of Public Law 20
1138+117–328 (136 Stat. 5681) is amended, in the matter 21
1139+being inserted into section 302(e) of the Controlled 22
1140+Substances Act, by striking ‘‘303(g)’’ and inserting 23
1141+‘‘303(h)’’; 24
1142+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00040 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
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1144+•S 331 RS
1145+(2) section 1262 of division FF of Public Law 1
1146+117–328 (136 Stat. 5681) is amended— 2
1147+(A) in subsection (a)— 3
1148+(i) in the matter preceding paragraph 4
1149+(1), by striking ‘‘303(g)’’ and inserting 5
1150+‘‘303(h)’’; 6
1151+(ii) in the matter being stricken by 7
1152+subsection (a)(2), by striking ‘‘(g)(1)’’ and 8
1153+inserting ‘‘(h)(1)’’; and 9
1154+(iii) in the matter being inserted by 10
1155+subsection (a)(2), by striking ‘‘(g) Practi-11
1156+tioners’’ and inserting ‘‘(h) Practitioners’’; 12
1157+and 13
1158+(B) in subsection (b)— 14
1159+(i) in the matter being stricken by 15
1160+paragraph (1), by striking ‘‘303(g)(1)’’ and 16
1161+inserting ‘‘303(h)(1)’’; 17
1162+(ii) in the matter being inserted by 18
1163+paragraph (1), by striking ‘‘303(g)’’ and in-19
1164+serting ‘‘303(h)’’; 20
1165+(iii) in the matter being stricken by 21
1166+paragraph (2)(A), by striking ‘‘303(g)(2)’’ 22
1167+and inserting ‘‘303(h)(2)’’; 23
1168+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00041 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
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1170+•S 331 RS
1171+(iv) in the matter being stricken by 1
1172+paragraph (3), by striking ‘‘303(g)(2)(B)’’ 2
1173+and inserting ‘‘303(h)(2)(B)’’; 3
1174+(v) in the matter being stricken by 4
1175+paragraph (5), by striking ‘‘303(g)’’ and in-5
1176+serting ‘‘303(h)’’; and 6
1177+(vi) in the matter being stricken by 7
1178+paragraph (6), by striking ‘‘303(g)’’ and in-8
1179+serting ‘‘303(h)’’; and 9
1180+(3) section 1263(b) of division FF of Public Law 10
1181+117–328 (136 Stat. 5685) is amended— 11
1182+(A) by striking ‘‘303(g)(2)’’ and inserting 12
1183+‘‘303(h)(2)’’; and 13
1184+(B) by striking ‘‘(21 U.S.C. 823(g)(2))’’ and 14
1185+inserting ‘‘(21 U.S.C. 823(h)(2))’’. 15
1186+SEC. 5. RULEMAKING. 16
1187+(a) I
1188+NTERIMFINALRULES.—The Attorney General— 17
1189+(1) shall, not later than 6 months after the date 18
1190+of enactment of this Act, issue rules to implement this 19
1191+Act and the amendments made by this Act; and 20
1192+(2) may issue the rules under paragraph (1) as 21
1193+interim final rules. 22
1194+(b) P
1195+ROCEDURE FORFINALRULE.— 23
1196+(1) E
1197+FFECTIVENESS OF INTERIM FINAL RULES .— 24
1198+A rule issued by the Attorney General as an interim 25
1199+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00042 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
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1201+•S 331 RS
1202+final rule under subsection (a) shall become imme-1
1203+diately effective as an interim final rule without re-2
1204+quiring the Attorney General to demonstrate good 3
1205+cause therefor, notwithstanding subparagraph (B) of 4
1206+the undesignated matter following paragraph (4) of 5
1207+section 553(b) of title 5, United States Code. 6
1208+(2) O
1209+PPORTUNITY FOR COMMENT AND HEAR -7
1210+ING.—An interim final rule issued under subsection 8
1211+(a) shall give interested persons the opportunity to 9
1212+comment and to request a hearing. 10
1213+(3) F
1214+INAL RULE.—After the conclusion of such 11
1215+proceedings, the Attorney General shall issue a final 12
1216+rule to implement this Act and the amendments made 13
1217+by this Act in accordance with section 553 of title 5, 14
1218+United States Code. 15
1219+SEC. 6. PENALTIES. 16
1220+(a) I
1221+NGENERAL.—Section 401(b)(1) of the Controlled 17
1222+Substances Act (21 U.S.C. 841(b)(1)) is amended— 18
1223+(1) in subparagraph (A)(vi), by inserting ‘‘or a 19
1224+fentanyl-related substance’’ after ‘‘any analogue of N- 20
1225+phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 21
1226+propanamide’’; and 22
1227+(2) in subparagraph (B)(vi), by inserting ‘‘or a 23
1228+fentanyl-related substance’’ after ‘‘any analogue of N- 24
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1231+•S 331 RS
1232+phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 1
1233+propanamide’’. 2
1234+(b) I
1235+MPORTATION AND EXPORTATION.—Section 3
1236+1010(b) of the Controlled Substances Import and Export 4
1237+Act (21 U.S.C. 960(b)) is amended— 5
1238+(1) in paragraph (1)(F), by inserting ‘‘or a 6
1239+fentanyl-related substance’’ after ‘‘any analogue of N- 7
1240+phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 8
1241+propanamide’’; and 9
1242+(2) in paragraph (2)(F), by inserting ‘‘or a 10
1243+fentanyl-related substance’’ after ‘‘any analogue of N- 11
1244+phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 12
1245+propanamide’’. 13
1246+(c) D
1247+EFINITION OF FENTANYL-RELATED SUB-14
1248+STANCE.—Section 102 of the Controlled Substances Act (21 15
1249+U.S.C. 802) is amended by adding at the end the following: 16
1250+‘‘(60) The term ‘fentanyl-related substance’ has the 17
1251+meaning given the term in subsection (e)(2) of schedule I 18
1252+of section 202(c).’’. 19
1253+SEC. 7. APPLICABILITY; OTHER MATTERS. 20
1254+(a) I
1255+NGENERAL.—Irrespective of the date on which 21
1256+the rules required by section 5 are finalized, the amend-22
1257+ments made by this Act apply beginning as of the date of 23
1258+enactment of this Act. 24
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1261+•S 331 RS
1262+(b) RULE OFCONSTRUCTION.—Nothing in the amend-1
1263+ments made by this Act may be construed as evidence that, 2
1264+in applying sections 401(b)(1) of the Controlled Substances 3
1265+Act (21 U.S.C. 841(b)(1)) and 1010(b) of the Controlled 4
1266+Substances Import and Export Act (21 U.S.C. 960(b)) with 5
1267+respect to conduct occurring before the date of the enactment 6
1268+of this Act, a fentanyl-related substance (as defined by such 7
1269+amendments) is not an analogue of N-phenyl-N-[1-(2- 8
1270+phenylethyl)-4-piperidinyl] propanamide. 9
1271+(c) S
1272+ENSE OFCONGRESS.—Congress agrees with the 10
1273+interpretation of the Controlled Substances Act (21 U.S.C. 11
1274+801 et seq.) in United States v. McCray, 346 F. Supp. 3d 12
1275+363 (W.D.N.Y. 2018). 13
1276+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00045 Fmt 6652 Sfmt 6203 E:\BILLS\S331.RS S331
1277+kjohnson on DSK7ZCZBW3PROD with $$_JOB Calendar No.
1278+18
1279+119
6241280 TH
6251281 CONGRESS
6261282 1
6271283 ST
6281284 S
6291285 ESSION
6301286
631-S. 331
632-AN ACT
1287+S. 331 A BILL
6331288 To amend the Controlled Substances Act with re-
6341289 spect to the scheduling of fentanyl-related sub-
6351290 stances, and for other purposes.
1291+M
1292+ARCH
1293+3, 2025
1294+Reported with an amendment
1295+VerDate Sep 11 2014 22:38 Mar 03, 2025 Jkt 059200 PO 00000 Frm 00046 Fmt 6651 Sfmt 6651 E:\BILLS\S331.RS S331
1296+kjohnson on DSK7ZCZBW3PROD with $$_JOB