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Referenced Laws
21 U.S.C. 812(c)
28 U.S.C. 801
Public Law 119–26
21 U.S.C. 811(h)
Section 1
1. Short title This Act may be cited as the Nitazene Control Act.
Section 2
2. Findings Congress finds the following: 2-Benzylbenzimidazole opioids are a class of synthetic opioids first synthesized in the 1950s that exhibit significant potency at the mu-opioid receptor, with some substances exceeding the potency of fentanyl. The Drug Enforcement Administration has temporarily or permanently scheduled multiple 2-benzylbenzimidazole opioids compounds under schedule I of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) due to their high abuse potential and lack of accepted medical use. Nitazenes and related compounds have emerged in the illicit drug supply as designer drugs and contribute to overdose and fatal poisonings in the United States. A class-wide permanent scheduling of 2-benzylbenzimidazole opioids is necessary to preemptively address the proliferation of new analogs, streamline enforcement, and protect public health. The HALT Fentanyl Act (28 U.S.C. 801 note; Public Law 119–26) created pathways for research using schedule I controlled substances that apply to scheduled nitazenes.
Section 3
3. Schedule I classification of nitazenes Schedule I of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) is amended by adding at the end the following: Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of a 2-benzylbenzimidazole opioid, or which contains the salts, isomers, and salts of isomers of a 2-benzylbenzimidazole opioid. For purposes of paragraph (1), the term 2-benzylbenzimidazole opioid includes the following: A substance that is structurally related to 2-benzylbenzimidazole with the following modifications: At the 1-position, substitution with an alkyl linker connected to a substituted amine group containing hydrogen, alkyl, alkenyl, or heteroaryl group, such as a morphilino, pyrrolidino, or piperidinyl groups, whether or not further substituted. At the 2-position— replacement of the alkyl portion of the benzyl group with a substituted or unsubstituted alkyl, alkoxy, carbamates group, nitrogen, sulfur, or oxygen atom; or replacement of the phenyl portion of the benzyl group with an aryl or heteroaryl group. Substitution on the phenyl portion of the benzimidazole ring with a hydrogen atom, halogen, nitro, cyano, substituted or unsubstituted amide, amine, alkyl, alkoxy, aryl, or heteroaryl group. At the 6-position, substitution with hydrogen, nitro, trifluoromethyl, methoxy, trifluoromethoxy, cyano, and halogen groups. A substance that exhibits agonist activity at the mu-opioid receptor. Etonitazene, clonitazene, metonitazene, isotonitazene, protonitazene, butonitazene, etodesnitazene, flunitazene, N-pyrrolidino etonitazene, N-desethyl isotonitazene, and N-piperidinyl etonitazene. Any substance included in the amendment made by subsection (a) that was temporarily scheduled under section 201(h) of the Controlled Substances Act (21 U.S.C. 811(h)) shall be deemed permanently scheduled and subject to the requirements of schedule I of section 202(c) of that Act (21 U.S.C. 812(c)) as of the date of enactment of this Act. Nothing in this subsection shall be construed to authorize the initiation of new research using 2-benzylbenzimidazole opioids, as defined in subsection (f) of schedule I of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)), as added by subsection (a) of this section, without proper registration and scheduling compliance. (f)
(1)
Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of a 2-benzylbenzimidazole opioid, or which contains the salts, isomers, and salts of isomers of a 2-benzylbenzimidazole opioid.
(2)
For purposes of paragraph (1), the term 2-benzylbenzimidazole opioid includes the following:
(A)
A substance that is structurally related to 2-benzylbenzimidazole with the following modifications:
(i)
At the 1-position, substitution with an alkyl linker connected to a substituted amine group containing hydrogen, alkyl, alkenyl, or heteroaryl group, such as a morphilino, pyrrolidino, or piperidinyl groups, whether or not further substituted.
(ii)
At the 2-position—
(I)
replacement of the alkyl portion of the benzyl group with a substituted or unsubstituted alkyl, alkoxy, carbamates group, nitrogen, sulfur, or oxygen atom; or
(II)
replacement of the phenyl portion of the benzyl group with an aryl or heteroaryl group.
(iii)
Substitution on the phenyl portion of the benzimidazole ring with a hydrogen atom, halogen, nitro, cyano, substituted or unsubstituted amide, amine, alkyl, alkoxy, aryl, or heteroaryl group.
(iv)
At the 6-position, substitution with hydrogen, nitro, trifluoromethyl, methoxy, trifluoromethoxy, cyano, and halogen groups.
(B)
A substance that exhibits agonist activity at the mu-opioid receptor.
(C)
Etonitazene, clonitazene, metonitazene, isotonitazene, protonitazene, butonitazene, etodesnitazene, flunitazene, N-pyrrolidino etonitazene, N-desethyl isotonitazene, and N-piperidinyl etonitazene.
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