Source: https://www.law.cornell.edu/cfr/text/21/1308.45
Timestamp: 2018-10-18 22:18:39
Document Index: 403873054

Matched Legal Cases: ['art 1308', '§ 1308', '§ 811', '§ 812', '§ 821', '§ 871', 'art 1308', 'arts 1300', 'arts 1300', 'arts 1301']

21 CFR 1308.45 - Final order. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter II › Part 1308 › Section 1308.45
21 CFR 1308.45 - Final order.
§ 1308.45 Final order.
[ 38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesignated at 62 FR 13968, Mar. 24, 1997]
§ 811 - Authority and criteria for classification of substances
§ 812 - Schedules of controlled substances
§ 821 - Rules and regulations
§ 871 - Attorney General
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 1308 after this date.
2018-06-13; vol. 83 # 114 - Wednesday, June 13, 2018
83 FR 27520 - Schedules of Controlled Substances: Temporary Placement of N-Ethylpentylone in Schedule I
FR Doc. 2018-12669
Docket No. DEA-482
DEPARTMENT OF JUSTICE, Drug Enforcement Administration
Proposed amendment; notice of intent.
The Acting Administrator of the Drug Enforcement Administration is publishing this notice of intent to issue an order temporarily scheduling N -1-(1,3-benzodioxol-5-yl)-2-(ethylamino)-1-pentanone ( N -ethylpentylone, ephylone) in schedule I. This action is based on a finding by the Acting Administrator that the placement of N -ethylpentylone in schedule I is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose regulatory requirements under the Controlled Substances Act (CSA) on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of N -ethylpentylone, as well as administrative, civil, and criminal remedies with respect to persons who fail to comply with such requirements or otherwise violate the CSA with respect to N -ethylpentylone.
83 FR 24696 - Schedules of Controlled Substances: Temporary Placement of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA Into Schedule I
FR Doc. 2018-11531
Docket No. DEA-479
The Acting Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule the synthetic cannabinoids, Naphthalen-1-yl 1-(5-fluoropentyl)-1 H -indole-3-carboxylate (trivial name: NM2201; CBL2201); N -(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1 H -indazole-3-carboxamide (trivial name: 5F-AB-PINACA); 1-(4-cyanobutyl)- N -(2-phenylpropan-2-yl)-1 H -indazole-3-carboxamide (trivial name: 4-CN-CUMYL-BUTINACA; 4-cyano-CUMYL-BUTINACA; 4-CN-CUMYL BINACA; CUMYL-4CN-BINACA; SGT-78); methyl 2-(1-(cyclohexylmethyl)-1 H -indole-3-carboxamido)-3-methylbutanoate (trivial names: MMB-CHMICA, AMB-CHMICA); and 1-(5-fluoropentyl)- N -(2-phenylpropan-2-yl)-1 H -pyrrolo[2,3-b]pyridine-3-carboxamide (trivial name: 5F-CUMYL-P7AICA), in schedule I. This action is based on a finding by the Acting Administrator that the placement of these synthetic cannabinoids in schedule I of the Controlled Substances Act (CSA) is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose regulatory requirements under the CSA on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of these synthetic cannabinoids, as well as administrative, civil, and criminal remedies with respect to persons who fail to comply with such requirements or otherwise violate the CSA with respect to these substances.
83 FR 21826 - Schedules of Controlled Substances: Placement of beta-Hydroxythiofentanyl Into Schedule I
FR Doc. 2018-10008
Docket No. DEA-484
Comments must be submitted electronically or postmarked on or before June 11, 2018. Interested persons may file a request for hearing or waiver of hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.45 and/or 1316.47, as applicable. Requests for hearing and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before June 11, 2018.
The Drug Enforcement Administration proposes placing beta-hydroxythiofentanyl ( N -[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]- N -phenylpropionamide) also known as N-[1-[2-hydroxy-2-(2-thienyl)ethyl]4-piperidinyl]N-phenyl-propanamide including its isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle beta-hydroxythiofentanyl.
83 FR 21834 - Schedules of Controlled Substances: Extension of Temporary Placement of beta-Hydroxythiofentanyl in Schedule I of the Controlled Substances Act
FR Doc. 2018-10009
Temporary rule; temporary scheduling order; extension.
This temporary scheduling order, which extends the final order (81 FR 29492, May 12, 2016), is effective May 12, 2018 and expires on May 12, 2019. If this order is made permanent, the DEA will publish a document in the Federal Register on or before May 12, 2019.
The Acting Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of beta-hydroxythiofentanyl ( N -[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]- N -phenylpropionamide) also known as N -[1-[2-hydroxy-2-(2-thienyl)ethyl]-4-piperidinyl]- N -phenylpropanamide including its isomers, esters, ethers, salts and salts of isomers, esters and ethers. The schedule I status of beta-hydroxythiofentanyl currently is in effect through May 12, 2018. This temporary order will extend the temporary scheduling of beta-hydroxythiofentanyl for one year, or until the permanent scheduling action for this substance is completed, whichever occurs first.
2018-04-20; vol. 83 # 77 - Friday, April 20, 2018
83 FR 17486 - Schedules of Controlled Substances: Placement of Butyryl Fentanyl and U-47700 Into Schedule I
FR Doc. 2018-08280
Docket No. DEA-478
Effective April 20, 2018.
With the issuance of this final order, the Administrator of the Drug Enforcement Administration maintains the placement of the substances butyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylbutanamide) and U-47700 (3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide), including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. This scheduling action discharges the United States obligations under the Single Convention on Narcotic Drugs (1961). This action continues to impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research or conduct instructional activities with, or possess), or propose to handle, butyryl fentanyl and U-47700.
2018-03-09; vol. 83 # 47 - Friday, March 9, 2018
83 FR 10367 - Schedules of Controlled Substances: Temporary Placement of Seven Fentanyl-Related Substances in Schedule I; Correction
FR Doc. 2018-04765
Docket No. DEA-475
Temporary amendment; temporary scheduling order; correcting amendment.
Effective March 9, 2018 until February 1, 2020.
83 FR 5188 - Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I
FR Doc. 2018-02319
Docket No. DEA-476
This temporary scheduling order is effective February 6, 2018, until February 6, 2020. If this order is extended or made permanent, the DEA will publish a document in the Federal Register .
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule fentanyl-related substances that are not currently listed in any schedule of the Controlled Substances Act (CSA) and their isomers, esters, ethers, salts and salts of isomers, esters, and ethers in schedule I. This action is based on a finding by the Administrator that the placement of these synthetic opioids in schedule I is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle fentanyl-related substances.
83 FR 4580 - Schedules of Controlled Substances: Temporary Placement of Seven Fentanyl-Related Substances in Schedule I
FR Doc. 2018-02008
This temporary scheduling order is effective February 1, 2018, until February 1, 2020. If this order is extended or made permanent, the DEA will publish a document in the Federal Register .
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule seven fentanyl-related substances in schedule I. These seven substances are: N -(1-phenethylpiperidin-4-yl)- N -phenylpentanamide (valeryl fentanyl), N -(4-fluorophenyl)- N -(1-phenethylpiperidin-4-yl)butyramide ( para -fluorobutyryl fentanyl), N -(4-methoxyphenyl)- N -(1-phenethylpiperidin-4-yl)butyramide ( para -methoxybutyryl fentanyl), N -(4-chlorophenyl)- N -(1-phenethylpiperidin-4-yl)isobutyramide ( para -chloroisobutyryl fentanyl), N -(1-phenethylpiperidin-4-yl)- N -phenylisobutyramide (isobutyryl fentanyl), N -(1-phenethylpiperidin-4-yl)- N -phenylcyclopentanecarboxamide (cyclopentyl fentanyl), and N -(2-fluorophenyl)-2-methoxy- N -(1-phenethylpiperidin-4-yl)acetamide (ocfentanil). This action is based on a finding by the Administrator that the placement of these seven synthetic opioids in schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, valeryl fentanyl, para -fluorobutyryl fentanyl, para -methoxybutyryl fentanyl, para -chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil.
83 FR 4406 - Schedules of Controlled Substances: Placement of MAB-CHMINACA Into Schedule I
FR Doc. 2018-01747
Docket No. DEA-421
Comments must be submitted electronically or postmarked on or before March 1, 2018. Interested persons may file a request for hearing or waiver of hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.45 and/or 1316.47, as applicable. Requests for hearing and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before March 1, 2018.
The Drug Enforcement Administration proposes placing N -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H -indazole-3-carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle MAB-CHMINACA.
83 FR 4411 - Schedules of Controlled Substances: Extension of Temporary Placement of MAB-CHMINACA in Schedule I of the Controlled Substances Act
FR Doc. 2018-01746
This temporary scheduling order, which extends the final order (81 FR 6171, February 5, 2016), is effective February 5, 2018 and expires on February 5, 2019. If DEA publishes a final rule making this scheduling action permanent, this order will expire on the effective date of that rule, if the effective date is earlier than February 5, 2019.
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of a synthetic cannabinoid, N -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H -indazole-3-carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA), including its optical, positional and geometric isomers, salts, and salts of isomers. The schedule I status of MAB-CHMINACA currently is in effect through February 4, 2018. This temporary order will extend the temporary scheduling of MAB-CHMINACA for one year, or until the permanent scheduling action for this substance is completed, whichever occurs first.
2018-01-04; vol. 83 # 3 - Thursday, January 4, 2018
83 FR 469 - Schedules of Controlled Substances: Temporary Placement of Cyclopropyl Fentanyl in Schedule I
FR Doc. 2017-28470
Docket No. DEA-474
This temporary scheduling order is effective January 4, 2018, until January 4, 2020. If this order is extended or made permanent, the DEA will publish a document in the Federal Register .
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic opioid, N -(1-phenethylpiperidin-4-yl)- N -phenylcyclopropanecarboxamide (cyclopropyl fentanyl), and its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers in schedule I. This action is based on a finding by the Administrator that the placement of cyclopropyl fentanyl in schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, cyclopropyl fentanyl.
82 FR 61700 - Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I
FR Doc. 2017-28114
82 FR 58557 - Schedules of Controlled Substances: Placement of MT-45 Into Schedule I
FR Doc. 2017-26853
Docket No. DEA-451
Effective January 12, 2018.
With the issuance of this final order, the Administrator of the Drug Enforcement Administration places the substance MT-45 (Systematic IUPAC Name: 1-cyclohexyl-4-(1,2-diphenylethyl)piperazine), including its salts, isomers, and salts of isomers into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act and is required in order for the United States to discharge its obligations under the Single Convention on Narcotic Drugs, 1961. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research or conduct instructional activities with, or possess), or propose to handle, MT-45.
82 FR 58575 - Schedules of Controlled Substances: Temporary Placement of Seven Fentanyl-Related Substances in Schedule I
FR Doc. 2017-26854
Proposed amendment; notification of intent.
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule seven fentanyl-related substances in schedule I. These seven substances are: N -(1-phenethylpiperidin-4-yl)- N -phenylpentanamide (valeryl fentanyl), N -(4-fluorophenyl)- N -(1-phenethylpiperidin-4-yl)butyramide ( para -fluorobutyryl fentanyl), N -(4-methoxyphenyl)- N -(1-phenethylpiperidin-4-yl)butyramide ( para -methoxybutyryl fentanyl), N -(4-chlorophenyl)- N -(1-phenethylpiperidin-4-yl)isobutyramide ( para -chloroisobutyryl fentanyl), N -(1-phenethylpiperidin-4-yl)- N -phenylisobutyramide (isobutyryl fentanyl), N -(1-phenethylpiperidin-4-yl)- N -phenylcyclopentanecarboxamide (cyclopentyl fentanyl), and N -(2-fluorophenyl)-2-methoxy- N -(1-phenethylpiperidin-4-yl)acetamide (ocfentanil). This action is based on a finding by the Administrator that the placement of these seven synthetic opioids in schedule I of the Controlled Substances Act (CSA) is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I controlled substances under the CSA on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of these synthetic opioids.
2017-11-22; vol. 82 # 224 - Wednesday, November 22, 2017
82 FR 55504 - Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] in Schedule II
FR Doc. 2017-25275
Docket No. DEA-344
The effective date of this final rulemaking is November 22, 2017.
This final rule adopts without changes an interim final rule with request for comments published in the Federal Register on March 23, 2017. On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9- trans -tetrahydrocannabinol (delta-9-THC)] oral solution. The Drug Enforcement Administration (DEA) maintains FDA-approved products of oral solutions containing dronabinol in schedule II of the Controlled Substances Act.
82 FR 55333 - Schedules of Controlled Substances: Temporary Placement of Cyclopropyl Fentanyl into Schedule I
FR Doc. 2017-25077
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule the synthetic opioid, N -(1-phenethylpiperidin-4-yl)- N -phenylcyclopropanecarboxamide (cyclopropyl fentanyl), into Schedule I. This action is based on a finding by the Administrator that the placement of this synthetic opioid into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to Schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of this synthetic opioid.
2017-11-03; vol. 82 # 212 - Friday, November 3, 2017
82 FR 51154 - Schedules of Controlled Substances: Temporary Placement of FUB-AMB Into Schedule I
FR Doc. 2017-24010
This temporary scheduling order is effective November 3, 2017, until November 4, 2019. If this order is extended or made permanent, the DEA will publish a document in the Federal Register .
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic cannabinoid, methyl 2-(1-(4-fluorobenzyl)-1 H -indazole-3-carboxamido)-3-methylbutanoate [FUB-AMB, MMB-FUBINACA, AMB-FUBINACA], and its optical, positional, and geometric isomers, salts, and salts of isomers into schedule I. This action is based on a finding by the Administrator that the placement of this synthetic cannabinoid into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, FUB-AMB.
82 FR 49504 - Schedules of Controlled Substances: Temporary Placement of ortho-Fluorofentanyl, Tetrahydrofuranyl Fentanyl, and Methoxyacetyl Fentanyl Into Schedule I
FR Doc. 2017-23206
Docket No. DEA-473
This temporary scheduling order is effective October 26, 2017, until October 28, 2019. If this order is extended or made permanent, the DEA will publish a document in the Federal Register .
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic opioids, N -(2-fluorophenyl)- N -(1-phenethylpiperidin-4-yl)propionamide ( ortho -fluorofentanyl or 2-fluorofentanyl), N -(1-phenethylpiperidin-4-yl)- N -phenyltetrahydrofuran-2-carboxamide (tetrahydrofuranyl fentanyl), and 2-methoxy- N -(1-phenethylpiperidin-4-yl)- N -phenylacetamide (methoxyacetyl fentanyl), into Schedule I. This action is based on a finding by the Administrator that the placement of ortho -fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to Schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, ortho -fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl.
82 FR 47971 - Schedules of Controlled Substances: Placement of AB-CHMINACA, AB-PINACA and THJ-2201 Into Schedule I
FR Doc. 2017-22325
Docket No. DEA-402
Effective October 16, 2017.
With the issuance of this final rule, the Drug Enforcement Administration places N -(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H -indazole-3-carboxamide (AB-CHMINACA), N -(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1 H -indazole-3-carboxamide (AB-PINACA), and [1-(5-fluoropentyl)-1 H -indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This rule continues the imposition of the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle AB-CHMINACA, AB-PINACA and THJ-2201.
82 FR 45436 - Schedules of Controlled Substances: Removal of Naldemedine From Control
FR Doc. 2017-20919
Docket No. DEA-468
The effective date of this rule is September 29, 2017.
With the issuance of this final rule, the Drug Enforcement Administration removes the substance naldemedine (4 R,4a S,7a R,12b S )-3-(cyclopropylmethyl)-4a,7,9-trihydroxy- N -(2-(3-phenyl-1,2,4-oxadiazol-5-yl)propan-2-yl)-2,3,4,4a,5,7a-hexahydro-1 H -4,12-methanobenzofuro[3,2- e ]isoquinoline-6-carboxamide) including its salts from the schedules of the Controlled Substances Act. Prior to the effective date of this rule, naldemedine was a schedule II controlled substance because it can be derived from opium alkaloids. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle naldemedine.
82 FR 42754 - Schedules of Controlled Substances: Temporary Placement of Ortho-Fluorofentanyl, Tetrahydrofuranyl Fentanyl, and Methoxyacetyl Fentanyl Into Schedule I
FR Doc. 2017-19283
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule the synthetic opioids, N -(2-fluorophenyl)- N -(1-phenethylpiperidin-4-yl)propionamide ( ortho -fluorofentanyl or 2-fluorofentanyl), N -(1-phenethylpiperidin-4-yl)- N -phenyltetrahydrofuran-2-carboxamide (tetrahydrofuranyl fentanyl), and 2-methoxy- N -(1-phenethylpiperidin-4-yl)- N -phenylacetamide (methoxyacetyl fentanyl), into Schedule I. This action is based on a finding by the Administrator that the placement of these synthetic opioids into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to Schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of these synthetic opioids.
82 FR 42624 - Schedules of Controlled Substances: Temporary Placement of FUB-AMB Into Schedule I
FR Doc. 2017-17639
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule the synthetic cannabinoid, Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [FUB-AMB, MMB-FUBINACA, AMB-FUBINACA], into Schedule I. This action is based on a finding by the Administrator that the placement of this synthetic cannabinoid into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to Schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, possession, importation, exportation of, and research and conduct with, instructional activities of this synthetic cannabinoid.
82 FR 32453 - Schedules of Controlled Substances: Temporary Placement of Acryl Fentanyl Into Schedule I
FR Doc. 2017-14880
Docket No. DEA-460
Temporary scheduling order.
This temporary scheduling order is effective July 14, 2017, until July 15, 2019, unless it is extended for an additional year or a permanent scheduling proceeding is completed. The DEA will publish a document in the Federal Register announcing an extension or permanence.
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic opioid, N -(1-phenethylpiperidin-4-yl)- N -phenylacrylamide (acryl fentanyl or acryloylfentanyl), and its isomers, esters, ethers, salts and salts of isomers, esters, and ethers, into Schedule I. This action is based on a finding by the Administrator that the placement of acryl fentanyl into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to Schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, acryl fentanyl.
2017-07-12; vol. 82 # 132 - Wednesday, July 12, 2017
82 FR 32153 - Schedules of Controlled Substances: Removal of Naldemedine From Control
FR Doc. 2017-14482
Interested persons may file written comments on this proposal in accordance with 21 CFR 1308.43(g). Comments must be submitted electronically or postmarked on or before August 11, 2017. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Interested persons, may file a request for hearing or waiver of hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.45, 1316.47, 1316.48, and/or 1316.49, as applicable. Requests for hearing and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before August 11, 2017.
The Drug Enforcement Administration (DEA) proposes to remove naldemedine (4 R, 4a S, 7a R, 12b S )-3-(cyclopropylmethyl)-4a,7,9-trihydroxy- N -(2-(3-phenyl-1,2,4-oxadiazol-5-yl)propan-2-yl)-2,3,4,4a,5,7a-hexahydro-1 H -4,12-methanobenzofuro[3,2- e ]isoquinoline-6-carboxamide) including its salts from the schedules of the Controlled Substances Act (CSA). This action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. Naldemedine is currently a schedule II controlled substance because it can be derived from opium alkaloids. This action would remove the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle naldemedine.
82 FR 26349 - Schedules of Controlled Substances: Placement of Acetyl Fentanyl Into Schedule I
FR Doc. 2017-11795
Docket No. DEA-413
With the issuance of this final order, the Administrator of the Drug Enforcement Administration will maintain the placement of the substance acetyl fentanyl ( N -(1-phenethylpiperidin-4-yl)- N -phenylacetamide), including its isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act and is required in order for the United States to discharge its obligations under the Single Convention on Narcotic Drugs, 1961. This action continues to impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research or conduct instructional activities with, or possess), or propose to handle, acetyl fentanyl.
82 FR 25564 - Schedules of Controlled Substances: Temporary Placement of Acryl Fentanyl Into Schedule I
FR Doc. 2017-11215
The date of this notice of intent is June 2, 2017.
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to issue a temporary order to schedule the synthetic opioid, N -(1-phenethylpiperidin-4-yl)- N -phenylacrylamide (acryl fentanyl or acryloylfentanyl), into Schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of this synthetic opioid into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to Schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of this synthetic opioid.
2017-05-03; vol. 82 # 84 - Wednesday, May 3, 2017
82 FR 20544 - Schedules of Controlled Substances: Temporary Placement of 4-Fluoroisobutyryl Fentanyl into Schedule I
FR Doc. 2017-08943
Docket No. DEA-452
This temporary scheduling order is effective May 3, 2017, until May 3, 2019, unless it is extended for an additional year or a permanent scheduling proceeding is completed. The DEA will publish a document in the Federal Register announcing an extension or permanence.
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic opioid, N -(4-fluorophenyl)- N -(1-phenethylpiperidin-4-yl)isobutyramide (4-fluoroisobutyryl fentanyl or para -fluoroisobutyryl fentanyl), and its isomers, esters, ethers, salts and salts of isomers, esters, and ethers, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of 4-fluoroisobutyryl fentanyl into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, 4-fluoroisobutyryl fentanyl.
82 FR 17119 - Schedules of Controlled Substances: Temporary Placement of Six Synthetic Cannabinoids (5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA) into Schedule I
FR Doc. 2017-07118
Docket No. DEA-446
This temporary scheduling order is effective on April 10, 2017. This temporary order will expire on April 10, 2019, unless it is extended for an additional year or a permanent scheduling proceeding is completed.
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule six synthetic cannabinoids: methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA], and their optical, positional, and geometric isomers, salts, and salts of isomers into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of these synthetic cannabinoids into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA or MDMB-FUBINACA.
82 FR 14815 - Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] in Schedule II
FR Doc. 2017-05809
Interim final rule, with request for comments.
The effective date of this rulemaking is March 23, 2017. Interested persons may file written comments on this rulemaking in accordance with 21 CFR 1308.43(g). Electronic comments must be submitted, and written comments must be postmarked, on or before April 24, 2017. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Interested persons, defined at 21 CFR 1300.01 as those “adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811),” may file a request for hearing or waiver of hearing pursuant to 21 CFR 1308.44. Requests for hearing and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before April 24, 2017.
On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9- trans -tetrahydrocannabinol (delta-9-THC)] oral solution. Thereafter, the Department of Health and Human Services (HHS) provided the Drug Enforcement Administration (DEA) with a scheduling recommendation that would result in Syndros (and other oral solutions containing dronabinol) being placed in schedule II of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing FDA-approved products of oral solutions containing dronabinol in schedule II of the CSA.
82 FR 14842 - Schedules of Controlled Substances: Temporary Placement of 4-Fluoroisobutyryl Fentanyl Into Schedule I
FR Doc. 2017-05728
The date of this notice of intent is March 23, 2017.
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to issue a temporary order to schedule the synthetic opioid, N -(4-fluorophenyl)- N -(1-phenethylpiperidin-4-yl)isobutyramide (4-fluoroisobutyryl fentanyl or para -fluoroisobutyryl fentanyl), into Schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of this synthetic opioid into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to Schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of this synthetic opioid.
2017-03-09; vol. 82 # 45 - Thursday, March 9, 2017
82 FR 13067 - Schedules of Controlled Substances: Placement of Brivaracetam Into Schedule V
FR Doc. 2017-04698
Docket No. DEA-435
The effective date of this final rulemaking is March 9, 2017.
This final rule adopts without change an interim final rule with request for comments published in the Federal Register on May 12, 2016. The Drug Enforcement Administration is placing the substance brivaracetam ((2 S )-2-[(4 R )-2-oxo-4-propylpyrrolidin-1-yl] butanamide) (also referred to as BRV; UCB-34714; Briviact) (including its salts) into schedule V of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act, as revised by the Improving Regulatory Transparency for New Medical Therapies Act which was signed into law on November 25, 2015.
82 FR 12171 - Schedules of Controlled Substances: Placement of 10 Synthetic Cathinones Into Schedule I
FR Doc. 2017-03974
Docket No. DEA-436
Effective date: March 1, 2017.
With the issuance of this final rule, the Drug Enforcement Administration places 10 synthetic cathinones: 4-methyl- N -ethylcathinone (4-MEC); 4-methyl- alpha -pyrrolidinopropiophenone (4-MePPP); alpha-pyrrolidinopentiophenone (α-PVP); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone, bk-MBDB e); 2-(methylamino)-1-phenylpentan-1-one (pentedrone); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone, bk-MBDP); 4-fluoro- N -methylcathinone (4-FMC, flephedrone); 3-fluoro- N -methylcathinone (3-FMC); 1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one (naphyrone); alpha-pyrrolidinobutiophenone (α-PBP) and their optical, positional, and geometric isomers, salts and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This rule continues the imposition of the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle 4-MEC, 4-MePPP, α-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or α-PBP.
2017-01-30; vol. 82 # 18 - Monday, January 30, 2017
82 FR 8688 - Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System (ITDS); Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments
FR Doc. 2017-01976
RIN 1117-AB41
Docket No. DEA-403
Effective Dates: This Final Rule is effective January 30, 2017. The effective date of the Final Rule amending 21 CFR parts 1300, 1301, 1302, 1303, 1304, 1308, 1309, 1310, 1312, 1313, 1314, 1315, 1316, and 1321 published in the Federal Register December 30, 2016, at 81 FR 96992 is delayed to March 21, 2017. However, compliance with the revisions to DEA regulations made by this rule is not required until July 31, 2017.
21 CFR Parts 1300, 1301, 1302, 1303, 1304, 1308, 1309, 1310, 1312, 1313, 1314, 1315, 1316, and 1321
On December 30, 2016, the Drug Enforcement Administration published a final rule to implement requirements associated with the International Trade Data System (ITDS) that will help streamline the export/import of tableting and encapsulating machines, controlled substances, and listed chemicals. That rule is scheduled to become effective January 30, 2017. In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled “Regulatory Freeze Pending Review,” this action hereby temporarily delays until March 21, 2017, the effective date of the final rule entitled “Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes to Implement the International Trade Data System (ITDS); Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments” (RIN 1117-AB41) published in the Federal Register on December 30, 2016, at 81 FR 96992. The temporary delay in the effective date will allow Department of Justice officials an opportunity to review any potential questions of fact, law and policy raised by this regulation, consistent with the Chief of Staff&apos;s memorandum of January 20, 2017.
82 FR 8590 - Schedules of Controlled Substances: Extension of Temporary Placement of THJ-2201, AB-PINACA and AB-CHMINACA in Schedule I of the Controlled Substances Act
FR Doc. 2017-01517
This temporary order is effective January 27, 2017. This temporary order will expire on January 29, 2018, or when a permanent scheduling proceeding is completed, whichever occurs first.
The Administrator of the Drug Enforcement Administration is issuing this temporary order to extend the temporary schedule I status of three synthetic cannabinoids pursuant to the temporary scheduling provisions of the Controlled Substances Act. The substances are: [1-(5-Fluoropentyl)-1 H -indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201); N -1-Amino-3-methyl-1-oxo-2-butanyl]-1-pentyl-1 H -indazole-3-carboxamide (AB-PINACA); N -[1-Amino-3-methyl-1-oxo-2-butanyl]-1-(cyclohexylmethyl)-1 H -indazole-3-carboxamide (AB-CHMINACA), including their optical, positional and geometric isomers, salts, and salts of isomers. The current final order temporarily placing THJ-2201, AB-PINACA and AB-CHMINACA into schedule I is in effect through January 29, 2017. This order will extend the temporary scheduling of THJ-2201, AB-PINACA and AB-CHMINACA for one year, or until the permanent scheduling action for these three substances is completed, whichever occurs first.
82 FR 8593 - Schedules of Controlled Substances: Placement of AB-CHMINACA, AB-PINACA and THJ-2201 Into Schedule I
FR Doc. 2017-01514
Interested persons may file written comments on this proposal in accordance with 21 CFR 1308.43(g). Comments must be submitted electronically or postmarked on or before February 27, 2017. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Interested persons, defined at 21 CFR 1300.01 as those “adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811),” may file a request for hearing or waiver of hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.45 and/or 1316.47, as applicable. Requests for hearing and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before February 27, 2017.
The Drug Enforcement Administration proposes placing N -(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H -indazole-3-carboxamide (AB-CHMINACA), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1 H -indazole-3-carboxamide (AB-PINACA) and [1-(5-fluoropentyl)-1 H -indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. This proposed scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. If finalized, this action would continue to impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle AB-CHMINACA, AB-PINACA and THJ-2201.
82 FR 2218 - Schedules of Controlled Substances: Temporary Placement of Six Synthetic Cannabinoids (5F-ADB-, 5F-AMB, 5F-APINACA, ADB-FUBINACA, NDMB-CHMICA and MDMB-FUBINACA) Into Schedule I
FR Doc. C1-2016-30595
82 FR 2280 - Schedules of Controlled Substances: Temporary Placement of Six Synthetic Cannabinoids (5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA) Into Schedule I
FR Doc. 2017-00275
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to temporarily schedule six synthetic cannabinoids: Methyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N -(adamantan-1-yl)-1-(5-fluoropentyl)-1 H -indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1 H -indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1 H -indole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA], into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act (CSA). This action is based on a finding by the Administrator that the placement of these synthetic cannabinoids into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. Any final order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I substances under the Controlled Substances Act on the manufacture, distribution, possession, importation, exportation of, and research and conduct with, instructional activities of these synthetic cannabinoids.
81 FR 96992 - Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System (ITDS); Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments
FR Doc. 2016-28966
This rule is effective January 30, 2017. However, compliance with the revisions to DEA regulations made by this rule is not required until June 28, 2017.
The Drug Enforcement Administration is updating its regulations for the import and export of tableting and encapsulating machines, controlled substances, and listed chemicals, and its regulations relating to reports required for domestic transactions in listed chemicals, gamma-hydroxybutyric acid, and tableting and encapsulating machines. In accordance with Executive Order 13563, the Drug Enforcement Administration has reviewed its import and export regulations and reporting requirements for domestic transactions in listed chemicals (and gamma-hydroxybutyric acid) and tableting and encapsulating machines, and evaluated them for clarity, consistency, continued accuracy, and effectiveness. The amendments clarify certain policies and reflect current procedures and technological advancements. The amendments also allow for the implementation, as applicable to tableting and encapsulating machines, controlled substances, and listed chemicals, of the President&apos;s Executive Order 13659 on streamlining the export/import process and requiring the government-wide utilization of the International Trade Data System (ITDS). This rule additionally contains amendments that implement recent changes to the Controlled Substances Import and Export Act (CSIEA) for reexportation of controlled substances among members of the European Economic Area made by the Improving Regulatory Transparency for New Medical Therapies Act. The rule also includes additional substantive and technical and stylistic amendments.
81 FR 93595 - Schedules of Controlled Substances: Temporary Placement of Six Synthetic Cannabinoids (5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA) Into Schedule I
FR Doc. 2016-30595
81 FR 90194 - Establishment of a New Drug Code for Marihuana Extract
FR Doc. 2016-29941
RIN 1117-AB33
Docket No. DEA-342
The Drug Enforcement Administration is creating a new Administration Controlled Substances Code Number for “Marihuana Extract.” This code number will allow DEA and DEA-registered entities to track quantities of this material separately from quantities of marihuana. This, in turn, will aid in complying with relevant treaty provisions. Under international drug control treaties administered by the United Nations, some differences exist between the regulatory controls pertaining to marihuana extract versus those for marihuana and tetrahydrocannabinols. The DEA has previously established separate code numbers for marihuana and for tetrahydrocannabinols, but not for marihuana extract. To better track these materials and comply with treaty provisions, DEA is creating a separate code number for marihuana extract with the following definition: “Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.” Extracts of marihuana will continue to be treated as Schedule I controlled substances.
2016-11-29; vol. 81 # 229 - Tuesday, November 29, 2016
81 FR 85873 - Schedules of Controlled Substances: Temporary Placement of Furanyl Fentanyl Into Schedule I
FR Doc. 2016-28693
Docket No. DEA-448
This final order is effective on November 29, 2016.
The Administrator of the Drug Enforcement Administration is issuing this final order to temporarily schedule the synthetic opioid, N -(1-phenethylpiperidin-4-yl)- N -phenylfuran-2-carboxamide (furanyl fentanyl), and its isomers, esters, ethers, salts and salts of isomers, esters and ethers, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of furanyl fentanyl into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, furanyl fentanyl.
81 FR 79389 - Schedules of Controlled Substances: Temporary Placement of U-47700 Into Schedule I
FR Doc. 2016-27357
Docket No. DEA-440
This final order is effective on November 14, 2016.
The Administrator of the Drug Enforcement Administration is issuing this final order to temporarily schedule the synthetic opioid, 3,4-dichloro- N -[2-(dimethylamino)cyclohexyl]- N -methylbenzamide (also known asU-47700), and its isomers, esters, ethers, salts and salts of isomers, esters and ethers, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of U-47700 into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, U-47700.
2016-10-13; vol. 81 # 198 - Thursday, October 13, 2016
81 FR 70652 - Withdrawal of Notice of Intent to Temporarily Place Mitragynine and 7-Hydroxymitragynine Into Schedule I
FR Doc. 2016-24659
Docket No. DEA-442W
Withdrawal of Notice of Intent; Solicitation of Comments.
The notice of intent that was published on August 31, 2016 (81 FR 59929) is withdrawn as of October 13, 2016. The comment period will be open until December 1, 2016. All comments for the public record must be submitted electronically or in writing in accordance with the procedures outlined below. Electronic comments must be submitted, and written comments must be postmarked, on or before December 1, 2016. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Please note that if you previously submitted a comment via email or regular mail following the August 31, 2016 notice, that comment is being considered by DEA—it is not necessary to resubmit the same comment unless you wish to provide additional information, or you wish to have your comment posted for public view in accordance with the instructions provided below.
2016-09-27; vol. 81 # 187 - Tuesday, September 27, 2016
81 FR 66181 - Schedules of Controlled Substances: Placement of Three Synthetic Phenethylamines Into Schedule I
FR Doc. 2016-23185
Docket No. DEA-423
Effective: October 27, 2016.
With the issuance of this final rule, the Administrator of the Drug Enforcement Administration places three synthetic phenethylamines: 2-(4-iodo-2,5-dimethoxyphenyl)- N -(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5), 2-(4-chloro-2,5-dimethoxyphenyl)- N -(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82), and 2-(4-bromo-2,5-dimethoxyphenyl)- N -(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36), including their optical, positional, and geometric isomers, salts and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This action continues the application of the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe.
81 FR 66224 - Schedules of Controlled Substances: Temporary Placement of Furanyl Fentanyl Into Schedule I
FR Doc. 2016-23183
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to temporarily schedule the synthetic opioid, N -(1-phenethylpiperidin-4-yl)- N -phenylfuran-2-carboxamide (furanyl fentanyl), into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of this synthetic opioid into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. Any final order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, possession, importation, exportation, research, and conduct of, instructional activities of this synthetic opioid.
81 FR 63576 - Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System; Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments
FR Doc. 2016-21589
Electronic comments must be submitted, and written comments must be postmarked, on or before October 17, 2016. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. All comments concerning collections of information under the Paperwork Reduction Act must be submitted to the Office of Management and Budget (OMB) on or before October 17, 2016.
The Drug Enforcement Administration is proposing to update its regulations for the import and export of tableting and encapsulating machines, controlled substances, and listed chemicals, and its regulations relating to reports required for domestic transactions in listed chemicals, gamma-hydroxybutyric acid, and tableting and encapsulating machines. In accordance with Executive Order 13563, the Drug Enforcement Administration has reviewed its import and export regulations and reporting requirements for domestic transactions in listed chemicals (and gamma-hydroxybutyric acid) and tableting and encapsulating machines, and evaluated them for clarity, consistency, continued accuracy, and effectiveness. The proposed amendments clarify certain policies and reflect current procedures and technological advancements. The amendments also allow for the implementation, as applicable to tableting and encapsulating machines, controlled substances, and listed chemicals, of the President&apos;s Executive Order 13659 on streamlining the export/import process and requiring the government-wide utilization of the International Trade Data System. This proposal additionally contains amendments that would implement recent changes to the Controlled Substances Import and Export Act (CSIEA) for reexportation of controlled substances among members of the European Economic Area made by the Improving Regulatory Transparency for New Medical Therapies Act. The proposal includes additional substantive and technical amendments.
81 FR 61636 - Schedules of Controlled Substances: Temporary Placement of U-47700 Into Schedule I
FR Doc. 2016-21477
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to temporarily schedule the synthetic opioid, 3,4-dichloro- N -[2-(dimethylamino)cyclohexyl]- N -methylbenzamide (also known as U-47700), into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of this synthetic opioid into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. Any final order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, possession, importation, exportation, research, and conduct of, instructional activities of this synthetic opioid.
81 FR 61130 - Schedules of Controlled Substances: Placement of PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA into Schedule I
FR Doc. 2016-21345
Docket No. DEA-433
With the issuance of this final rule, the Drug Enforcement Administration places quinolin-8-yl 1-pentyl-1 H -indole-3-carboxylate (PB-22; QUPIC), quinolin-8-yl 1-(5-fluoropentyl)-1 H -indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22), N -(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1 H -indazole-3-carboxamide (AB-FUBINACA) and N -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1 H -indazole-3-carboxamide (ADB-PINACA), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA.
81 FR 59929 - Schedules of Controlled Substances: Temporary Placement of Mitragynine and 7-Hydroxymitragynine Into Schedule I
FR Doc. 2016-20803
Docket No. DEA-442
81 FR 58834 - Schedules of Controlled Substances: Placement of Thiafentanil Into Schedule II
FR Doc. 2016-20463
Docket No. DEA-375
The effective date of this rule is August 26, 2016. Interested persons may file written comments on this rule in accordance with 21 U.S.C. 811(j)(3) and 21 CFR 1308.43(g). Electronic comments must be submitted, and written comments must be postmarked, on or before September 26, 2016. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Interested persons, defined at 21 CFR 1300.01 as those “adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811),” may file a request for hearing or waiver of hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.45 and/or 1316.47, as applicable. Requests for hearing and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before September 26, 2016.
21 CFR Parts 1301, 1305, and 1308
The Drug Enforcement Administration is placing the substance thiafentanil (4-(methoxycarbonyl)-4-(N-phenmethoxyacetamido)-1-[2-(thienyl)ethyl]piperidine), including its isomers, esters, ethers, salts and salts of isomers, esters and ethers as possible, into schedule II of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act, as revised by the Improving Regulatory Transparency for New Medical Therapies Act which was signed into law on November 25, 2015.
21 CFR 1304.11 — Inventory Requirements.
21 CFR 1308.44 — Request for Hearing or Appearance; Waiver.