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2018-02-16
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Schedules of Controlled Substances: Removal of Naloxegol From Control
Rules and Regulations
D09002ee1bdc35600
D09002ee1bdc356d1
United States
Department of Justice
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org
United States Government Agency or Subagency
United States
Drug Enforcement Administration
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org
United States Government Agency or Subagency
With the issuance of this final rule, the Administrator of the Drug Enforcement Administration removes naloxegol ((5[alpha],6[alpha])- 17-allyl-6-((20-hydroxy-3,6,9,12,15,18-hexaoxaicos-1-yl)oxy)-4,5- epoxymorphinon-3,14-diol) and its salts from the schedules of the Controlled Substances Act (CSA). This scheduling action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. Prior to the effective date of this rule, naloxegol 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 naloxegol.
80 FR 3468
https://www.govinfo.gov/app/details/FR-2015-01-23/2015-01172
2015-01172
fr23ja15-4
4410-09-P
Docket No. DEA-400
https://www.govinfo.gov/app/details/FR-2015-01-23/2015-01172
https://www.govinfo.gov/content/pkg/FR-2015-01-23/html/2015-01172.htm
https://www.govinfo.gov/content/pkg/FR-2015-01-23/pdf/2015-01172.pdf
Administrative Practice and Procedure
Drug Traffic Control
Reporting and Recordkeeping Requirements
3 p.
3468
3470
80 FR 3468
Code of Federal Regulations
Title 21 Part 1308
21 CFR Part 1308
Schedules of Controlled Substances: Removal of Naloxegol From Control; Federal Register Vol. 80, Issue
RULE
2015-01172
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
2015-01-23
Docket No. DEA-400
4410-09-P
2015-01172
Final rule.
With the issuance of this final rule, the Administrator of the Drug Enforcement Administration removes naloxegol ((5[alpha],6[alpha])- 17-allyl-6-((20-hydroxy-3,6,9,12,15,18-hexaoxaicos-1-yl)oxy)-4,5- epoxymorphinon-3,14-diol) and its salts from the schedules of the Controlled Substances Act (CSA). This scheduling action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. Prior to the effective date of this rule, naloxegol 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 naloxegol.
Effective Date: January 23, 2015.
Imelda L. Paredes, Office of Diversion
Administrative Practice and Procedure
Drug Traffic Control
Reporting and Recordkeeping Requirements
Schedules of Controlled Substances:
Naloxegol; Removal from Control
,
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
http://www.regulations.gov
Federal Register
Vol. 80, no. 15
Office of the Federal Register, National Archives and Records Administration
2015-01-23
continuing
daily
deposited
born digital
411 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2015-01-23
P0b002ee1987a7ff4
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr23ja15
https://www.govinfo.gov/app/details/FR-2015-01-23
https://www.govinfo.gov/content/pkg/FR-2015-01-23/pdf/FR-2015-01-23.pdf
https://www.govinfo.gov/content/pkg/FR-2015-01-23/xml/FR-2015-01-23.xml
fdlp
3463
3864
DGPO
2018-02-16
2023-04-29
FR-2015-01-23
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FR
FR-2015-01-23
80
15