Drug Enforcement Administration 2010 – Federal Register Recent Federal Regulation Documents
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Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting
The Drug Enforcement Administration (DEA) is conducting a public meeting to discuss procedures for the surrender of unwanted controlled substances by ultimate users and long term care facilities in the development of regulations to implement the Secure and Responsible Drug Disposal Act of 2010. Specifically, DEA invites all interested persons, including ultimate users, pharmacies, law enforcement, reverse distributors, and other third parties to express their views at the meeting or by written comment concerning the most safe and effective method of disposal of controlled substances consistent with the Controlled Substances Act and the Secure and Responsible Drug Disposal Act of 2010.
Schedules of Controlled Substances: Placement of 5-Methoxy-N,N-Dimethyltryptamine into Schedule I of the Controlled Substances Act
With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance 5- methoxy-N,N-dimethyltryptamine (5-MeO-DMT), including its 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 (CSA). This action by the DEA Deputy Administrator is based on a scheduling recommendation from the Assistant Secretary for Health of the Department of Health and Human Services (DHHS) and a DEA review indicating that 5-MeO-DMT meets the criteria for placement in schedule I of the CSA. This final rule will impose the criminal sanctions and regulatory controls of schedule I substances under the CSA on the manufacture, distribution, dispensing, importation, exportation, and possession of 5-MeO-DMT.
Established Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2011
This notice establishes the initial 2011 Assessment of Annual Needs for certain List I chemicals in accordance with the Combat Methamphetamine Epidemic Act of 2005 (CMEA).
Controlled Substances: Established Initial Aggregate Production Quotas for 2011
This notice establishes initial 2011 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA).
Final Revised Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2010
This notice establishes the Final Revised 2010 Assessment of Annual Needs for certain List I chemicals in accordance with the Combat Methamphetamine Epidemic Act of 2005 (CMEA), enacted on March 9, 2006.
Schedules of Controlled Substances: Temporary Placement of Five Synthetic Cannabinoids Into Schedule I
The Deputy Administrator of the Drug Enforcement Administration (DEA) is issuing this notice of intent to temporarily place five synthetic cannabinoids into the Controlled Substances Act (CSA) pursuant to the temporary scheduling provisions under 21 U.S.C. 811(h) of the CSA. The substances are 1-pentyl-3-(1-naphthoyl)indole (JWH-018), 1-butyl-3-(1-naphthoyl)indole (JWH-073), 1-[2-(4- morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200), 5-(1,1- dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP-47,497), and 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol; CP-47,497 C8 homologue). This intended action is based on a finding by the DEA Deputy Administrator that the placement of these synthetic cannabinoids into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. Finalization of this action will impose criminal sanctions and regulatory controls of Schedule I substances under the CSA on the manufacture, distribution, possession, importation, and exportation of these synthetic cannabinoids.
Listing of Approved Drug Products Containing Dronabinol in Schedule III
This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to modify the listing of the Marinol[supreg] formulation in schedule III so that certain generic drug products are also included in that listing. Several products are currently the subject of Abbreviated New Drug Applications (ANDAs) under review by the U.S. Food and Drug Administration (FDA). Each product is a generic formulation of Marinol[supreg] and contains dronabinol, the (-) isomer of delta-9- (trans)-tetrahydrocannabinol (THC), which is a schedule I controlled substance. Due to variations in formulation, these generic Marinol[supreg] products do not meet the specific conditions specified in the current schedule III listing. This proposed action expands the schedule III listing to include formulations having naturally-derived dronabinol and products encapsulated in hard gelatin capsules. This would have the effect of transferring the FDA-approved versions of such generic Marinol[supreg] products from schedule I to schedule III.
Schedules of Controlled Substances: Placement of Propofol Into Schedule IV
This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance propofol, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule IV of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Assistant Secretary for Health of the Department of Health and Human Services (DHHS) and on an evaluation of the relevant data by DEA. If finalized, this action would impose the regulatory controls and criminal sanctions of schedule IV on those who handle propofol and products containing propofol.
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