Drug Enforcement Administration 2005 – Federal Register Recent Federal Regulation Documents
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Control of Sodium Permanganate as a List II Chemical
The Controlled Substances Act (CSA) provides the Attorney General with the authority to specify, by regulation, additional chemicals as ``List II'' chemicals if they are used in the manufacture of a controlled substance in violation of the CSA. The Drug Enforcement Administration (DEA) is proposing the addition of sodium permanganate as a List II chemical because of its direct substitutability for potassium permanganate (a List II chemical) in the illicit production of cocaine. As a List II chemical, handlers of sodium permanganate would be subject to CSA chemical regulatory controls including recordkeeping, reporting, and import/export requirements. DEA has determined that these controls are necessary to prevent the diversion of this chemical to cocaine laboratories. DEA is also proposing that a cumulative threshold of 55 kilograms and 500 kilograms be established (respectively) for domestic and international transactions. As such, all transactions which meet or exceed these quantities (in a calendar month) shall be considered regulated transactions, subject to recordkeeping, reporting and/or import/export notification requirements. Additionally DEA is proposing that sodium permanganate chemical mixtures having less than or equal to 15 percent sodium permanganate shall qualify for automatic exemption from CSA chemical regulatory controls pursuant to 21 CFR part 1310. All handlers of the List II chemical sodium permanganate would also be subject to the applicable civil and criminal penalty provisions found in 21 U.S.C. 841, 842, 843, 959 and 960.
Schedules of Controlled Substances: Placement of Zopiclone Into Schedule IV
This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance zopiclone, including its salts, isomers and salts of isomers into Schedule IV of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Acting 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 will impose the regulatory controls and criminal sanctions of Schedule IV on those who handle zopiclone and products containing zopiclone.
Chemical Mixtures; Temporary Waiver of Import/Export Requirements
On December 15, 2004, the Drug Enforcement Administration (DEA) published a final rule that implemented regulations pertaining to chemical mixtures that contain any of 27 listed chemicals regulated under the Controlled Substances Act (21 U.S.C. 801 et seq.). That rulemaking became effective on January 14, 2005. Following publication of the final rule, certain segments of the chemical industry expressed concerns to DEA regarding difficulty in fully complying with DEA import/export notification requirements as specified in 21 CFR part 1313 by this deadline. Therefore, in order to avoid interruption of legitimate import/export distributions, DEA is providing a waiver of the import/export reporting requirements as specified in 21 CFR part 1313 until May 14, 2005. As such, regulated persons will temporarily not be required to submit advance notification for import, export and transshipment transactions for chemical mixtures regulated solely due to the presence of these 27 listed chemicals until May 14, 2005. This temporary waiver applies only to import, export and transshipment notification requirements; all other chemical control requirements set forth in the final rulemaking published on December 15, 2004, shall remain in full force and effect.
Solicitation of Comments on Dispensing of Controlled Substances for the Treatment of Pain
On November 16, 2004, DEA published in the Federal Register an Interim Policy Statement on the dispensing of controlled substances for the treatment of pain. The Interim Policy Statement stated that DEA would address the subject in greater detail in a future Federal Register document, taking into consideration the views of the medical community. DEA is hereby seeking comments from physicians and other interested members of the public as to what areas of the law relating to the dispensing of controlled substances for the treatment of pain they would like DEA to address in the upcoming Federal Register document.
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