Drug Enforcement Administration May 2005 – Federal Register Recent Federal Regulation Documents
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Schedules of Controlled Substances: Placement of Pregabalin into Schedule V
This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance pregabalin [(S)-3-(aminomethyl)-5-methylhexanoic acid], including its salts, and all products containing pregabalin into Schedule V 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 applicable to Schedule V non-narcotics on those who handle pregabalin and products containing pregabalin.
Preventing the Accumulation of Surplus Controlled Substances at Long Term Care Facilities
DEA is amending its regulations to allow, where State laws permit, for retail pharmacy installation of automated dispensing systems at long term care facilities. Automated dispensing systems would allow dispensing of single dosage units and mitigate the problem of excess stocks and disposal.
Definition and Registration of Reverse Distributors
DEA is finalizing, without change, the interim rule with Request for Comment published in the Federal Register July 11, 2003 at 68 FR 41222. The interim final rule amended Title 21, Code of Federal Regulations, parts 1300, 1301, 1304, 1305 and 1307 to define the term ``reverse distributor'' and establish a new category of registration for persons handling controlled substances. The amendments established the regulatory standards under which reverse distributors may handle unwanted, unusable, or outdated controlled substances acquired from another DEA registrant. These standards ensure the proper documentation and recordkeeping necessary to prevent diversion of such controlled substances to illegal purposes. This final rule makes these changes permanent.
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