Drug Enforcement Administration June 29, 2010 – Federal Register Recent Federal Regulation Documents
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Dispensing of Controlled Substances to Residents at Long Term Care Facilities
To analyze ongoing issues related to the dispensing of controlled substances to residents residing at long term care facilities (LTCFs), DEA is soliciting information on this subject from practitioners, pharmacists, LTCFs, nurses, residents and family of residents in long term care facilities, State regulatory agencies, and other interested members of the public. Specifically, DEA is exploring whetherwhile adhering to the framework of the Controlled Substances Actany further revisions to the DEA regulations are feasible and warranted toward the goal of making it easier for residents of LTCFs to receive controlled substance medications. This notice recites the pertinent statutory considerations and contains a series of questions designed to elicit public comment that will assist DEA in making this evaluation.
Correction of Code of Federal Regulations: Removal of Temporary Listing of Benzylfentanyl and Thenylfentanyl as Controlled Substances
This rulemaking corrects Title 21 Code of Federal Regulations (CFR) by deleting regulations which list the substances benzylfentanyl and thenylfentanyl as being temporarily subject to schedule I controls under the emergency scheduling provisions of the Controlled Substances Act (CSA). The temporary scheduling of benzylfentanyl and thenylfentanyl expired on November 29, 1986. DEA determined that these compounds were both essentially inactive, with no evidence of abuse potential. As such, these compounds are no longer schedule I controlled substances and all references to these compounds are being deleted from DEA regulations.
Control of Immediate Precursor Used in the Illicit Manufacture of Fentanyl as a Schedule II Controlled Substance
The Drug Enforcement Administration (DEA) is designating the precursor chemical, 4-anilino-N-phenethyl-4-piperidine (ANPP) as an immediate precursor for the schedule II controlled substance fentanyl under the definition set forth in 21 U.S.C. 802(23). Furthermore, DEA is finalizing the control of ANPP as a schedule II substance under the Controlled Substances Act (CSA), pursuant to the authority in 21 U.S.C. 811(e), which states that an immediate precursor may be placed in the same schedule as the controlled substance it produces, without regard to the procedures required by 21 U.S.C. 811(a) and (b) and without regard to the findings required by 21 U.S.C. 811(a) and 812(b).
Exempt Chemical Mixtures Containing Gamma-Butyrolactone
This rulemaking finalizes a November 12, 2008, Notice of Proposed Rulemaking in which DEA proposed that chemical mixtures that are 70 percent or less gamma-butyrolactone (GBL), by weight or volume, be automatically exempt from regulatory controls under the Controlled Substances Act (CSA). DEA is seeking through this rulemaking to exempt only those chemical mixtures that do not represent a significant risk of diversion. This regulation makes GBL chemical mixtures, in concentrations greater than 70 percent, subject to List I chemical regulatory requirements of the CSA, except if exempted through an existing categorical exemption. DEA is taking this action because there is a serious threat to the public safety associated with the ease by which GBL is chemically converted to the schedule I controlled substance gamma-hydroxybutyric acid (GHB).
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