Drug Enforcement Administration 2011 – Federal Register Recent Federal Regulation Documents

The Administrator of the Drug Enforcement Administration (DEA) is issuing this final order to temporarily schedule three synthetic cathinones under the Controlled Substances Act (CSA) pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). The substances are 4-methyl-N-methylcathinone (mephedrone), 3,4-methylenedioxy-N- methylcathinone (methylone), and 3,4-methylenedioxypyrovalerone (MDPV). This action is based on a finding by the Administrator that the placement of these synthetic cathinones and their salts, isomers, and salts of isomers into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. As a result of this order, the full effect of the CSA and its implementing regulations including criminal, civil and administrative penalties, sanctions and regulatory controls of Schedule I substances will be imposed on the manufacture, distribution, possession, importation, and exportation of these synthetic cathinones.

DEA wishes to emphasize that third-party audits of software applications for Electronic Prescriptions for Controlled Substances (EPCS) must encompass all applicable requirements in our regulations, including security, and must address ``processing integrity'' as set forth in our regulations. Likewise, where questions or gaps may arise in reviewing a particular application, DEA recommends consulting federal guidelines set forth in NIST Special Publication 800-53A. DEA is also announcing the first DEA approved certification process for EPCS. Certifying organizations with a certification process approved by DEA pursuant to the regulations are posted on DEA's Web site once approved.

DEA is amending its regulations to clarify the registration status of a registrant who voluntarily surrenders a Certificate of Registration. These changes clarify that a voluntary surrender of a registration signed by a registrant using any format has the legal effect of immediately terminating the registrant's registration without any further action by DEA.

This notice proposes the initial year 2012 assessment of annual needs for certain List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

This notice proposes to adjust the 2011 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act (CSA) and separately proposes to establish aggregate production quotas for five synthetic cannabinoids temporarily controlled in Schedule I.