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    • DEA Proposes E-Prescribing Regulations; Cumbersome and Strict Framework Could be an Obstacle to Widespread AdoptionJuly 6th, 2008

      On June 27, 2008, the U.S. Drug Enforcement Administration (“DEA”) published a much anticipated Notice of Proposed Rulemaking Regarding Electronic Prescriptions for Controlled Substances.  The proposed regulations are in addition to existing prescribing requirements for controlled substances and are expected to work in tandem with …

    • DEA Final Rule Increases the Allowable Number of Patients for Maintenance and DetoxMay 26th, 2008

      On May 22, 2008, the Drug Enforcement Administration (“DEA”) issued a final rule to allow every qualified practitioner to offer maintenance or detoxification treatment to 30 patients without obtaining a separate registration regardless of the number of other qualified practitioners within their medical practice.  DEA …

    • Court Denies DEA Injunction to Suspend Practitioner’s RegistrationMay 21st, 2008

      A U.S. District Court recently denied the Drug Enforcement Administration’s (“DEA’s”) attempt to use an injunction to suspend a physician’s DEA registration.  The court noted that the Controlled Substances Act (“CSA”) provides adequate administrative procedures to suspend a DEA registration.  The court also denied the …

    • WHO Set to Consider Dextromethorphan Scheduling in April 2009May 13th, 2008

      Dextromethorphan is an important ingredient in many cough/cold medications.  The World Health Organization (“WHO”) is considering whether to schedule dextromethorphan as a controlled substance under the international conventions of the United Nations system.  If that occurs, then the U.S. government will be obligated to schedule …

    • DEA Proposes Single Sheet DEA-222 Order FormJanuary 1st, 2008

      On November 27, 2007, the Drug Enforcement Administration (“DEA”) issued a proposed rule to implement a new format for DEA Official Order Forms (so-called “DEA-222s”).  DEA requires registrants to acquire Schedule I or II controlled substances using triplicate, carbon-paper DEA-222s.  DEA observes that processing transactions …

    • DEA Final Rule on Issuing Multiple Schedule II Prescriptions Goes Into EffectDecember 27th, 2007

      The Drug Enforcement Administration’s (“DEA”) final rule allowing individual practitioners to issue multiple Schedule II prescriptions to individual patients to be filled sequentially went into effect on December 19, 2007.  The rule will allow practitioners to prescribe up to a 90-day supply of a Schedule …

    • Methadone HCl 40 mg Tablets Voluntarily Restricted to Narcotic Treatment Programs and HospitalsDecember 26th, 2007

      The Drug Enforcement Administration (“DEA”) recently issued an advisory announcing that as of January 1, 2008, manufacturers of methadone HCl 40 mg tablets have voluntarily agreed to limit distribution due to the reported increase of adverse events related to methadone.  This raises new issues for …

    • DEA Proposes to Regulate all Pseudoephedrine and Phenylpropanolamine TransactionsNovember 27th, 2007

      On November 20, 2007, the Drug Enforcement Administration (“DEA”) issued a proposed rule to remove the thresholds for distributing, importing, and exporting pseudoephedrine and phenylpropanolamine (“PPA”).  In September 2007, DEA indicated in testimony before the Senate Finance Committee that the Agency was in the process …

    • Senate Will Take up Another Dextromethorphan Bill; CSA Scheduling MandatedNovember 15th, 2007

      In early October, we reported on legislation introduced in the U.S. House intended to restrict the distribution and possession of raw dextromethorphan, an antitussive drug found in many over-the-counter cold/cough drug products.  Dextromethorphan is not a federally-controlled substance, however, the Drug Enforcement Administration (“DEA”) recently …

    • Seventh Circuit Questions Equity of CSA Civil Monetary Penalty Involving Pseudoephedrine SalesNovember 8th, 2007

      The U.S. Court of Appeals for the Seventh Circuit, in its recent opinion in United States v. Global Distributors, Inc., remanded for reconsideration to the U.S. District Court for the Northern District of Illinois (Eastern Division) the imposition of the maximum allowable monetary penalties under …

    • House Committee Passes Dextromethorphan Distribution Act; DEA Reviewing for Possible ControlOctober 3rd, 2007

      On September 27, 2007, the U.S. House of Representatives Committee on Energy and Commerce passed H.R. 970, the Dextromethorphan Distribution Act of 2007, after a legislative “mark-up” session.  Similar legislation was introduced in the U.S. Senate in May 2007 (S. 1378) and was referred to …

    • DEA Proposes to Expand Definition of Dronabinol Drugs Classified in Schedule IIIOctober 1st, 2007

      On September 24, 2007, the Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking that would expand the classification of dronabinol, commonly known as delta-9-tetrahyrdocannabinol (“THC”), as a Schedule III controlled substance under the Controlled Substances Act.  THC is a federally-controlled Schedule I controlled …

    • Draft WHO Guidance Document Will Substantially Enhance the International Controlled Substance Scheduling ProcessSeptember 24th, 2007

      The United Nations (“UN”) drug control system is given authority, through treaties (called “conventions”), to establish international controls and monitor medicines that are subject to abuse.  Member countries that are signatories to the conventions are committed to control substances at the same level as dictated …