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    • House Bill Would Enhance Penalties for Meth to MinorsOctober 22nd, 2009

      By Larry K. Houck – In an effort to combat a new aspect of the methamphetamine epidemic, Congress has introduced yet amendment to the Controlled Substances Act (“CSA”).  Representative John Boozman (R-AR) has introduced legislation in the House that would enhance criminal penalties for methamphetamine …

    • DOJ Issues Medical Marijuana Investigation and Prosecution Guidelines; DEA Issues StatementOctober 22nd, 2009

      By Larry K. Houck – In a departure from US DOJ policy, Attorney General Eric Holder announced formal federal guidelines for U.S. Attorneys in states that have authorized marijuana for medical use.  The guidelines, set out in an October 19, 2009 memorandum authored by Deputy Attorney …

    • Senate Passes Bill Further Amending the CMEA (Our 600th FDA Law Blog Post!)July 19th, 2009

      By John A. Gilbert & Larry K. Houck – The Senate recently passed S. 256 which places additional requirements on retailers that sell ephedrine and pseudoephedrine.  The bill, known as the “Combat Methamphetamine Enhancement Act of 2009,” was referred to the House (H.R. 2923), which …

    • Scattered Oxycodone Shortages ReportedFebruary 15th, 2009

      By John A. Gilbert & Larry K. Houck –       WMSN-TV Fox 47 of Madison, Wisconsin, recently reported that pharmacies are experiencing difficulty obtaining oxycodone to fill their patients prescriptions.  Oxycodone, a schedule II opioid painkiller, is indicated for patients suffering from moderate to severe pain.  …

    • DEA Seeks Comments on Controlled Substance Disposal For Patients and Long Term Care FacilitiesJanuary 29th, 2009

      By John A. Gilbert & Larry K. Houck – The Drug Enforcement Administration (“DEA”) has published advance notice of proposed rulemaking that solicits comments on the disposal of controlled substances by non-registrants.  This proposal for the first time could authorize DEA registrants to accept controlled …

    • DEA Sets Self-Certification FeesJanuary 9th, 2009

      By John A. Gilbert & Larry K. Houck  –       The Drug Enforcement Administration (“DEA”) published a final rule on December 29, 2008 setting annual self-certification fees at $21 for “regulated sellers.”  “Regulated sellers,” persons and entities who sell scheduled listed chemical products at retail locations, …

    • FDLI to Hold Conference on Regulation of Controlled SubstancesNovember 25th, 2008

      By John A. Gilbert On December 4 and 5, FDLI will hold a conference on Regulation of Controlled Substances: Balancing Medical Need and Diversion Control.  The conference will focus on issues related to drug scheduling and regulation of controlled substances and List I chemicals and provide …

    • Congress Passes Legislation To Regulate Controlled Substance Dispensing Over the InternetOctober 15th, 2008

      In an effort to eliminate rogue pharmacies from dispensing controlled substances over the Internet, Congress passed legislation amending the Controlled Substances Act (“CSA”).  The Ryan Haight Act (H.R. 6353), which honors a teenager who died of an overdose of controlled drugs obtained over the Internet, …

    • DEA Actions Upheld by D.C. Court of AppealsAugust 27th, 2008

      A recent decision by the U.S. Court of Appeals for the District of Columbia in Chein v. DEA demonstrates the Court’s deference to agency expertise and a registrant’s heavy burden in overturning final action by the Drug Enforcement Administration (“DEA”) absent a “flagrant departure from …

    • District Court Rules on Jurisdiction and Non-Final Agency ActionAugust 26th, 2008

      In Novelty Distributors, Inc. v. Leonhart, the U.S. District Court for the District of Columbia recently confronted the issue of whether district courts have jurisdiction over a challenge to an agency action that is admittedly not final.    Novelty Distributors, Inc. (“Novelty”), a distributor of controlled …

    • 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 …