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    • Just What the Doctor Ordered? A Number of States have Introduced Legislation to Require Prescriptions for all Pseudoephedrine ProductsFebruary 16th, 2011

      By Peter M. Jaensch & John A. Gilbert – Since the passage of the federal Combat Methamphetamine Epidemic Act in 2005 and state legislation adopted in most states around the same time, retail sales of over-the-counter (“OTC”) cold and allergy products containing pseudoephedrine (“PSE”) have been subject to …

    • DEA to Hold Public Meeting on Controlled Substances Disposal RegulationsDecember 23rd, 2010

      By John A. Gilbert & Karla L. Palmer -  The Drug Enforcement Administration announced earlier this week that it is holding a public meeting to discuss with interested persons procedures for the surrender of unwanted controlled substances by ultimate users and long term care facilities.  The …

    • DEA Announces Emergency Scheduling of Synthetic CannabinoidsDecember 2nd, 2010

      By Karla L. Palmer and Peter M. Jaensch On November 24, 2010, using its emergency authority under section 202 of the Controlled Substances Act (“CSA”) (21 U.S.C. § 812), the U.S. Drug Enforcement Administration (“DEA”) published a Notice of Intent to temporarily place five synthetic cannabinoids in Schedule …

    • The DEA Opines on a Pharmacist’s “Corresponding Responsibility”December 1st, 2010

      By John A. Gilbert & Karla L. Palmer – The Drug Enforcement Administration (“DEA”) recently published a decision that considers the scope of a pharmacist’s “corresponding responsibility” under 21 C.F.R. § 1306.04(a).  East Main Street Pharmacy (Affirmance of Suspension Order) (Docket No. 09-48) (75 Fed. Reg. …

    • Confirmation Hearing for Michele Leonhart, Proposed DEA AdministratorNovember 18th, 2010

      By William T. Koustas – The confirmation hearing for Michele M. Leonhart for the Administrator of the U.S. Drug Enforcement Administration (“DEA”) was held by the Senate Judiciary Committee on Wednesday, November 17, 2010.  Ms. Leonhart has been Acting DEA Administrator since the resignation of former …

    • Redefining Dronabinol – Part DeuxNovember 7th, 2010

      By John A. Gilbert & Karla L. Palmer – On November 1, 2010, the Deputy Administrator of the Drug Enforcement Administration published for the second time in three years a proposed rule to modify the listing of approved drug products containing dronabinol as Schedule III controlled …

    • New Combat Meth Act Increases Retailer Self CertificationNovember 3rd, 2010

      By John A. Gilbert & Karla L. Palmer – On October 12th, President Obama signed into law the “Combat Methamphetamine Enhancement Act of 2010” (Public Law No: 111-268) (“Enhancement Act”).  The Enhancement Act amends the Controlled Substances Act by requiring all regulated retail sellers of certain …

    • DEA Publishes Policy on Prescribers’ Legitimate Use of AgentsOctober 8th, 2010

      By John A. Gilbert & Peter M. Jaensch – On October 6, 2010, the Drug Enforcement Administration (“DEA”) announced a Statement of Policy concerning the procedure by which a registrant-prescriber may use an agent, including a nurse in a long term care facility (“LTCF”), to communicate controlled substances …

    • UN Addresses Worldwide Controlled Substance IssuesMarch 18th, 2010

      By John A. Gilbert – The UN Commission on Narcotic Drugs (“CND”) held its 53rd meeting last week in Vienna, Austria. This meeting routinely coincides with the publication of the International Narcotics Control Board’s (“INCB’s”) annual report.  The INCB report provides an annual summary of …

    • WHO Accepts New Guidelines on Psychoactive Substances for International ControlJanuary 25th, 2010

      By James R. Phelps – By a series of treaties, the nations of the world have given the United Nations (“UN”) a significant role in the development of systems of regulation of substances, including vitally needed medicines, that might be abused.  The World Health Organization …

    • Senate Committee Seeks Improved Access to Controlled Meds for Long-Term Care and Hospice Patients; Drafts Legislation to Address IssueNovember 3rd, 2009

      By John A. Gilbert and Larry K. Houck – Senate Special Committee on Aging Chairman Herb Kohl (D-WI) and Member Sheldon Whitehouse (D-RI) have sent a letter to U. S. Attorney General Eric Holder seeking improved access to needed pain and other medications for long-term care …

    • 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.  …