• where experts go to learn about FDA
  • Drug Enforcement Administration

    • New Arkansas PSE Law Limits OTC Sales to Arkansas Residents and Imposes New Duties on PharmacistsApril 4th, 2011

      By John A. Gilbert & Peter M. Jaensch – Following what appears to have been the stall of the Arkansas prescription-only Pseudoephedrine bill (House Bill 1444) in mid-March, on March 23, 2011, Arkansas enacted a new law in the effort to combat illicit methamphetamine production.  …

    • Legislative Fixes Focus on Controlled Substance IssuesMarch 23rd, 2011

      By Larry K. Houck – Early March on Capitol Hill has seen a flurry of legislation designed to combat a number of perceived controlled substance problems, including opioid treatment, pain management, drugs marketed to kids and pill mills. Prescription Drug Abuse Prevention and Treatment Act of 2011 Senator …

    • DEA Seizes Georgia’s Sodium ThiopentalMarch 17th, 2011

      By Susan J. Matthees – A new development in the ongoing battle involving sodium thiopental, one of the drugs used for lethal injections, surfaced today when the Drug Enforcement Administration (“DEA”) seized Georgia’s supply of the drug.  According to the Atlanta Journal-Constitution, a DEA spokesperson confirmed …

    • Citing Imminent Hazard to Public Safety, DEA Temporarily Places Synthetic Cannabinoids Into Schedule IMarch 2nd, 2011

      By Karla L. Palmer & Larry K. Houck – Consistent with its November 24, 2010 Notice of Intent, the Drug Enforcement Administration (“DEA”) published its Final Order temporarily placing five synthetic cannabinoids into Schedule I under the Federal Controlled Substances Act (“CSA”) to avoid imminent hazard to …

    • 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 …