• where experts go to learn about FDA
  • Controlled Substances

    • Death, Taxes and DEA Inspections: Dealing with the InevitableNovember 22nd, 2011

      In his recent article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Of Counsel, and former diversion investigator for the Drug Enforcement Administration (“DEA”), Larry K. Houck, explains the scope of DEA pre-registration and cyclic inspections as a step-by-step guide to actions and procedures …

    • Pain Relief on the Way? Senator Kohl’s Proposed Bill to Provide Easier Access to Controlled Substances to Patients in Long-Term Care FacilitiesSeptember 20th, 2011

      By Karla L. Palmer & John A. Gilbert – Last week Senator Herb Kohl (D-WI) introduced a bill (S. 1560) to facilitate controlled substance access for residents of residential long-term care facilities.  The proposed bill, which would amend the federal Controlled Substances Act (“CSA”), specifically  21 …

    • DEA Proposes Raising Registration FeesJuly 12th, 2011

      By Larry K. Houck – The Drug Enforcement Administration (“DEA”) published a Notice of Proposed Rulemaking (“NPRM”) on July 6, 2011 seeking to raise initial registration and renewal fees for all registrants.  76 Fed. Reg. 39,318 (July 6, 2011).  Citing increased diversion control activities, DEA justified …

    • Consolidation of Seizure and Forfeiture Regulations under CAFRA – DEA Proposed RulemakingMay 18th, 2011

      By John A. Gilbert & Karla L. Palmer – On May 9, 2011, the Drug Enforcement Administration ("DEA") published a proposed rulemaking addressing the “Consolidation of Seizure and Forfeiture Regulations” to conform with the Civil Asset Forfeiture Reform Act ("CAFRA") of 2000.  When finalized, the rule will …

    • Do State Laws on Methamphetamine Precursors Burden Practitioners and Patients?May 17th, 2011

      In his recent article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Associate Peter M. Jaensch examines the increasing legislative efforts by states to require prescriptions for products containing methamphetamine precursors (such as pseudoephedrine and ephedrine), and to list them as Controlled Substances.  Mr. …

    • “Responding to America’s Prescription Drug Abuse Crisis”: Administration’s New Action Plan Includes Changes to the CSAApril 21st, 2011

      By John A. Gilbert, Jr. & Peter M. Jaensch – In a press conference at the National Press Club on April 19, 2011, the Administration presented its action plan (“Plan”) to address concerns about the increase in prescription drug abuse.  The Plan is entitled: “Epidemic: Responding to …

    • DEA Publishes Interim Final Rule for Mail-Order Distributors of Scheduled Listed Chemical ProductsApril 17th, 2011

      By John A. Gilbert & Karla L. Palmer – On Wednesday, April 13, 2011, the Drug Enforcement Administration (“DEA”) published an Interim Final Rule with a request for comments on the “Self-Certification and Employee Training of Mail-Order Distributors of Scheduled Listed Chemical Products.”  See 76 Fed. …

    • 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 …

    • 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 …

    • 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 …