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. …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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. …
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 …
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, …
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 …
