By Karla L. Palmer – The Senate passed a bill last Thursday, December 11, 2014, that will prohibit the use of certain designer anabolic steroids. H.R. 4771, titled the Designer Anabolic Steroid Control Act (“DASCA”), adds 25 specific over-the-counter designer substances to the category of "anabolic …
By Karla L. Palmer – Senators John Cornyn (R-TX) and Sherrod Brown (D-OH) introduced legislation late last week that would allow a pharmacist to dispense a controlled substance prescription for a patient and deliver the drug to a practitioner for administration in the doctor’s office. S. …
By Karla L. Palmer – Late last week, Senators Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI), both members of the Senate Committee on Health, Education, Labor, & Pensions, announced the introduction of S. 2862, the “Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act.” The legislation …
By Larry K. Houck & Andrew J. Hull – Last week, the Drug Enforcement Administration (“DEA”) published its final rule implementing the Secure and Responsible Drug Disposal Act of 2010 (“Disposal Act”). 79 Fed. Reg. 53,520 (Sept. 9, 2014). A post appeared here when DEA issued …
An article set to be published in the Albany Law Review in Spring 2015, titled “Drug Diversion Administrative Revocation and Application Hearings for Medical and Pharmacy Practitioners: A Primer for Navigating Murky, Drug-Infested Waters,” explores the increasingly complex and nuanced practice of administrative law before …
By Karla L. Palmer – The U.S. Drug Enforcement Administration (“DEA”) published last Friday a Final Rule rescheduling hydrocodone combination products (“HCPs”) from Schedule III to Schedule II. We posted about the proposed rescheduling here (NPRM published February 27, 2014). There was little doubt that DEA …
By Kurt R. Karst – We thought Eisai Inc.’s (“Eisai”) beef with FDA over New Chemical Entity (“NCE”) exclusivity might resurface at some point . . . and now it has. Last Friday, Eisai filed a Complaint in the U.S. District Court for the District of …
By John A. Gilbert, Jr. & Larry K. Houck – As expected, the Drug Enforcement Administration (“DEA”) published its final rule in the Federal Register today (79 Fed. Reg. 37,623 (July 2, 2014) placing tramadol (2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol) into schedule IV of the federal Controlled Substances Act (“CSA”). …
By James C. Shehan & Karla L. Palmer – In a curious posting on Friday, June 20, 2014, FDA with little fanfare set forth its latest position on medical marijuana. Amounting to little more than a statement of general support of scientific research on medical marijuana …
By Larry K. Houck – Deputy Assistant Administrator Joseph Rannazzisi, Office of Diversion Control, Drug Enforcement Administration (“DEA”), told the House of Representatives Energy and Commerce’s Subcommittee on Oversight and Investigations on April 29, 2014 that his agency “has steadily increased the frequency of compliance inspections” …
By Kurt R. Karst – On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along …
By Larry K. Houck – Prescriptions issued for controlled substances must contain the patient’s name and address; the drug name, strength and dosage form; the quantity prescribed; directions for use; and the practitioner’s name, address and Drug Enforcement Administration (“DEA”) registration number. DEA advised in its …
By Karla L. Palmer – The Energy and Commerce Committee’s Subcommittee on Health (chaired by Representative Joe Pitts (R-PA)), has scheduled a hearing for Monday, April 7, 2014, at 3:00 p.m. in room 2123 of the Rayburn House Office Building. The hearing is titled “Improving Predictability and …
By John A. Gilbert, Jr. – A new bill introduced in Congress, H.R. 4299 (titled “Improving Regulatory Transparency for New Medical Therapies Act”), would significantly streamline the drug scheduling process for new medical therapies and reduce the potential for unnecessary delays in the availability of these needed …
By John A. Gilbert, Jr. & Larry K. Houck – A bill introduced in the Maryland House of Delegates, HB 0596, would require wholesale distributors to notify their pharmacy customers at least thirty days prior to “imposing a limit on the quantity” of prescription drugs or …
