• where experts go to learn about FDA
  • Larry K. Houck

    • Congress To DEA: Update Schedule II Partial Fill Regulations SwiftlyDecember 29th, 2017

      Obscured last week amidst the tumultuous passage of tax reform, Congress urged the Drug Enforcement Administration (“DEA”) in a bipartisan letter to quickly update its regulations and guidance on the partial filling of schedule II controlled substance prescriptions. The letter notes that “[l]arge amounts of …

    • Latest FDLI Update Magazine Article Explains DEA Preregistration and Cyclic InspectionsDecember 13th, 2017

      The Drug Enforcement Administration (“DEA”), in response to the nationwide controlled pharmaceutical diversion and abuse crisis, now conducts more frequent regulatory inspections in greater depth to identify registrants who violate the Controlled Substances Act and implementing regulations. In addition to inspecting and auditing manufacturers, distributors, …

    • The Opioid Abuse Deterrence Act and DOJ Initiatives: Just What the Doctor Ordered?December 8th, 2017

      “For Americans under the age of 50, drug overdoses are now the leading cause of death.” DOJ, Attorney General Jeff Sessions Delivers Remarks Announcing New Tools to Combat the Opioid Crisis (Nov. 29, 2017) (here).  “With evidence suggesting that nearly 80 percent of individuals addicted …

    • Hemp Industries Association Seeks Contempt against DEA; Alleges Violation of 2004 Hemp OrderFebruary 23rd, 2017

      Last month we reported that the Hemp Industries Association (“HIA”) petitioned the U.S. Court of Appeals for the Ninth Circuit to block the Drug Enforcement Administration’s (“DEA’s”) implementation of its recent final rule on marijuana extracts. On February 6, 2017, HIA filed another action with …

    • Trying to Untie the Gordian Knot: New Attempts to Change Federal Law on MarijuanaFebruary 8th, 2017

      Representative Morgan Griffith (R-VA) has introduced two bills that would remove federal roadblocks to marihuana and cannabidiol (“CBD”) access by patients for legitimate medical purposes in states that allow such access. (We use the spelling of “marihuana” that appears in the federal Controlled Substances Act …

    • Hemp Industries Association Files Petition Against DEA Marijuana Extract Rule ImplementationJanuary 24th, 2017

      The Hemp Industries Association has filed a Petition for Review in the Ninth Circuit to block implementation of the Drug Enforcement Administration’s (“DEA’s”) recent final rule on Marijuana extracts. The DEA final rule designates non-psychoactive cannabinoids, including cannabidiol, as “marihuana extract” and adds all cannabinoids, …

    • DEA Finalizes Amendments on Imports and Exports, But Misses Opportunity to Improve Re-Export RequirementsJanuary 8th, 2017

      The Drug Enforcement Administration (“DEA”) published a final rule on December 30th revising its import and export regulations governing controlled substances, listed chemicals and tableting and encapsulating machines. Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including …