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

    • Ease on Down the Road: DEA Still Not Ready to Evaluate Marijuana Manufacturer RegistrationsAugust 29th, 2019

      In a September 2018 post, we observed that the Drug Enforcement Administration (“DEA”) had come to a fork in the road with respect to DEA’s August 12, 2016 policy statement that it would be accepting applications and would in fact issue additional marijuana manufacturer registrations …

    • Medical Cannabis Research Act Stirs DEA Marijuana Registration PotApril 10th, 2019

      We sometimes use the term “act of Congress” when referring to something that is difficult or requires large effort to achieve.  But, as nothing else has worked, a real act of Congress may be required to compel the Drug Enforcement Administration (“DEA”) to issue marijuana …

    • Three’s Finally a Crowd: DEA Proposes Replacing Triplicate DEA-222 Order Forms with Single-Sheet FormMarch 15th, 2019

      After years of talk about replacing the antiquated, carbon-leaved triplicate Official Order Form (“DEA Form 222” or “DEA-222s”) required for schedule I and II controlled substance transfers, the Drug Enforcement Administration (“DEA”) is proposing to implement a single-sheet order form.  New Single-Sheet Format for U.S. …

    • Farm Bill Creates Legal Framework for Hemp, But Challenges RemainDecember 21st, 2018

      In a rare display of bipartisanship in Washington, Congress has passed, and the President has signed, the Agricultural Improvement Act of 2018.  The agricultural legislation is far-ranging, but its most significant aspect from a controlled substance perspective is that it removes “hemp” as defined in the …

    • Upcoming WHO and CND Meetings Could Impact Scheduling of CBD and CannabisOctober 18th, 2018

      We previously blogged on the Drug Enforcement Administration’s (DEA’s) rescheduling of Epidiolex. In that blog we highlighted that further action by the World Health Organization (“WHO”) and the UN Commission on Narcotic Drugs (“CND”) could further affect scheduling of cannabidiol (“CBD”) and cannabis in the …

    • DEA Limits Rescheduling of CBD to FDA-Approved EpidiolexOctober 1st, 2018

      In a much-anticipated action since the Food and Drug Administration (“FDA”) approved Epidiolex, G.W. Pharma’s oral cannabidiol (“CBD”) solution for the treatment of seizures associated with Lennox-Gastaut and Dravet syndrome, today the Drug Enforcement Administration (“DEA”) issued a Final Order placing “FDA-approved drugs that contain …

    • Proposed Doubling of 2019 Marijuana Production Quota Brings DOJ and DEA To A Fork in the RoadSeptember 21st, 2018

      In the words of the inimitable Yogi Berra: “When you come to a fork in the road, take it.” Last month the U.S. Department of Justice (“DOJ”) and the Drug Enforcement Administration (“DEA”) proposed significant reductions of Schedule II opioid pain medication quantities to be manufactured …

    • The Third Cut Is the Deepest: DEA’s Continued Slashing Of Annual Quotas Lacks A Clear RationaleAugust 21st, 2018

      In an effort to address, in Attorney General Jeff Sessions’ words, “the worst drug crisis in American history,” the U.S. Department of Justice (“DOJ”) and the Drug Enforcement Administration (“DEA”), are for the third straight year proposing to reduce the quantity of Schedule II opioid …

    • California to Pharmacies: Start Balancing your Opioid CheckbookJuly 6th, 2018

      The Drug Enforcement Administration (“DEA”) and the states are struggling with how to confront the challenges posed by the opioid abuse crisis. One aspect of this problem relates to employee theft, particularly at the pharmacy level. The California Board of Pharmacy (“BOP”), as well as …

    • About Time: DEA Acknowledges that Long-Collected ARCOS Data is an Effective Enforcement Tool That Can Assist Manufacturers and DistributorsFebruary 21st, 2018

      Overprescribing and inappropriate prescribing of controlled substances are significant causes of the nationwide opioid abuse epidemic. We have long believed that to effectively address the opioid epidemic, the Drug Enforcement Administration (“DEA”) must focus on physicians and other practitioners who fail to comply with legitimate …

    • DEA Proposes a New Strategy to Ban Illicit Fentanyl-Related SubstancesJanuary 19th, 2018

      On December 29th, the Drug Enforcement Administration (“DEA”) published notice of its intent to temporarily control fentanyl-related substances that are not currently regulated under the Controlled Substances Act (“CSA”).  Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I, 82 Fed. Reg. 61700 …

    • Up in Smoke? Will the Feds Ramp Up Enforcement Action Against Budding State Marijuana Industry?January 4th, 2018

      Federal law continues to prohibit the possession, cultivation or distribution of marijuana and prohibits operating a business for these purposes. A number of states continue to follow Federal law and prohibit the use of marijuana under any circumstance, but a growing majority of other states …

    • 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 …