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

    • I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)May 21st, 2021

      Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown.  We are providing a post in three parts on …

    • I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)May 3rd, 2021

      Observers can be forgiven for thinking that the Drug Enforcement Administration’s (“DEA’s) primary focus is suspicious controlled substance orders or pharmacists’ “corresponding responsibility.”  While these areas have been the subject of increased enforcement activity because of the national opioid epidemic, DEA registrants should not forget …

    • If You Want It Done . . . Bill to Facilitate Marijuana and CBD Research Re-Introduced in the SenateMarch 16th, 2021

      The Senate recently reintroduced legislation that would promote research into medical use of marijuana.  The legislation would also importantly correct a deficiency in prior law and the Drug Enforcement Administration’s (“DEA’s”) recent rulemaking related to synthetically derived CBD. Marijuana remains classified as a schedule I controlled …

    • Getting Into the Weeds of USDA’s Hemp Production Program RegulationsFebruary 24th, 2021

      It seems as if the “hemp” debate has been raging forever.  Yet only a little over two years have passed since enactment of the Agricultural Improvement Act of 2018, the “Farm Bill,” in December 2018 that amended the Agricultural Marketing Act of 1946 directing the …

    • The Long and Winding Road: DEA Issues Final Marijuana Registration RuleJanuary 8th, 2021

      More than four years ago the Drug Enforcement Administration (“DEA”) started down a path by issuing a policy statement asserting that the agency “fully supports expanding research into the potential medical utility of marijuana and its chemical constituents.”  Applications to Become Registered Under the Controlled …

    • Muddy Waters: Cannabis Trying to Find its GrooveDecember 18th, 2020

      Apropos for the name of the great blues musician, Muddy Waters, the various federal, state and international classifications of cannabis and cannabis-derived substances is a complex scheme in search of the right rhythm.  Cannabis and cannabis-derived substances are controlled within different schedules under the federal …

    • Ready, Steady Go! Empire State Set to Establish Closed System For Cannabinoid Hemp Products Including CBDDecember 1st, 2020

      Cannabidiol (“CBD”) products are everywhere.  They are sold in pharmacies, as well as grocery, health food and convenience stores, and over the Internet.  To protect its citizens in the absence of federal requirements governing CBD and hemp-derived products for human consumption, the New York Department …

    • Code Blue All Clear: DEA Proposes Registering Emergency Medical Services AgenciesNovember 17th, 2020

      Recently, the Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking (“NPRM”) that provides much needed clarity on the requirements for how emergency medical services handle controlled substances.  The NPRM would codify its regulations consistent with the Protecting Patient Access to Emergency Medications Act …

    • Prescription Drug Wholesalers: Don’t Overlook Non-Resident State License RequirementsAugust 21st, 2020

      Owners and management of the Kilgoban Drug Company, a fictional prescription drug wholesaler in the fictional U.S. state of Moosissippi, are preparing to begin operations.  They have applied for and obtained all of the licenses required to operate their business, including a wholesaler license issued …

    • House Approves Amendment Shielding State-Authorized Cannabis ActivitiesAugust 6th, 2020

      Last week, in what has become an annual ritual, the House of Representatives voted 254-163 (222 of 228 Democrats, 31 of 188 Republicans) to approve an amendment prohibiting the Department of Justice (“DOJ”) from using appropriated funds to enforce federal laws against authorized marijuana activities …

    • Up, Up and But Not Away: DEA Raises Registration FeesJuly 29th, 2020

      An interesting aspect of a federal or state administrative agency seeking appropriations or raising fees is its justification for doing so and the light it sheds on the priorities for fulfilling its mission.  The Drug Enforcement Administration’s (“DEA’s”) recent increase of initial registration and renewal …

    • USDA Approves, Continues to Review, Additional Hemp Production PlansJune 3rd, 2020

      The U.S. Department of Agriculture (“USDA”) continues to consider and approve state and tribal hemp production plans, announcing the approval of plans for the U.S. Virgin Islands, Cheyenne River Sioux Tribe, Chippewa Cree Tribe, Lac Courte Oreilles Band of Superior Chippewa Indians, and Red Lake …

    • Open for Business: DEA’s Proposed Rule Would Make the Agency an Active Buyer and Seller of MarijuanaMarch 26th, 2020

      In 2009, Levon Helm, formerly of The Band, wrote and recorded “Growin’ Trade,” a song about a weary, disillusioned American farmer reluctantly staves off bankruptcy by growing illegal cannabis.  Helm nor anyone else could have known that in the ensuing years, a majority of states …

    • Have Methadone, Will Travel: DEA Proposal Facilitates Mobile Narcotic Treatment ProgramsFebruary 28th, 2020

      Under current law, a Narcotic Treatment Program (“NTP”) registered with the Drug Enforcement Administration (“DEA”) can only provide treatment at its registered location.  With the current opioid epidemic, the need to ensure access to medication-assisted treatment is more acute than ever.  To help address this …

    • 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 …