• where experts go to learn about FDA
  • Controlled Substances

    • DEA Pharmacy Decision Highlights Agency’s Thinking on Expert Credibility and Testimony, as well as Red Flag ResolutionFebruary 19th, 2025

      A recent DEA decision revoking the registration of a Louisiana pharmacy sheds light on the Agency’s approach to crediting one expert’s testimony over that of another expert during an administrative hearing.  The discussion of the Agency’s expectations of the form and substance of expert witness …

    • HPM’s Larry Houck Presenting at WCF Opioid and Fentanyl Abuse Management CongressFebruary 12th, 2025

      One of the most significant issues facing hospitals and other facilities is the diversion of controlled substances meant for patients by physicians, pharmacists, nurses and other trusted healthcare employees. Recent employee diversion of significant controlled substance quantities from hospitals has resulted in large civil monetary settlements, …

    • Prehearing Ruling Establishes Marijuana Rescheduling Hearing Ground RulesDecember 13th, 2024

      Administrative Law Judge (“ALJ”) John Mulrooney conducted a prehearing conference hearing on Monday, December 2nd, to kick off the public hearing on the Department of Justice’s (“DOJ’s”) notice of proposed rulemaking (“NPRM”) to reschedule marijuana.  The NPRM seeks to reschedule marijuana from schedule I of …

    • Gentlemen, Start Your Engines: DEA’s Marijuana Rescheduling Hearing Begins MondayNovember 27th, 2024

      Last May the Department of Justice (“DOJ”) and the Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) to transfer marijuana from schedule I of the Controlled Substances Act (“CSA”) to schedule III.  Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. Reg. …

    • It’s a Three-Peat: DEA and HHS Extend Telemedicine Flexibilities Until December 31, 2025November 22nd, 2024

      In a Temporary Rule announced on November 19, 2024, DEA with input from HHS again extended current telemedicine flexibilities, which were first initiated on January 31, 2020 at the inception of the COVID-19 pandemic. The federal telemedicine flexibilities (i.e., temporary exceptions from some of the …

    • Bring Out Your Meds! Bring Out Your Meds!October 21st, 2024

      Eric Idle, as a body collector, immortalized the phrase, “Bring out your dead!  Bring out your dead!” in the 1975 comedy classic, Monty Python and the Holy Grail.  The Drug Enforcement Administration (“DEA”) would do well to update that phrase as “Bring out your meds! …

    • DEA To Announce Hearing on Proposed Marijuana ReschedulingAugust 27th, 2024

      Who says nothing happens in Washington, D.C., in August?  The Drug Enforcement Administration (“DEA”) will announce Thursday in the Federal Register that it will hold a hearing on the proposed rescheduling of marijuana to schedule III at DEA Headquarters in Arlington, Virginia on December 2, …

    • Federal Marijuana Rescheduling: States Get ReadyAugust 9th, 2024

      States better get ready, Rescheduling may be coming, You may need to make changes, You may need to do more, Than just get on board. (With apologies to Curtis Mayfield) By the close of the public comment period for the Drug Enforcement Administration’s (“DEA’s”) proposal to reschedule marijuana two weeks ago, …

    • Former DEA Administrators Weigh in on Marijuana ReschedulingJuly 1st, 2024

      The Drug Enforcement Administration (“DEA”) has received more than 27,000 public comments in response to its May 21, 2024, Notice of Proposed Rulemaking (“NPRM”) to reschedule marijuana from schedule I to schedule III.  However, none may carry more weight than a short comment just over …

    • Pharmacists in Florida (and Elsewhere): Waive Prescribing Red Flags at Your PerilJune 28th, 2024

      We blogged in February 2022 about the Drug Enforcement Administration’s (“DEA’s”) revocation of Gulf Med Pharmacy’s registration after finding that it failed to exercise its corresponding responsibility by repeatedly filling controlled substance prescriptions that exhibited “obvious red flags of diversion without documenting the resolution of …

    • DEA’s Expected Guidance: It Should Reduce Current “Pain” at the (Intrathecal Pain) Pump Dispensing Process and Improve Therapeutic OutcomesJune 23rd, 2024

      For more than 50 years, the Drug Enforcement Administration (DEA) has enforced the central mandate of the Controlled Substances Act (CSA) to maintain a closed chain of distribution for drugs with a potential for abuse and diversion.  The CSA and regulations promulgated by DEA are …

    • HP&M’s Larry Houck A Panelist in FDLI’s Marijuana Rescheduling WebinarJune 10th, 2024

      Last month the Department of Justice and the Drug Enforcement Administration submitted a notice of proposed rulemaking to reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III.  Hyman, Phelps & McNamara, P.C. Director Larry Houck will participate as a …

    • More Diversion Cases and WCF’s Opioid & Fentanyl Abuse Management SummitJune 10th, 2024

      It seems as though we cannot get through a week without hearing about controlled substance diversion by employees at another hospital or healthcare facility. We learned this week that Palomar Health, one of California’s largest healthcare districts, agreed to pay $250,000 to resolve allegations that numerous …

    • Hospitals: Do You Know Where Your Controlled Substances Are?May 16th, 2024

      Employee diversion of controlled substances from hospitals has been an issue since at least 1986 when I became a diversion investigator with the Drug Enforcement Administration (“DEA”).  But there has been a recent string of large civil monetary settlements, some in the millions of dollars, …

    • DEA Concurs: Marijuana Meets Schedule III CriteriaMay 6th, 2024

      The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III.  US poised to ease restrictions on marijuana in historic shift, …