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  • Controlled Substances

    • 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, …

    • Democratic Lawmakers Advocate for Prompt Decontrol of MarijuanaApril 30th, 2024

      On April 23, 2024 we blogged about Republican Senators Mitt Romney, Pete Ricketts and James Risch advising Drug Enforcement Administration (“DEA”) Administrator Anne Milgram to consider U.S. treaty obligations under the Single Convention, 1961, when rescheduling marijuana.  Later Democratic lawmakers, eleven senators and ten members …

    • Senators to DEA: Consider Treaty Obligations In Marijuana ReschedulingApril 23rd, 2024

      Administrator Anne Milgram has been on the receiving end of high-level support for and against rescheduling marijuana since the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended the Drug Enforcement Administration (“DEA”) reschedule from schedule I to schedule III last August.  …

    • Clear that Cabinet Tour ‘24April 18th, 2024

      Medicine cabinet, stuffed to the gills Capsules, liquid, patches, and pills Expired oxy, hydro, benzos, and more All kind of old meds flowing out the door We will, we will, clear you We will, we will, clear you Back by popular demand, coming to a collection site in your town for …

    • Marijuana: Top Ten Reasons for Descheduling, Rescheduling or NotFebruary 12th, 2024

      With apologies to David Letterman, who introduced the first Top Ten List on Late Night with David Letterman on September 18, 1985, we present “Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not.”* The wide range of assertions supporting or opposing Health and Human Services’ (“HHS’”) …

    • Stop the Presses! DEA and DOJ Fine eBay for not Reporting Sales of Tableting and Pill Press MachinesFebruary 8th, 2024

      Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines.  As stated in …

    • Hyman, Phelps & McNamara, P.C. (HP&M) is Pleased to Announce the Addition of Sara M. Keup as the new State Licensing Regulatory Expert for the Firm’s Licensing PracticeFebruary 6th, 2024

      HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. With regulations varying significantly from one state to another, companies in these sectors …

    • ACI’s 42nd FDA Boot Camp – New York City EditionJanuary 24th, 2024

      The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp”—now in its 42nd iteration—is scheduled to take place from March 13-14, 2024, at the SpringHill Suites NY Manhattan Times Square South, New York. The conference is billed as the premier event to provide folks with a …

    • Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation UnveiledJanuary 19th, 2024

      In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III.  By doing so, FDA determined that marijuana not …

    • HP&M’s Larry Houck Presenting “HHS’ Cannabis Rescheduling Recommendation: A Long Strange Trip with Potholes”December 21st, 2023

      In October 2022 President Joseph Biden directed the Secretary of Health and Human Services (“HHS”) and the Attorney General to begin the administrative process of reviewing expeditiously how cannabis is scheduled under federal law.  HHS recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from …

    • Governors’ Push President on Cannabis Rescheduling But Overlook What Schedule III Would RequireDecember 15th, 2023

      Last week, in a letter thanking President Joe Biden for his leadership to federally reschedule cannabis, Democratic governors sought to make the case for rescheduling.  Letter to President Joseph R. Biden, Jr., from Governor Jared Polis et al., Dec. 5, 2023.  The governors (of Colorado, Illinois, …

    • Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary TalesDecember 5th, 2023

      Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances.  On October 10th, based on ability to pay, the U.S. District Court for the Western …

    • DEA Updates Special Surveillance List of Precursor Chemicals and EquipmentOctober 31st, 2023

      The Drug Enforcement Administration (“DEA”) has issued its notice finalizing updates to its longstanding Special Surveillance List of chemicals and equipment used in the illicit manufacture of controlled substances and listed chemicals.  Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture …

    • We Will Clear You: DEA’s National Prescription Drug Take Back DayOctober 19th, 2023

      Medicine cabinet, stuffed to the gills Capsules, liquid, patches, and pills Expired oxy, hydro, benzos, and more All kind of meds flowing out the door We will, we will, clear you We will, we will, clear you Were the Drug Enforcement Administration (“DEA”) a rock band, it might promote the upcoming …