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    • DEA Tweaks Order Form RequirementJuly 28th, 2021

      Last week the Drug Enforcement Administration (“DEA”) issued a direct final rule clarifying requirements about who may record the supplier’s DEA registration number on a single-sheet DEA Form 222 (“single-sheet form”).  Clarification Regarding the Supplier’s DEA Registration Number on the Single-Sheet DEA Form 222, 86 …

    • DEA To Mobile Narcotic Treatment Programs: “Hit the Road, Jack, But You Better Come Back”July 12th, 2021

      The Drug Enforcement Administration (“DEA”) recently issued its final rule authorizing the use of mobile narcotic treatment programs (“MNTPs”) to allow registered Narcotic Treatment Programs (“NTPs”) employing mobile units to dispense medication for maintenance or detoxification treatment remotely.  Registration Requirements for Narcotic Treatment Programs with …

    • Minnesota Proposes to Reduce Opioid Product Registration Fees Related to HospitalsJune 29th, 2021

      A recent proposed amendment to Minnesota’s Opiate Product Registration Fee appears intended to ensure continued availability of certain opiate products at hospitals.  On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services …

    • I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 3)June 28th, 2021

      This is the third in a series of posts on what DEA registrants can expect during cyclic and on-site inspections.  Our series focuses on the background of such inspections, how investigators conduct them and how registrants should proactively prepare for and manage them.  Part 1, …

    • 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 …

    • REMINDER: Controlled Substances Act Issues: Legal Perspectives and Analytical Trends WebinarApril 20th, 2021

      Hyman, Phelps & McNamara, P.C. and Analysis Group are partnering to host a two-hour timely, informative and free program to discuss current important legal perspectives and analytical trends concerning the Controlled Substances Act and the Drug Enforcement Administration.  The webinar is scheduled to take place …

    • Controlled Substances Act Issues: Legal Perspectives and Analytical Trends WebinarApril 12th, 2021

      Hyman, Phelps & McNamara, P.C. and Analysis Group are partnering to host a two-hour timely, informative and free program to discuss current important legal perspectives and analytical trends concerning the Controlled Substances Act and the Drug Enforcement Administration.  The webinar is scheduled to take place …

    • 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 …

    • New HHS Policy on Buprenorphine for the Treatment of Opioid Use Disorder – Finally, Treatment is More Accessible than Opioids…. UPDATEJanuary 26th, 2021

      In the waning days of the Trump administration, the Department of Health and Human Services announced a fairly significant change in addiction medicine policy. The new policy permits physicians (and only physicians) more flexibility to prescribe buprenorphine – a much used and effective drug that …

    • 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 …

    • DEA Proposes Rule to Expand Partial Filling of Schedule II Prescriptions; Will the Benefit be Cost-Effective?December 11th, 2020

      Pharmacists, in general, can partially fill any prescription for non-controlled and most Schedule III-V controlled substances.  Partial filling has several benefits, including reducing waste and potentially lowering the cost of a prescription.  However, Schedule II (C-II) controlled drugs are an exception to general rule allowing …

    • FDA Law Alert – December 2020December 4th, 2020

      To close out 2020, Hyman, Phelps & McNamara, P.C. is pleased to present the latest issue of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on regulatory and enforcement …