• where experts go to learn about FDA
  • Page 1 of 11123...10...Last »

    Drug Enforcement Administration

    • 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 …

    • DEA Issues Decisions in Pharmacy CasesJune 18th, 2018

      Over the last couple of months, DEA has issued four decisions revoking the registrations of pharmacies (recall that DEA issued only one decision in 2017 involving a pharmacy). In February 2018, the Acting Administrator revoked the registrations of Trinity Pharmacy I, 83 Fed. Reg. 7220 …

    • DEA, Nunc Pro Tunc Rulings, and Hearings That Never HappenedJune 13th, 2018

      A couple of months ago, the DEA Acting Administrator issued an order revoking the registration of David A. Ruben, M.D., on the grounds of lack of state authority (the Arizona Medical Board suspended his medical license in 2017). The same doctor was the subject of …

    • 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 …

    • DEA Administrative Decisions: 2017 in ReviewJanuary 12th, 2018

      It was a somewhat unsettling year for the Drug Enforcement Administration. The Agency faced a barrage of criticism in the press regarding its involvement in passage of the Ensuring Patient Access and Effective Drug Enforcement Act (EPAEDEA), which some criticized as hobbling DEA’s immediate suspension …

    • 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 …

    • Reminder: ACI’s Legal, Regulatory, & Compliance Forum on Controlled SubstancesNovember 22nd, 2017

      The American Conference Institute’s Legal, Regulatory, & Compliance Forum on Controlled Substances is scheduled to take place in Washington, D.C. from January 29-31, 2018. Esteemed, top-notch faculty speaking at the conference include current and former officials from the DEA and FDA, representatives from State Attorney General …

    • What to Do When You Receive a DEA Order to Show CauseNovember 16th, 2017

      You may be a doctor, dentist, veterinarian, pharmacy, wholesale distributor, or manufacturer, and you just received an Order to Show Cause from the Drug Enforcement Administration (DEA). An Order to Show Cause can have a significant impact on your ability to handle controlled substances and, …

    • ACI’s Legal, Regulatory, & Compliance Forum on Controlled SubstancesOctober 22nd, 2017

      The American Conference Institute’s Legal, Regulatory, & Compliance Forum on Controlled Substances is scheduled to take place in Washington, D.C. from January 29-31, 2018. Esteemed, top-notch faculty speaking at the conference include current and former officials from the DEA and FDA, representatives from State Attorney General …

    • Judicial Efficiency: DEA’s Expanding Use of Summary Dispositions to Narrow the Opportunity for an Administrative HearingOctober 15th, 2017

      There is a long history and established precedent in Drug Enforcement Administration (“DEA”) administrative cases in the use of summary dispositions (i.e., determination without a hearing) related to the loss of state licensing authority (e.g., state medical or controlled substance license) (see our previous post …

    • DEA Announces “Groundbreaking” Guidance that is Inconsistent with the Settlement they are Announcing – Time at Last for Rulemaking?July 20th, 2017

      On July 11, 2017, the Department of Justice and the Drug Enforcement Administration (“DEA”) announced that Mallinckrodt LLC, a pharmaceutical manufacturer, agreed to pay $35 million to settle allegations related to the adequacy of its efforts to detect and inform DEA of suspicious orders of …

    Page 1 of 11123...10...Last »