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    • FDA Law Alert: Issue #2August 7th, 2019

      Hyman, Phelps & McNamara, P.C. is pleased to publish this second issue of the FDA Law Alert, a newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and enforcement …

    • HP&M Shares Experience with 16 Externally-Led Patient-Focused Drug Development Meetings; Summarizes Commonalities in Rare Disease Patient Perspectives in Comment to FDAMay 31st, 2019

      On April 29, 2019, the Food and Drug Administration (FDA) convened a public meeting entitled “Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities.” This meeting was attended by people with rare diseases, their caregivers and family members, patient advocates, industry representatives and …

    • Medical Cannabis Research Act Stirs DEA Marijuana Registration PotApril 10th, 2019

      We sometimes use the term “act of Congress” when referring to something that is difficult or requires large effort to achieve.  But, as nothing else has worked, a real act of Congress may be required to compel the Drug Enforcement Administration (“DEA”) to issue marijuana …

    • Three’s Finally a Crowd: DEA Proposes Replacing Triplicate DEA-222 Order Forms with Single-Sheet FormMarch 15th, 2019

      After years of talk about replacing the antiquated, carbon-leaved triplicate Official Order Form (“DEA Form 222” or “DEA-222s”) required for schedule I and II controlled substance transfers, the Drug Enforcement Administration (“DEA”) is proposing to implement a single-sheet order form.  New Single-Sheet Format for U.S. …

    • HP&M Releases 2018 Litigation BriefingJanuary 9th, 2019

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to present its annual report highlighting the leading cases and settlements from 2018 that affect the FDA- and DEA-regulated industries. Each page provides a concise summary of the relevant facts and key takeaways for our clients. We …

    • HP&M to Co-Host “DEA Compliance During the Opioid Epidemic” WebinarNovember 12th, 2018

      Hyman, Phelps & McNamara, P.C. is co-hosting a complimentary webinar, with Five Rivers Rx, on DEA compliance during the current opioid epidemic. The webinar is scheduled for November 15, 2018 (3:00-4:00 PM ET) and is geared especially towards DEA-registered manufacturers, distributors, importers, exporters and practitioners. The …

    • HP&M Director Larry Houck Receives NASCSA President’s AwardNovember 6th, 2018

      Last week during the 34th annual National Association of State Controlled Substances Authorities (“NASCSA”) conference in Scottsdale, Arizona, Hyman, Phelps & McNamara, P.C. (“HP&M”) Director Larry Houck was honored with the organization’s 2018 President’s Award. NASCSA provides a forum for state, federal and local regulators, …

    • Upcoming WHO and CND Meetings Could Impact Scheduling of CBD and CannabisOctober 18th, 2018

      We previously blogged on the Drug Enforcement Administration’s (DEA’s) rescheduling of Epidiolex. In that blog we highlighted that further action by the World Health Organization (“WHO”) and the UN Commission on Narcotic Drugs (“CND”) could further affect scheduling of cannabidiol (“CBD”) and cannabis in the …

    • DEA Limits Rescheduling of CBD to FDA-Approved EpidiolexOctober 1st, 2018

      In a much-anticipated action since the Food and Drug Administration (“FDA”) approved Epidiolex, G.W. Pharma’s oral cannabidiol (“CBD”) solution for the treatment of seizures associated with Lennox-Gastaut and Dravet syndrome, today the Drug Enforcement Administration (“DEA”) issued a Final Order placing “FDA-approved drugs that contain …

    • Proposed Doubling of 2019 Marijuana Production Quota Brings DOJ and DEA To A Fork in the RoadSeptember 21st, 2018

      In the words of the inimitable Yogi Berra: “When you come to a fork in the road, take it.” Last month the U.S. Department of Justice (“DOJ”) and the Drug Enforcement Administration (“DEA”) proposed significant reductions of Schedule II opioid pain medication quantities to be manufactured …

    • The Third Cut Is the Deepest: DEA’s Continued Slashing Of Annual Quotas Lacks A Clear RationaleAugust 21st, 2018

      In an effort to address, in Attorney General Jeff Sessions’ words, “the worst drug crisis in American history,” the U.S. Department of Justice (“DOJ”) and the Drug Enforcement Administration (“DEA”), are for the third straight year proposing to reduce the quantity of Schedule II opioid …

    • 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 …