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    • DEA Publishes Proposed Rulemaking Addressing Reporting of Thefts and Significant Losses of Controlled SubstancesJuly 30th, 2020

      On July 29, 2020, DEA published a Notice of Proposed Rulemaking titled, “Reporting of Thefts or Significant Loss of Controlled Substances.”  (85 Fed. Reg. 45547 (Jul. 29, 2020)). See Federal Register notice here.  As registrants are well aware, the current DEA regulation addressing reporting to …

    • Up, Up and But Not Away: DEA Raises Registration FeesJuly 29th, 2020

      An interesting aspect of a federal or state administrative agency seeking appropriations or raising fees is its justification for doing so and the light it sheds on the priorities for fulfilling its mission.  The Drug Enforcement Administration’s (“DEA’s”) recent increase of initial registration and renewal …

    • USDA Approves, Continues to Review, Additional Hemp Production PlansJune 3rd, 2020

      The U.S. Department of Agriculture (“USDA”) continues to consider and approve state and tribal hemp production plans, announcing the approval of plans for the U.S. Virgin Islands, Cheyenne River Sioux Tribe, Chippewa Cree Tribe, Lac Courte Oreilles Band of Superior Chippewa Indians, and Red Lake …

    • Just a Decade Later, DEA Reopens Comment Period for Electronic Prescriptions for Controlled SubstancesApril 24th, 2020

      A little more than ten years ago, on March 31, 2010, the Drug Enforcement Administration published its  Interim Final Rule (IFR) with request for comments, titled “Electronic Prescriptions for Controlled Substances” (Docket No. DEA-218, RIN 1117-AA61). The rule became effective June 1, 2010, and is …

    • Open for Business: DEA’s Proposed Rule Would Make the Agency an Active Buyer and Seller of MarijuanaMarch 26th, 2020

      In 2009, Levon Helm, formerly of The Band, wrote and recorded “Growin’ Trade,” a song about a weary, disillusioned American farmer reluctantly staves off bankruptcy by growing illegal cannabis.  Helm nor anyone else could have known that in the ensuing years, a majority of states …

    • USDA Announces Delay of Enforcement of Requirement for DEA Registration of Hemp Testing LaboratoriesMarch 5th, 2020

      On February 27, the U.S. Department of Agriculture (USDA) announced the delay of enforcement of certain requirements under the interim final rule (IFR) for the U.S. Domestic Hemp Production Program. As we previously reported, on Nov. 7, 2019, USDA published its much-anticipated rule establishing the requirements …

    • Have Methadone, Will Travel: DEA Proposal Facilitates Mobile Narcotic Treatment ProgramsFebruary 28th, 2020

      Under current law, a Narcotic Treatment Program (“NTP”) registered with the Drug Enforcement Administration (“DEA”) can only provide treatment at its registered location.  With the current opioid epidemic, the need to ensure access to medication-assisted treatment is more acute than ever.  To help address this …

    • FDA Law Alert – November 2019November 6th, 2019

      Hyman, Phelps & McNamara, P.C. is pleased to publish the third installment of the FDA Law Alert, a quarterly 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 …

    • Ease on Down the Road: DEA Still Not Ready to Evaluate Marijuana Manufacturer RegistrationsAugust 29th, 2019

      In a September 2018 post, we observed that the Drug Enforcement Administration (“DEA”) had come to a fork in the road with respect to DEA’s August 12, 2016 policy statement that it would be accepting applications and would in fact issue additional marijuana manufacturer registrations …

    • 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 …