Larry P. Cote

DEA Chronicles Blog Feed

http://deachronicles.quarles.com/

DEA Chronicles is our blog dedicated to helping you comply with DEA requirements for controlled substance distribution and prescription dispensing -- and all that comes along with it. The blog is led by Quarles & Brady’s premier DEA Compliance and Litigation Practice Group leaders, Linden Barber and Larry Cote, former senior-level DEA attorneys, the only practicing attorneys with substantial DEA compliance experience to leave DEA’s Office of Chief Counsel in nearly 20 years.

Recent Blog Posts

  • On November 10, 2016, the DEA issued its final decision and order in the case against Jones Total Health Care Pharmacy, L.L.C. (“Jones Pharmacy”) and SND Health Care L.L.C. (“SND”). The Administrator ordered that the DEA deny Jones Pharmacy’s registration renewal application and also deny SND’s pending registration application. These orders were consistent with the Administrative Law Judge’s (“ALJ’s”) recommendations, which were largely based on circumstantial evidence that Jones Pharmacy ignored “red flags” that prescriptions it dispensed were not for a... More
  • DEA recently announced a significant change to its registration renewal process. For several years, DEA’s registration unit has allowed for a grace period for registrants who file an untimely application for renewal.  While DEA’s regulations do not contemplate such a grace period, registrants, especially individual practitioners, were allowed to keep their existing registration number — which was considered valid and active during the grace period — despite the failure to file a timely renewal application and despite multiple notifications from DEA.On... More
  • Last week, the U.S. Surgeon General, Dr. Vivek H. Murthy, sent a letter to 2.3 million American health professionals asking them to lead a national movement to “turn the tide” on the nation’s prescription opioid epidemic.  After visiting communities hardest hit by the opioid epidemic, Dr. Murthy’s appeal to clinicians was personal:   “Everywhere I travel, I see communities devastated by opioid overdoses. I meet families too ashamed to seek treatment for addiction. And I will never forget my own patient whose... More
  •   Marijuana is less dangerous than some substances in other schedules, but it will stay in Schedule I for now, DEA said Thursday. The agency also said that it supports marijuana research, is developing an online application system to apply for Schedule I research registrations, and will allow more manufacturers to grow marijuana for research. DEA says FDA analysis shows marijuana’s medical effectiveness has not been proven In a letter to the governors of Rhode Island and Washington and a resident of New... More
  • On May 11, 2016, the Drug Enforcement Administration filed its brief in Masters Pharmaceutical, Inc. v. Drug Enforcement Administration (Docket No: 15-1335), in the United States Court of Appeals for the District of Columbia. The vast majority of the Government’s brief addresses whether “substantial evidence” (the applicable standard of review) supports Acting Administrator Rosenberg’s decision to revoke Masters’ DEA registration. Curiously, the Government does not dedicate much effort to one of the seminal issues in the case: whether DEA imposed... More
  • On February 18, 2015, the DEA issued its final decision and order in the case against prescriber Hatem M. Ataya (“Ataya”). The Administrator ordered Ataya’s registration to be revoked and his pending applications for additional registrations to be denied on the grounds that Ataya has, since the proceedings began, lost the authority to dispense controlled substances under state law. Still, the Administrator’s decision also details the bases on which he agreed with the Administrative Law Judge’s (ALJ’s) findings that Ataya... More
  • On November 16, 2015, the House of Representatives agreed to the Senate’s amended version of the Improving Regulatory Transparency for New Medical Therapies Act (H.R. 639). We previously described how the version of H.R. 639 originally passed by the House gave manufacturers clarity and security on the timing of DEA actions related to the entrance of new drugs into the market. The Senate’s amendment maintains these provisions and then sweetens the deal, with one exception. What’s New:  H.R. 639 allows for re-exportation among... More
  • On November 13, 2015, the DEA issued its final decision and order in the case against Perry County Food & Drug (“PCFD”). The Administrator denied PCFD’s pending application to renew its registration based on stipulations by PCFD that its pharmacist-in-charge, who happened to be the son of PCFD’s owner, created and filled fraudulent prescriptions and committed numerous other acts that each amounted to “an outright drug deal.” The Administrator also found that the owner was informed of his son’s diversion... More
  • On November 4, 2015, DEA Acting Administrator Chuck Rosenberg announced the results of the 2015 National Drug Threat Assessment Summary (NDTA). In addition to reporting in-depth findings regarding the availability and use of nine drugs of abuse, the 2015 NDTA focuses on the increasing threat of transnational criminal organizations (“TCOs”), confirming Michelle Leonhart’s testimony before her departure from the Agency about the integral role of TCOs in the “new face of organized crime.”    Controlled Prescription Drugs The number of individuals reporting... More
  • The Chronicles welcomes guest blogger, Julia Hudson, an associate in the Q&B Health Law Group.     Final Order on Hold! On September 15, 2015, the DEA issued a sweeping decision that revoked the registration of Masters Pharmaceutical, Inc. and left many with a lot of questions about the scope of a distributor’s compliance obligations under the CSA.  For any readers still trying to work their way through the Administrator’s 300-page order (or come to terms with it), take pause — at least for... More