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 leader, Larry Cote, a former senior-level DEA attorney, one of the only practicing attorneys with substantial DEA compliance experience to leave DEA’s Office of Chief Counsel in nearly 20 years.

Recent Blog Posts

  • Nobody would argue with the fact that there is an opioid crisis in our country – it is a demonstrable fact. However, there has recently been a significant focus on whether drug wholesalers and their business partners including lobbyists have caused people to die from overdoses, including a recent segment by 60 Minutes. While the segment sought to educate viewers on the causes of prescription drug abuse and the alleged slowdown in enforcement efforts by the government, it is of... More
  • The West Virginia Board of Pharmacy (“Board”) rolled out a new mandatory suspicious order reporting form for wholesalers at its board meeting last month.  The one-page form is designed to be filled out for each individual suspicious order being reported. This will require wholesalers that currently create and submit automated suspicious order reports to adapt their reporting for West Virginia. In addition to the information generally provided to regulators, the form requires the wholesaler to disclose the reason it classified the... More
  • Federal and state policy makers struggle to come up with solutions to the ongoing opioid crisis. As with many areas of public policy, political leaders are turning to the tax laws as a possible way to curtail opioid abuse. In the past two years, there have been many proposals to impose special or excise taxes on the sale of opioids. To date none have passed. But we believe that without the implementation of other policies to address the issue, a... More
  • On June 30, 2017, the Court of Appeals for the D.C. Circuit issued an order in Masters Pharmaceutical, Inc. v. Drug Enforcement Administration (No. 15-1335). In sum, the Court denied Masters Pharmaceutical, Inc.’s (“Masters”) Petition for Review seeking to overturn the Drug Enforcement Administration’s (“DEA”) revocation of Masters’ DEA registration. This decision has wide-ranging implications for DEA-registered wholesalers, who are required to detect and report suspicious orders of controlled substances. Here are a few takeaways from the Court’s decision: The facts here... More
  • Recently, the Oregon Board of Pharmacy adopted a new rule for wholesale distributors, requiring that they report suspicious orders to the Board for review. The rule goes into effect on July 1, 2017. The adoption of the new rule followed several recent settlements by wholesale distributors around the country, who are facing severe penalties for failing to report suspicious orders of controlled substances to the Drug Enforcement Administration (DEA). The new regulation states: A wholesale distributor must notify the Board in writing of suspicious... More
  • The opioid crisis in the United States continues to worsen, with the Centers for Disease Control reporting more than 33,000 human deaths by overdose in 2015 – up from about 29,000 in 2014 and quadruple the number in 1999. As in-house counsel from some of the nation’s 65,000 retail pharmacies prepare to meet in Chicago for Quarles & Brady’s 2017 Pharmacy Law Symposium this July, partners Amy Cotton Peterson and Roger Morris discussed the opioid epidemic. The partners also discussed... More
  • The battle is over! For now. Yesterday, Alabama lawmakers blocked the proposal to move Alprazolam into Schedule II, as well as blocking the other proposed changes described in this series of client updates. See here and here. The pharmacy community in Alabama took an active role in opposing these changes. According to this article from Alabama Live, members of the Alabama Pharmacy Association opposed this change and as noted in our most recent update, the Alabama Board of Pharmacy was also... More
  • As an update to our January 9, 2017 blog post, the Alabama Department of Public Health (ADPH) has continued with its efforts to make Alprazolam a Schedule II drug, along with rescheduling all other benzodiazepines from Schedule IV to Schedule III. The rule change would also reschedule pregabalin from Schedule V to Schedule IV and reschedule zolpidem from Schedule IV to Schedule III. The proposed rule was passed by the State Committee of Public Health and is currently scheduled to be... More
  • An Oklahoma doctor wrote 19 Schedule II controlled substance prescriptions for a patient with low back pain over eight months without thoroughly documenting the patient’s history, confronting the patient over aberrant drug tests, or talking to other doctors who were prescribing the patient controlled substances. The Chief Administrative Law Judge felt the doctor should be granted a new registration, but placed on probation for one year. Acting Administrator Chuck Rosenberg disagreed. He reviewed the case and concluded that DEA proved... More
  • The Washington Post reported last week that it obtained sealed court documents describing how National Football League teams have violated federal prescription drug laws regarding the storage, tracking, transportation, and distribution of controlled substances. The documents—prepared by lawyers representing more than 1,800 former professional football players—include testimony and records that implicate all 32 NFL teams and a number of league personnel. Plaintiffs filed Evans v. Arizona Cardinals Football Club, LLC in the U.S. District Court of Northern California in May 2015,... More