Tag Archives: diversion

West Virginia Imposes New Suspicious Order Reporting Requirements

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 … Continue Reading

DEA Prevails Over Masters Pharmaceutical, Inc.

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 … Continue Reading

DEA Decisions: Evidence of “Red Flags” of Drug Diversion

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 … Continue Reading

The Continued Evolution of DEA’s Due Diligence Requirements

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 … Continue Reading

GAO Issues Another Report Involving DEA

On July 27, 2015, the Government Accountability Office (GAO) released a report titled, Prescription Drugs: More DEA Information about Registrants’ Controlled Substances Roles Could Improve Their Understanding and Help Ensure Access.  GAO’s report examined, (1) to what extent registrants interact with DEA about their CSA responsibilities, and registrants’ perspectives on those interactions, (2) how state … Continue Reading

DEA to Continue Take Back Programs

On September 23, 2014, DEA announced that its ninth Take Back Day would be the agency’s last.  The announcement was made shortly after DEA published the Final Rule implementing the Secure and Responsible Drug Disposal Act of 2010.  The regulations promulgated by DEA allow “authorized collectors” the opportunity to receive and securely dispose of prescription … Continue Reading

DEA Announces Major Enforcement Action

On May 20, 2015, DEA issued a press release regarding a recent major enforcement action in Arkansas, Alabama, Louisiana, and Mississippi. Operation Pilluted targeted alleged pill mills that were engaged in the illegal distribution of oxycodone, hydrocodone and Xanax. The operation resulted in the arrest of 280 individuals, including 22 doctors and pharmacists. Executing 21 search … Continue Reading

DEA Decisions: In the Matter of The Medicine Shoppe

In the Matter of the Medicine Shoppe (October 2, 2014) DEA recently revoked the registration of the Medicine Shoppe, a San Antonio, Texas,  pharmacy, based on a finding that the pharmacy violated the Controlled Substances Act in all of the following ways: dispensed controlled substances without a prescription; dispensed controlled substances when the prescription was “signed” … Continue Reading

DEA to Publish Final Rule Rescheduling Hydrocodone Combination Products

In 45 days, hydrocodone combination products (“HCPs”) will be Schedule II controlled substances.  This means that by early October, manufacturers, wholesalers, pharmacies, prescribers, and everyone in the drugs’ supply chains will have to be in compliance with the more restrictive regulatory requirements applicable to Schedule II drugs. In a previous post we discussed whether the … Continue Reading

DEA Decisions: In the Matter of Moore Clinical Trials, L.L.C.

In the Matter of Moore Clinical Trials, L.L.C (July 11, 2014) DEA last month denied the DEA research registration application of an Arkansas clinical research company, finding that the person who would be primarily responsible for ordering and storing controlled substances had a “shocking” lack of knowledge of the fundamental requirements imposed by the Controlled … Continue Reading

FedEx Pleads Not Guilty

As expected, FedEx appeared in federal district court and entered a plea of not guilty to the charges brought against the company by the Drug Enforcement Administration (“DEA”) and the United States Attorney’s Office for the Northern District of California.  As we have recently discussed, this is an unprecedented action by the government seeking to … Continue Reading

NABP Releases “Red Flags”

At the 110th Annual Meeting of the National Association of Boards of Pharmacy (“NABP”) a new educational video entitled “Red Flags” was released by NABP to assist pharmacists in properly exercising their corresponding responsibility and identifying the warning signs of prescription drug abuse and diversion.  The educational video was sponsored by Mallinckrodt Pharmaceuticals, Cardinal Health, … Continue Reading

Suspicious Order Monitoring – What’s Next?

Come join us at the 2014 HDMA Distribution Management Conference and Technology Expo.  We are excited to share our perspective on the latest developments in suspicious order monitoring and reporting.  As an added bonus, we will also be available for a post-presentation discussion to continue the conversation on this very important topic.  Yet another bonus … Continue Reading

DEA Takes the First Step Towards Rescheduling Hydrocodone Combination Products

On Thursday, February 27, 2014, the DEA issued a long-awaited Notice of Proposed Rulemaking (NPRM) seeking to reschedule hydrocodone combination products as Schedule II controlled substances.  In a previous post we questioned whether such a step would actually have an impact on the abuse and diversion of these drugs.  DEA relied on the scientific analysis … Continue Reading

A Pharmacist’s Obligation: Corresponding Responsibility and Red Flags of Diversion

Corresponding responsibility is perhaps one of the most commonly misunderstood and/or (unfortunately) unknown concepts found in DEA’s regulations.  And yet, enforcement actions against pharmacies are most frequently initiated when a pharmacist fails to exercise his/her corresponding responsibility.  I have had countless conversations with practicing pharmacists who are either unfamiliar with the concept of a “corresponding … Continue Reading

Upcoming DEA Conferences

The DEA has announced an upcoming Manufacturer/Importer/Exporter Conference to be held in June 2013 at the National Harbor, Gaylord National Resort & Convention Center. “The purpose of this conference is to provide a forum to present federal laws and regulations that affect the pharmaceutical and chemical manufacturing, importing, and exporting industry and to discuss practices … Continue Reading
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