Tag Archives: DEA

Senate Committee Questions DEA on Quota Process

On May 5, 2015, the United States Senate, Caucus on International Narcotics Control held a hearing exploring the findings and recommendations of a Government Accountability Office investigation into the Drug Enforcement Administration’s management of its quota process.  The hearing, called by Senators Grassley and Feinstein, sought to explore the connection between DEA’s quota process and … Continue Reading

GAO Report Criticizes DEA Quota Process

On March 4, 2015, the Government Accountability Office (GAO) released a report titled, Drug Shortages: Better Management of the Quota Process for Controlled Substances Needed; Coordination between DEA and FDA Should Be Improved.  GAO’s report examined, (1) the trends in such shortages, (2) the effect on patients and providers, (3) DEA’s administration of the quota … Continue Reading

Second Bill Introduced in the Senate to Amend the Controlled Substances Act

As we previously reported, on February 12, 2015, Senators Hatch and Whitehouse introduced the Ensuring Patient Access and Effective Drug Enforcement Act of 2015.  Also on that date, the Senators introduced legislation that would also amend the Controlled Substances Act, as well as the Food, Drug, and Cosmetic Act.  This legislation addresses, among other things, … Continue Reading

Legislation Introduced in Senate Seeking to Amend CSA

On February 12, 2015, Senators Hatch and Whitehouse introduced the Ensuring Patient Access and Effective Drug Enforcement Act of 2015.  This is the companion bill to H.R. 471, sponsored by Representatives Marino, Blackburn, Welch, and Chu that was recently approved by the Subcommittee on Health, Energy and Commerce Committee. At a recent Congressional hearing, Linden … 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

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

DEA Decisions: In the Matter of Hoi Y. Kam, M.D.

In the Matter of Hoi Y. Kam, M.D. (October 22, 2013) In July 2011, the New York Department of Health revoked Dr. Hoi Kam’s medical license on the ground that he previously committed Medicaid fraud and had been excluded from the Medicaid program in 2006.  Three months later, however, the State’s Administrative Review Board (ARB) … Continue Reading

DEA Decisions: In the Matter of Kenneth Harold Bull, M.D.

In the Matter of Kenneth Harold Bull, M.D. (October 22, 2013) Dr. Kenneth Bull is a New Mexico psychiatrist known for treating difficult or complex psychiatric conditions.  During his long career, Dr. Bull worked as the chief of psychiatry or medical director of psychiatric services at nearly every hospital in the Albuquerque area, and he … Continue Reading

DEA Holds Drug Take-Back Event

On October 26, 2013, DEA will hold its seventh National Prescription Drug Take Back Day at locations throughout the United States.  As we previously discussed, 69% of individuals misusing prescription drugs obtain the drugs from a family member or a friend.  This is a great opportunity to get rid of expired, unused or unwanted prescription drugs … Continue Reading

DEA Finalizes 2014 Quota

Sometimes consistency is a bad thing… On September 9, 2013, the DEA published the 2014 Aggregate Production Quota (APQ) and Annual Assessment of Needs (AAN).  This is noteworthy because it continues the DEA’s streak of failing to meet the deadline for establishing the APQ going back at least to 1998 and the AAN since the … 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

DEA and Walgreens Settlement

On June 11, 2013, the DEA announced that Walgreens Corporation agreed to pay $80 million in civil penalties, the largest settlement in DEA history.  This settlement resolves both the DEA’s administrative actions against Walgreens and the U.S. Attorney’s Office’s civil penalty investigation.  In addition to the civil penalty, Walgreens agreed to a two year suspension … 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

Obtaining DEA Quota to Manufacture Controlled Substances

DEA Quota Season is Upon Us This is the first of several discussions we will have regarding the DEA quota process and the adverse impact DEA’s handling of the quota process can have on the availability of controlled substances for the legitimate medical needs of the United States.  Some context and background is required to … Continue Reading
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