Tag Archives: DEA

DEA Reverses Decision to Change Registration Policy

We recently reported that the Drug Enforcement Administration (DEA) was changing its longstanding policy of allowing for a grace period for registrants who file an untimely application for renewal. This notice was posted on the homepage of DEA’s Office of Diversion Control’s website. A Revised Announcement Regarding Renewal Applications is now posted on DEA’s website indicating … Continue Reading

DEA Changes Longstanding Registration Policy

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 — … Continue Reading

DEA Will Not Reschedule Marijuana

  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. … 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

Amendment to CSA Closer to Becoming Law

DEA Chronicles welcomes guest blogger Julia Hudson, a Q&B Health Law attorney. On September 30, 2015, the Improving Regulatory Transparency for New Medical Therapies Act moved one step closer to becoming federal law by passing the Senate Health, Education, Labor and Pensions Committee.  The bill, which was introduced on February 2, 2015 and passed in the House on … Continue Reading

DEA Administrator Overrules ALJ, Revokes Distributor Registration in Sweeping Decision

The Chronicles welcomes guest blogger Katea Ravega, a Q&B Health Law attorney. In a 308-page decision dated September 8, 2015, the new Acting Administrator of the DEA, Chuck Rosenberg, issued an Order revoking the DEA registration of wholesale distributor Masters Pharmaceuticals, Inc. (“Masters”). In doing so, the Administrator rejected the recommendation from DEA’s own Administrative … 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

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

Don’t Squeeze the Balloon: An International Perspective on Preventing Prescription Drug Overdoses

Last year the United Nations Office on Drugs and Crime (UNODC) and the World Health Organization (WHO) published a paper on reducing opioid overdose mortality.  The paper addressed opioid overdoses related to heroin use and concluded that reduction in supply is an effective measure governments can take to reduce heroin overdoses.  The UNODC and WHO … Continue Reading

Defining, but Protecting, DEA’s Suspension Powers: the Impact of HR 4069

The “Ensuring Patient Access and Effective Drug Enforcement Act” introduced by Representatives Blackburn and Marino defines the term “imminent danger.”  The Controlled Substances Act requires DEA to find that a registrant poses an imminent danger to public health or safety before the Agency can issue an immediate suspension order, but the current law does not define … Continue Reading

Congressional Hearing on CSA Amendment

Today at 3 p.m., I will be joining DEA’s Mr. Joseph Rannazzisi, HDMA CEO John Gray and others to testify before the House Energy and Commerce Subcommittee on Health regarding a proposed amendment to the Controlled Substances Act.  H.R. 4069, introduced by Representative Tom Marino of Pennsylvania and Representative Marsha Blackburn of Tennessee, defines two key … Continue Reading

Non-Suspicious is Suspicious: DEA Moved the Goal Post Again!

Just when you thought it was safe to have a robust order monitoring program to detect and report suspicious orders, DEA has moved the goal post.  In previous posts (here and here), we’ve talked about DEA’s “extra-regulatory” guidance on both suspicious orders and “due diligence”.  In late February-early March, the DEA held a hearing in … Continue Reading

Sometimes Numbers Lie: Decline in Opioid Prescriptions is Hollow

According to the Milwaukee Journal Sentinel, IMS has reported that the number of prescriptions for opioids declined 5% in 2013 compared to 2012.  Although this could signal a positive step in combating opioid abuse, data suggest otherwise.  The decline in the number of prescriptions for opioids signals one thing only — a decline in the number of prescriptions.  … Continue Reading
LexBlog