Tag Archives: Controlled Substances Act

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

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

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

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

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
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