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By Hunter DeKoninck & Scott Brinks This post is Part II of a two-part series on the corresponding responsibility. Part I titled “Pharmacists' “Corresponding Responsibility” Part I: The Legal Requirements”  covered the legal requirements related to pharmacists’ corresponding responsibility. This post discusses the legal consequences for pharmacies and pharmacists when controlled substance prescriptions are dispensed without fulfilling the corresponding responsibility. Identify

By: Hunter DeKoninck As Scott Brinks and I emphasized in our August post " Is DEA Hurtling Us Toward the Telehealth Cliff ," we have been quickly approaching the year-end expiration of DEA's third extension to its COVID-era telemedicine flexibilities, threatening to create significant disruption and potential patient harm for a nation that has grown dependent on telemedicine services over the last five years. We are now one step closer to seeing that expiration extended. On

By Hunter DeKoninck  & Scott Brinks Take a beat to evaluate your pharmacy's corresponding responsibility practices (and documentation of those practices) and let's consider what enhancements are needed. This post is Part I of a two-part series on the corresponding responsibility. This first post will cover the legal requirements related to pharmacists’ corresponding responsibility. The second post will then discuss the legal consequences for pharmacies and pharmacists when co

By Hunter DeKoninck & Scott Brinks Most DEA Diversion Investigators  (“DIs”) are professional, knowledgeable, and committed to ensuring compliance in a collaborative way. However, every now and then, a registrant encounters a DI who may not only be misinformed about the regulations but is also condescending or unprofessional in how they conduct their investigation or interact with registrants and their employees. How you handle a difficult DI depends, in part, on the reason

By: Hunter DeKoninck & Scott Brinks When a DEA registrant receives a letter from DOJ threatening civil monetary penalties under the CSA, it must be treated as a serious event and handled delicately. The CSA provides administrative, civil and criminal enforcement options for non-compliance and pre-filing letters signal to registrants that DOJ is assessing potential civil liability and it often means you have limited time to react before it files suit. Failing to properly res

By Scott Brinks & Hunter DeKoninck This post is part of a 7-part blog series designed to outline various types of DEA enforcement action registrants need to understand and prepare themselves for. This series will discuss how registrants should: Consider the types of DEA personnel they may encounter Handle DEA inspections Engage bad DIs (or DIs who misunderstand/misapply DEA’s regulations) Respond to LOAs React to MOAs Defend against OTSCs Engage DOJ after receiving a pre-fili

If it believes more serious action than an LOA (an enforcement tool discussed in PART III of this series) is needed to bring a registrant into compliance, DEA may seek a memorandum of agreement (“MOA”). An MOA is a formal agreement between DEA and a registrant that identifies areas of non-compliance and imposes contractual obligations on the registrant that are designed to fully bring the registrant into compliance. MOAs are forceful and effective enforcement tools at DEA’s d

By Scott Brinks & Hunter DeKoninck   This post is part of a 7-part blog series designed to outline various types of DEA enforcement action registrants need to understand and prepare themselves for. This series will discuss how registrants should: Understand the types of DEA personnel they will encounter Handle DEA inspections Engage bad DIs (or DIs who misunderstand/misapply DEA’s regulations) Respond to LOAs React to MOAs Defend against OTSCs Engage DOJ after receiving a pre

By: Hunter DeKoninck & Scott Brinks The regulatory landscape governing pharmaceutical compliance is characterized by a multifaceted array...

By Scott Brinks & Hunter DeKoninck This post is part of a 7-part blog series designed to outline various types of DEA enforcement action registrants need to understand and prepare themselves for. This series will discuss how registrants should: ·       Handle DEA inspections, ·       Engage bad DIs (or DIs who misunderstand/misapply DEA’s regulations), ·       Respond to LOAs, ·       React to MOAs, ·       Defend against OTSCs and ·       Engage DOJ after receiving a pre-fi

This post is part of a 7-part blog series designed to outline various types of DEA enforcement actions that registrants must understand...

In response to yesterday's blog post that discussed DOJ's deprioritizing and withdrawing of key DEA rulemaking plans, I received several...

Today, the U.S. Department of Justice ("DOJ") withdrew four of DEA's Proposed Rules (‘‘NPRMs’’) and Advance Notices of Proposed...

When registrants face new DEA-related compliance issues for which they need support, they will often need to answer the threshold...

As its December 31, 2025 deadline looms, the DEA has given no signal on the future of telemedicine prescribing for controlled substances....

Confusion persists on how DEA intends to regulate and enforce pharmacies’ delivery of patient-specific medication to physicians’ offices...

Last week, the Drug Enforcement Administration’s (“DEA”) last remaining administrative law judge (“ALJ”) retired, leaving DEA with no ALJ...

In February 2024, DEA announced it entered into a settlement agreement with Morris & Dickson Co., LLC (“Morris & Dickson”), resolving the...

On August 31, 2023, DEA published a final rule (“Final Rule”) regarding its management of controlled substance and List 1 Chemical (“L1...

Over the last decade, the increased use of Controlled Substance Ordering System (“CSOS”) applications (i.e., platforms used to...