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By Hunter DeKoninck Published: October 7, 2026 Last week's post flagged something easy to miss in the St. Michael's Pharmacy decision: for the first time since the Fifth Circuit's ruling came out in Neumann's Pharmacy v. DEA, DEA quietly reasserted the very same negligence-based "red flag" standard that Neumann's rejected, which went unchecked because the St. Michael's Pharmacy had defaulted and failed to request a hearing in the matter. This morning (just five days later), D

By Hunter DeKoninck Published: October 2, 2026 DEA published two Decisions today—one revoking a narcotic treatment program’s (“NTP”) registration and the other revoking a pharmacy’s registration. Clients have asked whether either decision signals a new DEA enforcement theory or a novel position the agency hasn’t historically taken. From my read, one of the decisions signals something “new” for NTPs. The other is a quieter story: DEA reasserting a legal standard that a contro

By Hunter DeKoninck This post is for general informational purposes and does not constitute legal advice. Nearly five months after DOJ moved medical marijuana into Schedule III, DEA is still rushing to build a new registration framework for dispensers and implement a broader regulatory scheme for all FDA-approved products containing marijuana (currently, no such products exist) and state-regulated marijuana products for which a state license is issued. Despite DEA’s best ef

By: Hunter DeKoninck This post is for general informational purposes and does not constitute legal advice. On August 28, 2026, Walmart agreed to pay $50 million to resolve DOJ’s civil lawsuit, which accused the company of violating the CSA by filling thousands of unlawful opioid prescriptions and failing to report suspicious orders to DEA. Most media coverage on this settlement seems to be focused on the $50 million figure, which is a fraction of what DOJ’s complaint suggeste

On August 27, 2026, the DEA published an interim final rule placing cipepofol — brand name Cypsedo — into Schedule IV of the CSA. The rule took effect immediately upon publication, which means every DEA registrant who intends to handle this drug is already subject to Schedule IV obligations, whether or not they've had time to update their compliance program. If your pharmacy, distributor, or health system anticipates stocking Cypsedo once it reaches the U.S. market, here's wh

Back in July, I referred to DEA's 2026 rulemaking agenda as "downright skinny" — four active priorities, down from 28 as recently as Fall 2023 — and flagged the telemedicine special registration rule as the one item on that thin list actually worth watching. We noted the obvious pressure point: the current telemedicine prescribing flexibilities expire December 31, 2026, and DEA would either have to finalize the rule or extend the flexibilities again. We now appear to have an

On July 6, 2026, the Office of Management and Budget released the 2026 Unified Agenda of Regulatory and Deregulatory Actions, which sets out DEA's current rulemaking priorities. Before turning to those priorities, it is worth reflecting on the broader deregulatory environment that has shaped this agenda. Over the past year, DOJ withdrew more than a dozen pending rulemaking priorities—a clear signal of the current administration's commitment to deregulation. (For more informat

By: Hunter DeKoninck On March 23, 2026, a federal district court issued an important ruling in Adya LLC v. United States DEA, 2026 U.S. Dist. LEXIS 60710 , granting partial relief to an Orlando-based pharmacy after finding serious legal flaws in how DEA went about issuing an ISO against it. Background: A Sudden Shutdown Adya LLC, operating as SmartCareRx, spent five years serving hundreds of customers in Orlando. In December 2025, DEA issued an Immediate Suspension Order (ISO

By: Hunter DeKoninck (with credit to Scott Brinks ) In August 2025, I authored a post highlighting the persisting c onfusion pharmacies were experiencing with DEA's regulation of pharmacies’ delivery of patient-specific controlled substances to physicians’ offices in instances where in-office administration was either medically necessary or required by the FDA under a REMS program (e.g. Spravato® was the REMS drug most commonly caught in the crosshairs of this issue). In th

The Fifth Circuit’s opinion in Neumann’s Pharmacy, L.L.C. v. Drug Enforcement Administration is more than a routine administrative law decision. It represents a potentially significant recalibration of DEA’s long-asserted “corresponding responsibility” and “red flag” doctrine—the theory that pharmacists share responsibility with prescribing practitioners to ensure that controlled substance prescriptions are issued for a legitimate medical purpose. For pharmacies and pharmaci

By: Hunter DeKoninck On February 5, 2026, the Drug Enforcement Administration (DEA) published a final rule implementing major changes to how Emergency Medical Services (EMS) agencies are registered under the Controlled Substances Act (CSA) and changes to EMS agencies’ obligations regarding the handling of controlled substances (the “Final Rule”). The Final Rule fulfills statutory requirements of the Protecting Patient Access to Emergency Medications Act of 2017 (the “Act”),

By: Hunter DeKoninck & Scott Brinks Breaking News: The Federal Register has confirmed that DEA's Telemedicine Flexibilities Extension will officially be published on December 31, 2025 —just in time to avoid a regulatory gap. This announcement is more than a bureaucratic update; it’s a pivotal moment for healthcare delivery in the United States. DEA's telemedicine flexibilities were initially introduced during the COVID-19 pandemic to ensure patients could access care remote

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