On July 23, 2019, the Food and Drug Administration (FDA) announced the issuance of a Warning Letter to the manufacturer of certain products containing cannabidiol (CBD). Specifically, the FDA provided a laundry list of examples where Curaleaf, Inc. (Curaleaf)
Cote Law PLLC
Cote Law PLLC is a legal publisher specializing in issues related to Drug Enforcement Administration (DEA) litigation and compliance. The firm provides analysis and commentary on regulatory compliance, enforcement actions, controlled substance laws, and due diligence requirements under the Controlled Substances Act. Their publications often address challenges faced by distributors, pharmacies, and manufacturers in navigating DEA regulations, suspicious order monitoring, and state versus federal law conflicts. The content includes legislative updates, enforcement guidance, and practical compliance solutions, reflecting the firm's focus on controlled substance regulatory matters and risk management within the pharmaceutical supply chain.
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Does the New Rule on Interlocutory Appeals Undermine the Independence of DEA’s ALJs?
As I have previously written, there is a long list of regulatory changes coming from DEA in the next few years. Rather than publish one or more of the long overdue regulations listed on DEA’s Regulatory Agenda, on April 30,…
Key Takeaways from the Rochester Drug Co-Op Deferred Prosecution Agreement
As you undoubtedly should know by now, on April 22, 2019, the United States Attorney for the Southern District of New York entered into a Deferred Prosecution Agreement (the “Agreement”) with the Rochester Drug Co-operative, Inc. (“RDC”).
Specifically, the…
Breaking News: DEA Provides Additional Access to ARCOS Data
As required by the “SUPPORT for Patients and Communities Act” (Public Law 115-217), DEA just announced that it has implemented a new tool to provide drug manufacturers and distributors with access to anonymized ARCOS information.
This an enhancement to DEA’s…
DEA Issues Notice of Proposed Rulemaking for New 222 Form
On February 21, 2019, the Drug Enforcement Administration (DEA) published a Notice of Proposed Rulemaking (NPRM), New Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222). This is the agency’s second attempt…
Did You Miss Me?
After a brief hiatus, DEA Chronicles is back. As always, I will be keeping you informed on changes in the relevant laws and regulations and how these may impact your business. But, as regular readers know, we go beyond simple reporting.…
DEA to Propose Significant Regulatory Changes in the Coming Year
The Department of Justice recently published its list of proposed regulatory actions for the near and long term. It appears that the Drug Enforcement Administration’s (DEA’s) Regulatory Drafting and Support Section is going to have a busy year. The Unified…
DEA Slashes Opioid Manufacturing Quotas for 2019
In a joint statement by the U.S. Department of Justice and the Drug Enforcement Administration, the government announced continued efforts to tackle the opioid crisis by reducing the quantity of controlled substances permitted to be manufactured next year. The…
House Opioid Measure Frenzy Continues
Over a period of two weeks in June, the House passed several bills aimed at combating the ongoing opioid epidemic. Our summary of the earlier measures can be found here. Key points of these additional legislative initiatives are summarized below.…
House Passes 12 Bills Aimed at Combating Opioid Crisis
On Tuesday, the House of Representatives passed a fleet of bills aimed at combating the ongoing opioid crisis, most aimed at developing preventative measures to curb opioid addiction by funding research. The measures passed with overwhelming bipartisan support. Key points…