Cote Law PLLC

DEA Proposes 21% Increase in Registration Fees

By Larry P. Cote

March 12, 2020

On March 13, 2020, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) seeking to raise registration fees on all DEA registrants. The proposed fees represent a 21% increase over current fees for all registrant categories. DEA indicates that the increase will provide an additional $318 million for the Diversion Fee Account over the next three fiscal years. As discussed here, the Controlled Substances Act requires that registration fees “shall…

DEA Chronicles

DEA Publishes New Rule Expanding Access to Maintenance and Detoxification Treatment

By Larry P. Cote

February 25, 2020

The Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) revising the registration requirements for mobile narcotic treatment programs (NTP). DEA’s justification for the rule is to “make maintenance or detoxification treatments more widely available,” especially in rural and underserved communities.…

DEA Chronicles

Healthcare Supply Chain Management: Suspicious Order Monitoring and More

By Larry P. Cote

February 18, 2020

If you are involved in pharmaceutical distribution, I highly recommend you check out this year’s Healthcare Distribution Alliance (HDA) Distribution Management Conference and Expo, an annual event on my list of “must-attend” conferences on healthcare supply chain management. On Tuesday, March 10, 2020, I will again be serving on a panel at a session on controlled substances where my colleagues and I will share our perspective on suspicious orders monitoring and reporting along with other…

DEA Chronicles

DEA Poised to Roll Out Three Regulations in the Coming Months

By Larry P. Cote

February 10, 2020

It appears that the Drug Enforcement Administration (DEA) is on the cusp of publishing a new regulation in the next few weeks, with two more to follow in the coming months. This is based on notifications received by the Office of Management and Budget (OMB), the government’s final review authority for Executive Branch regulations.…

DEA Chronicles

2019 National Drug Threat Assessment: Key Takeaways

By Larry P. Cote

February 4, 2020

On January 30, 2020, the Drug Enforcement Administration (DEA) released the 2019 National Drug Threat Assessment (NDTA). The 152-page publication “outlines the threats posed to the United States by domestic and international drug trafficking and the abuse of illicit drugs.” Of specific relevance to readers of DEA Chronicles, the report also discusses the abuse and misuse of controlled prescription drugs (CPDs). While I encourage you to read the entire report, here are a few key takeaways…

DEA Chronicles

DEA Signals that Substantive SOM Guidance is Not Likely Forthcoming

By Larry P. Cote

January 30, 2020

On January 20, 2020, the Government Accountability Office (GAO) released its report Drug Control: Actions Needed to Ensure Usefulness of Data on Suspicious Opioid Orders. The report, mandated by Congress in the SUPPORT Act, focuses almost exclusively on the need for the Drug Enforcement Administration (DEA) to beef up its capabilities for analyzing the vast amount of data provided to DEA by registrants. GAO’s investigation revealed, among other things, that DEA conducted “limited proactive…

DEA Chronicles

What to Expect from DEA in 2020 – One Guy’s Opinion

By Larry P. Cote

January 16, 2020

Note: The following is my best guess for what to expect in the coming year regarding controlled substance compliance obligations. I have relied on publicly available information, my experience and expertise with all things involving pharmaceutical controlled substance, and a Magic 8 Ball in creating the list below. Suspicious Orders This is the year (I think) that DEA will publish a Notice of Proposed Rule Making (NPRM) updating 1301.74(b). While industry is anxiously awaiting the…

DEA Chronicles

The Curious Case of Colorado: DEA Sues the BOP

By Larry P. Cote & Russell Day

November 13, 2019

DEA is investigating two pharmacies in Colorado. It doesn’t want those pharmacies to know it is investigating them. But it needs information relating to these pharmacies and the prescriptions they are dispensing to assist with its investigation. So DEA is doing what it does on a regular basis in many states. It is issuing subpoenas for the Colorado Prescription Drug Monitoring Program (“PDMP”) data relevant to these registrants. And Colorado is objecting.…

DEA Chronicles

Judge Dissolves ISO Against West Virginia Pharmacy: Suspicion Of Diversion Not Enough to Support Suspension

By Larry P. Cote & Russell Day

November 1, 2019

In a decision issued on October 30, Judge Joseph Goodwin of the Southern District of West Virginia dissolved an Order of Immediate Suspension of Registration (“ISO”) issued by DEA against Oak Hill Hometown Pharmacy, a West Virginia pharmacy. Without getting too far into the factual weeds of this case, I do think there are two or three critical takeaways related to both the adjudication of this matter and to DEA’s view of Subutex vs. Suboxone.…

DEA Chronicles

DEA Announces its New Suspicious Orders Report System Online: the devil is in the details we don’t yet have

By Larry P. Cote

October 23, 2019

On October 23, 2019, the Drug Enforcement Administration (DEA) announced the launch of its Suspicious Orders Report System (SORS) Online, a portal allowing for the centralized reporting of suspicious orders, as required by the SUPPORT ACT. According to DEA’s announcement, 12 registrant business activity classes will utilize this reporting system: Distributors Manufacturers Importers Pharmacies Hospitals/Clinics Teaching Institutions Practitioners Mid-Level Practitioners Mid-Level Practitioners – Ambulance Services Researchers Analytical Labs Narcotic Treatment Programs (NTPs) Reverse distributors…

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DEA Proposes 21% Increase in Registration Fees

DEA Publishes New Rule Expanding Access to Maintenance and Detoxification Treatment

Healthcare Supply Chain Management: Suspicious Order Monitoring and More

DEA Poised to Roll Out Three Regulations in the Coming Months

2019 National Drug Threat Assessment: Key Takeaways

DEA Signals that Substantive SOM Guidance is Not Likely Forthcoming

What to Expect from DEA in 2020 – One Guy’s Opinion

The Curious Case of Colorado: DEA Sues the BOP

Judge Dissolves ISO Against West Virginia Pharmacy: Suspicion Of Diversion Not Enough to Support Suspension

DEA Announces its New Suspicious Orders Report System Online: the devil is in the details we don’t yet have

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