Cote Law PLLC

DEA Proposes Decreasing Opioid Quotas for 2020

By Larry P. Cote & Russell Day on September 11, 2019

Quota Reductions DEA is out with its proposed 2020 aggregate production quotas for Schedule I and II controlled substances, and they have been reduced dramatically from 2019’s numbers. From the press release: DEA proposes to reduce the amount of fentanyl produced by 31 percent, hydrocodone by 19 percent, hydromorphone by 25 percent, oxycodone by nine percent and oxymorphone by 55 percent. Combined with morphine, the proposed quota would be a 53 percent decrease in…

DEA Chronicles

DEA Decisions: Registrations Not Automatically Revoked by Medicare/Medicaid Exclusions

By Larry P. Cote & Russell Day on September 6, 2019

Jeffrey Stein, M.D.; Decision and Order Uttam Dhillon, DEA Acting Administrator, issued a final order today in the case of the revocation of a New York doctor’s DEA registration. But its implications go well beyond this doctor’s circumstances. The Facts Here are the basics. Dr. Jeffrey Stein was convicted of tax-related crimes in the Southern District of New York in 2015. Specifically, Dr. Stein had provided false receipts and other fabricated documents to his accountant…

DEA Chronicles

DEA and the Surgeon General Issue Statements Regarding Marijuana

By Larry P. Cote on September 2, 2019

Last week was an active week when it comes to marijuana policy. The Drug Enforcement Administration (DEA) announced that it will begin considering (and approving?) applications to allow for the manufacture (growing) of marijuana for research purposes. Shortly thereafter, United States Surgeon General, Vice Admiral Jerome M. Adams (Dr. Adams), issued an advisory regarding the significant adverse effects of marijuana use by adolescents and by women during pregnancy. Both developments could foreshadow the long road…

DEA Chronicles

Be Part of the Solution to the Opioid Crisis – Make the Pledge!

By Larry P. Cote on August 27, 2019

Just as there are several factors that contributed to the opioid epidemic, there are a myriad of solutions that, in tandem, will make a difference in the lives of those impacted by opioid abuse and may prevent others from misusing and abusing these drugs. Roger Krone and his team at Leidos are executing a program that should be emulated by companies across the United States. After receiving an email from an employee whose son recently lost …

DEA Chronicles

FDA Issues Another Warning Letter Involving CBD Products

By Larry P. Cote on July 24, 2019

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) made unsubstantiated claims on its website and on social media “that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.” The FDA considers Curaleaf’s actions as the…

DEA Chronicles

Does the New Rule on Interlocutory Appeals Undermine the Independence of DEA’s ALJs?

By Larry P. Cote on April 29, 2019

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, 2019, the agency will publish a Final Rule creating a “discretionary review” process allowing the Administrator to review an Administrative Law Judge’s (“ALJ’s”) denial of a request for an interlocutory appeal. Note that this…

DEA Chronicles

Key Takeaways from the Rochester Drug Co-Op Deferred Prosecution Agreement

By Larry P. Cote on April 24, 2019

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 government announced that “RDC agreed to accept responsibility for its conduct by making admissions and stipulating to the accuracy of an extensive Statement of Facts, pay a $20 million penalty, reform and enhance its Controlled…

DEA Chronicles

Breaking News: DEA Provides Additional Access to ARCOS Data

By Larry P. Cote on February 26, 2019

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 existing tool that previously provided very limited ARCOS information. The new functionality in the tool “will allow DEA-registered manufacturers and distributors to view and download the number of distributors and the amount (anonymized data in…

DEA Chronicles

DEA Issues Notice of Proposed Rulemaking for New 222 Form

By Larry P. Cote on February 20, 2019

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 at bringing the DEA Form 222 into the 21st Century. In 2007, the agency issued a similar NPRM, but never published a Final Rule. The current NPRM not only changes the format of the…

DEA Chronicles

Did You Miss Me?

By Larry P. Cote on February 13, 2019

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 Chronicles identifies DEA enforcement trends. We engage in policy analysis across the spectrum of issues involving controlled substances. What regulatory approaches best combine an effective strategy for combating diversion with a workable framework for the various…

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DEA Proposes Decreasing Opioid Quotas for 2020

DEA Decisions: Registrations Not Automatically Revoked by Medicare/Medicaid Exclusions

DEA and the Surgeon General Issue Statements Regarding Marijuana

Be Part of the Solution to the Opioid Crisis – Make the Pledge!

FDA Issues Another Warning Letter Involving CBD Products

Does the New Rule on Interlocutory Appeals Undermine the Independence of DEA’s ALJs?

Key Takeaways from the Rochester Drug Co-Op Deferred Prosecution Agreement

Breaking News: DEA Provides Additional Access to ARCOS Data

DEA Issues Notice of Proposed Rulemaking for New 222 Form

Did You Miss Me?

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