When was the last time you went to an in-person conference? Well, it’s time. The American Society of Pharmacy Law is meeting in person (and virtually) this year in Summerlin, Nevada for its 32nd Annual Pharmacy Law Seminar. The team
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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In Pharmaceutical Distribution? Join Me Virtually at the Distribution Management Conference
The 2021 Healthcare Distribution Alliance Distribution Management Conference and Expo is still on! Yes, it’s virtual, and if you are involved in pharmaceutical distribution, you will want to register for one of the industry’s “must-attend” healthcare supply chain management events.…
Active Prosecution Continues for Controlled Substance Violations
The COVID pandemic notwithstanding, the Drug Enforcement Administration (DEA), Department of Justice and other federal and state agencies continue to actively pursue and prosecute pharmacies, pharmacists, doctors and others in the industry for violations of the Controlled Substance Act, False…
Not So Fast: Biden Expected to Halt Expansion of Buprenorphine Prescribing
The Washington Post reports that the Biden Administration is preparing to pull back recent Health and Human Services (HHS) guidance designed to expand access to prescribing buprenorphine for opioid use disorders (OUD).
On January 14, 2021, HHS published Practice Guidelines…
Confusion Persists with the 5% Rule
As I was reviewing the public comments regarding the Drug Enforcement Administration’s (DEA’s) Notice of Proposed Rulemaking (NPRM) providing a much-needed update to the agency’s suspicious order regulations, I noticed a similar issue raised by multiple commenters. Apart from the…
DEA Proposes Regulations for Partial Fills of C-IIs
More than four years ago, the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) was signed into law. CARA, among other things, includes provisions allowing for the partial filling of prescriptions for Schedule II controlled substances. On December 4, 2020,…
DEA Creates Two-Option Framework for Reporting Suspicious Orders
Update: DEA has reopened the comment period for the proposed rulemaking from February 25, 2021, until March 29, 2021.
The Drug Enforcement Administration (DEA) published its long-awaited Notice of Proposed Rulemaking (NPRM) regarding suspicious orders of controlled substances. This…
ASPL Virtual Conference: Your Rx for Developments in Pharmacy Law
Pharmacies and pharmacists have always been on the front lines in terms of medication safety and the pandemic has produced a new layer of challenges for the industry. I know we are all tired of Zoom meetings (and cheesy headlines),…
NTIS Ending Its DEA Registration Subscription Service
Based on information posted on its website, the National Technical Information Service (NTIS) will end its Controlled Substances Act (CSA) subscription service, effective November 17, 2020. As you may recall, the NTIS CSA subscription service provides near-real time information…
