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Larry P. Cote

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HDA 2021

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.

2021 Distribution Management Virtual Conference and Expo
August 9 to 12, 2021

On Tuesday, August 10, I will again be serving on a virtual panel: Navigating the Controlled Substances Regulatory Landscape. My colleagues and I will address a broad range of initiatives and challenges faced by entities regulated by the Drug Enforcement Administration in their quest to use the statutory authorities available to them to avert the misuse of controlled substances.

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 Claims Act and other controlled substance-related crimes.

I’ve compiled news reports on such cases from the last two months, confirming that prosecuting health care fraud and illegal distribution of controlled substances continues to be top of mind for law enforcement.

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 for the Administration of Buprenorphine for Treating Opioid Use Disorder.  In a nutshell the…

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 myriad of comments and requests seeking greater clarity from DEA on several definitions and provisions, there appears to remain a misunderstanding of using the 5% rule for distributions amongst practitioners.

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, the Drug Enforcement Administration (“DEA”) published a Notice of Proposed Rulemaking (“NPRM”) implementing the partial fill provisions of CARA. While DEA does include additional provisions in the NPRM “to address certain regulatory requirements not addressed by the CARA[,]” the agency appears to have neglected to fully address circumstances when a prescription for a Schedule II is partially filled.

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 will likely be the most heavily scrutinized rule issued by DEA this year. Registrants impacted by this rule should submit comments by March 29, 2021.

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), but this year’s American Society for Pharmacy Law Fall Meeting is the one conference you should attend if you want to stay on top of evolving pharmacy law regulations and industry trends.

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 on all active and retired DEA registrations. This is/was a useful tool, particularly for distributors and pharmacies, to check the status of a DEA registration before controlled substances are distributed or dispensed. Many entities have embedded and automated this data into their order management and/or dispensing software. So, this is potentially a big deal.

On October 5, 2020, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) establishing a registration category for emergency medical services (EMS) agencies and the corresponding regulatory requirements for the new category of registrants.  This regulatory action implements the ‘‘Protecting Patient Access to Emergency Medications Act of 2017 (the Act). The NPRM includes the following provisions mandated by the Act: