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Larry P. Cote

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The Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) seeking to “revoke the exempted prescription product status for all butalbital products previously granted exemptions.”

If finalized as proposed, the significant impact of this change will be felt throughout the pharmaceutical supply chain.

The Controlled Substances Act and DEA’s regulations provide the agency with authority to exempt a prescription drug product containing a controlled substance from regulatory requirements and administrative, civil, and criminal sanctions.  DEA is authorized, among other reasons, to exempt nonnarcotic prescription drug products from application of all or any part of the CSA if the product also contains one or more active ingredients which are not controlled substances and in such quantities “as to vitiate the potential for abuse.“

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On November 19, 2021, the Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) “to allow the transfer of electronic prescriptions for schedule II-V controlled substances between registered retail pharmacies for initial filling on a one-time basis.”

This proposed rule aligns with the regulatory guidance provided by DEA in October 2017, that specifically restricted the transfer of unfilled prescriptions for controlled substances to electronic prescriptions.

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On November 17, 2021, the Drug Enforcement Administration (DEA) issued an Advanced Notice of Proposed Rulemaking (the “Notice”) seeking the public’s help with understanding the “practice, industry, and state regulations of telepharmacy.”

As DEA acknowledges in the Notice, telepharmacy is not a term defined by the Controlled Substances Act or DEA’s regulations. The agency’s current understanding of telepharmacy is that it involves “the provision of pharmacist care by a remote pharmacist, through the use of telecommunications and other technologies, to a patient located at a dispensing site.” DEA further states that the dispensing site is usually a “brick and mortar remote site” or “self-service, automated machines.”

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 at ASPL has again gathered industry experts from around the country to provide guidance on managing pharmacy legal risk and compliance.

DPLXXXII Seminar
Summerlin, NV
November 4-7, 2021

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.