In a highly regulated industry, such as controlled substance distribution, having clarity of regulatory requirements facilitates implementation and execution of an effective compliance program. Uncertainty on expectations from regulators and/or significant “grey area” in compliance requirements present additional risk for companies and may adversely impact the public’s access to medication for legitimate medical purposes. There are few things that can make managing a controlled substance compliance program more difficult. A state legislature that passes legislation imposing requirements that directly contradict and undermine the requirements and expectations of the Drug Enforcement Administration (DEA) is high on that list.    

Which brings us to Arkansas.

There is legislation making the rounds on Capitol Hill that seeks to provide clarity regarding the process for reviewing orders for controlled substances to determine if an order is a “suspicious order” that should be reported to the Drug Enforcement Administration (DEA) and withheld from shipment.  Sponsored by Rep. Harshbarger (R-Tenn.), the title of the bill is the “Block, Report, and Suspend Suspicious Shipments Act of 2022.” An identical bill, was passed in the House of Representative in the last Congress; however, it did not come up for a vote in the Senate. 

What does it say?

On January 20, 2023, the Drug Enforcement Administration (DEA’s) issued a Guidance Document reiterating DEA’s long-held position regarding the detection and reporting of suspicious orders. Specifically, DEA “clarified” that “neither the Controlled Substance Act (CSA) nor [DEA] regulations establish quantitative thresholds or place limits on the volume of controlled substances DEA registrants can order and dispense.”

Why the need for a clarification? 

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.“

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.

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.”

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.

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: