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?

Happy New Year everyone!  I wanted to share with you some news about a project I have been working on that I believe can be a game-changer for your controlled substance compliance needs. 

Whether you are a “Mom & Pop” pharmacy or a Fortune 500 company, you know that failure to sufficiently analyze your data or data provided to you by a customer can lead to disastrous results for your business or company.  It can also lead to dire consequences for patients and the public at large.  I am a firm believer that all facets of the pharmaceutical supply chain have a legal and moral obligation to work together to detect and prevent diversion and to be “part of the solution.”  An effective compliance program with the right tools is a great starting point. 

But let’s be honest, there are currently very few software programs and analytical tools available that provide meaningful support to address your controlled substance compliance needs.  There are even fewer that are created by experts in controlled substance compliance.  Unfortunately, unless you have the internal resources and expertise to create data analytical tools, you are left with few options, if any. 

That is no longer the case…

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.“

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.

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:

Prescription and magnifying glassWith the filing of two class action lawsuits, one against Walgreens and Costco, and one against CVS, in two federal district courts on August 6, pharmacies find themselves in a perplexing situation (yet again). For these suits were filed not by those who suffered from the over-dispensing of opioids, but by chronic pain patients who were denied opioid medication by pharmacies.