(If this song is stuck in your head all day long, you are welcome.)
As my loyal readers are aware (too Bridgerton?), customer due diligence obligations, especially for distributors and manufacturers, have significantly evolved over the past several years. When I joined the Drug Enforcement Administration (DEA) nearly two decades ago (back when registrants
Today, the Drug Enforcement Administration announced the revocation of Coconut Grove Pharmacy’s DEA registration.
DEA issued an Order to Show Cause and Immediate Suspension of Registration back in September 2022, premised on Coconut Grove’s alleged failure to identify, resolve, and document the resolution of potential red flags associated with prescriptions for controlled substances. If
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?
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.“
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.”
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