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.
DEA Establishes Registration Category for EMS Agencies
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:
DEA’s New/Old View on Due Diligence Requirements
On September 30, 2020, DEA published a Final Rule (FR) adopting the Interim Final Rule (IFR) implementing the Ryan Haight Act. The FR made a few technical changes to the regulations and did not substantively change the IFR. What garnered my attention was DEA’s response to comments submitted after publication of the IFR.
Lawsuits Filed Against Retail Chain Pharmacies: The Corresponding Responsibility Catch-22
With 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.
OMB Has a Backlog of DEA Regulatory Actions
On June 5, 2020, the Office of Management and Budget (OMB) received an Interim Final Rule from the Drug Enforcement Administration titled, Implementation of the SUPPORT Act: Dispensing and Administering Controlled Substances for Medicated-Assisted Treatment. This rule implements certain provisions of the SUPPORT Act “relating to the expansion of medication-assisted treatment providers and to the delivery of a controlled substance by a pharmacy to a practitioner.”
DEA: COVID-19 Does Not Relieve Distributors of Certain Compliance Obligations
In response to issues raised by the Healthcare Distribution Alliance (“HDA”), earlier this week the Drug Enforcement Administration (“DEA”) published additional guidance for DEA-registered distributors on the agency’s COVID-19 Information Page. Among other issues previously addressed by DEA, the recent guidance addresses suspicious order monitoring and conducting due diligence on customers.
DEA Announces Exception to 5% Rule
In its ongoing efforts to ensure an adequate supply of controlled substances for the legitimate medical needs of the United States, DEA is granting a temporary exception to 21 C.F.R. 1307.11 – what industry commonly refers to as the 5% Rule.
The 5% Rule allows practitioners to distribute controlled substances without being registered as a distributor, if they fulfill certain requirements. In addition to the security and recordkeeping obligations, practitioners wishing to use the authority granted by the 5% Rule must ensure that the “total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section … during each calendar year in which the practitioner is registered to dispense does not exceed 5 percent of the total number of dosage units of all controlled substances distributed and dispensed by the practitioner during the same calendar year.”
DEA Issues Additional Guidance in Response to COVID-19 Pandemic
As you are likely aware, the Drug Enforcement Administration (DEA) has created a COVID-19 Information Page to “assure that there is an adequate supply of controlled substances” during the current public health emergency associated with the coronavirus. DEA previously published guidance regarding telemedicine and Medication Assisted Treatment, where the agency granted certain exceptions to regulatory requirements.
In the past few days, DEA issued additional guidance regarding other areas of concern brought to the agency’s attention by the regulated industry. Below is a quick summary of that guidance:
DEA Poised to Roll Out Three Regulations in the Coming Months
It appears that the Drug Enforcement Administration (DEA) is on the cusp of publishing a new regulation in the next few weeks, with two more to follow in the coming months. This is based on notifications received by the Office of Management and Budget (OMB), the government’s final review authority for Executive Branch regulations.
DEA Signals that Substantive SOM Guidance is Not Likely Forthcoming
On January 20, 2020, the Government Accountability Office (GAO) released its report Drug Control: Actions Needed to Ensure Usefulness of Data on Suspicious Opioid Orders. The report, mandated by Congress in the SUPPORT Act, focuses almost exclusively on the need for the Drug Enforcement Administration (DEA) to beef up its capabilities for analyzing the vast amount of data provided to DEA by registrants. GAO’s investigation revealed, among other things, that DEA conducted “limited proactive and robust analysis of industry reported data” and that DEA did not have the appropriate data governance structure in place to manage drug transaction data.