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
DEA Chronicles
Controlled Substance Litigation & Compliance Issues
DEA Chronicles, published by Cote Law PLLC, focuses on legal and regulatory issues related to the Controlled Substances Act and Drug Enforcement Administration (DEA) compliance. The blog covers topics such as controlled substance litigation, DEA enforcement actions, suspicious order monitoring, due diligence obligations, drug policy, legislation affecting controlled substances, and state law interactions. It also addresses challenges faced by distributors, pharmacies, and manufacturers in maintaining compliance, including the impact of new regulations and enforcement trends. The blog provides updates on DEA guidance, compliance software solutions, and legislative developments relevant to controlled substance regulation and enforcement.
Latest from DEA Chronicles - Page 4
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…
DEA Proposes Significant Changes to Administrative Hearings
The Drug Enforcement Administration (DEA), through a Notice of Proposed Rulemaking (NPRM), is seeking to make significant changes to its administrative hearing procedures. The proposed changes include the following, among others:…
DEA Submits Proposed Quotas for 2021
By Larry P. Cote & Russell Day
DEA rolled out its proposed aggregate production quotas for 2021 earlier this week, the same day, in fact, that it proposed adjustments to its 2020 quotas. Let’s start off by looking at the Big Five, at least as far…
Lawsuits Filed Against Retail Chain Pharmacies: The Corresponding Responsibility Catch-22
By Larry P. Cote & Russell Day
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…
DEA Proposes Changes to Theft/Loss Reporting and Finalizes New Registration Fees
Theft and Loss Reporting
On July 29, 2020, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) related to the reporting of thefts or significant losses of controlled substances. Specifically, DEA proposes two changes to the…
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…
DEA Re-Opens Comments for EPCS
A little more than 10 years ago the Drug Enforcement Administration (DEA) issued an Interim Final Rule with Request for Comment regarding Electronic Prescriptions for Controlled Substances (EPCS). The Interim Final Rule became effective on June 1, 2010. DEA received…
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…
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%…