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 Chronicles
Drug Enforcement Administration Compliance & Litigation Issues
Latest from DEA Chronicles - Page 3
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%…
Healthcare Supply Chain Management: Suspicious Order Monitoring and More
UPDATE: The Healthcare Distribution Alliance has retooled its annual conference and expo and is now offering the programs via webinar at no cost.
If you are involved in pharmaceutical distribution, I highly recommend you check out this year’s lineup. Whether…
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…
DEA Proposes 21% Increase in Registration Fees
On March 13, 2020, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) seeking to raise registration fees on all DEA registrants. The proposed fees represent a 21% increase over current fees for all registrant categories.…
DEA Publishes New Rule Expanding Access to Maintenance and Detoxification Treatment
The Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) revising the registration requirements for mobile narcotic treatment programs (NTP). DEA’s justification for the rule is to “make maintenance or detoxification treatments more widely available,” especially in…