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 reporting process:…

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.”…

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 over 200 comments but never issued a Final Rule. On April 21, 2020, DEA issued a second Interim Final Rule regarding EPCS, this time re-opening the comment period to obtain additional feedback from industry. …

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.…

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…

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 virtual or in person, this annual event remains on my list of “must-attend” conferences on healthcare supply chain management. HDA Distribution Management Webinar Series April 14-16, 2020 On Thursday, April 16, 2020, I will again…

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…