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…

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 indicates that the increase will provide an additional $318 million for the Diversion Fee Account over the next three fiscal years. As discussed here, the Controlled Substances Act requires  that registration fees “shall…

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 rural and underserved communities.…

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.…