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.”
The transmittal of this rule increases the number of DEA regulatory actions “pending review” at OMB to five. Below is a quick summary of the other actions awaiting OMB approval. In OMB’s defense, four out of the five actions have only been with OMB for less than three weeks, so this should not be seen as a criticism, just an observation.
- The Proposed Rule for Suspicious Orders of Controlled Substances was received by OMB more than four months ago, on February 6, 2020.
- The Final Rule for Registration and Reregistration fees was sent to OMB on May 27, 2020. There were not a lot of substantive comments for this rule, so I don’t expect it will be at OMB for an extended period of time. The only wildcard here is whether OMB will agree with comments made by some that implementation of the fees should be delayed due to COVID-19.
- A Proposed Rule seeking to “allow emergency medical services (EMS) registrants to transport controlled substances for the purpose of dispensing under certain circumstances, and provide the EMS community with specific requirements for EMS programs handling controlled substances” was received by OMB on June 1, 2020. According to the Unified Agenda, various iterations of this rule have been percolating since 2014!
- And in the “better late than never” category, on June 2, 2020, OMB received a Proposed Rule seeking to implement certain provisions of the Comprehensive Addition and Recovery Act of 2016 (!) regarding the partial filling of prescriptions for Schedule II controlled substances.
I am not sure I can remember a time when so many DEA regulations were teed up like this. If you are a DEA compliance employee for your organization be prepared for a flurry of activity and due dates for comments in the coming months. As always, I will do my best to let you know as rules are published. At least until school starts in the Fall and we go back to distance learning – my two avid readers know how I feel about distance learning.