A Thinner Rulemaking Agenda: DEA's Rulemaking Plans that Survived...For Now.

In response to yesterday's blog post that discussed DOJ's deprioritizing and withdrawing of key DEA rulemaking plans, I received several questions about what DEA's rulemaking agenda looks like going forward in this new environment of deregulation. So, through this post, I want to outline and comment on what rulemaking plans remain in tact and what we can expect to see come out of DEA during this administration.

DEA is now only prioritizing the promulgation of six regulations (which is just half of the twelve that it has been pursuing over the last year). The six remaining rulemaking efforts are:

• Changes to a Prescription, which is still in the proposed rule stage. This regulation is expected to bring much clarity for pharmacies in what its pharmacists can and cannot do in altering specific elements of controlled substance prescriptions.

• Emergency Medical Services (EMS), which is at the final rule stage. This regulation is expected to create an EMS-specific registrant type and clarify various regulatory requirements for EMS agencies ordering, storing and handling controlled substances. Hospital systems and EMS agencies alike anxiously await DEA's finalizing of this rule so they can finally have certainty for ensuring EMS vehicles have adequate supplies for emergency use.

• Special Registrations for Telemedicine and Limited State Telemedicine Registrations, which is at the final rule stage. This regulation was discussed in detail in my August 26th post.

• Implementation of the SUPPORT Act: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment, which is at the final stage. This regulation is expected to clarify many issues in this post-"X Waiver" environment but, importantly, DEA is also expected to address the "delivery of a controlled substance by a pharmacy to a practitioner," which is an emerging issue for certain REMS drugs like Spravato as I discussed in the August 7th post.

• Expansion of Induction of Buprenorphine via Telemedicine Encounter, which is at the final rule stage.

• Amending Regulations to Conform to the Controlled Substance Ordering System (CSOS) Modernization, which is at the final rule stage. This regulation is essential for updating DEA's existing CSOS regulations to account for significant technological changes that have come about since they were originally promulgated in 2003.

While DEA remains concentrated on the six regulations outlined above, it holds a handful of key proposed regulations in a dormant state by migrating them to a "long-term action stage." Long-term actions are those rulemaking efforts that are expected to be addressed and finalized over the next 12-month period. DEA lists eight long-term actions:

• Electronic Prescriptions for Controlled Substances - The industry has been waiting for a final rule for EPCS since 2010. Current EPCS regulations are grounded in an interim final rule for which DEA never brought to final form. A final rule is necessary not only to finalize requirements that DEA has enforced for 15 years but it is also necessary to update those requirements and account for significant technological changes the pharmacy industry has experienced over that period of time.

• Suspicious Orders of Controlled Substances - DEA published a notice of proposed rulemaking for SORs back in late 2020 and, after running into a bureaucratic nightmare with the Department of Health & Human Services, it has been unable to publish a final rule. In reality, DEA's SORs rule will merely memorialize the two-option framework established in 2015 by Masters Pharmaceuticals, Inc.; Decision and Order, published in the Federal Register at 80 FR 55418. The DEA has demanded use of the Masters two-option approach for many years and, in large part, the industry has adjusted its systems to comply with that approach. Thus, a SORs rule is unlikely to create much change for the industry.

• Implementation of the Agriculture Improvement Act of 2018.

• Technical Amendment to Number Each Definition.

• DEA Registration for Religious Organizations Under the Religious Freedom Restoration Act.

• Import/Export and Domestic Transactions of Tableting and Encapsulating Machines.

• Automation of Reports and Consolidated Orders System (ARCOS) Monthly Reporting. This regulation seeks to change the frequency of ARCOS submissions from quarterly reports to monthly reports. In practice, many wholesalers already do monthly submissions, so this rule would largely memorialize what many registrants are already doing.

• Extension of Reexportation Period.