“Get in loser, we’re rescheduling.” – Regina George (DEA)

As we at Budding Trends reported last week, the DEA is set to finally accept the recommendation of the U.S. Department of Health and Human Services (HHS) to reschedule marijuana from Schedule I to Schedule III under the Controlled Substances Act. This is a monumental (and overdue) step for the DEA after HHS made its rescheduling recommendation in August 2023.

So, jump in, buckle up, and grab your munchie(s) of choice — we’re taking a trip down the road to rescheduling.

Stop One: White House Office of Management and Budget (OMB) Review

Once the DEA makes the rescheduling news official, the first stop on the road to rescheduling will be the White House. The OMB will conduct a review of DEA’s rescheduling proposal for budget and regulatory impact, as well as legislative coordination. If all goes to plan, the OMB will sign off on the DEA’s proposed rule. While the upcoming election does give the White House a heavy incentive to move OMB review along expeditiously, the process could still take up to 90 days.

Stop Two: Publication of Notice of Proposed Rulemaking  

After what will likely be a short pit stop at the White House for OMB review and approval, the formal rulemaking process will begin upon publishing of a Notice of Proposed Rulemaking in the Federal Register. The formal rulemaking process will then proceed as prescribed by the Controlled Substances Act, 21 U.S.C. § 811(a), which calls for rulemaking “on the record after opportunity for a hearing pursuant to the rulemaking procedures proscribed by [the Administrative Procedures Act].”

Stop Three: Public Comment

The next significant pit stop will be the public comment process. The DEA will accept public comments on the proposed rule for a set period of time, likely 60 to 90 days. Interested stakeholders — anyone from your next-door neighbor to healthcare providers to major drug manufacturers — can take part in the public comment process. Based on the comments received, the DEA also has the option of modifying its proposed rule at this time.

Stop Four: ALJ Review and Inevitable Litigation  

The next stop will be before an administrative law judge who will review the DEA’s proposal and who can choose to hold a hearing on the proposal to gather input, evidence, and arguments from stakeholders. By this time, we can also expect significant litigation attacking the rescheduling rulemaking from all angles, including lawsuits seeking to block the implementation of any final rescheduling rule.

Stop Five: The Final Rule

At long last, the DEA will then review the entire record and publish its final rescheduling rule in the Federal Register. After the DEA does so there will still be a short period of time before the final rule goes into effect. For reference, the DEA issued its final rule rescheduling Hydrocodone Combination Products (HCPs) on August 22, 2014, and the final rule did not go into effect until October 6, 2014.

Future Roadblocks: Judicial Review and Congressional Action

The DEA’s decision to reschedule or deschedule a substance through the administrative process is subject to judicial review pursuant to the Controlled Substances Act, 21 U.S.C. § 877. Aggrieved parties will have 30 days after the final decision on rescheduling is made to seek judicial review. Fortunately, a court will only set aside the DEA’s rescheduling decision if it is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law. And, while unlikely to be an issue given the current breakdown of Congress, there is also the possibility of congressional review and challenge pursuant to the Congressional Review Act, 5 U.S.C. § 801 et seq., by which Congress may disapprove agencies’ rules by enacting a joint resolution of disapproval.

We at Budding Trends will continue to monitor the road to rescheduling and will report on any significant roadblocks as they (inevitably) arise.