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.

Registration Requirements for Mobile Narcotic Treatment Programs

The Fall 2019 Unified Agenda indicates that:

The DEA is proposing to modify the regulations related to the registration requirements of DEA registrants relating to Mobile Narcotic Treatment Programs. As a result of these modifications, the DEA would also modify the registration, security, ordering, and recordkeeping requirements for those registrants who wish to transport controlled substances for the purpose of dispensing for narcotic treatment.

On or about January 21, 2020, OMB completed its review of the proposed regulation and returned the Notice of Proposed Rulemaking (NPRM) to DEA.  It is expected that the NPRM will be published in the coming weeks.

In addition to expanding access to medication-assisted treatment, this regulation may also provide insight to and the building blocks for future regulations regarding registrations for mobile anesthesiologists.

Registration and Reregistration Fees for Controlled Substance and List I Chemical Registrants

On January 30, 2020, OMB received the NPRM for new registration fees for review and approval.  Recall that the last time DEA raised its registration fees was 2012.  My guess is that registration fees for non-practitioners (distributors, manufacturers, etc…) will increase significantly, with moderate increases for practitioners.

Industry should pay close attention to the justifications provided by DEA for raising fees and comment accordingly.  The Controlled Substances Act requires  that registration fees “shall be set at a level that ensures the recovery of the full costs of operating the various aspects of [the diversion control program].” 21 USC 886a(1)(C).  Since the last fee rule, DEA has greatly increased fee-funded positions to support the expansion of DEA’s enforcement efforts, including funding significant increases in Special Agent positions to staff Tactical Diversion Squads and other positions that have historically been filled by Diversion Investigators.  While this is somewhat understandable, DEA must also be held accountable to direct fee funds to non-enforcement operational support of DEA registrants.  This includes addressing the IT shortcomings of the Diversion Control Division highlighted by the GAO’s recent report, much-needed upgrades to the CSOS Program, and greater educational support to DEA registrants, to name a few.  Striking the appropriate balance between funding its programs and keeping fees “reasonable,” as required by law, is admittedly a difficult proposition.  For that reason, the regulated industry must participate in the process, comment on the proposed regulation, and take additional action, if appropriate.

Suspicious Orders of Controlled Substances

OMB received the draft NPRM for suspicious orders on February 6, 2020.  I don’t think there is much to say about the new suspicious order regulations that hasn’t been already said.  If you are new to DEA Chronicles or haven’t been paying attention, you can read this, this, and this.

It typically takes OMB 90 days or so to review and/or approve proposed agency regulations.  The mobile narcotic treatment program registration regulation (mentioned above) was at OMB for a a little more than 100 days.  Assuming there are no substantial changes to be made, DEA will usually publish the NPRM within 30 days of OMB approval.  This means that the new fee rule and the suspicious orders regulations should be published by early Summer.