DEA's Rulemaking Plans Get Shut Down

Today, the U.S. Department of Justice ("DOJ") withdrew four of DEA's Proposed Rules (‘‘NPRMs’’) and Advance Notices of Proposed Rulemaking (‘‘ANPRMs’’) and, in doing so, DOJ confirmed it "plans no further action" with the NPRMs and ANPRMs. At the same time, DOJ also withdrew thirteen of DEA's projected rulemaking priorities and announced they are regulatory efforts the government "no longer intends to pursue." DOJ confirmed its decision to wind down and tighten DEA's rulemaking agenda is in response to President Trump’s deregulation directives issued to federal agencies under E.O. 14192. This all comes on the heels of last week's development where, on September 4th, DEA’s suspicious order monitoring (SOM) Final Rule was deprioritized and moved it to long-term consideration. 

DOJ's withdrawing of DEA's rulemaking priorities is particularly noteworthy because, as emphasized below, many of those priorities were expected to bring clarity and certainty to key regulatory issues the industry has had to wrestle with for many years (often times having to manage and navigate DEA's inconsistent handling of the issues across its field offices). For instance, DEA intended to promulgate rules regarding the application and scope of campus registrations, which has been an area of concern and confusion for most hospital systems across the nation. Additionally, DEA had intended to promulgate rules regarding the meaning of the CFR's use of the clause "principal place of business or professional practice" with respect to locations for which DEA registrations may be issued, which has increasingly become a point of contention between DEA and telehealth prescribers seeking DEA registrations in states where their distant patients are located.

The four withdrawn NPRMs and ANPRMs are:

• Providing Controlled Substances to Ocean Vessels, Aircraft, and Other Entities, 87 FR 42662.

• Regulation of Telepharmacy Practice, 86 FR 64096.

• Schedules of Controlled Substances; Exempted Prescription Products, 87 FR 21588.

• Controlled Substance Destruction Alternatives to Incineration, 88 FR 74379.

The thirteen withdrawn rulemaking priorities are:

• Amendments to the Drug Enforcement Administration Hearing Regulations.

• Principal Place of Business or Professional Practice.

• Electronic Submission of DEA Form 41 (Registrant Record of Controlled Substances Destroyed).

• Termination of Registration Upon Discontinuation of Business or Change of Ownership.

• Disaster Registration Emergency Authorities.

• Campus Registration.

• Employment Bar and New Employment Waivers.

• Operation of Automated Dispensing Systems at Long Term Care Facilities by Hospital/Clinic Pharmacies.

• Medical Missions.

• Amending Regulations to Separate K–9 Handlers From the Researcher Category.

• Analytical Labs and Hemp. Medical Marijuana and Cannabidiol Research Expansion.

• Revision of Application for Manufacturing Quota.

DOJ's restricting of DEA's rulemaking agenda carries significant implications for the industry and will invariably contribute to further confusion among registrants and DEA field offices.