The Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) revising the registration requirements for mobile narcotic treatment programs (NTP). DEA’s justification for the rule is to “make maintenance or detoxification treatments more widely available,” especially in rural and underserved communities.
As background, the Controlled Substances Act (CSA) requires entities to obtain a DEA registration at each principle place of business or professional practice where controlled substances are manufactured, distributed, and dispensed. 21 U.S.C. 822(e)(1). The statutory language, reiterated in DEA’s regulations, has been an impediment for non-traditional medical service providers such as mobile anesthesiologists and mobile narcotic treatment programs, who bring their services, including the administering and dispensing of controlled substances, to locations other than their principle places of business.
DEA is using its discretion to waive existing registration requirements and will permit a mobile NTP “to dispense narcotic drugs in schedules II-V at a location remote from, but within the same state, as the NTP’s registered location,” will consider the remote dispensing of these drugs “a coincident activity permitted under the NTP’s registration,” and will require the NTP to obtain “prior approval from the local DEA office.” It is not clear from the NPRM what criteria the local DEA office must use when determining whether to approve a written request to operate a mobile NTP.
The rule also lays out inventory, recordkeeping and security requirements to ensure accountability of the dispensing activities and in-transit security of the controlled substances. Among other requirements, the NTP must keep and maintain records of its mobile activities at its registered location and the controlled substances must be stored, when in transit, in a safe that is affixed to the vehicle and equipped with an alarm system.
To be clear, this regulation only applies to mobile NTPs. It could provide a road map for DEA to promulgate similar regulations for mobile anesthesiologists; however, it is not clear whether such action is a priority of the agency.
For those inclined to do so, written comments must be submitted within 60 days of publication of the NPRM.