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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations This CSA requirement of separate registrations for each principal place of business or professional practice where the practitioner dispenses controlled substances allows DEA to monitor the dispensing of controlled substances.
This requirement thereby reduces the potential for diversion of those substances. Accordingly, the CSA only authorizes the Administrator by delegation from the Attorney General to issue regulations waiving this requirement if he finds doing so to be consistent with the public health and safety. 21 U.S.C. 822d.
As explained in the NPRM and above, DEA has concluded that allowing NTPs to operate mobile NTPs under the conditions specified in this rule is consistent with the public health and safety. See NPRM, 85 FR 11008, 11010.
This conclusion, however, only extends to mobile NTP components used for maintenance and detoxification treatment; any other use is beyond the scope of this rule.
In this rulemaking, DEA has not considered whether waiving the separate registration requirement in any other circumstances would be consistent with the public health and safety, because such a determination was not necessary for this rulemaking.
It is, in other words, beyond the scope of this rule. This final rule, therefore, does not change the requirement for separate registrations at each principal place of business or professional practice for any other registrants including specialty doctors that dispense controlled substances. To the degree interested parties believe that the separate registration requirement should be waived in other circumstances, they may petition DEA to do so by regulation.

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Setting a Mileage Limit for Mobile NTP
Dispensing Comments: One commenter suggested that the proposed rule clarify the radius outside of the dispensary i.e., the NTPs registered location within which the dispenser i.e., the mobile NTP
can deliver. Another commenter was concerned that the proposed rule suggested a mileage limit which might not be realistic, especially when applied to larger States. The commenter stated that there may be value in allowing each individual State to set and adjust the mileage limit that would be most appropriate for mobile NTPs operating in their State. Several other commenters discussed in more detail below suggested that DEA allow mobile NTPs to operate within a 200-mile radius of the NTPs registered location, even if
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that radius included areas in neighboring states.
DEA Response: DEA will not define an exact distance that the mobile component can travel from its registered location. As further explained below, DEA has concluded that mobile NTPs must be required to return to their registered locations upon the completion of their operations each day and that such a requirement can be met while still increasing access to maintenance or detoxification treatment in rural and underserved areas. A
specified mileage limit, however, is not necessary to ensure that mobile NTPs will return to their registered locations daily. NTPs are better positioned than DEA to determine how far from their registered location the mobile components can travel while still allowing adequate time to return to their registered location at the end of the day, especially given that this distance is likely to vary between different geographic regions given differences in roads, traffic, and other conditions.
Mobile Components Crossing State Lines Comments: Several organizations, practitioners, and non-profit organizations; a university policy think tank and researcher; and members of the general public were opposed to the proposed rules requirement that mobile NTP components only operate in the same State as their registered NTP
location. Multiple commenters voiced concern that this requirement would hinder the effectiveness of the proposed rule in providing services to underserved communities. One commenter noted that for many rural communities, the closest NTP may be across state lines. Five commenters cited studies that provided statistics on the number of NTP patients that traveled across state lines to access services, and calculated the mean driving distance to a methadone clinic in five rural states. These studies noted that many of these patients lived in areas that have been hit hardest by the opioid epidemic, and would benefit greatly from mobile medication delivery. Another commenter provided a citation to an article that showed the ineffectiveness of limiting mobile NTPs to intrastate in rural and underserved communities. These commenters urged DEA to allow NTPs located in one State to provide services to underserved areas in neighboring States. Commenters suggested that one way of allowing the mobile components to cross State lines would be to authorize an NTPs mobile component to operate across State lines so long as it remains within a 200-mile
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radius of the NTPs registered location, which would increase access to remote areas that otherwise might remain underserved. Commenters went on to say that as long as the NTP abided by the applicable State laws and secured approval from local DEA field offices, the mobile component should be allowed to cross State lines. Finally, one commenter suggested making requirements based on distance and population, and creating regulations built on collaboration. The commenter stated this approach would allow an NTP with mobile capabilities in one state to collaborate with an NTP that seeks to provide those services in a different state if the two NTPs share a patient base within a certain geographic area.
Another commenter expressed concern that NTPs would choose to only operate within their own State if 1
State methadone authorities hesitated to license a mobile component with a registered location in another State, or 2 States placed more onerous licensing processes on mobile components from another State. The commenter suggested that DEA should not prohibit this at the Federal level. The commenter further suggested that if States are willing to approve mobile components that are based in another State to promote access for their own citizens, DEA should defer to the States and permit mobile NTPs to operate in a different State than that of the NTPs registered location if the provider can obtain the requisite license from the State methadone authority.
Finally, one organization and an anonymous commenter supported the requirement that a mobile NTP only operate in the same State in which the NTP is registered with DEA. The organization noted that State regulations can vary greatly, and the organization was aware of the immediate regulatory crisis that would exist if DEA
promulgated Federal regulations around mobile NTPs that permitted the mobile NTPs to dispense controlled substances in States in which they are not registered. The organization expressed concern that any potential for conflict within the treatment delivery system could put patient care in jeopardy and foster confusion that may fuel additional stigma against an already overly stigmatized medical treatment.
The organization also noted that mobile NTPs are governed by State regulations in addition to the Federal regulations promulgated by DEA and the Substance Abuse and Mental Health Services Administration SAMHSA. The organization further noted that operating a mobile NTP across State lines would call into question which
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