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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations
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the secure, fenced-in area. The proposed new paragraph did not previously address this security condition.
This final rule does not change the proposed new requirement in 1301.72e, that upon completion of the operation of the mobile NTP on a given day, the conveyance must be immediately returned to the registered location, and all controlled substances must be removed from the conveyance and secured within the registered location. However, this rule adds a provision in 1301.72e that expressly allows NTPs to apply for an exception to this requirement, following the process set forth in 21 CFR 1307.03, which allows any person to apply for an exception to any provision of the DEA
regulations. In addition, the revised 1301.72e specifically provides that the application must include certain other information, and that DEA will evaluate each application on a case-bycase basis to determine whether the applicant has demonstrated exceptional circumstances that warrant a waiver of the daily return requirement.
Finally, this rule makes a variety of minor changes in capitalization, abbreviation, word choice, and grammar throughout the regulatory text, but these are not intended as substantive revisions. For example, whereas the proposed text used both narcotic treatment program and NTP, the revised text more consistently uses NTP throughout. Similarly, proposed new 1301.74j and l referred to an NTP physician, whereas the revised text uses the more general term practitioner.
Below are summaries of provisions contained in the final rule.
Part 1300: Definitions In section 1300.01, DEA adds a definition for a mobile NTP. This definition reflects that a mobile NTP is an NTP operating from a motor vehicle that serves as a mobile component of the NTP. As such, a mobile NTP engages in maintenance and/or detoxification treatment with narcotic drugs in schedules IIV, at a location or locations remote from, but within the same State as, the registered NTP, and operates under the registration of the NTP.
Because the mobile NTP definition references a motor vehicle, DEA also separately defines motor vehicle as a vehicle propelled under its own motive power and lawfully used on public streets, roads, or highways with more than three wheels in contact with the ground; a motor vehicle does not include a trailer in this context.
Therefore, a trailer could not serve as a mobile NTP.

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Part 1301: Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances DEA regulations have always required that all registrants maintain effective security to guard against theft and diversion of controlled substances. See 21 CFR 1301.7177. The need for such security applies equally in the mobile NTP context. Thus, this final rule contains provisions described below that require NTPs to secure controlled substances while operating a mobile component away from the registered location.
In this final rule, DEA revises section 1301.13 to make operating a mobile component of an NTP a coincident activity of an existing NTP registration, provided the NTP has obtained prior approval from the local DEA office. DEA
intends to reduce the regulatory burden on NTPs by waiving the separate DEA
registration requirement, as discussed above, and allowing them to operate a mobile component of an NTP in the same State as the registered NTP, under its existing registration. As a result, the mobile component of a registered NTP
will not have to apply for a separate registration, as its operation is considered coincident activity. In addition, DEA specifies in the regulations that the records generated during the operations of a mobile component of an NTP shall be maintained at the NTPs registered location, rather than requiring such records to be stored in the mobile component. Section 1301.13 is also revised to explicitly state that registered NTPs may operate mobile components at correctional facilities where otherwise permitted by law.
DEA revises section 1301.72 to ensure controlled substances in a mobile component of an NTP are protected against theft and diversion. To achieve this end, the security requirements under 21 CFR 1301.72a1 and 21 CFR
1301.72d apply to the mobile component of an NTP. The storage area for controlled substances in a mobile component of an NTP must not be accessible from outside the vehicle. The requirement to secure the controlled substances in a securely locked safe in the conveyance will assist in adequately securing the controlled substances.
Since small quantities of controlled substances will be present in the mobile component, DEA is requiring that the safe used by these mobile components have safeguards against forced entry, lock manipulation, and radiological attacks. The safe must also be bolted or cemented to the floor or wall in such a way that it cannot be readily moved.

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DEA is also requiring that the safe be equipped with an alarm system that transmits a signal directly to a central protection company or a local or State police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Administrator may approve if there is an attempted unauthorized entry into the safe.
Upon completion of the operation of the mobile NTP on a given day, the conveyance will need to immediately return to the registered location, and all controlled substances removed from the conveyance and secured within the registered location. After the controlled substances have been removed, the conveyance may be parked until its next use at the registered location or any secure, fenced-in area, once the local DEA office has been notified of the location of this secure, fenced-in area. If the mobile component is disabled for any reason mechanical failure, accident, fire, etc., the registrant will be required to have a protocol in place to ensure that the controlled substances on the conveyance are secure and accounted for. If the conveyance is taken to an automotive repair shop, all controlled substances will need to be removed and secured at the registered location.
NTPs will not be required to obtain a separate registration for conveyances mobile components utilized by the registrant to transport controlled substances away from registered locations for dispensing within the same State at unregistered locations. Vehicles must possess valid county/city and State information e.g., a vehicle information number VIN or license plate number on file at the NTPs registered location. NTPs are also required to provide State and local licensing and registration documentation to DEA at the time of inspection and prior to transporting controlled substances away from their registered location.
Regarding the requirement for the mobile NTP to return daily to the registered location, and to store its controlled substances at the registered location, DEA revises 21 CFR 1301.72e to expressly allow the NTP to apply for an exception to this requirement, following the process set forth in 21
CFR 1307.03. In addition, the revised 1301.72e specifically provides that the application must include the proposed alternate return period, enhanced security measures, and any other factors the applicant wishes the Administrator to consider. DEA will evaluate each application on a case-bycase basis to determine whether the
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