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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations
i Registrants are not required to obtain a separate registration for conveyances mobile components utilized by the registrant to transport controlled substances away from registered locations for dispensing at unregistered locations as part of a mobile NTP. Vehicles must possess valid county/city and State information e.g., a vehicle information number license plate number on file at the registered location of the NTP.
Registrants are also required to provide proper city/county and State licensing and registration to DEA at the time of inspection, and prior to transporting controlled substances away from their registered location.
ii A mobile NTP is not permitted to reverse distribute, share, or transfer controlled substances from one mobile component to another mobile component while deployed away from the registered location. NTPs with mobile components are not allowed to modify their registrations to authorize their mobile components to act as collectors under 21 CFR 1301.51 and 1317.40. Mobile components of NTPs may not function as hospitals, long-term care facilities, or emergency medical service vehicles, and will not transport patients.
iii A mobile NTP may operate at any remote location or locations within the same State as its registered location, including correctional facilities, so long as doing so is otherwise consistent with applicable Federal, State, tribal, and local laws and regulations, and so long as the local DEA office, when notified pursuant to this section, does not otherwise direct.

5. In 1301.72, revise the section heading and add paragraph e to read as follows:
1301.72 Physical security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs; storage areas.

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e Mobile Narcotic Treatment Programs. 1 For any conveyance operated as a mobile narcotic treatment program NTP, a safe must be installed and used to store narcotic drugs in schedules IIV for the purpose of maintenance or detoxification treatment, when not located at the registrants registered location. The safe must conform to the requirements set forth in paragraph a1 of this section.
The mobile component must also be equipped with an alarm system that conforms to the requirements set forth in paragraph a1iii of this section.

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The storage area of the mobile component must conform to the accessibility requirements in paragraph d of this section. The storage area for controlled substances in a mobile component of an NTP must not be accessible from outside of the vehicle.
Personnel transporting the controlled substances on behalf of the mobile NTP
are required to retain control over all controlled substances when transferring them between the registered location and the conveyance, while en route to and from the dispensing location or locations, and when dispensing at the dispensing location or locations. At all other times during transportation, all controlled substances must be properly secured in the safe. 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. After the conveyance has returned to the registered location and 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. All NTPs with mobile components shall be required to establish a standard operating procedure to ensure, if the mobile component becomes inoperable mechanical failure, accidents, fire, etc., that all controlled substances on the inoperable conveyance are accounted for, removed from the inoperable conveyance, and secured at the registered location.
2 With regard to the requirement of paragraph e1 of this section, 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, an NTP may apply for an exception to this requirement as provided in this paragraph. The application for such an exception must be submitted in accordance with 1307.03 of this chapter and must include the proposed alternate return period, enhanced security measures, and any other factors the applicant wishes the Administrator to consider. The Administrator may grant such an exception in his discretion and will evaluate each application on a case-by-case basis in determining whether the applicant has demonstrated exceptional circumstances that warrant the
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exception. In making this determination, the Administrator will consider the applicants security and recordkeeping as well as any other factors he deems relevant to determining whether effective controls against diversion will be maintained.
6. In 1301.74:
a. Revise the section heading;
b. Revise paragraphs j through l;
c. Redesignate paragraph m as paragraph o; and d. Add new paragraphs m and n.
The revisions and additions read as follows:
1301.74 Other security controls for nonpractitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs.

j Persons enrolled in any narcotic treatment program NTP, including those receiving treatment at a mobile NTP, will be required to wait in an area that is physically separated from the narcotic storage and dispensing area by a physical entrance such as a door or other entryway. Patients must wait outside of a mobile NTP component if that conveyance does not have seating or a reception area that is separated from the narcotic storage and dispensing area. This requirement will be enforced by the program practitioner and NTP
employees.
k All NTPs, including mobile NTPs, must comply with standards established by the Secretary of Health and Human Services after consultation with the Administration respecting the quantities of narcotic drugs which may be provided to persons enrolled in a NTP or mobile NTP for unsupervised use e.g., take home or non-directly observed therapy.
l DEA may exercise discretion regarding the degree of security required in NTPs, including mobile NTPs, based on such factors as the location of a program, the number of patients enrolled in a program, and the number of practitioners, staff members, and security guards. Personnel that are authorized to dispense controlled substances for narcotic treatment must ensure proper security measures and patient dosage. Similarly, DEA will consider such factors when evaluating existing security or requiring new security at a narcotic treatment program or mobile NTP.
m Any controlled substances being transported for disposal from the dispensing location of a mobile NTP
shall be secured and disposed of in compliance with part 1317, and all other applicable Federal, State, tribal, and local laws and regulations.

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