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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations
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that the communities served by mobile NTPs will be harmed by diverted methadone.
Requiring the mobile NTP and its controlled substances to return to the registered location of the NTP also reduces the likelihood that controlled substances will be lost or mishandled.
Requiring an NTPs mobile component to return nightly better enables the NTP
to monitor its mobile components dispensing, and thus become more readily aware of any problemssuch as the double-dipping discussed below under Recordkeeping Requirements for Mobile Componentsor other discrepancies that may signal that the mobile NTPs controlled substances are being diverted or otherwise improperly dispensed.8 For similar reasons, DEA
will not allow NTPs to enter into agreements with local or State law enforcement entities closer to the remote service area to secure the controlled substances in their facility while the mobile NTP is not in operation. Even assuming that these law enforcement entities are equipped to securely store the controlled substances, the regular transfer of these substances back and forth between mobile NTPs and the law enforcement entities would inhibit the NTPs and ultimately DEAs ability to monitor the controlled substances and unnecessarily create opportunities for the substances to be stolen, mislaid, or otherwise mishandled.
Additionally, allowing mobile NTPs to remain in operation for multiple days without returning to their registered locations not only presents an elevated risk of diversion, there are alternative options that make it generally unnecessary. For example, nothing in this rule impacts the ability of an NTP
to register at an additional physical location. Thus, if an NTP wishes to treat patients with methadone at a remote correctional facility or similar rural location, that NTP could simply register a physical location in the area to which to return its mobile component and where to secure its controlled substances. Indeed, a correctional facility can itself register with DEA as 8 DEA appreciates commenters suggestions that the risk of theft or diversion of controlled substances left in a mobile NTP overnight could be mitigated by increasing the security requirements for mobile NTPs. While such measures could reduce the danger of theft or diversion somewhat, they would not suffice to overcome the inherent enhanced dangers of leaving controlled substances in an unmanned conveyance overnight at an unregistered location. And such enhanced security measures would do nothing to address the reduction in the registered NTPs ability to monitor the mobile components dispensing that would result if mobile NTPs were not required to return to their registered NTP location nightly.

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an NTP. While some correctional facilities have obtained an NTP
registration, DEA wishes to emphasize this option for those who may be unaware of it. Moreover, many OUD
patients may be successfully treated with alternative medications such as buprenorphine or naltrexone.
Buprenorphine is a schedule III narcotic drug approved by the U.S. Food and Drug Administration FDA for the treatment of OUD, and, as such, may be dispensed for such purpose without the dispenser being registered as an NTP.9
Naltrexone is a non-controlled substance and, as such, may be dispensed without a DEA registration.
Accordingly, OUD treatment involving the use of either buprenorphine or naltrexone does not require the use of a mobile NTP.
In sum, DEA has concluded, for the reasons stated above, that it is necessary and appropriate to maintain in the final rule the requirement that a mobile NTP
return to its registered location each day. However, in view of the comments DEA received on this issue, DEA wishes to emphasize that it has decided to add to the text of the final rule a provision that expressly allows NTPs to apply for an exception to this requirement. The process for applying for such an exception will be as set forth in 21 CFR
1307.03, which allows any person to apply for an exception to any provision of the DEA regulations. As with all applications for an exception to any provision of the regulations submitted pursuant to section 1307.03, each application for an exception to the requirement that a mobile NTP return each day will be evaluated by DEA on a case-by-case basis in determining whether the applicant has demonstrated exceptional circumstances that warrant a waiver of the regulation. In making this determination, DEA will consider the applicants security and recordkeeping as well as other factors relevant to determining whether effective controls against diversion will be maintained. DEA is revising 21 CFR
1301.72e from that proposed in the NPRM to reflect this change to the regulatory text.
In addition, DEA will continue to evaluate the risk of diversion that might result from eliminating, in some circumstances, the requirement that a mobile NTP return to its registered location each day. DEA will closely monitor applications seeking an exception to that requirement. One year after this rule is finalized, DEA will 9 The CSA requirements governing the dispensing of buprenorphine are set forth in 21 U.S.C.
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review whether additional rulemaking is necessary to improve access to treatment via mobile NTPs. In conducting its review, DEA will consult with the Department of Health and Human Services HHS and the Office of National Drug Control Policy ONDCP.
If the volume and nature of such applications and an evaluation of the associated risk of diversion warrant it, DEA will further amend the regulations to allow mobile NTPs to be excepted from this requirementwithout having to apply for an exceptionunder certain specified circumstances. If DEA
determines that such additional amendment to the regulations is warranted, it will initiate a separate rulemaking proceeding to do so in accordance with the Administrative Procedure Act APA.
Security Requirements for Mobile Components Comments: Several commenters addressed the security requirements that were detailed in the proposed rule. Two commenters, who recommended a 72hour return instead of the proposed same day return requirement for mobile NTPs see discussion above, suggested that the final rule add additional security requirements during this 72hour time frame. The commenters suggested either utilizing armed security guards outside the mobile component, or locking the mobile component in a secure fenced-in location and using, possibly, unarmed rather than armed security guards. One commenter believed such security measures would not present any additional diversion issues and noted that DEA
acknowledged thefts from mobile NTPs in the past had not been an issue.
One commenter pointed out the known criminal activity risks associated with having controlled substances on site, such as theft, and noted that brickand-mortar NTPs often protect their employees and patients through various security measures. The commenter provided two examples of these measures: 1 A panic button that, when activated, triggers law enforcement to immediately respond, and 2 the local law enforcement knows the existence and whereabouts of an NTP and, therefore, can respond quickly and efficiently to an emergency. In contrast, the commenter stated that the proposed rule fails to mention whether mobile NTPs must take any explicit security measures to protect their employees and patients, including installing panic buttons, or making local law enforcement aware of the mobile NTPs exact locations at any given moment, including during travel. The commenter
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