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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations
travel to a rural area each day from an urban area.
Many commenters suggested that DEA
allow these mobile components to stay in the field for longer periods of time.
The commenters indicated that costs would be reduced significantly and there would be more time for providing care to patients, thus making the mobile components more effective, if the components were allowed to return to the registered location less frequently.
The majority of commenters proposed only requiring the mobile NTPs to return to the registered location once a week, while another commenter suggested a 72-hour turnaround time, and another commenter simply requested that the mobile NTP be allowed to remain in the field for multiple days. One of the commenters who suggested returning once a week, alternatively recommended the mobile NTPs not be required to return more frequently than every other day.
Another commenter stated that DEA
should not specify when the mobile component must return or, as an alternative, suggested that DEA should consider increasing the intervals between returns and only requiring weekly returns.
Most commenters believed that requiring the mobile components to return to the registered location less frequently would increase access to treatment while still maintaining appropriate safeguards against potential theft and diversion. Indeed, several commenters asserted that these longer turnaround times were feasible given that DEA was proposing to apply existing security protocols to mobile components. One commenter similarly stated that the security measures required by the proposed rule were adequate to prevent diversion while the mobile component is in the field.
However, one commenter suggested that if the mobile components are allowed to stay in the field for longer periods of time, additional security measures should be taken. The commenter suggested requiring an armed guard outside the mobile component or requiring the mobile component to be locked in a secure, fenced-in location.
Finally, one commenter stated that in the absence of evidence of abuse, DEA
should not require the mobile component to return to the registered NTP location daily or store the controlled substances in the registered location at the end of each day. The commenter stated that the proposed rule includes multiple safety measures and procedures that are adequate to protect controlled substances, which the commenter felt acted as a significant
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check against theft and diversion. The commenter further contended that it is not clear that moving the mobile component back to the registered location and removing the controlled substances daily decreases the risk of diversion. Furthermore, the commenter asserted that DEA does not provide evidence or reasoning to explain how these requirements reduce the risk of diversion. The commenter insisted that pending the development of better information regarding the risks of diversion, DEA should not specify when the mobile component must return to the NTPs registered location.
DEA Response: DEA appreciates commenters concerns over the proposed requirement that the mobile component and the controlled substances it carries return to the NTPs registered location daily. As stated before, the intent of the rule is to ensure that more individuals have access to treatment despite geographical limitations. The need to ensure that individuals in these remote locations can access the care that they need has to be balanced against security and recordkeeping requirements to ensure that the controlled substances on board the mobile component are not diverted for illicit use.
Several concerns drive DEAs conclusion that, upon the completion of their daily operations, mobile NTPs generally must return to their registered locations and secure all controlled substances within their registered location.
The first and most important concern is the danger associated with controlled substances that mobile NTPs will be carrying, should those substances be diverted. Of course, mobile NTPs will primarily be storing and distributing methadone, and methadone is an extremely dangerous drug if abused.
More specifically, methadone is a potent schedule II opioid with a relatively long elimination half-life of 859 hours with an average of 24 hours depending on the individual.2 As such, methadone can accumulate in an individuals body if taken more frequently than prescribed or in doses that exceed an individuals tolerance for the medication.3
Methadone has been associated with adverse events and opioid overdose deaths in those lacking experience with 2 Substance Abuse and Mental Health Services Administration, Medications for Opioid Use Disorder. Treatment Improvement Protocol TIP
Series 63, Publication No. PEP200201006, Rockville, MD: Substance Abuse and Mental Health Services Administration 2020.
3 Roxane Laboratories, Dolophine hydrochloride package insert, Fda.gov/media/76020/download accessed May 10, 2021.

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the drug as well as in experienced users who overuse the drug or combine it with other illicit drugs or with other prescribed medications that have adverse drug-drug interactions with methadone.4
Methadone is also a demonstrated diversion risk.5 It has significant street value, and its misuse and abuse has been documented.6 And mobile NTPs, especially if they were allowed to remain away from their registered locations for multiple days, are likely to be carrying methadone in substantial quantities, enough to be of great street value and to impose a significant risk to an entire community should a fully stocked mobile NTP have its methadone diverted.7
So long as methadone remains in a mobile component, it is at an elevated risk of theft both because the mobile conveyance itself could be stolen, and because security measures in a mobile NTP will generally be less robust than those at the NTPs registered location.
This risk is manageable when the mobile NTP is in operation and thus secured by staff to guard against theft.
However, the risk becomes unwieldy especially given that dangers posed by such quantities of methadonewhen the mobile NTP is not in use and is unattended, generally at night, and the likelihood of theft is greater. Thus, by requiring NTPs to secure their controlled substances within their registered NTP location after operation each day, DEA decreases the risk that those controlled substances will be stolenand thereby decreases the risk 4 Food and Drug Administration, Public health advisory: Methadone use for pain control may result in death and life-threatening changes in breathing and heartbeat, Silver Spring, MD: U.S.
Department of Health and Human Services, 2006, https www.fda.gov/ForConsumers/Consumer Updates/ucm12346.htm accessed May 10, 2021;
Modesto-Lowe V, Brooks D, Petry N., Methadone deaths: Risk factors in pain and addicted populations, J Gen Intern Med 25: 305309 2010;
Madden ME, Shapiro SL, The methadone epidemic:
Methadone-related deaths on the rise in Vermont, Am J Forensic Med Pathol. 322: 131135, 2011.
5 McCance-Katz EF. The National Survey on Drug Use and Health: 2019. Slide 14. SAMHSA.gov/data/
release/2019-national-survey-on-drug-use-andhealth-nsduh-releases accessed May 10, 2021.
6 National Drug Intelligence Center. Methadone diversion, abuse and misuse: Deaths increasing at alarming rate. Justice.gov/archive/ndic/pubs25/
25930/index.htmDiversion 2007 accessed May 10, 2021; Wright N, DAgnone O, Krajci P, et al.
Addressing misuse and diversion of opioid substitution medication: Guidance based on systematic evidence review and real-world experience. J Public Health. 38 3: e368e374, 2016.
7 For example, an average dose range for an individual on methadone maintenance is 60120
mg daily, which would be multiplied by the number of individuals for whom the mobile NTP
conveyance carries doses. See SAMSHA TIP 63, supra note 2.

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