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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations
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applicant has demonstrated exceptional circumstances that warrant a waiver of the daily return requirement. 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 revises 21 CFR 1301.74 to include mobile components of DEAregistered NTPs, since the existing regulations do not contain such a provision. As described in the revisions to section 1301.74, personnel who are authorized to dispense controlled substances for narcotic treatment must ensure proper security measures and patient dosage. For example, DEA is now requiring that persons enrolled in any NTP, including those who receive treatment at a mobile NTP, 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.
Mobile NTPs may only be stocked with narcotic drugs in schedules IIV
from the registered NTP location.
Personnel designated to transfer narcotic drugs in schedules IIV from the registered location to mobile NTPs are not able to: Receive narcotic drugs in schedules IIV from other mobile NTPs or any other entity; deliver narcotic drugs in schedules IIV to other mobile NTPs or any other entity; or conduct reverse distribution of controlled substances on a mobile NTP.
Any controlled substances being transported to the registered NTP
location for disposal from the dispensing locations of the mobile component shall be secured and disposed of in compliance with 21 CFR
part 1317 and all other applicable Federal, State, tribal, and local laws and regulations.
Finally, the physical security controls of mobile components will need to be implemented by the NTP pursuant to 21
CFR 1301.72 and 1301.74. In the event of a security breach in which controlled substances are lost or stolen, the registrant must determine the significance of the loss and comply with the theft and significant loss reporting requirements in 21 CFR 1301.74c.
Part 1304: Records and Reports of Registrants Under the final rule, the recordkeeping requirements of 21 CFR
part 1304 apply to mobile components of NTPs. DEA revises sections 1304.04
and 1304.24 to include mobile components. As with registered NTP
locations, the records of the mobile components will be stored at the registered location of the NTP in a
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manner that meets all applicable security and confidentiality requirements, and must be readily retrievable.
21 CFR 1304.24b requires that an NTP maintain the records, required by 21 CFR 1304.24a, in a dispensing log at the registered location. It is understood that this log is in paper form. As an alternative to maintaining a paper dispensing log, DEA is permitting an NTP or its mobile component to also use an automated/computerized data processing system for the storage and retrieval of its dispensing records, if a number of conditions are met: The automated system maintains the same information required in 21 CFR
1304.24a for paper records; the automated system has the capability of producing a hard copy printout of the programs dispensing records; the NTP
or its mobile component prints a hard copy of each daily dispensing log, which is then initialed appropriately by each practitioner who dispensed medication to the NTPs patients; and the automated system is approved by DEA.
The NTPs computer software program must be capable of producing accurate summary dispensing reports for the registered NTP location and its mobile component, for any time-frame selected by DEA personnel during an investigation. Further, if summary reports are maintained in hard copy form, they should be stored in a systematically organized file at the registered location of the NTP.
Additionally, a back-up of all computer generated records of dispensing by the NTP and its mobile component is required to be maintained off-site.
Finally, NTPs are required to retain all records for the registered NTP
location as well as any mobile components for two years from the date of execution. This time period is the same period as that required by 21 CFR
1304.04a. However, because some States require that records be retained for longer than two years, the NTP
should contact its State opioid treatment authority for information about State requirements.
Regulatory Analyses Summary of Costs and Benefits DEA examined each of the provisions of the final rule to estimate its economic impact. DEAs analytic approach focuses on comparing the costs and/or cost-savings of a no action baseline regulatory environment with the costs and/or cost-savings of the regulatory environment that would result from the promulgation of this final rule. This is
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the standard analytic framework codified in the Office of Management and Budget OMB Circular A4, published on September 17, 2003. This final rule is an enabling rule designed to expand access to MAT offered by NTPs in underserved communities.
Previously, DEA had only authorized mobile NTPs on an ad hoc basis, and had placed a moratorium on further such authorizations in 2007. Thus, DEA
compared the costs of delivering MAT
services in a baseline regulatory environment, in which no new mobile NTPs are authorized, to the costs of delivering an equivalent level of MAT
services in the final rules regulatory environment, in which a registered NTP
may begin to operate a mobile component as a coincident activity, if authorized by DEA. This analysis, detailed below, finds that this final rule will result in a cost savings for DEAregistered NTPs in the form of reduced startup, labor, and operating costs of MAT services delivered via a mobile component. DEA also recognizes that this final rule is likely to result in benefits in the form of economic burden reductions healthcare costs, criminal justice costs, and lost productivity costs as access to treatment for underserved communities is expected to expand.
However, DEA does not have a basis to estimate the totality of this benefit with any accuracy since data on the number of patients treated via existing mobile components are not available. Thus, while these benefits are not quantified, DEA expects that this final rule will result in a net benefit to society.
MAT has been shown to be an effective opioid treatment optiona 2014 meta-analysis concluded that MAT
has significantly increased treatment retention and decreased illicit opioid use.13 While SAMHSA estimated that 2
million Americans have an OUD
involving medications, and another 526,000 had an OUD involving heroin, in 2018, only 19.7 percent of Americans with an OUD received any specialty treatment.14 A review of private insurance data collected from 2010 to 2014 found that, following an opioidrelated hospitalization, fewer than 11
percent of covered patients received 13 Thomas CP, Fullerton CA, Kim M, et al.
Medication-Assisted Treatment with Buprenorphine: Assessing the Evidence. Psychiatry Serv. 2014; 652:158170. doi:10.1176/
appi.ps.201300256.
14 Substance Abuse and Mental Health Services Administration. 2019. Key substance use and mental health indicators in the United States:
Results from the 2018 National Survey on Drug Use and Health HHS Publication No. PEP195068, NSDUH Series H54. Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration.

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