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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations Another commenter noted that current regulations provide DEA
discretion to prescribe security requirements to the NTP based on certain factors. However, this commenter stated that it would seem practically impossible for DEA to fully exercise its discretion under 21 CFR
1301.73l and effectively set security standards for mobile components, given the changing locations of mobile components when contrasted with registered NTP locations.
DEA Response: Under the final rule, DEA will review the security systems used on these mobile components and make a determination on which security systems meet DEA requirements on a case-by-case basis before approving the operation of a mobile NTP. DEA
appreciates the concern that such caseby-case evaluation of mobile NTPs security systems may lead to delays and differences in enforcement between local DEA offices. As it is DEAs intent to ensure that there are no delays or unfairness in getting mobile components up and running, DEA will endeavor to prevent such problems from occurring.
DEA, however, cannot forego case-bycase determinations, even if they inevitably bring some risk of delay or enforcement discrepancies. As discussed above, although this final rule and DEA regulations more broadly articulate basic security requirements, they cannot account for all security situations. Some situations may require additional security measures for a mobile NTP to be able to adequately guard against loss through theft or other forms of diversion. Attempting to account for all such scenarios in advance through regulation is ineffective and may impose unnecessary restrictions on other mobile NTPs. DEA
can best ensure that mobile NTPs provide adequate security by enabling local DEA offices to conduct case-bycase evaluations as appropriate. That said, DEA is slightly modifying the proposed regulatory language describing how these case-by-case evaluations are conducted in this final rule to clarify that DEA, not any other entity, applies the factors.
DEA has concluded that mobile NTPs changing locations will not compromise its ability to make such assessments.
DEA already evaluates the security arrangements provided by a wide range of registrants under many different circumstances. Although mobile NTPs do present some unique challenges, DEA is confident that it can work with mobile NTPs to ensure that they operate securely.

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Comment: Finally, one commenter stated that DEAs security requirements in 21 CFR 1301.72 through 1301.76 are extremely outdated and currently put all registered NTPs, as well all DEA
registrants, at high risk for diversion, and that this risk would extend to mobile NTPs. In particular, this commenter claimed that, in todays environment, the controls outlined in 21
CFR 1301.75a and b are inconsistent with those in 21 CFR 1301.71a, and stated that securing controlled substances consistent with DEAs nonpractitioner requirements in 21 CFR
1301.72a can potentially reduce crime by 7585 percent. This commenter encouraged DEA to strengthen and enhance the schedule IV physical security requirements for all registrants consistent with 21 CFR 1301.72a, by utilizing currently available market technologies.
DEA Response: DEA appreciates this comment suggesting in general terms that it broadly update the security requirements of its regulations to better reflect currently available security technologies. DEA recognizes that technologies change, but has concluded that the security regulations in this rule adequately protect against theft and diversion in the use of mobile NTPs given current technologies. The sort of broader changes to DEA security regulations suggested by the commenter are beyond the scope of this rule.
Recordkeeping Requirements for Mobile Components Comments: One commenter stated that they did not see a reason why all of the records mobile components would be required to keep could not be electronically logged in on a daily basis, while still being in compliance with the proposed amendment to 21 CFR part 1304. Another commenter noted that the proposed rule allows mobile NTPs to maintain electronic dispensing logs;
however, the mobile NTP would still need to print out a hard copy of such log daily with the dispenser of each dose initialing each relevant entry. The commenter advocated for allowing these dispensers to use digital signatures in these logs because the processes for digital signatures are readily available and widely used, and using digital signatures would reduce unnecessary paperwork for physicians. In addition, the commenter stated that DEA should not require pre-approval of the mobile NTPs electronic recordkeeping system for the dispensing log because this could create unnecessary delays in the transition to electronic recordkeeping.
Further, if DEA permits digital signatures in the final rule, the
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commenter requested that DEA clarify that DEAs approval of an electronic recordkeeping system for a registered NTP location will be sufficient for the mobile component.
DEA Response: DEA recognizes the concerns expressed by commenters regarding the use of electronic dispensing logs. In the proposed rule, DEA proposed an alternative to maintaining a paper dispensing log, stating that an NTP or its mobile component may also use an automated/
computerized data processing system for the storage and retrieval of the programs dispensing records, if a number of conditions were met. The requirement that the NTP or its mobile component print a hard copy of each days dispensing log, which is then initialed appropriately by each person who dispensed medication to the programs patients, is one of the conditions that must be met. This requirement, along with the others specified in section 1304.24b1, is based on recommendations in the Narcotic Treatment Programs Best Practice Guideline April 2000.10
Furthermore, DEA emphasizes that the rule is not adding additional recordkeeping requirements to NTPs.
The rule is instead simply applying already-existing recordkeeping requirements of 21 CFR part 1304 to mobile NTPs, as well as providing NTPs and their mobile components the option of using a computerized data processing system, instead of a paper dispensing log. DEA believes the recordkeeping requirements in this rule are necessary to ensure accountability and prevent diversion. Thus, DEA generally agrees that electronic logging of dispensing records is appropriate. These electronic records, however, will still have to be logged on a daily basis, and must comply with the requirements in 21
CFR part 1304. Finally, requiring the NTP employee who dispensed the medication to review and initial the hard copy of the dispensing log at the end of each day is important for maintaining accurate records and ensuring accountability.
DEA also notes the commenters concerns about the requirement that 10 The Narcotic Treatment Programs Best Practices Guideline, developed by DEA in collaboration with the American Methadone Treatment Association now the American Association for the Treatment of Opioid Dependence, provided assistance in understanding the provisions of the CSA and in the implementation of the regulations as they apply to dosage reconciliation practices in NTPs. DEA
rescinded the guideline after publication of the NPRM, but the recommendations it contained continue to represent best practices for NTP
operation.

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