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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations
requested that the final rule more fully address how mobile NTPs will implement such security measures to improve the safety of their employees and patients.
DEA Response: DEA appreciates the concerns expressed regarding the security requirements for mobile NTPs.
DEA regulations have always required that all registrants maintain effective security to guard against theft and diversion of controlled substances. See, e.g., 21 CFR 1301.71a. The need for such security applies equally to mobile NTPs. Thus, under this final rule, the security requirements of 21 CFR
1301.72e and 1301.74jn apply to the mobile components of NTPs to ensure this need for security is met.
Of course, under certain circumstances, mobile NTPs may need additional security measures beyond those specifically required by DEA
regulations to effectively protect against theft or diversion of controlled substances. Because the need for such measures is circumstance-specific, DEA
is not including them in the final rule, but rather will rely on local DEA
personnel, NTPs themselves, and any other relevant laws and regulations to determine what additional measures, if any, are necessary. In particular, DEA
will leave the decision on whether armed or unarmed security personnel will be utilized by the mobile component while it is away from its registered location to the NTP, as there are many factors that should be considered when making this decision.
For example, the NTP may want to consider the location to which the mobile components will be traveling, the cost of security personnel, and whether or not these security personnel would fit in to any standard operating procedures used by the NTP. Thus, DEA
will not mandate that armed or unarmed security personnel be utilized by these mobile components.
The proposed rule stated in proposed 21 CFR 1301.72e that the mobile component must be returned to the registered location on a daily basis. See NPRM, 85 FR 11008, 11011, 11019. DEA
appreciates that some registered NTP
locations might not have enough room to park the mobile component overnight; therefore parking the mobile component in a secure fenced-in location would be permissible, as long as all DEA security requirements are met, the controlled substances are removed from the mobile component at the end of the day, and the local DEA
office is notified of the location where the mobile component will be parked overnight.

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For similar reasons, DEA will leave the decision on what safety measures the NTP would like to take to ensure the safety of the mobile components staff and patients to the NTP and any relevant government bodies outside of DEA. There are many factors like the location of the NTP, the number of patients it treats, cost, etc., which would affect the NTPs decision when deciding which safety measures would ensure patient and staff safety. Aside from DEA
security requirements, there are other Federal, State, local, and tribal laws these NTPs must take into consideration when making their decision. Thus, because the appropriate safety measures for a mobile NTP will vary based on circumstances and legal requirements, DEA will not attempt to specify additional safety requirements for NTPs as part of this rule. If such requirements are necessary, other Federal, State, local, and tribal authorities can create them.
Comment: One commenter stated that the proposed rule was silent on what would happen to the medication if the mobile NTP breaks down, and recommended that DEA include a requirement for a standard operation procedure or contingency plan if the vehicle breaks down while en route to the communities where services are provided remotely, and if the mobile NTP is out of service for an extended period due to repairs. The commenter suggested that at a minimum, the standard operating procedure needs to include plans for dosing patients in the following circumstances: 1 If the mobile NTP breaks down while en route to the community, and 2 when the mobile NTP is out of service for an extended period due to repairs. The commenter expressed concern that if these plans are not in place, patients may encounter barriers to receiving their medication in an alternative manner e.g., transportation and costs to reach a registered NTP location, waivers by NTP for patients to have take home privileges for the medication and be put at increased risk for overdose. The commenter also noted possible limitations in the responsiveness of a mobile NTPs security system, reliant on Wi-Fi capability, when the mobile NTP
has weak or no access to Wi-Fi while in rural communities and is not near the registered NTP location.
DEA Response: DEA has concluded that it is unnecessary for this rule to require NTPs to create a contingency plan for dosing patients served by the mobile NTP if the mobile NTP breaks down or is placed out of service. NTPs may well decide that such plans are appropriate, and other laws, regulations, or governing bodies may require them.

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The requirements DEA is imposing in this rule, however, are appropriately focused on DEAs duty under the CSA
to protect against the diversion of controlled substances. Thus, DEA is requiring a contingency plan for safeguarding the mobile NTPs controlled substances if it breaks down.
In the proposed rule, DEA stated that if the mobile component was disabled for any reason mechanical failure, accident, fire, etc., the registrant would be required to have a protocol in place to ensure that the controlled substances on the conveyance are secure and accounted for. DEA went on to state that if the conveyance is taken to an automotive repair shop, all controlled substances would need to be removed and secured at the registered location.
However, other than those security requirements, DEA will not specify what should be included in the NTPs standard operating procedures, or what plans NTPs should implement regarding dosing patients while the mobile component is out of service. Such matters are beyond the scope of this rule, and properly within the judgment of the NTP and any relevant regulatory bodies outside of DEA.
Comment: Another commenter noted that the proposed amendment to DEA
regulations at 21 CFR 1301.74l would provide DEA discretion to require additional security measures for mobile NTPs based on certain factors. The commenter acknowledged that DEA
currently has this discretion for NTPs but could not locate any DEA guidance on how DEA utilizes the listed factors to determine if an NTP applying for registration warrants additional security measures. The commenter stated that this proposed provision similarly did not provide any information regarding how DEA would use these factors to evaluate security measures for mobile components, nor did DEA provide a single example of the security measures it might require for such a component if the factors were relevant.
As a result, the commenter believed this provision to not be clear or transparent and could lead to DEA field offices unevenly or arbitrarily applying the regulations. The commenter further stated that a registered NTP considering starting a mobile NTP would likely have to reach out to the local DEA field office early in the planning phase which could result in delays getting the mobile component up and running. Therefore, the commenter recommended that DEA
not finalize this proposed provision, or at the very minimum, that DEA provide clarity in the final rule preamble regarding the factors and additional security measures.

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