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Registration Requirements for Narcotic Treatment Programs With Mobile Components rule (2021)

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The Registration Requirements for Narcotic Treatment Programs With Mobile Components rule is a significant rule issued by the Drug Enforcement Administration, U.S. Department of Justice (DOJ) effective July 28, 2021, that waived separate registration requirements at each place of practice or business that dispenses narcotics in schedules II-V if they meet the criteria of the rule, per the Controlled Substances Act (CSA).[1]

HIGHLIGHTS
  • Name: Registration Requirements for Narcotic Treatment Programs With Mobile Components
  • Code of Federal Regulations: 21 CFR 1300, 1301, and 1304
  • Agency: Drug Enforcement Administration, U.S. Department of Justice (DOJ)
  • Action: Final rule
  • Type of significant rule: Other significant rule

    • Timeline

    The following timeline details key rulemaking activity:

    Background

    The Controlled Substance Act (CSA) granted the Attorney General the authority to waive registration requirements for certain entities where controlled substances are manufactured, distributed, or dispensed if he finds it consistent with maintaining or improving public health. The Attorney General delegated his authority to the Administrator of the Drug Enforcement Administration, and for the purposes of maintenance or detoxification treatments, they issued this rule that aimed to facilitate easier remote dispensation of narcotics.[1]

    Summary of the rule

    The following is a summary of the rule from the rule's entry in the Federal Register:

    “ The Drug Enforcement Administration (DEA) is publishing this final rule to revise existing regulations for narcotic treatment programs (NTPs) to allow the operation of a mobile component associated with a DEA-registered NTP to be considered a coincident activity permitted under the NTP's registration. Based on these revisions, NTP registrants that operate or wish to operate mobile components (in the State in which the registrant is registered) to dispense narcotic drugs in schedules II–V at remote location(s) for the purpose of maintenance or detoxification treatment do not need a separate registration for such mobile component. This final rule waives the requirement of a separate registration at each principal place of business or professional practice where controlled substances are dispensed for those NTPs with mobile components that fully comply with the requirements of this rule. These revisions to the regulations are intended to make maintenance or detoxification treatments more widely available, while ensuring that safeguards are in place to reduce the likelihood of diversion.[1][2] ”

    Summary of provisions

    The following is a summary of the provisions from the rule's entry in the Federal Register:[1]

    DEA added a definition for a "mobile NTP," which is an NTP operating from a motor vehicle providing maintenance and detoxification treatment with narcotic drugs within the same State as the registered NTP. The regulations aimed to ensure security against theft and diversion of controlled substances in mobile components. Notably, the DEA allowed NTPs to operate a mobile component under their existing registration with prior approval, eliminating the need for a separate registration. Security measures, including a securely locked safe with specific requirements, are outlined for the storage of controlled substances in mobile components. The text also addressed the return of the mobile component to the registered location, exceptions to this requirement, and the need for an application process. Additional provisions covered personnel requirements, drug stocking, and recordkeeping for mobile components. The DEA extended recordkeeping requirements to include mobile components, allowing the use of automated systems with specific conditions. The retention period for records was set at two years, but NTPs were advised to check state requirements for potential longer periods.

    Significant impact

    See also: Significant regulatory action

    Executive Order 12866, issued by President Bill Clinton (D) in 1993, directed the Office of Management and Budget (OMB) to determine which agency rules qualify as significant rules and thus are subject to OMB review.

    Significant rules have had or might have a large impact on the economy, environment, public health, or state or local governments. These actions may also conflict with other rules or presidential priorities. Executive Order 12866 further defined an economically significant rule as a significant rule with an associated economic impact of $100 million or more. Executive Order 14094, issued by President Joe Biden (D) on April 6, 2023, made changes to Executive Order 12866, including referring to economically significant rules as section 3(f)(1) significant rules and raising the monetary threshold for economic significance to $200 million or more.[1]


    The text of the Registration Requirements for Narcotic Treatment Programs With Mobile Components rule states that OMB deemed this rule significant, but not economically significant:

    “ While the findings of the regulatory impact analysis of this final rule support the conclusion that this rulemaking is not economically significant, the Office of Information and Regulatory Affairs (OIRA) has nonetheless determined that the final rule is a significant regulatory action under E.O. 12866, section 3(f).[2] ”

    Text of the rule

    The full text of the rule is available below:[1]

    See also

    External links

    Footnotes

    1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 Federal Register, "Registration Requirements for Narcotic Treatment Programs With Mobile Components," December 20, 2023.
    2. ↑ 2.0 2.1 Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
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