DEA's Mobile Narcotic Treatment Program

April 28, 2020

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Introduction

Practitioners who want to administer methadone, a schedule II controlled substance, to treat opioid use disorder must first obtain a registration from DEA to operate as a Narcotic Treatment Program (NTP). The Controlled Substances Act (CSA) requires that each person registered with the DEA to dispense controlled substances must obtain a separate registration “at each principal place of business or professional practice.”[1] This requirement generally extends to NTPs. However, the statute also gives DEA the authority to waive this requirement if “consistent with the public health and safety.”[2]

There are approximately 1,700 NTPs at brick-and-mortar locations registered with DEA.[3] DEA previously authorized mobile components on an ad hoc basis, but in 2007 placed a moratorium on approving new mobile components. Under this proposed rule, DEA would repeal its moratorium and waive the requirement that a mobile NTP must have a separate registration, provided the mobile component follows certain conditions laid out in the proposal. Under the proposed rule framework, only NTPs that are already registered with DEA would have the ability to start a mobile component. DEA would not approve a standalone mobile NTP. DEA concludes that waiving the registration requirement for mobile components is “consistent with the public health and safety” because it will increase access to treatment for opioid use disorder while posing minimal diversion risk.[4]

This public interest comment assesses the proposed rule and offers four sets of recommendations: a) DEA should immediately begin approving mobile components in response to the coronavirus crisis, while the agency works towards finalizing the proposed rule, b) DEA should revise or remove conditions in the proposed rule that do not decrease the risk of diversion but do increase the burden of expanding mobile components, c) DEA should issue an updated economic analysis, and d) DEA should commit to conducting an evaluation of the mobile NTP program.

 

[1]   21 U.S.C. § 822(e)(1) (2018).

[2]   21 U.S.C. § 822(d).

[3]    Registration Requirements for Narcotic Treatment Programs with Mobile Components, 85 Fed. Reg. 11008, 11009 (proposed Feb. 26, 2020).

[4]    Registration Requirements for Narcotic Treatment Programs with Mobile Components, 85 Fed. Reg. at 11008.