April 5, 2020

April 05, 2020

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April 03, 2020

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DEA Initiates Rule making to Waive Separate Registration for Mobile NTP

On February 26, 2020, the US Drug Enforcement Administration (DEA) issued a Notice of Proposed Rule Making (NPRM), which proposes waiving the requirement of a separate DEA registration at each principal place of business or professional practice where controlled substances are dispensed for narcotic treatment programs (NTP) that utilize a mobile component in the state in which the DEA registrant is registered. The DEA noted that its intent was to make maintenance and detoxification treatments more widely available, especially in rural and underserved communities.

Under the federal Controlled Substances Act (CSA), a DEA registration is required for each principle place of business or professional practice where controlled substances are manufactured, distributed or dispensed. 21 U.S.C. 822(e)(1). This requirement has posed a challenge to providers such as mobile narcotic treatment programs, whose services—including administering and dispensing controlled substances—logically take place in locations other than the principle place of business.

Under the proposed rule, an NTP would be allowed to dispense controlled substances is schedules II–V at a location remote from, but within the same state as, the NTP’s registered location for the purpose of maintenance or detoxification treatment regardless of whether dispensing occurred on such a regular basis that the location would constitute a principal place or business or professional practice.

Although the proposed rule would make operating a mobile component of an NTP a coincident activity of an existing NTP registration, in order to operate the mobile component, the NTP must obtain prior explicit written approval from its local DEA office. The proposed rule also sets forth requirements for security and recordkeeping. Some of these proposed requirements include the following:

  • Persons receiving treatment at a mobile NTP must wait in an area physically separated from the narcotic storage and dispensing area either by a physical entrance (i.e., door or other entryway). If the NTP does not have a separate seating or reception area, patient will need to wait outside of the mobile NTP.
  • When not in use, controlled substances must be stored in a securely locked safe that is bolted or cemented to the floor or wall, equipped with an alarm and not accessible from outside of the mobile NTP.
  • At the end of each day, the mobile NTP must return to the DEA registrant’s location, and all controlled substances must removed from the mobile NTP and secured within the DEA registrant’s location.
  • Records generated during the operations of the mobile component of an NTP must be maintained at the location of the registered NTP and retained for two years.

In issuing the NPRM, the DEA noted allowing for the operation of mobile NTPs under the conditions specified in the proposed rule would increase access to opioid use treatment with minimal risk of diversion.

DEA is accepting public comments on the proposed rule until April 27, 2020.

© 2020 McDermott Will & Emery


About this Author

Karen Owen Gibbs, Health, Life sciences, Attorney, McDermott Will, Law Firm

Karen Owen Gibbs is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Chicago office.  She has extensive background in regulatory, compliance and policy issues in the health care and life sciences industries, including pharmacies (retail, mail and specialty), pharmaceutical and biologics manufacturers, pharmacy benefit management (PBM) companies, device manufacturers, durable medical equipment (DME) suppliers, hospitals, retail clinics and senior living facilities.   Karen also has substantial experience advising investors and lenders focused on those...

Marika Miller Health Care Attorney McDermott

Marika Miller provides regulatory compliance counsel to hospitals, health systems, and other healthcare organizations across the full spectrum of operational legal matters, ranging from Medicare and Medicaid reimbursement and medical staff bylaws to transaction agreement reviews and tax exemption issues. She is particularly focused on healthcare fraud and abuse law, analyzing physician group acquisitions and other complex arrangements for Stark Law and Anti-Kickback Statute implications.

Prior to joining McDermott, Marika served as a legal fellow for a Chicago-area hospital. While in law school, Marika served as a legal extern in the general counsel’s office and risk management office at two Chicago area hospitals and as a law clerk for an Illinois Medicaid managed care organization. She also served as President of Loyola’s Health Law Society, a published member and senior editor of Loyola’s Annals of Health Law and as a member of the Loyola University Chicago Law Journal. Marika received a CALI Award for Advanced Legal Writing – Business Practice, as well as the Loyola Leadership, Service and Public Interest Recognition Award.

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