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DEA Eases Regulations for Mobile Methadone

The Drug Enforcement Administration (DEA) on Feb. 26 proposed a regulation that revises the Controlled Substances Act (CSA) to permit narcotic treatment programs (NTPs)—opioid treatment programs, detoxification services that use methadone, and compounders— to operate mobile components, or mNTPs, without separate registrations.

The rule also proposes requirements related to security, recordkeeping, reporting, and inventory. The purpose of the rulemaking is to address the opioid epidemic by expanding access to methadone treatment, especially for residents of rural and underserved communities.

Background

Currently, each mobile component of an NTP must be separately registered, as the components dispense narcotic drugs regularly and therefore constitute a “principal place of business” or a “professional practice.” The CSA permits waivers to this requirement in instances that serve public health. The DEA had provided waivers on an ad hoc basis until a moratorium was implemented in 2007; after that, there was a subsequent decline in the number of operational mobile components.

The proposed rule obviates the need for ad hoc waivers by establishing mobile unit operations as a permissible “coincident activity” under the CSA with prior approval of a local DEA office.

Selected Summary of Requirements

• Registration
  • Registrants notify the local DEA office in writing about intent to operate an mNTP and receive explicit written approval prior to operation.
  • The mNTP functions within the same states that the NTP is registered.
    • Practitioners maintain a DEA license in each state where they dispense controlled substances.
  • Vehicles possess valid county/city and state information on file at the NTP.
  • mNTPs are a controlled premise subject to administrative inspection; registrants provide licensing and registration to DEA at time of the inspection and before transportation of substances.
  • mNTPs may not serve as hospitals, long-term care facilities, emergency medical service vehicles, or patient transportation.

• Security
  • Storage area must not be accessible from the outside of the mNTP vehicle.
  • Substances are secured in a locked safe:
    • with safeguards against forced entry, lock manipulation, and radiological attacks;
    • cemented to the floor or wall such that it cannot be readily removed;
    • equipped with an alarm system that can directly signal a protection company, local or State policy agency, or 24-hour registrant-operated control station, or other DEA Administrator approved protection.
  • Transportation personnel retain control over the controlled substances when transferring, traveling, and dispensing the substances.
  • mNTP is returned to registration location after operations are completed.
    • Substances are removed and secured within the registered NTP location.
    • Protocols allow for securing substances if the component is disabled.
    • Substances are removed and secured if the vehicle is taken to an automotive shop for repair.
  • For security breaches such as theft and loss, the NTP must abide by theft and loss reporting requirements.
  • NTPs follow state and federal regulations or whichever is more stringent and consults with State Opioid Treatment Authority to ensure compliance.

• Other security controls
  • Ensure proper security measures and patient dosage, e.g., enrolled individuals wait in an area of the mNTP that is physically separated from the narcotic storage and dispensing area by a physical entrance.
    • If no seating is available, patient will wait outside of the mNTP.
  • mNTPs will abide by existing HHS standards for quantity of substances provided for unsupervised use.
  • Degree of security is at DEA discretion, based on factors including the location, number of patients, staff, and security guard.
  • Disposal of controlled substances is done consistent with all applicable laws and regulations.
  • Distribution and delivery of controlled substances to mNTP is only done at the registered location. Persons delivering narcotic drugs to mNTP may not:
    • Receive or deliver controlled substances to another mNTP or other entity while deployed outside the registered location.
    • Act as reverse distributors (or collectors).

• Records and Reports
  • mNTP records are maintained in a paper dispensing log at the registered NTP, or
  • Use of automated/computerized system if the system:
    • maintains the same information as required for paper records;
    • has the capability to produce hard copies of the dispensing records;
    • the mNTP prints each day’s dispensing log which is initialed by individuals who dispense the medication;
    • produces accurate summary reports for any time frame requested by DEA in an investigation;
    • Hard copies of summaries are systematically organized at the NTP;
    • Computer generated information has off-site back-up;
    • DEA approves of the system.
  • mNTP maintain records for two years, or longer if required by the state.

Please contact Sarah Wattenberg, NABH’s director of quality and addiction services, at sarah@nabh.org, or 202.393.6700, ext. 114.