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DEA proposes to revise the existing regulations found in 21 CFR 1306.07(b), regarding the administration of narcotic drugs to prevent or mitigate opioid withdrawal, as instructed by Congress in Public Law 116-215 (effective December 11, 2020). The existing regulation is inadequate for emergency treatment purposes, as practitioners are prohibited from administering narcotic drugs, for the purpose of relieving acute withdrawal symptoms, to a patient for not more than one day at a time for not more than three consecutive days. In accordance with the statute, DEA proposes to allow non-pharmacy individual practitioners to dispense (including prescribe) up to a three-day supply of opioid medications in schedules III, IV, or V at one time to prevent or mitigate opioid withdrawal.

Statement of Need:

The Drug Enforcement Administration (DEA) is revising existing regulations to expand access to medications for the treatment of opioid use disorder pursuant to the Easy Medication Access and Treatment for Opioid Addiction Act (the Act).   The Act directed DEA to revise its regulation to allow practitioners to dispense not more than a three-day supply of narcotic drugs to one person or for one person’s use at one time for the purpose of relieving acute withdrawal symptoms associated with opioid use disorder.  DEA is amending the relevant regulation by allowing all DEA-registered non-pharmacy individual practitioners, subject to certain conditions, to dispense up to a three-day supply of narcotic medications in schedules III, IV, or V approved by the Food and Drug Administration specifically for use in maintenance or treatment of opioid use disorder, for the purpose of relieving acute withdrawal symptoms while arrangements are being made for referral for treatment, along with adding a new record keeping requirement.  Additionally, DEA is redesignating the relevant subsections within the affected regulation in order to achieve greater organization and clarity.

Summary of the Legal Basis:

DEA implements and enforces the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act (CSA), and the Controlled Substances Import and Export Act (CSIEA), as amended. [1]   DEA publishes the implementing regulations for these statutes in 21 CFR parts 1300 to end.  These regulations are designed to ensure a sufficient supply of controlled substances for medical, scientific, and other legitimate purposes, and to deter the diversion of controlled substances for illicit purposes.  

As mandated by the CSA, DEA establishes and maintains a closed system of control for the manufacturing, distribution, and dispensing of controlled substances, and requires any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances to register with DEA, unless they meet an exemption, pursuant to 21 U.S.C. 822.  The CSA authorizes the Administrator of DEA (by delegation of authority from the Attorney General) to register an applicant to manufacture, distribute or dispense controlled substances if the Administrator determines such registration is consistent with the public interest. The CSA further authorizes the Administrator to promulgate regulations necessary and appropriate to execute the functions of subchapter I (Control and Enforcement) and subchapter II (Import and Export) of the CSA.

Alternatives:

There are no feasible alternatives to this proposed rule.

Anticipated Costs and Benefits:

Under the IFR, the patient will be able to receive three days of medication with just one visit to the emergency department (ED).  The increased medication may lead to an improved patient outcome, resulting in benefits associated with lower societal cost of opioid abuse, discussed below.  Furthermore, additional physician’s time will not be needed to dispense medication, resulting in time and cost savings to the ED.  However, practitioners must check the individual’s PDMP, and maintain a record that the PDMP was reviewed, which will increase costs to the ED.

Additionally, the expansion to include all DEA-registered non-pharmacy individual practitioners allows an individual to be treated not only by a physician, but also by other non-pharmacy practitioners.  This greatly expands access to treatment and helps alleviate the burden on hospitals and urgent care centers that are short-staffed or that do not always have a physician on duty.  The intent of this regulation is to provide non-DATA waived practitioners, and those not registered as an NTP, with a means to treat individuals experiencing acute withdrawal symptoms on an emergency basis while future, continued treatment is coordinated.  

Risks:

DEA believes any risks associated with this IFR will be minimal and will be greatly outweighed by the benefits this IFR will provide.