Department of Justice, Drug Enforcement Administration: Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment

B-338776

October 8, 2026

The Honorable Bill Cassidy
Chairman
The Honorable
Ranking Member Bernie Sanders
Committee on Health, Education, Labor, and Pensions
United States Senate

The Honorable Brett Guthrie
Chairman
The Honorable Frank Pallone, Jr.
Ranking Member
Committee on Energy and Commerce House of Representatives

Subject: Department of Justice, Drug Enforcement Administration: Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment

Pursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on a major rule promulgated by the Department of Justice, Drug Enforcement Administration (DEA) entitled “Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment” (RIN: 1117-AB55). We received the rule on September 23, 2026. It was published in the Federal Register on June 9, 2026. 91 Fed. Reg. 34754. The effective date of the rule is July 9, 2026.

According to DEA, this rule adopts the provisions of an interim final rule promulgated in November 2020 that previously amended DEA regulations to make them consistent with the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 (SUPPORT Act), Pub. L. No. 115-271, 132 Stat. 3894 (Oct. 24, 2018), and implement its requirements. As the Restoring Hope for Mental Health and Well‑Being Act of 2022, Pub. L. No. 117-328, div. FF, title I, 136 Stat. 4459, 5634 (Dec. 29, 2022), removed many of the statutory provisions of the SUPPORT Act, this rule adopts provisions from the interim final rule that are still applicable as final, with minor changes. DEA also stated that this rule implements related provisions of the Restoring Hope for Mental Health and Well-Being Act of 2022.

The Congressional Review Act (CRA) requires a 60-day delay in the effective date of a major rule from the date of publication in the Federal Register or receipt of the rule by Congress, whichever is later. 5 U.S.C. § 801(a)(3)(A). The 60-day delay in effective date does not apply, however, if the agency finds for good cause that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, and the agency incorporates the finding and a brief statement of its reasons in the rule. 5 U.S.C. § 808(2). Here, DEA determined that this rule is not subject to the 60-day delayed effective date requirement because it found that prior notice and comment was unnecessary for this rule. 91 Fed. Reg. at 34767. DEA noted that portions of this rule were introduced in the previous interim final rule, for which DEA received comments and responded to them in this rule. However, after the passage of the Restoring Hope for Mental Health and Well-Being Act of 2022, the legal provisions underlying much of the already implemented provisions of the rule were eliminated. DEA concluded that it was unnecessary to accept comments on provisions that implement the Restoring Hope for Mental Health and Well-Being Act of 2022 or other federal laws that cross‑reference existing regulatory provisions for clarity without changing or expanding their applicability, or that standardize language without making any new interpretation. 91 Fed. Reg. at 34762.

Enclosed is our assessment of DEA’s compliance with the procedural steps required by section 801(a)(1)(B)(i) through (iv) of title 5 with respect to the rule. If you have any questions about this report or wish to contact GAO officials responsible for the evaluation work relating to the subject matter of the rule, please contact me (202) 512-8156.

Shirley A. Jones
Managing Associate General Counsel

Enclosure

cc: Katie A. Laughery
Deputy Assistant Administrator, Diversion Control Division
Drug Enforcement Administration

ENCLOSURE

REPORT UNDER 5 U.S.C. § 801(a)(2)(A) ON A MAJOR RULE
ISSUED BY THE
DEPARTMENT OF JUSTICE,
DRUG ENFORCEMENT ADMINISTRATION
ENTITLED
“IMPLEMENTATION OF THE SUBSTANCE USE-DISORDER PREVENTION
THAT PROMOTES OPIOID RECOVERY AND TREATMENT FOR PATIENTS
AND COMMUNITIES ACT OF 2018: DISPENSING AND ADMINISTERING
CONTROLLED SUBSTANCES FOR MEDICATION-ASSISTED TREATMENT”
(RIN: 1117-AB55)

(i) Cost-benefit analysis

The Department of Justice, Drug Enforcement Administration (DEA) stated its belief that this rule will be of net economic benefit. Based on an estimated maximum number of impacted practitioners, DEA estimated a maximum annualized cost of $368,278,282 and $387,997,558 at 3 percent and 7 percent discount rates, respectively. 91 Fed. Reg. 34754, 34762 (June 9, 2026). DEA believes this rule has a low breakeven point due to potentially high societal cost savings from the expected increase in the number of patients treated for opioid use disorder. Id.

(ii) Agency actions relevant to the Regulatory Flexibility Act (RFA), 5 U.S.C. §§ 603–605, 607, and 609

DEA stated that RFA applies to rules that are subject to notice and comment under section 553(b) of the Administrative Procedure Act. 91 Fed. Reg. at 34766. DEA determined there is good cause to exempt this final rule from notice and comment. Thus, DEA stated that it is not required to conduct a Final Regulatory Flexibility Analysis for this rule. Id.

(iii) Agency actions relevant to sections 202–205 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. §§ 1532–1535

DEA determined that this rule will not result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year, and will not significantly or uniquely affect small governments. 91 Fed. Reg. at 34767.

(iv) Other relevant information or requirements under acts and executive orders

Administrative Procedure Act, 5 U.S.C. §§ 551 et seq.

On November 2, 2020, DEA published an interim final rule with request for comments. 85 Fed. Reg. 69153. DEA stated that they received comments from various interested parties on the interim final rule, and responded to comments in this rule. See 91 Fed. Reg. at 34756–34760.

DEA noted that portions of this final rule were originally introduced as the interim final rule. 91 Fed. Reg. 34761. However, after the passage of the Restoring Hope for Mental Health and Well-Being Act of 2022, the legal provisions underlying much of the already implemented provisions of the rule were eliminated. DEA concluded that it was unnecessary to accept comments on provisions that implement the Restoring Hope for Mental Health and Well-Being Act of 2022 or other federal laws that cross-reference existing regulatory provisions for clarity without changing or expanding their applicability, or that standardize language without making any new interpretation. Id. at 34762.

Paperwork Reduction Act (PRA), 44 U.S.C. §§ 3501–3520

DEA determined this rule involves an existing information collection but does not impose a new collection or modify an existing collection of information. 91 Fed. Reg. at 34767. DEA stated that a modification mentioned in the rule has already been submitted to the Office of Management and Budget (OMB) and approved. Id.

Statutory authorization for the rule

DEA promulgated this rule pursuant to sections 823 and 829a of title 21, United States Code.

Executive Order No. 12866 (Regulatory Planning and Review)

DEA determined that this rule is a significant regulatory action under section 3(f) of the Order and submitted it to OMB for review. 91 Fed. Reg. at 34762.

Executive Order No. 13132 (Federalism)

DEA determined this rule does not have federalism implications. 91 Fed. Reg. at 34766.