§ 8.1 - Scope.

§ 8.1 Scope.

(a) Subparts A through C Scope. This subpart and subparts B through D of this part establish the procedures by which the Secretary of Health and Human Services (the Secretary) will determine whether a practitioner an applicant seeking to become an Opioid Treatment Program (OTP) is qualified under section 303(gh) of the Controlled Substances Act (CSA) (21 U.S.C. 823(gh)) to dispense opioid drugs Medications for Opioid Use Disorder (MOUD) in the treatment of opioid use disorders. The regulations also establish Opioid Use Disorder (OUD), and establishes the Secretary's standards regarding the appropriate quantities of opioid drugs MOUD that may be provided for unsupervised use by individuals undergoing such treatment (21 U.S.C. 823(gh)(1)). Under these regulations, a practitioner who intends to dispense opioid drugs in the treatment of opioid use disorder this subpart and subparts B through D, an applicant seeking to become an OTP must first obtain from the Secretary or, by delegation, from the Administrator, Substance Abuse and Mental Health Services Administration (SAMHSA)Assistant Secretary for Mental Health and Substance Use, a certification that the practitioner applicant is qualified under the Secretary's standards and will comply with such standards. Eligibility for certification will depend upon the practitioner applicant obtaining accreditation from an accreditation body Accreditation Body that has been approved by SAMHSA. These regulations the Secretary. This subpart and subparts B through D also establish the procedures whereby an entity can apply to become an approved accreditation body. This part also establishes Accreditation Body, and the requirements and general standards for accreditation bodies Accreditation Bodies to ensure that practitioners OTPs are consistently evaluated for compliance with the Secretary's standards for treatment of opioid use disorder with an opioid agonist treatment medicationOUD with MOUD.

(b) The regulations in subpart F Severability. Any provision of this part establish the procedures and requirements that practitioners who are authorized to treat up to 100 patients pursuant to a waiver obtained under section 303(g)(2) of the CSA (21 U.S.C. 823(g)(2)), must satisfy in order to treat up to 275 patients with medications covered under section 303(g)(2)(C) of the CSA.

[81 FR 44736, July 8, 2016]

held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, or stayed pending further agency action, shall be construed so as to give it the maximum effect permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event such provision shall be severable from this part and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances.