Tenn. Comp. R. & Regs. 0940-05-36-.04

Current through June 10, 2024

Section 0940-05-36-.04 - LICENSING CRITERIA

(1) Eligibility

(a) In order to be authorized to dispense buprenorphine containing products, the interested entity must be a current Full licensed Office-Based Opiate Treatment Facility in good standing with the Department that has been in licensed operation for at least one (1) calendar year.

(b) The Facility seeking dispensing authorization shall comply with Rule 0940-05-35-.04.

(2) Procedures

(a) The current Full licensed Office-Based Opiate Treatment Facility shall make a request for dispensing authorization in written form and shall pay a $50 fee - as established in Rule 0940-05-02-.23 - via invoice provided by the Office of Licensure.

(b) The Facility seeking dispensing authorization shall be subject to an on-site inspection to ensure compliance with Rule 0940-05-36-.05 Medication Storage.

(c) Each Facility seeking a license must submit to the Office of Licensure proof that every authorized provider at the facility has submitted to their respective professional licensing board notice of his or her intent to dispense buprenorphine products.

(d) Each Facility seeking a license must submit to the Office of Licensure proof that the Facility is participating in the Central Registry.

(3) Prior to renewal of the license, the OBOT Plus shall be required to develop written policies and procedures that are specific to the dispensing of buprenorphine products, and substantially comply with the provisions of this Rule, as well as with Administrative Chapters 0940-05-06 and 0940-05-35.

(4) With or without notice, the Department, or its representatives, shall have the right to enter upon or into the premises of an OBOT Plus in order to make inspections and/or investigations deemed necessary to determine compliance with applicable law. The OBOT Plus shall comply with all reasonable requests of the Department and allow it to obtain information from third parties if necessary.

(5) The Department shall be given the authority to enter upon the premises of an unlicensed facility dispensing buprenorphine products to better determine that unlicensed facility's need for TDMHSAS oversight. The Department shall attempt to conduct inspections and investigations in the least intrusive manner needed in order to obtain necessary information. The facility shall be required to provide reasonable amounts of information to the Department for this determination.

(a) "Reasonable amounts of information," in this context, may be considered aggregate, non-patient identifying information to include, but not be limited to:

1. Patient de-identified identifiers;

2. Lists of medications prescribed to that de-identified patient;

3. Lists of medications dispensed to that de-identified patient;

4. The total number of medications dispensed at the physical location in question; and

5. The total number of patients seen at the physical location in question.

(6) No provider shall dispense buprenorphine to a patient until an OBOT Plus license has been issued by the Office of Licensure.

Tenn. Comp. R. & Regs. 0940-05-36-.04

Original rule filed August 29, 2003; effective December 29, 2003. Repeal filed July 21, 2004; effective November 26, 2004. New rules filed March 29, 2019; effective 6/27/2019.

Authority: T.C.A. §§ 4-3-1601, 4-4-103, 4-5-202, 4-5-204, 33-1-302, 33-1-305, 33-1-309, 33-2-301, 33-2-302, 33-2-402, 33-2-403, 33-2-404, 33-2-407, and Chapter 978 of the Public Acts of 2018.