Okla. Admin. Code § 450:70-4-7.3

Current through Vol. 41, No. 19, June 17, 2024

Section 450:70-4-7.3 - Operations - Dosing considerations

(a) The OTP shall have written policy and procedure stating that methadone shall be dispensed orally and in liquid form only. Non-oral forms and tablet form methadone are prohibited from use. Tablet and sublingual forms of buprenorphine are allowed.

(b) Each OTP shall develop written policies and procedures giving preference to the use of liquid and diskette forms of methadone. Diskettes shall be dissolved in liquid prior to being dispensed, or dissolved in liquid by the patient in full and clear view of OTP staff.

(c) OTPs shall have written policies and procedures adequate to ensure that each opioid agonist and partial agonist treatment medication used by the program is administered and dispensed in accordance with its approved product labeling.

(d) Written policy and procedure shall reflect that dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling. These procedures must ensure that any significant deviations from the approved labeling, including deviations with regard to dose, frequency, or the conditions of use described in the approved labeling, are specifically documented in the clinical record.

(e) The OTP shall have written policy and procedure stating the OTP shall use only those opioid agonist treatment medications that are approved by the Food and Drug Administration for use in the treatment of significant opioid use disorders and opioid dependence.

(f) The OTP shall be fully compliant with the protocol of any investigational use of a drug and other conditions set forth in the application may administer a drug that has been authorized under an investigational new drug application through all applicable Federal law for investigational use in the treatment of significant opioid use disorders and opioid dependence.

(g) Compliance with 450:70-4-7.3 may be determined by:

(1) A review of policies and procedures,

(2) Treatment records,

(3) Interviews with staff, and

(4) Other facility documentation.

Okla. Admin. Code § 450:70-4-7.3

Added at 30 Ok Reg 1447, eff 7-1-13

Amended by Oklahoma Register, Volume 34, Issue 24, September 1, 2017, eff. 10/1/2017

Amended by Oklahoma Register, Volume 40, Issue 22, August 1, 2023, eff. 9/15/2023