9 CSR 30-3.132 Opioid Treatment Programs

(2) Medication Administration, Dispensing, and Use. OTPs shall only utilize medications approved by the FDA for the treatment of opioid use disorder.

(A) Opioid agonist, partial agonist, and antagonist treatment medications shall be administered and dispensed by a practitioner licensed in Missouri and registered under the appropriate state and federal laws to administer or dispense opioid drugs.

(B) Written policies and procedures shall be maintained to ensure the following dosage form and initial dosing requirements are met:

1. Methadone is prescribed by a qualified prescriber, administered and dispensed only in oral form, and formulated in a manner to reduce its potential for parenteral abuse;

2. For newly admitted individuals, the initial dose of methadone does not exceed thirty (30) milligrams and the total dose for the first day does not exceed forty (40) milligrams, unless the program physician documents in the individual record that forty (40) milligrams did not suppress opioid abstinence symptoms; and

3. Each opioid agonist medication is administered and dispensed in accordance with its approved product labeling. Dosing and administration decisions shall be made by a qualified prescriber familiar with the most up-to-date product labeling. These procedures must ensure 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 individual record.