1. (a) Detoxification Dosage Levels.

   1. (1) The medical director or program physician shall individually determine each patient's medication schedule based on the following criteria:

      1. (A) Medications shall be administered daily under observation;
      2. (B) Dosage levels shall not exceed that which is necessary to suppress withdrawal symptoms; and
      3. (C) Schedules shall include initial, stabilizing, and reducing dosage amounts for a period of not more than 21 days.
   2. (2) The medical director or program physician shall record, date, and sign in the patient's record each change in the dosage schedule with reasons for such deviations.

2. (b) Detoxification Dosage Levels Specific to Methadone.

   1. (1) The first-day dose of methadone shall not exceed 30 milligrams unless:

      1. (A) The dose is divided and the initial portion of the dose is not above 30 milligrams; and
      2. (B) The subsequent portion is administered to the patient separately after the observation period prescribed by the medical director or program physician.
   2. (2) The total dose of methadone for the first day shall not exceed 40 milligrams unless the medical director or program physician determines that 40 milligrams is not sufficient to suppress the patient's opioid abstinence symptoms, and documents in the patient's record the basis for his/her determination.

3. (c) Maintenance Dosage Levels.

   1. (1) Each program furnishing maintenance treatment shall set forth in its protocol the medical director or program physician's procedures for medically determining a stable dosage level that:

      1. (A) Minimizes sedation.
      2. (B) Decreases withdrawal symptoms.
      3. (C) Reduces the potential for diversion of take-home medication.
   2. (2) Deviations from these planned procedures shall be noted by the medical director or program physician with reason for such deviations, in the patient's record.
   3. (3) The medical director or program physician shall review the most recent approved product labeling for up-to-date information on important treatment parameters for each medication. Deviation from doses, frequencies, and conditions of usage described in the approved labeling shall be justified in the patient's record.
   4. (4) The medical director or program physician shall review each patient's dosage level at least every three months.

4. (d) Maintenance Dosage Levels Specific to Methadone.

   1. (1) The medical director or program physician shall ensure that the first-day dose of methadone shall not exceed 30 milligrams unless:

      1. (A) The dose is divided and the initial portion of the dose is not above 30 milligrams; and
      2. (B) The subsequent portion is administered to the patient separately after the observation period prescribed by the medical director or program physician.
   2. (2) The total dose of methadone for the first day shall not exceed 40 milligrams unless the medical director or program physician determines that 40 milligrams is not sufficient to suppress the patient's opioid abstinence symptoms, and documents in the patient's record the basis for his/her determination.
   3. (3) A daily dose above 100 milligrams shall be justified by the medical director or program physician in the patient's record.

5. (e) Maintenance Dosage Levels Specific to LAAM.

   1. (1) The medical director or program physician shall ensure that the initial dose of LAAM to a new patient whose tolerance for the drug is unknown does not exceed 40 milligrams, unless:

      1. (A) The dose is divided, with the initial portion of the dose not above 40 milligrams and the subsequent portion administered to the patient separately after the observation period prescribed by the medical director or program physician; or
      2. (B) The patient's tolerance for the medication is known by the medical director or program physician and he/she documents in the patient's record the basis for this determination.
   2. (2) The medical director or program physician shall ensure that the initial dose of LAAM to a patient stabilized on replacement narcotic therapy and administered methadone on the previous day is less than or equal to 1.3 times the patient's daily methadone dose, not to exceed 120 milligrams.
   3. (3) After a patient's tolerance to LAAM is established, LAAM shall be administered to more frequently than every other day.
   4. (4) A dose above 140 milligrams shall be justified by the medical director or program physician in the patient's record.

6. (f) Maintenance Dosage Levels Specific to buprenorphine and buprenorphine products.

   1. (1) Each program shall develop and maintain current procedures that require administering and dispensing buprenorphine and buprenorphine product treatment medication in accordance with the medication's approved product labeling. These procedures shall include the requirement that any deviation from approved product labeling, including deviations regarding dose, frequency, or the conditions of use described on the approved product label, shall be documented and justified in the patient's record.
   2. (2) Dosing decisions shall be made by the medical director or a program physician, who shall be knowledgeable about the most current and approved product labeling.

7. (g) Dosage Schedule Following Patient Absence.

   When a patient has missed three (3) or more consecutive doses of replacement narcotic therapy, the medical director or program physician shall provide a new medication order before continuation of treatment. The new medication order shall be provided by the medical director or program physician, either in person, by verbal order, or through other electronic means, and shall be documented and justified in the patient's record.

8. (h) Changes in the Dosage Schedule.

   Only the medical director or program physician is authorized to change the patient's medication dosage schedule, either in person, by verbal order, or through other electronic means.

Note: Authority cited: Sections 11750, 11755, 11835, 11839.3 and 11839.20, Health and Safety Code. Reference: Sections 11839.2, 11839.3 and 11839.20, Health and Safety Code.

History

1. Change without regulatory effect renumbering and amending parts of former sections 10214 and 10224 to 10355 filed 6-3-91 pursuant to section 100, title 1, California Code of Regulations (Register 91, No. 34).

2. Amendment of section heading, section and Note filed 3-15-96 as an emergency; operative 3-15-96 (Register 96, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-13-96 or emergency language will be repealed by operation of law on the following day.

3. Amendment of section heading, section and Note refiled 7-8-96 as an emergency; operative 7-12-96 (Register 96, No. 28). A Certificate of Compliance must be transmitted to OAL by 11-12-96 or emergency language will be repealed by operation of law on the following day.

4. Amendment of section heading, section and Note refiled 10-23-96 as an emergency; operative 10-29-96 (Register 96, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-26-97 or emergency language will be repealed by operation of law on the following day.

5. Amendment of section heading, section and Note refiled 2-11-97 as an emergency; operative 2-24-97 (Register 97, No. 7). A Certificate of Compliance must be transmitted to OAL by 6-24-97 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 2-11-97 order transmitted to OAL 3-4-97; disapproved by OAL and order of repeal as to 2-11-97 order filed 4-15-97 (Register 97, No. 16).

7. Amendment of section heading, section and Note filed 4-15-97 as an emergency; operative 4-15-97 (Register 97, No. 16). A Certificate of Compliance must be transmitted to OAL by 8-13-97 or emergency language will be repealed by operation of law on the following day.

8. Certificate of Compliance as to 4-15-97 order, including amendment, transmitted to OAL 6-2-97 and filed 6-13-97 (Register 97, No. 24).

9. Amendment of subsection (c)(4) filed 6-29-98; operative 6-29-98 pursuant to Government Code section 11343.4(d) (Register 98, No. 27).

10. Change without regulatory effect repealing subsections (d)(4) and (e)(5) and amending Note filed 1-2-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 1).

11. Change without regulatory effect amending subsection (c)(1) and Note filed 4-19-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 16).

12. Amendment of subsections (b)(2) and (d)(2), new subsections (f)-(f)(2), subsection relettering, amendment of newly designated subsection (g) and amendment of Note filed 5-7-2020; operative 7-1-2020 (Register 2020, No. 19).