methadone laboratory regulatory program

Background

The Methadone Laboratory Regulatory Program supports the Department of Health Care Services, Licensing and Certification Division, Counselor and Medication Assisted Treatment Section (CMATS), which licenses California narcotic treatment programs. The program serves 147 narcotic treatment clinics and approximately 42,000 narcotic maintenance patients in California.

Program Activities

Proficiency testing of the laboratories. The Abused Substance Analysis Section (ASAS) conducts monthly proficiency tests of licensed and applicant laboratories in order to evaluate the accuracy of the drug analyses performed by the laboratories.
On-site inspections of the licensed laboratories. Each licensed laboratory’s facility must be inspected regularly to ensure that all regulatory requirements are being met and that the laboratory is properly documenting its procedures and using properly trained staff.
Review and approval of laboratory methods and procedures. ASAS reviews methods and procedures submitted by licensed and applicant laboratories to determine that they meet the required standards of procedure and standards of performance set forth in the regulations.

Regulations

CALIFORNIA CODE OF REGULATIONS

TITLE 17., DIVISION 1., CHAPTER 2., SUBCHAPTER 1., GROUP 5.5. METHADONE DRUG ANALYSIS LABORATORIES, ARTICLES 1–8, SECTIONS 1160–1196

Laws

CALIFORNIA HEALTH AND SAFETY CODE, HEALTH AND SAFETY CODE SECTION 11839.21

CALIFORNIA HEALTH AND SAFETY CODE, HEALTH AND SAFETY CODE SECTION 11839.23 - 11839.34

List of Approved and Licensed Methadone Drug Analysis Laboratories

List of Certified methadone Laboratories (PDF)

Forms

Form A (PDF)

Form B (PDF)

Form C (PDF)

Form D (PDF)

Form E (PDF)

Reviewer’s Checklist (PDF)

Memorandum, “Urinalysis Services for Methadone” (PDF)