REVISED May 2019 - Solicitation of Interest for Laboratories to Perform Testing of Medical Marijuana Products in New York State

Guidance Procedure

• Microbiology - Medical Marijuana guidance procedure for a Demonstration of Capability (DOC)
• Guidance Document for the Use of PathogenDx Microarray for Analysis of NYS Medical Marijuana Products
• Guidance Document for the Homogenization of Whole Flower

Methods

• Item No. 180.7 - List of approved methods and analytes
• NYS DOH LINC-250, revision 3.0 - Metals and Metalloids in Medical Marijuana Products by ICP-MS
• NYS DOH MML-300, revision 7.1  - Measurement of Phytocannabinoids in Medical Marijuana using HPLC-PDA
• NYS DOH MML-301, revision 8   - Medical Marijuana Sample Preparation Protocols for Potency Analysis
• NYS DOH MML-303, revision 6.1   - Measurement of Mycotoxins in Medical Marijuana by LC-MS/MS
• NYS DOH MML-306, revision 5.1  - Determination of the Plant Growth Regulator Indole-3-butyric Acid and Pesticides in Medical Marijuana using LC-MS/MS
• NYS DOH MML-307, revision 4.1 - Determination of the Pesticide Myclobutanil and the Synergist Piperonyl Butoxide in Medical Marijuana using LC-MS/MS with positive ion detection
  • Certification for the myclobutanil pesticide is optional. A commercial lab is not required to test for this analyte.
•  NYS DOH MML-308, revision 3.1  - Determination of Natural Pyrethrins in Medical Marijuana Products Using Gas Chromatography-Tandem Mass Spectrometry
• Appendix A - Medical Marijuana Microbial Testing Plan flowcharts (NYS DOH LEB-600 series)
• Excel Form - Microbiology Batch Sample Calculations (NYS DOH LEB-XLS-603A, Revision 2)
  • Preparation of samples: NYS DOH LEB-603, revision 5.1
  • Microbial Presumptive Presence/Absence Test: NYS DOH LEB-604, revision 4.1
  • Aerobic Bacteria and Mold Plate Counts: NYS DOH LEB-605, revision 5.1
  • Identification of BTGN Bacteria: NYS DOH LEB-606, revision 3.0 
  • Identification of Clostridium botulinum: NYS DOH LEB-607, revision 3.0 
  • Identification of E. coli: NYS DOH LEB-608, revision 3.0 
  • Mold Identification using qPCR: NYS DOH LEB-609, revision 3
  • Identification of Psuedomonas:  NYS DOH LEB-610, revision 3.0 
  • Identification of Salmonella: NYS DOH LEB-611, revision 3.0 
  • Identification of Enterococcus: NYS DOH LEB-612, revision 4.0 
  • Identification of Thermophilic Actinomycetes: NYS DOH LEB-613, revision 3.0
  • Set-Up and Analysis of RT-PCR Assays for Mold Identification: NYS DOH LEB-618, revision 3 

Forms

• Application for Approval - form 107 MM
• Application for Primary Accreditation - form 110

Accreditation is ELAP (New York State) primary only. A DEA license is no longer required as in the past.