The State of Florida requires medical marijuana products to be tested before they are sold. Section 381.986 subsection (8)(e)(11)(d) of the Florida Statutes mandates that all Medical Marijuana Treatment Centers (MMTCs) conduct tests on all processed marijuana in a licensed testing laboratory. The results of the tests on processed medical marijuana must be verified and signed by two employees from the medical marijuana treatment center. The criteria that tested marijuana must meet before it can be dispensed are:
Some tests are required by the Office of the Medical Marijuana Use (OMMU) of the Florida Department of Health to be conducted on the processed medical marijuana. These tests are:
Proficiency test: This test is conducted on samples of processed marijuana to determine the accuracy of specific analytes and matrices in the samples.
Potency test: This test analyzes the concentration of cannabinoids and the total amount of Delta-9-Tetrahydrocannabinol (d9-THC) and Cannabidiol (CBD) in a processed medical marijuana product.
Quality control tests: These are different tests developed under the provisions of the ISO 17025 standards to ensure that processed marijuana meets the required level of quality expected by the OMMU. Quality control laboratory tests include:
Yes, Florida licenses independent medical marijuana testing facilities for the testing of processed marijuana in the state. The government does not conduct medical marijuana testing directly through any of its agencies. The Office of Medical Marijuana Use of Florida Department of Health has licensed seven medical marijuana testing laboratories in the state. The licensure of these testing laboratories is done in accordance with Section 391.988 of the Florida Statutes. The list of the licensed medical marijuana testing laboratories in Florida is as follows:
40 S Dewey Street
Eustis, Florida 32726
Telephone: (352) 308-8020
721 Cortaro Drive
Sun City Center, Florida 33575
Telephone: (813) 634-4529
4001 South West 47th Avenue, Suite 208
Davie, Florida 33314
Telephone: (833) 837-8223
Kaycha Labs Davie
4131 South East 47th Avenue, Suite 1408
Davie, Florida 33314
Telephone: (833) 465-8378
Kaycha Labs Gainesville
2444 North East 1st Boulevard, Suite 700
Gainesville, Florida 32609
Method Testing Labs
4620 Eagle Falls Place
Tampa, Florida 33619
Telephone: (813) 769-9567
Modern Canna Labs
4705 Old Road 37
Lakeland, Florida 33813
Telephone: (863) 608-7800
Florida requires all medical marijuana testing facilities to have an ISO/IEC 17025 accreditation. Rule 64-4.016 for Marijuana Testing Laboratories requires all tests on processed marijuana in Florida to be done in accordance with the standards of the ISO/IEC 17025:2017 or ISO/IEC 17025:2005. Medical marijuana testing facilities in Florida also need to provide documents of satisfactory results from two of the most recent proficiency tests conducted by an ISO/IEC 17043:2010 accredited body. The ISO/IEC 17025 is an accreditation for calibration and testing laboratories and forensic laboratories. The ISO/IEC 17043 certification is for proficiency test providers. These certifications and other national standard accreditations are issued by the American National Standards Institute (ANSI) National Accreditation Board as evidence of compliance with required operational standards. The possession of these certificates by a testing facility is also an affirmation that the testing facility has a quality management system and that the test results they produce are reliable.
To obtain an ISO/IEC 17025 (non-forensic) testing laboratory accreditation, the ANSI National Accreditation Board requires a medical marijuana testing laboratory to:
Participate in the required proficiency testing (PT)/Inter-laboratory comparisons (ILC) that captures the parameters, required procedures, and methods stipulated in the scope of the accreditation. The accreditation board defines proficiency testing as an evaluation of participants’ performances in relation to established criteria using inter-laboratory comparisons.
Have a documented plan on how the medical marijuana testing laboratory will ensure that they conduct representative sampling on all activities identified in the scope of the accreditation. The documented plan must cover a minimum of three years. The proficiency testing plan must also contain an evaluation of the risks that could be involved with the tests identified within the scope of the accreditation and the risk management plans.
Show a commitment to investigate any laboratory test result that does not fall within predefined performance criteria, such as unsatisfactory results. There are specific actions that a medical marijuana testing laboratory may take in the case of unsatisfactory results. These actions include:
Organize their operations such that performance testing activities for the facility are not done by the same staff, especially if the laboratory has other qualified personnel to perform the same task.
Applicants for a medical marijuana testing laboratory license are required to complete and submit the Application for Marijuana Testing Certificate Form. The application form is designed by the Office of Medical Marijuana Use of the Florida Department of Health.
A medical marijuana testing laboratory license application is expected to be sectionalized into tabs labeled in alphabetical order. Each tab should contain specific information about the application. All the tabs should be labeled and bound into a three-ring notebook when submitting the application. The tabs and the specific information they should contain include:
Tab A: This should contain the applicant’s general information and application fee. The applicant will be required to complete the application form attached to the application instruction online and enclose a cashier’s check or money order prepared in favor of “Florida Department of Health” in the application package.
Tab B: This section is informational. It guides the applicant on how to protect any sensitive information submitted in the application, such as trade secrets and any information the applicant may wish to exempt from public inspection. The section advises the applicant to prominently and consciously mark all the applicable information as “Confidential-Exempt from Public Disclosure.” However, the applicant will be required to submit a brief or written description of the basis on which they claim exemption from public information. They will also be required to mention the specific statutory citation that justifies the exemption. Except for properly demanded exemptions, all information submitted with an application is subject to public inspection and copying as authorized in Florida’s Public Records Law, Chapter 119, Florida Statutes.
Tab C: This section requires the applicant to present documentation to show that they possess ISO/IEC 17025:2017 accreditation. The applicable documents required to be submitted in the section are:
Tab D: This section of the application requires the applicant to provide documents affirming their capability to conduct tests for each applicable testing field. The testing fields applicable for respective matrix groups are stated below. Documents required to be presented are evidence of satisfactory results obtained from two of the most recent proficiency tests administered by an ISO/IEC 17043:2010 accredited body. Below are the respective matrix groups and the applicable testing fields under them in which an applicant must provide evidence of their capacity to test.
Tab E: This section of the application requires the applicant to present documents stating their organizational operations. They are to present:
An organizational chart, showing the supervisory structure of each of the independently operating testing laboratories that the applicant is applying for their licenses. The applicant must include the identities of all the directors, analysts, samplers, and employees in the testing facility in the organizational chart.
Document stating the duties and responsibilities of each position listed in the organizational chart.
Documents showing that the laboratory director in the testing facility meets the following requirements:
Document showing that each analyst employed by the medical marijuana testing laboratory meets the following requirements:
Document showing that each sampler employed by the medical marijuana testing laboratory meets the following requirements:
Document showing that every other employee engaged by the medical marijuana testing laboratory meets the following requirements:
Tab F: This section of the application requires the applicant to provide infrastructural plans and security of the facility, which includes:
Tab G: This section of the application requires the applicant to provide information on their operations and accountability. They are to provide documents explaining their operating procedure, which must comply with Rule 64-4.301(6)(f) of the Florida Administrative Code.
Tab H: This section of the application requires the applicant to supply documents to assure the Florida Department of Health that the testing facility is not owned by a medical marijuana treatment center. Documents required to be supplied include:
Tab I: This section of the application is for the business agreements of the medical marijuana testing laboratory. The applicant is required to submit a copy of each of all current business agreements between the testing facility and any medical marijuana testing facility. The business agreements must comply with the requirements of Rule 64-4.301(7) of the Florida Administrative Code.
After completing and providing necessary documentation, a complete copy of the application prepared in PDF format should be saved on a USB flash drive and submitted. The content of the PDF copy should be identical to the content of the original version of the application that will also be submitted. However, if there are any discrepancies between the original copy and the PDF version, the FDH will decide based on the content of the original hard copy.
The application package should be submitted to:
Florida Department of Health
ATTN: Office of Medical Marijuana Use
4052 Bald Cypress Way, Bin M-01
The Office of Medical Marijuana Use of the Florida Department of Health charges a $62,945.25 application fee for a medical marijuana testing laboratory license. This fee is payable to the “Florida Department of Health” in a check or money order and must be submitted with the application package. The license application will only be processed when payment is confirmed.
The Office of Medical Marijuana Use of the Florida Department of Health sets the regulations for cannabis testing facilities in the state. There are no other regulations set by any county or local authorities to guide the operations of medical marijuana testing facilities.