- Microbiological tests
- Tests for mycotoxins
- Tests for residual solvents
- Tests for heavy metals
- Tests for pesticides
- Moisture and water activity
- Cannabinoid profile
Does Florida License Independent Marijuana Testing Facilities?
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. As of January 2024, there are 9 licensed medical marijuana testing laboratories in Florida.
What Accreditations Do Marijuana Testing Facilities Need in Florida?
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:
- Notifying the ANSI National Accreditation Board promptly about the unsatisfactory result obtained from the laboratory test. Individuals can notify the ANSI National Accreditation Board through email using the ANAB FM 2830 Client Notification form
- Submitting a document stating the time frame within which corrective actions regarding unsatisfactory results obtained in the course of laboratory testing will be taken
- Recording the summary of the investigation and the steps taken concerning each case of unsatisfactory results encountered
How to Get a Marijuana Testing Laboratory License in Florida
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:
- All the materials and documents that the applicant submitted for the most recent ISO/IEC 17025:2017 audit
- A document that states the identity of the person that awarded the ISO/IEC 17025:2017 accreditation to the medical marijuana testing laboratory. They should also present documents that show the recognition of the testing laboratory with the International Laboratory Accreditation Cooperation (ILAC)
- Documents of initial certification reports concerning the ISO/IEC 17025:017 or the most recent audit report from an auditing body having an ILAC accreditation
- Usable whole flower marijuana
- Microbiology
- Mycotoxins
- Heavy metals
- Pesticides
- Water activity
- Moisture
- Cannabinoid profile
- Microbiology
- Mycotoxins
- Residual solvents
- Heavy metals
- Pesticides
- Water activity
- Moisture
- Cannabinoid profile
- Microbiology
- Mycotoxins
- Residual solvents
- Heavy metals
- Pesticides
- Water activity
- Moisture
- Cannabinoid profile
- 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:
- Each laboratory director engaged by the applicant only oversees one of the applicants’ medical marijuana testing laboratories
- The laboratory director is 21 years old or over
- The laboratory director has passed level 2 background screening as directed by section 435.04 of Florida Statutes. They must not have been found guilty of perjury, racketeering, illegal debts, money laundering, or any offenses mentioned in chapters 837, 895, and 896 of the Florida Statutes
- The laboratory director possesses a bachelor’s degree in a natural science course, such as biology, chemistry, physics, engineering, or environmental sciences. Alternatively, the laboratory director may hold a current license from the Florida Board of Clinical Laboratory Personnel
- The laboratory director must have a minimum of three years of experience working in a regulated laboratory environment
- The analyst is 21 years old or over
- The analyst has passed level 2 background screening as required by section 435.04 of Florida Statutes. The analyst must not have been found guilty of perjury, racketeering, illegal debts, money laundering, or any offenses mentioned in chapters 837, 895, and 896 of the Florida Statutes
- The analyst possesses a bachelor’s degree in a natural science course such as biology, chemistry, physics, engineering, or environmental sciences. Alternatively, the analyst may hold a current license from the Florida Board of Clinical Laboratory Personnel
- The analyst has undergone training on the medical marijuana testing laboratory operating procedures for sampling and security
- The sampler is 21 years of age or over
- The sampler has passed level 2 background screening as required by section 435.04 of Florida Statutes. They must not have been found guilty of perjury, racketeering, illegal debts, money laundering, or any offenses mentioned in chapters 837, 895, and 896 of the Florida Statutes
- The sampler has undergone training in the skills needed to conduct sampling and medical marijuana laboratory testing standard operating procedures
- The employee is 21 years old or over
- The employee has passed level 2 background screening as required by section 435.04 of Florida Statutes. The analyst must not have been found guilty of perjury, racketeering, illegal debts, money laundering, or any offenses mentioned in chapters 837, 895, and 896 of the Florida Statutes
- A floor plan of the facility area, including the location of all storage areas in the facility
- A detailed plan of security measures taken by the testing facility. This is expected to comply with Rule 64-4.301 (6)(e) of the Florida Administrative Code
- A document containing a list of the types of shares held and the aggregate sum of shares associated with the organization, either owners or investors
- A document containing all contractual relationships concerning the change of ownership, management, or investors to the company, either executed or not executed
- A document containing the list of owners, officers, and board members who led the company within the last 12 months prior to the application. The document should contain the dates in which they served in the company and documents of the level 2 background screening for each of them. This is as required by the Florida Administrative Code. Each of these persons shall be required to visit the Florida Department of Law Enforcement (FDLE) or any of their approved vendors for a fingerprint
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 hand-delivered to:
Florida Department of Health
Office of the General Counsel
ATTN: Agency Clerk
2585 Merchants Row Blvd., Suite 110
Tallahassee, FL 32399
Florida Department of Health
Office of the General Counsel
ATTN: Agency Clerk
4052 Bald Cypress Way, Bin A-02
Tallahassee, FL 32399
How Much Does a Marijuana Testing Laboratory License Cost in Florida?
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” with a cashier’s check and must be submitted with the application package. The license application will only be processed when payment is confirmed.
Are there Local Regulations for Cannabis Testing Facilities in Florida?
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.
