The following words and phrases have the meanings provided below and apply to Rules 64-4.301-4.315, F.A.C.:

1. (1) Acceptable Limit – The maximum concentration allowed for a specified Target Analyte.
2. (2) AFRNP - The Applicant Fingerprint Retention and Notification Program authorized by section 943.05(2)(b), F.S., and established by the Florida Department of Law Enforcement, as provided in Rule 11C-6.010, F.A.C.
3. (3) Agricultural Agents – Any pesticide, herbicide, fungicide, fertilizer, synergist, or root stimulant applied to the plant or substrate, at any stage of cultivation or processing.
4. (4) Analyst – An Employee of a CMTL whose duties include conducting analyses on analytical instrumentation, analyzing and recording results, maintaining testing-related workspaces and equipment, and maintaining marijuana Samples.
5. (5) Analytical Batch – A group of no more than 30 Analytical Samples, which behave similarly with respect to the sampling or the testing procedures being employed, that are prepared together by the same Analyst within 24 hours of beginning preparation procedures.
6. (6) Analytical Method – An approved method, as provided in Rule 64-4.306, F.A.C., that is used for the testing and analysis of Analytical Samples.
7. (7) Analytical Sample – A Testing Sample that has undergone all preparatory procedures specified within the Analytical Method and is in a form to be analyzed.
8. (8) Applicant – An individual or entity that seeks certification as a CMTL pursuant to s. 381.988(2), F.S., and Rule 64-4.301, F.A.C.
9. (9) Automatic Integration – The process used by chromatographic software using defined parameters for integration to determine peak area or height used for quantitation.
10. (10) Baseline – The recorded response in a chromatograph when only the mobile phase, background noise, and Matrix signal are detected.
11. (11) Baseline Resolution – The amount of resolution between adjacent peaks at which the detector signal will drop to the baseline.
12. (12) Calibration – The set of analyses that establish, under conditions specified in the analysis SOP, the relationship between values of quantities indicated by the measuring instrument or measuring system, or values represented by a material measure of a Certified Reference Material, and the corresponding values realized by standards.
13. (13) Calibration Curve – The mathematical relationship between the known values, such as the concentrations of a series of Calibration Standards, and their instrument response, prepared at multiple concentrations that cover the working range of the instrument.

14. (14) Calibration Drift – A calculation used to measure the change in accuracy of the Calibration Curve over time, calculated for the CCV as

    
    

    and for the ICV as

    
    

15. (15) Calibration Standard – A Certified Reference Material used to calibrate an instrument.
16. (16) Cannabinoid Profile – An analysis conducted to determine the level of concentration of d9-THC, d8-THC, THCA, THCV, CBD, CBDA, CBDV, CBG, CBGA, CBN, and CBC in a Final Product.
17. (17) Certificate of Analysis (COA) – A document created by a CMTL that certifies the quality and purity of the tested Final Product and meets the requirements of the CMTL Certificate of Analysis rule.
18. (18) Certified Marijuana Testing Laboratory (CMTL) – A laboratory that has been certified by the department to collect and analyze marijuana samples from an MMTC pursuant to s. 381.988, F.S., and Rule 64-4.301, F.A.C.
19. (19) Certified Reference Material – A material characterized by a metrologically valid procedure performed by an ISO/IEC 17034:2017 accredited provider for one or more specified properties, accompanied by a certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability.
20. (20) Contaminants Unsafe for Human Consumption – Any Microbe, Mycotoxin, Agricultural Agent, Residual Solvent, Heavy Metal, Moisture, Water Activity, or Filth and Foreign Material found in an amount that exceeds any of the department’s Acceptable Limits.
21. (21) Continuing Calibration Verification (CCV) – A traceable standard solution from an ISO/IEC 17034:2017 accredited Certified Reference Material provider containing all Target Analytes in the Calibration Curve. These standards are used to check the drift of a Calibration Curve on a daily basis (before the analysis and every 12 hours thereafter or after every 10 Injections, whichever occurs first).
22. (22) Control – Voting power which includes the power to vote, or the power to direct the voting, of an Owner’s interest.
23. (23) Cultivar – A variety, strain, or race that has originated and persisted under cultivation and has been developed through artificial selection for specific morphological, physiological, or chemical characteristics.
24. (24) Data Packages – Analytical testing data that is collected and prepared by a CMTL and contains information about the testing performed, Quality Assurance and Quality Control data, and the results of any tests performed.
25. (25) Data Reduction - The transformation of raw analytical results into corrected and ordered Target Analyte concentrations using Analytical Sample acceptance/rejection criteria, peak integration, Quality Control Samples, Calibration Curves, CCVs, ICVs, Surrogates, and Internal Standards.
26. (26) Derivative Batch – A portion of Derivative Product that contains the same product type and was processed using the same methods, SOPs, equipment, and ingredients.
27. (27) Derivative Product – Usable product created from marijuana, infused with marijuana, or that otherwise includes or contains marijuana.
28. (28) Dilution Factor – the ratio by which the concentration of an Analytical Sample is reduced by dilution with a Target-Analyte-free solvent.
29. (29) Duplicate – The second instance of the same Analytical Sample or Quality Control Sample being analyzed within one Analytical Batch.
30. (30) Edible – Derivative Product that is a commercially produced food item made with, or infused with, marijuana oil, but no other form of marijuana, that is produced and dispensed by an MMTC. The term “Edible” includes any Derivative Product made with, or infused with, marijuana oil that otherwise meets the definition of “food” in s. 500.03, F.S. and complies with the Standards for Production of Edibles rule. The term does not include pills, capsules, tinctures, topicals, and similar Derivative Products.
31. (31) Employee – Any person whose duties or activities involve any aspect of Regulatory Compliance Testing or research and development (R&D) testing of marijuana for a CMTL, whether or not they are compensated for their work.
32. (32) Environmental Contaminant Testing – Physical and chemical testing analyses, to include Heavy Metals, Agricultural Agents, Residual Solvents, Moisture, Water Activity, and Mycotoxins.
33. (33) Filth and Foreign Materials – Mold, mildew, hair, insects, feces, manufacturing waste, or marijuana cultivation and manufacturing by-products.
34. (34) Final Product – Any Usable Whole Flower Marijuana or Derivative Product in its receptacle and final, labeled form intended for use by a qualified patient, to include all parts consumed (i.e., gel-capsule, rolling papers) during administration.
35. (35) Flower Batch – A portion of Usable Whole Flower Marijuana of uniform Cultivar, cultivated with the same Agricultural Agents, and harvested at the same time.
36. (36) Formulation – The specific combination of ingredients combined to produce a Final Product.
37. (37) Gas Chromatography – An analytical technique used to separate and analyze the chemical components of a Sample mixture by vaporization.
38. (38) Heavy Metals – A metallic chemical element that has a relatively high density and is toxic or poisonous at low concentrations.
39. (39) Increment – A subsample taken from an Edible for the purposes of homogeneity testing.
40. (40) Initial Calibration Verification (ICV) – A traceable Calibration Standard from a second ISO/IEC 17034:2017 accredited Certified Reference Material provider or separate production lot from the same provider, different from the Calibration Curve lot, containing all Target Analytes in the Calibration Curve. These standards are used to check the Calibration Drift of a Calibration Curve.
41. (41) Initial Display of Competency (IDOC) – An assay used to determine whether an Employee can correctly, accurately, and repeatedly perform a specific analysis or preparation, or analyze a specific measurement.
42. (42) Injection – The introduction of an Analytical Sample or any other substance into an analytical instrument for the purposes of analysis, Calibration, or Quality Control.
43. (43) Interest – Any form of ownership in, or Control of, an Applicant, a CMTL, or MMTC. This includes, but is not limited to, ownership of stock, membership interests, partnership interests, a sole proprietorship, or that which otherwise conveys to the holder thereof an ownership right, interest in, or right to the profits, capital, or voting rights with respect to such Applicant, CMTL, or MMTC.
44. (44) Internal Audit - A review conducted by the CMTL to ensure the CMTL has the proper controls, governance, and risk management processes required for operation in accordance with ISO17025:2017 and sections 381.986 and 381.988, F.S., and department rules. This review should include, at a minimum, audits on SOPs, data retention and traceability, employee training, sampling, consumable handling, and security.
45. (45) Internal Standard – A pure Target Analyte of known concentration, not expected to be found in the Testing Samples, added to the Analytical Samples before analysis and used to measure the relative response of other Target Analytes and Surrogates to correct for variations.
46. (46) Investor – Any person who, directly or indirectly, owns a legal or equitable Interest (actually or beneficially), or Controls less than a 5% share of Interests of an Applicant or CMTL.
47. (47) Laboratory Batch – A series that includes the Analytical Batch as well as all applicable Quality Control Samples, to include one Method Blank, duplicate Laboratory Fortified Blanks, duplicate Matrix Spike Samples, and at least one duplicate Sample for Mycotoxins, Residual Solvents, Agricultural Agents, Cannabinoid Profile, and Heavy Metals.
48. (48) Laboratory Director – An individual who oversees all Analysts, Employees, Managers, and the functions of testing Usable Whole Flower Marijuana, Derivative Product, and Edibles at only one physically independent Testing Facility operated by the CMTL.
49. (49) Laboratory Fortified Blank – A Quality Control Sample, created using a Matrix similar to the Testing Sample Matrix, and initially without Target Analytes, prepared along with Testing Samples, that have been amended with a known concentration of a Target Analyte or analytes for competency assessment purposes.
50. (50) Limit of Detection (LOD) – The lowest quantity of a Target Analyte that can be distinguished from the absence of that Target Analyte within a stated confidence limit. The LOD must be 1/5th of the Acceptable Limit or less with an instrument signal-to-noise ratio of 3:1 or greater for each Target Analyte tested.
51. (51) Limit of Quantitation (LOQ) – The minimum concentration of a Target Analyte in a specific Matrix that can be reliably quantified while also meeting predefined goals for bias and imprecision. The LOQ must be equal to ½ the Acceptable Limit or less, with an instrument Signal-to-noise Ratio of 10:1 or greater for each Target Analyte tested.
52. (52) Liquid Chromatography – An analytical technique used to separate and analyze the chemical components of a Sample mixture that are dissolved in a solvent.
53. (53) Livescan Service Provider – A vendor, entity, or agency authorized by s. 943.053(13), F.S., that scans fingerprints electronically and submits them to FDLE.
54. (54) Manager – Any person with direct or indirect authority to exercise or contribute to the operational control, direction, or management of an Applicant or a CMTL or who has direct or indirect authority to supervise any Employee of an Applicant or a CMTL. The term includes all officers, Laboratory Directors, and members of the board of directors, as well as any other person engaged to undertake management or Control of the Applicant or a CMTL, or any person in Control of an entity engaged to undertake management or Control of the Applicant or CMTL.
55. (55) Manual Integration - The process employed by the Analyst to integrate peak height or area by manually setting the baseline, splitting chromatographic peaks, or identifying a peak using chromatographic software.
56. (56) Matrix – The component or substrate containing a Target Analyte(s).
57. (57) Matrix Group – The components of a Testing Sample other than the Target Analytes.
58. (58) Matrix Spike Sample – An aliquot from a Testing Sample, which has been amended with a known concentration of a Target Analyte(s) to test for potential Matrix interference.
59. (59) Method Blank – A Target Analyte-free Matrix (e.g., plant material, oil, or food product similar to Edible being tested) which is carried through the complete preparation and analytical procedure, and measures no Target Analytes above the LOD, used to evaluate contamination resulting from the complete analytical procedure.
60. (60) Metered Dose Inhalers (MDI) – A pressurized canister of Derivative Product intended to be inhaled through the mouth that, when sprayed, gives a reliable, consistent dose.
61. (61) Microbe – Any microscopic organism, including bacteria and fungi.
62. (62) Microbiological Contaminant Testing – The analysis of microbes.
63. (63) Medical Marijuana Treatment Center (MMTC) – Any individual or entity licensed by the department pursuant to s. 381.986, F.S.
64. (64) Moisture – The total amount of water present in a Sample, calculated as a percentage of weight.
65. (65) Mycotoxins – Any toxin produced by a fungus.
66. (66) Non-Oral Transmucosal Product – A Derivative Product with routes of administration other than oral and heated inhalation, to include, but not limited to, nasal and throat sprays, MDI, suppositories, and similar transmucosal routes of administration.

67. (67) Owner – Any person who, directly or indirectly, owns a legal or equitable Interest (actually or beneficially), or otherwise Controls, any share of Interests of the Applicant or CMTL. In the event that one person owns a beneficial right to Interests and another person holds the voting rights with respect to such Interests, both persons are the Owner of such Interests. In determining who are Owners of the Applicant or a CMTL, the attribution of ownership rules set forth in the Treasury Regulations cited as 26 C.F.R. § 1.414(c)-4(b) and (c) (4-1-19 edition), incorporated by reference and available at HYPERLINK "https://flrules.org/Gateway/reference.asp?No=Ref-19582"https://flrules.org/Gateway/reference.asp?No=Ref-19582, apply with the following modifications:

    1. (a) The use of the term “Option” in 26 C.F.R. § 1.414(c)-4(b) shall be interpreted broadly to include, without limitation, options, warrants, calls, rights of first refusal and any other right to acquire an Interest (as defined herein), whether such right is vested or unvested and regardless of whether such right is then exercisable or becomes exercisable at a future date or upon the occurrence of a future event.
    2. (b) The exception for attribution of a spouse’s interest, as set forth in 26 C.F.R. § 1.414(c)-4(b)(5)(ii), does not apply. The term “Interest” as used in 26 C.F.R. § 1.414(c)-4(b)(6) shall have the meaning as set forth in subsection (43) above.
    3. (c) The age limitation contained in 26 C.F.R. § 1.414(c)-4(b)(6) applies only to children who have not attained the age of 18 years. The term “Interest” as used in 26 C.F.R. § 1.414(c)-4(b)(6) shall have the meaning as set forth in subsection (43) above.
    4. (d) If a person under the age of 18 owns or is deemed an Owner of an Interest, such person must be disclosed to the department. Persons under the age of 18 must submit to a background screening only in the event that the Interest or ownership was not imputed to another family member or guardian.
    5. (e) As used in 26 C.F.R. § 1.414(c)-4(b)(3), the term “Actuarial Interest” shall be interpreted broadly and shall include, but not be limited to, the right of a beneficiary of a trust or an estate to receive either income or principal distributions with respect to an Interest held by such trust or estate.
    6. (f) With regard to publicly traded companies with ownership Interests in the Applicant or CMTL, any person who holds 5% or more Interest in the publicly traded company is an Owner.
68. (68) Peak Enhancement – The action of adding to the integrated peak area, usually by integrating along the baseline that is not part of the target peak or lowering the integrated area below the baseline.
69. (69) Peak Shaving – The action of removing area from the integrated peak area, usually by raising the integration area above the baseline, or not integrating the entire width of the peak.

70. (70) Percent Recovery – A calculation of the recovery of spiked analytes in Laboratory Fortified Blanks and Matrix Spike Quality Control Samples, calculated as:

    QUOTE
    
    

71. (71) Potency Testing – The analysis of the relative strength of cannabinoids as labeled by the MMTC on the Final Product, and the total amount, in milligrams.
72. (72) Proficiency Testing – Testing by an Applicant or CMTL of unknown samples supplied to the Applicant or CMTL by an ISO/IEC 17043:2023 accredited body to determine the accuracy of the analysis for specific Target Analytes and Matrix Groups.
73. (73) Quality Assurance – A set of procedures developed by an Applicant or CMTL to ensure that products and services delivered are as accurate and precise as possible.
74. (74) Quality Assurance Manual – A written collection of all Quality Assurance systems or protocols to include the management policies, objectives, principles, organizational structure and authority, responsibilities, and implementation of an Applicant or CMTL to ensure the quality and utility of the service rendered.
75. (75) Quality Control – A set of procedures developed in accordance with ISO/IEC 17025:2017 standards, to verify that the required level of quality in analyses are met and maintained, including determination that appropriate equipment and instruments are used, continued inspection and overview of all facets of the testing procedure, and undertaking corrective action as necessary.
76. (76) Quality Control Samples – Samples analyzed along with Analytical Samples to ensure accurate instrument analysis and proper Analytical Sample preparation, to include Method Blanks, Laboratory Fortified Blanks, Matrix Spikes, Duplicates, CCV, and ICV.
77. (77) R&D Testing – The testing of any component of the marijuana plant, its byproducts, or any other product used in the cultivation or processing of medical marijuana or low-THC cannabis other than Final Product testing or Proficiency Testing.
78. (78) Reagent – A compound or mixture used in a chemical analysis to cause a chemical reaction or test if a reaction occurs.
79. (79) Receptacle – The container, canister, or material that comes into direct contact with the usable product. In the case of some derivative products, “receptacle” means the container, canister, or material that comes into direct contact with the usable derivative product’s immediate covering (e.g., a vape cartridge that contains derivative product). In the case of edibles, “receptacle” means the container, canister, or material that comes into direct contact with the individually wrapped edible. Where the usable product is dispensed inside of a marijuana delivery device (e.g., a vape pen that contains derivative product), the receptacle means the container, canister, or material that comes into direct contact with the delivery device.
80. (80) Regulatory Compliance Testing – The testing of a representative sample of Final Products in a Retail Batch for the required Cannabinoid Profile, Potency Testing, Microbiological Contaminant Testing, Mycotoxins, Heavy Metals, Residual Solvents, Agricultural Agents, Moisture, Water Activity, Homogeneity, and Filth and Foreign Material Testing Fields to comply with all requirements in Rule 64-4.308, F.A.C.

81. (81) Relative Percent Difference (RPD) – A calculation of the precision of the measured recovered concentration of duplicate Laboratory Fortified Blanks, duplicate Matrix Spike Samples, or duplicate Testing Samples, calculated as:

    
    

82. (82) Remediation - Additional processing steps completed by an MMTC to transform a Retail Batch that has failed Regulatory Compliance Testing into new Final Product(s). The new Final Product(s) created from the failed Retail Batch must pass all required Regulatory Compliance Testing to be considered successfully remediated by the MMTC.
83. (83) Residual Solvents – Volatile chemicals used during the manufacturing of a Final Product, which have not been completely removed by manufacturing techniques.
84. (84) Retail Batch – A portion of one Flower Batch or one Derivative Batch that is used to create a Final Product that consists of one product type at one concentration and one volume or weight, is intended to have a defined and uniform character and quality, and is produced during the same cycle of manufacture.
85. (85) Retention Time – A measure of the time taken for a solute to pass through a chromatography column and be measured on the instrument detector.
86. (86) Retention Time Window – A specified amount of time variation from the expected retention time from a chromatographic peak, outside of which the identification of the peak, compared to a known standard, is brought into question.
87. (87) Sample – A group of individual Final Products collected by a CMTL from an MMTC for the purposes of Regulatory Compliance Testing by the CMTL.
88. (88) Sampler – An Employee of a CMTL who collects Samples of marijuana from an MMTC for testing and has undergone required training to fulfill this function.
89. (89) Secure Storage – The segregation of Usable Whole Flower Marijuana, Derivative Product, or Edibles in a manner that prevents access by unauthorized persons, compromise of the product’s integrity, or premature spoilage.
90. (90) Signal-to-noise Ratio – The ratio of the power of a Target Analyte response to the power of background response.
91. (91) Spike Solution – A solution of Target Analytes of known concentrations that is used to fortify a Laboratory Fortified Blank or Matrix Spike Sample. For Analytical Methods with multiple Target Analytes, a representative number of Target Analytes may be chosen for the Spike Solution.
92. (92) Standard Operating Procedure (SOP) – Written documents that detail the techniques and procedures of methods of an operation, analysis, or action appropriate as a method of performing certain routine or repetitive tasks.
93. (93) Standard Solution – A solution created with a Certified Reference Material obtained from an ISO/IEC 17034:2017 accredited provider, containing a known concentration of a substance or substances that is used to determine the concentration of that same substance or substances and used to create Standard Curves and Spike Solutions.
94. (94) Surrogate – A Target Analyte or mix of Target Analytes that behave similarly to the Target Analyte but are not expected in the Analytical Sample, may be added to all Testing and Quality Control samples before Testing Sample preparation to measure Analytical Method efficiency.
95. (95) Tamper-evident Device – A mechanism that makes unauthorized access to protected objects easily detectable.
96. (96) Target Analyte – A substance or chemical constituent to be quantitatively measured in an Analytical Method.
97. (97) Testing Facility – The location of a real property or the area within a real property to be utilized as a CMTL.
98. (98) Testing Field – The suite of Target Analytes tested within a Matrix Group.
99. (99) Testing Sample – A homogenized sample for analysis created from a Sample.
100. (100) Total Active CBD - The concentration of CBD + (concentration of CBDA multiplied by 0.877) in milligrams per gram or milligrams per milliliter multiplied by the labeled size of the product in grams or milliliters.
101. (101) Total Active THC - The concentration of delta-9 THC + the concentration of delta-8 THC + (concentration of THCA multiplied by 0.877) in milligrams per gram or milligrams per milliliter multiplied by the labeled weight of the product in grams or milliliters.
102. (102) Total Combined Yeast and Mold – The total detected yeast, mold, and other fungi in Final Products.
103. (103) Total Contaminant Load (TCL) – The sum of all Heavy Metals and Agricultural Agents present in an amount above the LOQ but below the Acceptable Limit.
104. (104) Unique Identifier – A string of alpha-numeric characters used to differentiate between different Samples during the Regulatory Compliance Testing process, including but not limited to during sampling, analysis, and reporting. A Unique Identifier cannot be used to identify more than one Sample.
105. (105) Usable Whole Flower Marijuana – The flowers of the female cannabis plant, including low-THC cannabis, that is suitable to be dispensed from an MMTC for use by a qualified patient. Usable Whole Flower Marijuana does not include seeds, stems, roots, leaves, resin extracted from any part of the plant, or any compound, manufacture, salt, derivative, mixture, or preparation of the plant or its seeds or resin. Usable Whole Flower Marijuana is not a Derivative Product.
106. (106) Water Activity – The measure of the quantity of free water (i.e., water that is not chemically bound to the cannabis product) in a product that is available and, therefore, capable of supporting bacteria, yeasts, mold, and fungi.

Rulemaking Authority Art. X, § 29, Fla. Const., 381.988(2), 381.988(3), 381.988(9) FS. Law Implemented Art. X, § 29, Fla. Const., 381.988 FS. History–New 5-28-26.