Florida Administrative Code

(1) Submission of an application for Dispensing Organization approval or renewal constitutes permission for entry by the department at any reasonable time during the approval or renewal process, into any Dispensing Organization facility to inspect any portion of the facility; rev…

(1) Ordering physicians licensed under Chapter 458 or 459, F.S., meeting the educational requirements of section 381.986(4), F.S., may access the Compassionate Use Registry using their existing MQA Services credentials. (2) Other persons may request access to the Compassionate Us…

(1) All patients and caregivers are required to have a valid Medical Marijuana Use Registry identification card to obtain marijuana or a marijuana delivery device. (2) To apply for a patient Medical Marijuana Use Registry identification card, a person must: (a) Be a Florida resid…

(1) For purposes of this chapter, the term "pesticide" has the meaning given as defined in Section 487.021(49), F.S. (2) Any pesticide used in the production of medical marijuana or low-THC cannabis must be registered with the Florida Department of Agriculture and Consumer Servic…

(1) A medical marijuana treatment center may request a variance from the representations made in the initial application pursuant to Section 381.986(8)(e), F.S. (2) In order to obtain a variance from the representations made in the initial application, the medical marijuana treat…

(1) The department may conduct random and unannounced inspections of any MMTC facility or vehicle utilized by an MMTC to determine compliance with Section 381.986, F.S., the department's rules, and the specific representations in the MMTC's application(s) on file with the departm…

(1) An MMTC that produces edibles must comply with all requirements for food establishments in Chapter 500, F.S., and any rules adopted pursuant to that chapter. (2) All edibles must be produced by the MMTC in the MMTC's department-approved processing facility and packaged and la…

(1) As used in this rule, the term "Marijuana Waste" includes the following materials: (a) Plant material waste, which means leaves, stalks, stems, and any other part of the marijuana plant that contains tetrahydrocannabinol and is not processed with solvent or used in the proces…

(1) Required Background Screening. (a) No person may serve as an employee, owner, or manager, as those terms are defined by this chapter, of an MMTC unless and until the person has undergone and successfully passed a background screening, as provided in Section 381.986, F.S. (b) …

(1) For the purposes of this rule, the terms below shall have the following meanings: (a) "Carbon Dioxide Solvent" means carbon dioxide in a liquid or supercritical state. (b) "Closed Loop System" means a commercially manufactured extraction system that is sealed during operation…

(1) Pursuant to Section 381.986, F.S., the department provides within this rule disciplinary guidelines that will be imposed upon licensed MMTCs. The purposes of discipline are to penalize MMTCs for violations; to deter them from future violations; to offer opportunities for corr…

(1) The capitalized terms used in this rule shall have the same meaning as provided in Emergency Rule 64ER20-1, F.A.C. (2) An MMTC must contact a Certified Marijuana Testing Laboratory (CMTL) and arrange for the CMTL to select and collect a random and representative sample of Fin…

(1) The capitalized terms used in this rule shall have the same meaning as provided in Emergency Rule 64ER20-1. (2) An MMTC may remediate a previously failed Retail Batch as provided for herein. (3) Prior to remediating a previously failed Retail Batch, an MMTC must provide the f…

(1) An MMTC may not cultivate marijuana until it has received cultivation authorization from the department. (2) An MMTC may not process marijuana until it has received processing authorization from the department. (3) An MMTC may not dispense marijuana or marijuana delivery devi…

(1) For purposes of this rule, the term "final approval for licensure" means final agency action issuing an MMTC license. (2) Within ten business days after final approval for licensure as an MMTC, the MMTC must post a bond, provide an irrevocable letter of credit payable to the …

(1) All usable product shall be placed inside of a receptacle at the MMTC's department-approved processing facility. Receptacles shall be placed inside of a package with a physical patient package insert that complies with subsection (10) of this rule before the usable product is…

(1) For purposes of this rule, the following definitions apply: (a) "Department STS Tracking System" means the computer software seed-to-sale (STS) tracking system established, maintained, and controlled by the department pursuant to s. 381.986(8)(d), F.S. (b) "Internal STS Track…

(1) For the purposes of this rule, the following definitions apply: (a) "Department STS Tracking System" shall have the same meaning as provided in Rule 64-4.221, F.A.C. (b) "Internal STS Tracking System" shall have the same meaning as provided in Rule 64-4.221, F.A.C. (c) "Point…

(1) Background Screening Requirement. Except as provided in subsection (5) below, individuals applying for a caregiver Medical Marijuana Use Registry (MMUR) identification card must complete a level 2 background screening in accordance with section 381.986(9), F.S., and this rule…

(1) Pursuant to s. 381.986(4)(f), F.S., a qualified physician may not issue a physician certification for more than three 70-day supply limits of marijuana or more than six 35-day supply limits of marijuana in a form for smoking. The 70-day supply limit and 35-day supply limit ar…

The following words and phrases have the meanings provided below and apply to Rules 64-4.301-4.315, F.A.C.: (1) Acceptable Limit - The maximum concentration allowed for a specified Target Analyte. (2) AFRNP - The Applicant Fingerprint Retention and Notification Program authorized…

(1) This rule establishes the application and ongoing certification requirements for CMTLs. Any Applicant seeking certification as a CMTL must apply for certification as provided for in this rule. (2) Certification will be on a per-Testing Facility basis. Separate applications mu…

(1) Each CMTL seeking renewal of its certification for a Testing Facility must submit a renewal application to the department in compliance with Form DH5063-OMMU-04/2025 (Eff. 4/2025), "Certified Marijuana Testing Laboratory Renewal Application Instructions, Requirements, and For…

(1) The department may conduct announced or unannounced inspections of any CMTL Testing Facility, including any vehicle utilized by a CMTL, to determine compliance with ss. 381.986 and 381.988, F.S. and department rules. All inspections will be initiated during a CMTL's normal bu…

(1) CMTLs must develop, maintain, and implement testing methods and a corresponding written Quality Assurance Manual in conformity with this rule and any required accreditation pursuant to Rule 64-4.301, F.A.C. (2) A CMTL must create and maintain SOPs compliant with s. 381.988, F…

(1) CMTLs shall test Final Products for the following as specified in Rule 64-4.301, F.A.C.: tetrahydrocannabinol (THC) potency, concentration of cannabidiol (CBD), Cannabinoid Profile, Contaminants Unsafe for Human Consumption, Moisture, and Water Activity. (a) Notwithstanding t…

(1) Calibration Standards must be prepared by diluting Certified Reference Materials to produce working standards to be used in the Calibration of instruments, the quantitation of Analytical Samples, and for use in Laboratory Fortified Blanks and Matrix Spike Samples. CMTLs must …

(1) A CMTL must generate a COA containing the results from each Final Product tested, containing all the information required in paragraph (1)(a) below, and all the information required in paragraphs (1)(b) and (1)(c) below, as applicable. Additional information, analysis, or gra…

(1) CMTLs must create and maintain Retention Time Windows for each Target Analyte, Surrogate, and Internal Standard for each Testing Field in which chromatography is used for analysis. (a) The Retention Time Window is calculated by multiplying three (3) times the standard deviati…

(1) As used in this rule, the term "Marijuana Waste" includes the following materials: (a) Testing Waste, which means spent solvents, lab wastes, and similar materials used in the testing of Usable Whole Flower Marijuana or Derivative Product ready for disposal; (b) Product Waste…

(1) Required Background Screening. (a) No person may serve as an Employee, Owner, or Manager, as those terms are defined in section 381.988, F.S., until the person has passed a level 2 background screening. (b) A CMTL that allows a person to serve as an employee, owner, or manage…

(1) The department may suspend or revoke a CMTL's certification, or refuse to renew a CMTL's certification, if the department finds that the CMTL committed a violation of s. 381.986, F.S., s. 381.988, F.S., or department rules. (2) The department will provide to the CMTL a writte…

A physician licensed under Chapter 458 or 459, F.S., a nurse midwife certified under Part I of Chapter 464, F.S. or a midwife licensed under Chapter 467, F.S. shall report adverse incidents, as defined in Section 456.0495, F.S., over which he or she could exercise control that ar…

(1) The Department will issue a notice of violation to any business entity, governmental entity or educational institution found in violation of Section 381.00316, F.S., prior to final agency action. Such notice will include hearing rights pursuant to Section 120.569, F.S. (2) Ea…

(1) The Department will issue a notice of violation to any governmental entity or educational institution found in violation of Section 112.0441, F.S., prior to final agency action. Such notice will include hearing rights pursuant to Section 120.569, F.S. (2) Each violation of Se…

(1) Parents or legal guardians of newborns and infants identified as having sickle cell disease or sickle cell trait through the newborn screening program as described in s. 383.14, F.S., may opt out of inclusion in the Sickle Cell Registry (Registry) by completing DOH Form - DH8…

Rulemaking Authority 456.004(5), 456.017(1) FS. Law Implemented 456.013(1), 456.017(1) FS. History-New 9-7-98, Amended 7-20-03, 9-30-09, Repealed 3-30-14.

Rulemaking Authority 456.004(5), 456.017(1) FS. Law Implemented 456.017(1) FS. History-New 9-7-98, Amended 7-20-03, 9-30-09, Repealed 3-30-14.

Rulemaking Authority 456.004(5), 456.017(1)(a), (d), (f) FS. Law Implemented 456.017(1) FS. History-New 9-7-98, Amended 7-20-03, 3-26-07, 4-7-08, 9-30-09, Repealed 3-30-14.

Rulemaking Authority 456.004(5), 456.017(1) FS. Law Implemented 456.017(1) FS. History-New 9-7-98, Amended 7-20-03, 9-30-09, Repealed 12-21-15.

(1)(a) The department will provide reasonable and appropriate accommodations to candidates with physical, mental, or specific learning disabilities to the extent permitted by cost, administration restraints, security considerations and availability of resources. Accommodations ma…

Rulemaking Authority 456.004(5), 456.017(1) FS. Law Implemented 456.017 FS. History-New 9-7-98, Amended 7-20-03, 9-30-09, Repealed 3-30-14.

Rulemaking Authority 456.004(5), 456.017(1) FS. Law Implemented 456.017(1) FS. History-New 9-7-98, Amended 7-20-03, 9-30-09, Repealed 3-30-14.

(1) Grading of all examinations shall be processed as follows: (a) National examinations shall be graded solely and exclusively by the national examination provider or its contract provider. (b) Department-developed practical or clinical or computer-based testing examinations sha…

Rulemaking Authority 456.004(5), 456.014, 456.017(2) FS. Law Implemented 456.014, 456.017 FS. History-New 9-7-98, Amended 2-21-00, 7-20-03, 6-19-08, 9-30-09, Repealed 12-21-15.

(1) National examinations will be certified by the department according to the criteria established in this rule. National examinations shall be recertified during contract renewal periods as established by the department. (a) The national examination shall be developed either by…

Rulemaking Authority 456.004(5), 456.017(1)(e) FS. Law Implemented 456.017(1)(e) FS. History-New 9-7-98, Repealed 3-30-14.