Fla. Admin. Code R. 64-4.315 – CMTL Fines, Suspension, and Revocation

(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 written notice of violation. A CMTL must provide a proposed corrective action plan to the department within seven (7) calendar days of receipt of a notice of violation. The corrective action plan must conform to the ASTM D8229-19 Standard Guide for Corrective Action and Preventative Action (CAPA) for the Cannabis Industry. The department has determined that posting the incorporated material on the internet would constitute a violation of the federal copyright law. The materials incorporated herein have been deemed copyright protected and are available for inspection at the Department of Health, 2585 Merchants Row Boulevard, Tallahassee, Florida 32399-1710, or at the Department of State, R.A. Gray Building, 500 South Bronough Street, Tallahassee, Florida 32399-0250. The department may extend the timeframe for submittal of a corrective action plan for good cause (e.g., untimely delivery of notice of violation) shown. Upon review of the corrective action plan by the department, the CMTL may be required to take specific additional actions to cure the violation. The CMTL must comply with and perform all such additional curative actions as directed by the department. A CMTL is subject to discipline notwithstanding the implementation of a corrective action plan.
(3) A CMTL that loses or has its required accreditation suspended must report the loss or suspension within 24 hours of its occurrence to the department via email to OMMUlabs@flhealth.gov.
1. (a) Within seven (7) calendar days of receiving notice of the loss or suspension of its required accreditation, a CMTL must provide the following to the department:
  1. Documentation identifying the cause of the loss or suspension of accreditation; and
  2. Documentation evidencing that written notice of the loss or suspension of accreditation has been provided to each MMTC for which the CMTL conducts testing.
2. (b) A CMTL is prohibited from testing marijuana product or providing results to an MMTC during the time that its accreditation is lost or suspended.
3. (c) A CMTL must reestablish accreditation within 180 days of the effective date of the loss or suspension of accreditation. If a CMTL fails to reestablish its accreditation within 180 days of its loss or suspension, the CMTL’s certification will be subject to revocation.
(4) The department may, in addition to or in lieu of suspension or revocation, impose a fine of up to $10,000 per violation, as set forth in the schedule provided in subsection (13). The schedule of fines is meant to serve as a guideline. The maximum fines listed in the schedule reflect the maximum fines that the department may impose per violation. Where there are multiple incidents resulting in more than one violation of the same provision, the department may impose a fine, up to the maximum, for each incident. For violations that are ongoing and continuous in nature, each day a violation continues constitutes a distinct violation.
(5) The department will use the factors set forth in s. 381.988(8)(a)-(d), F.S., to determine what discipline will be imposed, including suspension or revocation. The department will also consider the following in determining the severity of the violation and the amount of the fine to be imposed, if applicable:
1. (a) Frequency or number of occurrences of the violation;
2. (b) Potential for rehabilitation through department-approved corrective action;
3. (c) Impact on the department;
4. (d) Impact on an MMTC’s business practices;
5. (e) Potential and/or actual harm to a qualified patient or a member of the public;
6. (f) Willfulness and deliberateness of the violation;
7. (g) Severity of noncompliance;
8. (h) Length of noncompliance;
9. (i) Any good faith effort to prevent a violation; and
10. (j) Any corrective action taken by the CMTL related to the current violation or prior violations.
(6) The department may suspend, for a period of up to three (3) weeks, the testing operations of a CMTL that has received three (3) written notices of violation in a twelve-month time-period for the same violation.
(7) The issuance of a suspension under this part does not relieve the CMTL of the obligation to timely comply with all license renewal requirements. A license suspension does not toll the CMTL’s license renewal deadline.
(8) No CMTL, including its owners and controlling interests, whose license has been revoked may apply for licensure under s. 381.988, F.S., and department rules, for at least five (5) years from the date of such revocation. However, if a CMTL’s violation of statute or rule is a substantial contributing factor to the death of a patient, the CMTL, including its owners and controlling interests will be permanently barred from applying for licensure.
(9) If a CMTL’s license is suspended, revoked, or relinquished, no part of any application fee or renewal fee will be returned.
(10) A CMTL whose license is revoked must cease operations as a CMTL on or before the effective date of the revocation. All Testing Samples, Analytical Samples, and retained samples are deemed Marijuana Waste once a CMTL’s license is revoked. The CMTL must dispose of all Marijuana Waste in accordance with Rule 64-4.313, F.A.C. The CMTL must also return any Final Product that has not been removed from its original packaging to the originating MMTC. The CMTL must comply fully with the requirements of this subsection within seven (7) calendar days of the effective date of the revocation.
(11) A CMTL whose license is suspended must cease operations in accordance with any suspension order issued by the Department, pursuant to this rule.
(12) A CMTL that relinquishes its license must cease operations as a CMTL on or before the effective date of the relinquishment. All Testing Samples, Analytical Samples, and retained samples are deemed Marijuana Waste once a CMTL relinquishes its license. The CMTL must dispose of all Marijuana Waste in accordance with Rule 64-4.313, F.A.C. The CMTL must also return any Final Product that has not been removed from its original packaging to the originating MMTC. The CMTL must comply fully with the requirements of this subsection within seven (7) calendar days of the effective date of the relinquishment. For the purposes of this subsection, the effective date of relinquishment is the date the department sends written notice to the CMTL approving the CMTL’s request to relinquish its license.
(13) For the purposes of the following schedule of fines, the descriptions of the violations are abbreviated, and the full statute or rule may be found by referring to the cited statutory or rule provision.

	VIOLATION	MINIMUM FINE PER VIOLATION	MAXIMUM FINE PER VIOLATION
(a)	Failing to retain copies of all marijuana transportation manifests for at least three years. (Section 381.986(8)(g)1.g.(III), F.S.)	$1,000	$2,000
(b)	Employing a qualified physician. (Section 381.986(3)(b), F.S.)	$500	$1,000
(c)	Granting a direct or indirect economic interest to a qualified physician. (Section 381.986(3)(b), F.S.)	$500	$1,000
(d)	Illegally acquiring marijuana from an entity other than a medical marijuana treatment center or another CMTL. (Section 381.988(4), F.S.)	$5,000	$10,000
(e)	Selling, distributing, or transferring marijuana, except to transfer a sample to another CMTL or the department. (Section 381.988(4), F.S.)	$5,000	$10,000
(f)	Failing to properly dispose of a received Sample. (Section 381.988(5), F.S.) (Rule 64-4.313, F.A.C.)	$1,000	$2,000
(g)	Being owned or controlled by an MMTC. (Section 381.988(1)(a), F.S.) (Rule 64-4.301, F.A.C.)	$5,000	$10,000
(h)	Permitting unauthorized persons to perform technical procedures or issue reports. (Section 381.988(7)(a), F.S.)	$2,500	$5,000
(i)	Demonstrating incompetence or making consistent errors in the performance of testing or erroneous reporting. (Section 381.988(7)(b), F.S.)	$5,000	$10,000
(j)	Performing a test and rendering a report thereon to a person or entity not authorized by law to receive such services. (Section 381.988(7)(c), F.S.)	$5,000	$10,000
(k)	Failing to file any report required under s. 381.986, F.S., s. 381.988, F.S., or department rules. (Section 381.988(7)(d), F.S.)	$500	$1,000
(l)	Reporting a test result if the test was not performed. (Section 381.988(7)(e), F.S.)	$5,000	$10,000
(m)	Violating or aiding and abetting in the violation of any provision of s. 381.986, F.S., s. 381.988, F.S., or department rules. (Section 381.988(7)(g), F.S.)	$5,000	$10,000
(n)	Testing marijuana, or providing testing results to an MMTC, while required accreditation is lost or suspended. (Paragraph 64-4.315(3)(b), F.A.C.)	$5,000	$10,000
(o)	Failing to maintain required accreditation. (Rule 64-4.301, F.A.C.)	$5,000	$10,000
(p)	Failing to report loss or suspension of required accreditation or to provide required documentation upon such loss or suspension. (Paragraph 64-4.315(3)(a), F.A.C.)	$1,000	$2,000
(q)	Failing to comply with Proficiency Testing requirements. (Rules 64-4.301, 64-4.303, and 64-4.306, F.A.C.)	$1,000	$2,000
(r)	Employing unqualified personnel. (Rule 64-4.301, F.A.C.)	$1,000	$2,000
(s)	Failing to train employees on the requirements in 381.988, F.S., or department rules. (Rules 64-4.301, 64-4.312, and 64-4.313, F.A.C.)	$1,000	$2,000
(t)	Failing to maintain adequate controls against the diversion, theft, or other loss of marijuana, the tampering or compromise of samples, and the tampering or compromise of testing equipment and materials. (Rule 64-4.301 F.A.C.)	$5,000	$10,000
(u)	Failing to comply with the security requirements listed under Rule 64-4.301, F.A.C. (Rule 64-4.301, F.A.C.)	$1,000	$5,000
(v)	Failing to create, maintain, and utilize Standard Operating Procedures, including a Quality Assurance Manual addressing every aspect of its Quality Assurance program. (Rules 64-4.301, 64-4.305, and 64-4.312, F.A.C.)	$2,000	$4,000
(w)	Failing to have the Laboratory Director or authorized Employee review, amend as necessary, and approve the Testing Facility’s Quality Assurance Manual and Quality Assurance program at least once per calendar year, or whenever a change of method, equipment, or Laboratory Director occurs. (Rule 64-4.301, F.A.C.)	$500	$2,000
(x)	Failing to notify and request approval from the department in writing of all contractual relationships to change Control of the entity holding the certification, or to change its Managers, Owners, or Investors, prior to the execution of the change. (Rule 64-4.301, F.A.C.)	$5,000	$10,000
(y)	Failing to have a Laboratory Director review, approve, sign, and date each Standard Operating Procedure and each revision thereto. (Rule 64-4.305, F.A.C.)	$500	$1,000
(z)	Failing to keep the latest revised Standard Operating Procedures on Testing Facility premises or accessible to all Employees during all hours of operation. (Rule 64-4.305, F.A.C.)	$500	$1,000
(aa)	Failing to use or properly maintain testing equipment when testing Final Product. (Rules 64-4.301 and 64-4.306, F.A.C.)	$1,000	$2,000
(bb)	Failing to maintain records in accordance with department rules. (Rules 64-4.304 and 64-4.311, F.A.C.)	$1,000	$2,000
(cc)	Failing to perform internal audits. (Rule 64-4.301, F.A.C.)	$1,000	$2,000
(dd)	Utilizing a tracking system that does not have the capabilities specified in Rules 64-4.301 and 64-4.312, F.A.C. (Rules 64-4.301 and 64-4.312, F.A.C.)	$1,000	$10,000
(ee)	Failing to maintain or utilize an operational tracking system. (Rule 64-4.301, F.A.C.)	$5,000	$10,000
(ff)	Failing to obtain required background screenings. (Section 381.988(1)(d), F.S.) (Rules 64-4.301 and 64-4.314, F.A.C.)	$500	$1,000
(gg)	Failing to notify the department after becoming aware of any of the disqualifying offenses as provided in Rule 64-4.314, F.A.C. (Rule 64-4.314, F.A.C.)	$1,000	$2,000
(hh)	Failing to terminate an Employee or Manager or remove the Owner from his or her position after receiving written notice from the department that CMTL Owner, Manager, or Employee is ineligible to serve as a CMTL Owner, Manager, or Employee. (Rule 64-4.314, F.A.C.)	$1,000	$2,000
(ii)	Performing Testing Fields within Matrix Groups for which the CMTL is not approved to perform. (Rule 64-4.303, F.A.C.)	$1,000	$2,000
(jj)	Testing and providing results to an MMTC for any Target Analyte, Matrix, or other measurement for which its analysis was unsatisfactory when the CMTL has failed to satisfactorily complete two of the three most recent Proficiency Testing rounds, prior to providing the department with satisfactory Proficiency Testing Results from the required accredited body and receiving department approval to resume testing. (Rule 64-4.303, F.A.C.)	$2,000	$5,000
(kk)	Refusing to allow entry or inspection of a CMTL Testing Facility, including any vehicle utilized by a CMTL. (Rule 64-4.304, F.A.C.)	$5,000	$10,000
(ll)	Failing to cooperate or provide responses in a timely manner to the department’s inquiries during an inspection or data audit. (Rule 64-4.304, F.A.C.)	$2,500	$5,000
(mm)	Failing to resolve a deficiency or violation in the time period specified by the department or specified in a corrective action plan. (Section 381.988(7)(f), F.S.) (Rules 64-4.304 and 64-4.315, F.A.C.)	$5,000	$10,000
(nn)	Using an unapproved Analytical Method. (Rule 64-4.306, F.A.C.)	$2,000	$4,000
(oo)	Failing to demonstrate an Initial Display of Competency for a testing method prior to analyzing an Analytical Sample using the method. (Rule 64-4.306, F.A.C.)	$2,000	$4,000
(pp)	Failing to follow required field sampling protocols when sampling Final Product for testing. (Rule 64-4.307, F.A.C.)	$500	$1,000
(qq)	Failing to maintain and implement a chain of custody protocol. (Rule 64-4.307, F.A.C.)	$1,000	$2,000
(rr)	Failing to obtain an adequate number of Final Products for testing. (Rule 64-4.307, F.A.C.)	$500	$1,000
(ss)	Failing to transport samples in a manner that prevents degradation, contamination, commingling, and tampering. (Rule 64-4.307, F.A.C.)	$1,000	$2,000
(tt)	Failing to prepare Testing Samples within established timeframes. (Rule 64-4.307, F.A.C.)	$500	$1,000
(uu)	Failing to notify the department if the CMTL is unable to complete regulatory compliance testing after sampling. (Rule 64-4.307, F.A.C.)	$500	$1,000
(vv)	Failing to comply with the MMTC Regulatory Compliance Testing rule when resampling and retesting a previously failed Retail Batch. (Rule 64-4.307, F.A.C.)	$500	$5,000
(ww)	Failing to transport samples in accordance with Rule 64-4.307, F.A.C. (Rule 64-4.307, F.A.C.)	$500	$1,000
(xx)	Failing to generate a Certificate of Analysis for each Final Product tested that contains all required information as enumerated in Rule 64-4.311, F.A.C. (Rule 64-4.311, F.A.C.)	$500	$1,000
(yy)	Reporting false or inaccurate information on a Certificate of Analysis. (Rule 64-4.311, F.A.C.)	$1,000	$10,000
(zz)	Reporting Usable Whole Flower Potency at a Moisture content other than the CMTL tested Moisture content. (Rule 64-4.308, F.A.C.)	$1,000	$10,000
(aaa)	Failing to create and maintain Data Packages for every analyzed Laboratory Batch. (Rule 64-4.311, F.A.C.)	$2,000	$4,000
(bbb)	Failing to include the required information enumerated in Rule 64-4.311, F.A.C., for each Data Package. (Rule 64-4.311, F.A.C.)	$1,000	$2,000
(ccc)	Failing to have a Certificate of Analysis and Data Package reviewed by the CMTL’s Laboratory Director, or designee, prior to dissemination. (Rule 64-4.311, F.A.C.)	$500	$1,000
(ddd)	Failing to provide requested documentation to the department within the timeframe required by Rule 64-4.311, F.A.C. (Rule 64-4.311, F.A.C.)	$500	$2,000
(eee)	Failing to perform reanalysis of a failed Target Analyte in accordance with Rule 64-4.308, F.A.C. (Rule 64-4.308, F.A.C.)	$1,000	$2,000
(fff)	Failing to report testing failures to the department. (Rule 64-4.308, F.A.C.)	$5,000	$10,000
(ggg)	Failing to provide the information required under Rule 64-4.308 F.A.C., to the department after resampling and retesting a previously failed Retail Batch. (Rule 64-4.308, F.A.C.)	$1,000	$2,000
(hhh)	Failing to report Testing Samples found to contain a contaminant that could be injurious to human health. (Rule 64-4.308, F.A.C.)	$1,000	$5,000
(iii)	Failing to maintain at least one sterile untested portion of each Testing Sample in accordance with Rule 64-4.308, F.A.C. (Rule 64-4.308, F.A.C.)	$500	$1,000
(jjj)	Failing to prepare required Quality Control samples in accordance with Rules 64-4.308 and 64-4.309, F.A.C. (Rules 64-4.308 and 64-4.309, F.A.C.)	$1,000	$2,000
(kkk)	Failing to analyze required Quality Control samples within an Analytical Batch. (Rule 64-4.309, F.A.C.)	$2,500	$10,000
(lll)	Failing to evaluate Quality Control samples to the required criteria. (Rule 64-4.309, F.A.C.)	$1,000	$5,000
(mmm)	Continuing to conduct an analysis of a Quality Control sample that repeatedly falls outside of accepted criteria after reanalysis and being tested as a new Laboratory Batch. (Rule 64-4.309, F.A.C.)	$1,000	$2,000
(nnn)	Failing to generate Quality Control sample reports in accordance with Rule 64-4.309, F.A.C. (Rule 64-4.309, F.A.C.)	$1,000	$5,000
(ooo)	Failing to prepare required Calibration Standards in compliance with Rule 64-4.310, F.A.C. (Rule 64-4.310, F.A.C.)	$2,500	$5,000
(ppp)	Failing to analyze required Calibration Standards to quantitate an Analytical Batch. (Rule 64-4.310, F.A.C.)	$2,500	$5,000
(qqq)	Failing to evaluate Calibration Standards to the required criteria. (Rule 64-4.310, F.A.C.)	$2,500	$5,000
(rrr)	Using a Calibration Curve which does not meet LOD and/or LOQ requirements. (Rule 64-4.310, F.A.C.)	$2,500	$5,000
(sss)	Failing to determine the LOD in compliance with Rule 64-4.310, F.A.C. (Rule 64-4.310, F.A.C.)	$2,500	$5,000
(ttt)	Failing to manually integrate analytical peaks in compliance with Rule 64-4.312, F.A.C. (Rule 64-4.312, F.A.C.)	$2,500	$5,000
(uuu)	Failing to create and maintain retention time windows. (Rule 64-4.312, F.A.C.)	$2,500	$5,000
(vvv)	Failing to maintain proper resolution between the chromatographic peak of interest and adjacent peak(s) whether target or non-target peak(s). (Rule 64-4.312, F.A.C.)	$2,500	$5,000
(www)	Changing the Automatic Integration parameters after the Calibration Curve is established. (Rule 64-4.312, F.A.C.)	$2,500	$5,000
(xxx)	Failure to maintain integration documentation in accordance with Rule 64-4.312, F.A.C. (Rule 64-4.312, F.A.C.)	$2,500	$5,000
(yyy)	Failure to perform an annual review for all Testing Fields utilizing chromatography. (Rule 64-4.312, F.A.C.)	$2,500	$10,000
(zzz)	Failing to comply with all applicable federal and state laws and regulations for solid and liquid wastes and any applicable local regulations or ordinances. (Rule 64-4.313, F.A.C.)	$1,000	$2,000
(aaaa)	Failing to render marijuana waste unusable and unrecognizable or irretrievable in accordance with Rule 64-4.313, F.A.C. (Rule 64-4.313, F.A.C.)	$1,000	$5,000
(bbbb)	Failing to render non-hazardous waste that doesn’t meet the definition of “Marijuana Waste” unusable, unrecognizable, and unidentifiable. (Rule 64-4.313, F.A.C)	$1,000	$2,000
(cccc)	Failing to dispose of unusable and unrecognizable or irretrievable marijuana waste in accordance with Rule 64-4.313, F.A.C. (Rule 64-4.313, F.A.C.)	$1,000	$5,000
(dddd)	Failing to maintain and comply with a waste management plan in accordance with Rule 64-4.313, F.A.C. (Rule 64-4.313, F.A.C.)	$1,000	$2,000
(eeee)	Failing to maintain accurate records of generated marijuana waste in accordance with Rule 64-4.313, F.A.C. (Rule 64-4.313, F.A.C.)	$500	$1,000
(ffff)	Failing to maintain compliance with all parts of ISO/IEC 17025:2017 accreditation. (Rule 64-4.301, F.A.C.)	$1,000	$5,000
(gggg)	A violation of any other provision of s. 381.986, F.S., s. 381.988, F.S., or department rule or emergency rule. (Section 381.988(8), F.S.) (Rule 64-4.315, F.A.C.)	$100	$10,000

Rulemaking Authority Art. X, § 29, Fla. Const., 381.988(8), 381.988(9) FS. Law Implemented Art. X, § 29, Fla. Const., 381.986, 381.988 FS. History—New 6-2-26.