29525168, 64-4.300 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 29525168

Notice of Proposed Rule

Department:

DEPARTMENT OF HEALTH

Chapter:

COMPASSIONATE USE

Overview

RULE:

64-4.300	CMTL Definitions
64-4.301	Requirements for CMTL Certification and Application
64-4.302	Renewal Application Requirements for CMTLs
64-4.303	CMTL Testing
64-4.304	CMTL On-Site Inspection
64-4.305	CMTL Standard Operating Procedures
64-4.306	CMTL Testing Methods
64-4.307	CMTL Submission for Product Testing
64-4.308	CMTL Sample Testing
64-4.309	CMTL Quality Control Samples
64-4.310	CMTL Calibration Standards
64-4.311	CMTL Certificate of Analysis
64-4.312	CMTL Manual Integration
64-4.313	CMTL Waste Management and Disposal
64-4.314	CMTL Background Screening
64-4.315	CMTL Fines, Suspension, and Revocation

PURPOSE:

This rulemaking initiates nonemergency rulemaking to replace the emergency rules (64ER20-1, 64ER20-3, 64ER20-4, 64ER20-6, 64ER20-7, 64ER20-10, 64ER20-11, 64ER20-12, 64ER20-14, 64ER20-15, 64ER20-38, 64ER20-39, 64ER21-6, 64ER22-5, 64ER22-6) adopted by the Department to implement sections 381.986 and 381.988, Florida Statutes.

SUMMARY:

Rule 64-4.300, F.A.C. supersedes and amends Emergency Rule 64ER20-1 by providing additional definitions necessary to clarify and interpret the rules relating to certified marijuana testing laboratories (CMTLs). Rule 64-4.301, F.A.C., supersedes and amends Emergency Rule 64ER20-14 by updating the CMTL initial application fee and providing additional requirements on a CMTL’s Quality Assurance program and tracking system capabilities. Rule 64-4.302, F.A.C., supersedes and amends Emergency Rule 64ER22-6 by clarifying the requirements and process for the renewal of a CMTL certification. Rule 64-4.303, F.A.C., supersedes and amends Emergency Rule 64ER20-3 by updating the procedures and requirements for Proficiency Testing conducted by CMTLs. Rule 64-4.304, F.A.C., supersedes and amends Emergency Rule 64ER20-4 by clarifying procedures relating to the Department’s inspections of a CMTL. Rule 64-4.305, F.A.C., supersedes and amends Emergency Rule 64ER20-6 by clarifying the requirements for Standard Operating Procedures created by CMTLs. Rule 64-4.306, F.A.C., supersedes and amends Emergency Rule 64ER20-7 by clarifying the permissible testing methods to be used by CMTLs. Rule 64-4.307, F.A.C., supersedes and amends Rule 64ER20-38 by clarifying and adding requirements for the collecting, tracking, transporting, and storing samples of Final Products from medical marijuana treatment centers for Regulatory Compliance Testing by CMTLs. Rule 64-4.308, F.A.C., supersedes amends Emergency Rule 64ER20-39 by clarifying and updating requirements for sample testing of Final Products by CMTLs.  Rule 64-4.309, F.A.C., supersedes and amends Emergency Rule 64ER20-10 by clarifying and updating requirements for quality control samples used by CMTLs. Rule 64-4.310, F.A.C., supersedes and amends Emergency Rule 64ER20-11 by clarifying the requirements for calibration standards and Limit of Detection determinations made by CMTLs. Rule 64-4.311, F.A.C., supersedes and amends Emergency Rule 64ER20-12 by enhancing and clarifying requirements for Certificates of Analysis generated by CMTLs. Rule 64-4.312, F.A.C., establishes guidelines and requirements for performing, documenting, and reviewing integrations and chromatography conducted by a CMTL. Rule 64-4.313, F.A.C., supersedes and amends Emergency Rule 64ER21-6 by clarifying procedures for managing and disposing of waste by CMTLs. Rule 64-4.314, F.A.C., supersedes and amends Emergency Rule 64ER20-15 by clarifying requirements for the level 2 background screenings of CMTL employees, owners, and managers as required by section 381.988, F.S. Rule 64-4.315, F.A.C., supersedes and amends Emergency Rule 64ER22-5 by establishing guidelines related to fines, suspension, and revocation imposed upon a CMTL for violations of rule and statute.

RULEMAKING AUTHORITY:

Art. X, § 29, Fla. Const., 381.986(8)(e)11.d., 381.986(8)(k), 381.988(2), 381.988(3), 381.988(9), 943.05(2)(h)3., FS.

LAW:

Art. X, § 29, Fla. Const., 381.986, 381.988, 943.05, FS.

PRINT PUBLISH DATE:

4/30/2025 Vol. 51/84

COMMENTS:

From 4/30/2025 To 5/21/2025 (21 Days)
The public comment period for this notice has already expired.

REFERENCE MATERIALS:

No reference(s).

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