The purpose of this rule is to set forth the procedures for inspections of medical marijuana treatment centers (MMTCs) as set forth in section 381.986(10), FS. The effect is to apprise MMTCs of the requirements related to inspections and the ...

DEPARTMENT OF HEALTH

RULE NO.:RULE TITLE:

64-4.202MMTC Inspection Procedures

PURPOSE AND EFFECT:  The purpose of this rule is to set forth the procedures for inspections of medical marijuana treatment centers (MMTCs) as set forth in section 381.986(10), FS.  The effect is to apprise MMTCs of the requirements related to inspections and the procedures to be followed.

SUMMARY: This rule outlines the inspection procedures for MMTCs.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: Pursuant to section 381.986(17), FS, rules adopted pursuant to section 381.986, FS, before July 1, 2020 are not subject to ss. 120.54(3)(b) and 120.541, F.S.

RULEMAKING AUTHORITY: 381.986(10)(h), FS.

LAW IMPLEMENTED: 381.986, FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Courtney Coppola [phone] or [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64-4.202 MMTC Inspection Procedures.

(1) The department may conduct random and unannounced inspections of any MMTC facility or vehicle utilized by an MMTC.  An MMTC’s refusal to allow entry or inspection is grounds for discipline under this chapter.

(2) An MMTC must allow department personnel complete, immediate, and unrestricted access to enter, inspect, monitor, and observe all areas and operations of an MMTC's facilities, vehicles, and all areas where MMTC records are kept.  MMTCs must allow department personnel to interview MMTC personnel during any inspection.  MMTC personnel must cooperate with the department’s inspection and provide responses to inquiries.

(3) An MMTC must maintain at its facilities records necessary to substantiate its 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 department, including any department approved amendments or variances.  The MMTC must make all such records available to the department for review during any inspection.

(4) During any inspection, an MMTC must demonstrate 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 department, including any department approved amendments or variances.

(5) If during any inspection the department identifies any deficiencies or violations of section 381.986, F.S., the department’s rules, or the specific representations in the MMTC’s application(s) on file with the department, including any department approved amendments or variances, the department will send written notice of the violation to the MMTC identifying the deficiencies or violations.  Within seven calendar days of receipt of a written notice of a deficiency or violation, the MMTC must deliver to the department a written corrective action plan to resolve the deficiencies or violations.  The corrective action plan must include, at a minimum, the action steps the MMTC intends to take to resolve the deficiency or violation, the specific deadlines for each action step, and the additional steps the MMTC intends to take to prevent future deficiencies and violations. 

(6) Upon review of the corrective action plan by the department, the MMTC may be required to take specific additional action steps to cure the deficiencies or violations.  The MMTC must comply with and perform all such additional steps as directed by the department.

(7) An MMTC is subject to additional inspections by the department to confirm that the deficiencies or violations have been resolved and that the corrective action plan has been implemented.

(8) An MMTC’s failure to resolve any deficiencies or violations identified during an inspection in the time period required by the department or specified in a corrective action plan is grounds for disciplinary action pursuant to this chapter.

Rulemaking Authority 381.986(10)(h), FS. Law Implemented 381.986 FS. History – New.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Courtney Coppola, Chief of Staff and Marijuana Coordinator

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Scott A. Rivkees, MD, Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 11, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: December 10, 2019