Office of Compassionate Use Notice of Proposed Regulation
The Department of Health, Office of Compassionate Use hereby provides notice of its proposed regulation pursuant to the Department's authority under Article X, Section 29, of the Florida Constitution. The person to be contacted regarding the proposed regulation or to submit comments is: Courtney Coppola at Courtney.Coppola@flhealth.gov.
THE TEXT OF THE PROPOSED REGULATION IS:
1-1.01 Medical Marijuana for Debilitating Medical Conditions
(1) For the purposes of this chapter, in accordance with Article X, Section 29, Fla. Const., the following definitions shall apply:
(a) “Fla. SB 8-A (2017)” shall mean the enrolled version dated June 9, 2017 available at: https://www.flsenate.gov/Session/Bill/2017A/8A/BillText/er/PDF.
(b) “Medical Marijuana Treatment Center (MMTC)” shall have the meaning provided in Article X, Section 29, Fla. Const.
(c) “Caregiver” shall have the same meaning as provided in s. 381.986(1)(a), F.S. as amended by Fla. SB 8-A (2017) and must meet the requirements of s. 381.986(6), F.S. as amended by Fla. SB 8-A (2017) provided however, that a Caregiver shall not be required to complete the certification course provided in s. 381.986(6)(a)(5) F.S. as amended by Fla. SB 8-A until such course has been developed by the Department of Health.
(d) “Close Relative” shall have the same meaning as provided in s. 381.986(1)(c), F.S. as amended by Fla. SB 8-A (2017).
(e) “Medical use” shall have the same definition as medical use in s. 381.986(1)(j), F.S. as amended by Fla. SB 8-A (2017).
(f) “Qualified patient” shall mean a qualified patient as defined by s. 381.986(1)(l), F.S., as amended by Fla. SB 8-A (2017).
(g) “Qualifying debilitating medical condition” shall have the same meaning as a Qualifying Medical Condition as provided in s. 381.986(2), F.S. as amended by Fla. SB 8-A (2017).
(h) The 70 day supply limitation set forth in s. 381.986(8)(e)13.b., F.S. as amended by Fla. SB 8-A (2017), shall be an adequate supply for a qualifying patient’s medical use.
(i) “Qualified physician” has the same meaning as s. 381.986(1)(m), F.S. as amended by Fla. SB 8-A (2017). A qualified physician must meet the requirements of s. 381.986(3), F.S. as amended by Fla. SB 8-A (2017).
(j) “Physician certification” has the same meaning as s. 381.986(1)(k), F.S. as amended by Fla. SB 8-A (2017) and may be issued by a qualified physician pursuant to the requirements of s. 381.986(4), F.S. as amended by Fla. SB 8-A (2017).
(2) All MMTCs, physicians, patients, and caregivers must be registered in the online Compassionate Use Registry as required by Rule 64-4.009, F.A.C. All orders for medical marijuana must be entered into the registry for processing accordingly.
(3) All patients and caregivers must have a valid Compassionate Use Registry identification card to obtain medical marijuana or a medical marijuana delivery device as required by Rule 64-4.011, F.A.C.
(4) Each prospective caregiver shall present to Florida Department of Law Enforcement or one of its approved vendors for fingerprinting. At that time, a prospective caregiver shall provide the entity ORI number FL924890Z. The report will be sent directly to the Department of Health.
(5) Any entity that holds an active, unrestricted license to cultivate, process, transport, and dispense low-THC cannabis, medical cannabis, and cannabis delivery devices, under s. 381.986, F.S. (2016) shall be registered as an MMTC upon certification to the Department of Health that the prospective MMTC meets the requirements set forth in s. 381.986(8), F.S. as amended by Fla. SB 8-A (2017). If Fla. SB 8-A (2017) becomes law, the Department of Health shall immediately begin the process to implement regulations and or rules as necessary to register additional MMTCs pursuant to the requirements and limitations set forth in s. 381.986(8), F.S. as amended by Fla. SB 8-A (2017).
(6) All MMTCs shall be held to the representations made within its initial application for licensure and shall be subject to the operational and licensing requirements of s. 381.986(8), F.S. as amended by Fla. SB 8-A (2017). All MMTC’s are subject to the inspections and penalties set forth in s. 381.986(10), F.S. as amended by Fla. SB 8-A (2017)
(7) All MMTCs shall follow record keeping standards through a seed-to-sale tracking system as set forth in s. 381.986, F.S., as amended by Fla. SB 8-A (2017).
(8) All MMTCs shall abide by the security, product testing, labeling and safety standards set forth in s. 381.986, F.S as amended by Fla. SB 8-A (2017).
Regulation Authority Art. X, § 29(d), Fla. Const. History – New ______.
