The Florida Department of Health, Office of Compassionate Use (“DOH”), released its newly revised draft rule to implement the Compassionate Medical Cannabis Act of 2014, commonly referred to as “Charlotte’s Web,” after holding a workshop on December 30, 2014. DOH released the draft rule on Thursday, January 15, 2015. The draft rule is considered a first draft and will be followed by additional drafts that will be finalized prior to a negotiated rulemaking proceeding that will take place before a negotiating committee and a mediator. An eight-member negotiating committee will be selected from members of representative groups, including a plant nursery, a qualified patient/representative, a testing laboratory, a member of The Florida Bar experienced in administrative law, an individual experienced in agricultural practices and regulation, a physician authorized to order low-THC cannabis, an individual with experience in establishing/navigating regulatory structures for cannabis, and representatives from the DOH.
The negotiated rulemaking proceeding will take place on the following dates, times, and location:
February 4, 2015, 8:00 a.m. – 10:00 p.m.
February 5, 2015, 8:00 a.m. until concluded
Department of Health, Room 301
4052 Bald Cypress Way
Tallahassee, FL 32399
The purpose of this proceeding is to address the regulatory structure of the new draft rule and requires the negotiating committee to bargain and agree to mutually acceptable rules. The January 15 draft rule makes several changes to the previously written proposed rules that were struck down by an administrative law judge in November 2014. Some of the important changes are as follows:
- Eligible dispensing organizations must detail, among other requirements, their technical and technological ability to cultivate and produce low-THC cannabis in detail. This requirement was absent from previous draft rules.
- Applicants must submit an application fee; however, the draft rule does not state the amount, leaving it open to negotiation. The prior draft rules required a non-refundable $150,000 application fee.
- The lottery system for the selection of five dispensing organizations has now been replaced with a competitive selection process that will use DOH Form “Scorecard for Low-THC Cannabis Dispensing Organization Selection” that incorporates the detailed requirements set forth in the rule. The applicant with the highest aggregate score for each respective region will be selected as the region’s dispensing organization. (Note, there will be five regions within the state.)
- The selection of the five dispensing organizations will be completed by a selection committee comprised of the Director of the Office of Compassionate Use, a member of the Drug Policy Advisory Council appointed by the State Surgeon General, and a certified public accountant appointed by the State Surgeon General.
For a copy of the draft rule, please click here.