DOH revises regulations for Charlotte’s Web

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The Department of Health has issued a revised rule for the implementation of the state’s medicinal marijuana law. The revised draft of regulations keeps a lottery in place for the awarding of five licenses to cultivate process and dispense a cannabis extract.

“Today’s publication of a changed rule demonstrates that our focus has been to get this product to the market as soon as possible with an emphasis on patient safety,” said DOH Secretary John Armstrong. “We want to avoid unnecessary delays. We want to help children with refractory epilepsy and patients with advance cancer as quickly and safely as possible.”

The department’s revision comes after a day-long public hearing Friday and a 19 page letter seeking clarification of provisions in a proposed rule by a legislative committee which must certify the department has responded to questions and did not exceed it authority in developing the regulations.

“The publication of a changed rule could be viewed as a good-faith effort to get things right with this legislation,” said Taylor Patrick Biehl of the Medical Marijuana Business Association.

“The legislature spoke and the department listened. While the rule is not perfect as it relates to patient access, it has significantly improved as it relates to regulating the manufacturing process,” said Biehl.

The major revision in the new rule is clarification of a 25-percent ownership provision for a qualified applicant. The department will consider applications from an organization that includes 25 percent ownership by a qualified nursery or 100 percent of the owners of a nursery that meets the requirements.

The previous draft had defined an applicant as “an entity with at least 25% ownership by a nursery.” Stakeholders had complained that the department lacked the authority to do so.

“The only applicant identified in the law is a nursery in operation for 30 years and with an inventory of 400,000 plants,” said Louis Rotundo who represents the Florida Medical Cannabis Association.

The notice of change for the proposed rules sets the timetable back another 21 days before the rule may be adopted. The department must notify the Joint Procedure and Administrative Committee of the change. JPAC must then certify that the department has responded to all comments and inquiries before the department can adopt the rule. Once it is adopted then DOH will submit the rule to the Department of State and it will become effective 20 days later.

Once it is effective then applicants will have 15 days to submit an application for one of the five licenses. If there are no further challenges then the application period will close on November 4.

With a lottery remaining as a tiebreak among qualified applicants, though, some are expecting a challenge.

“A pre-qualifying for the lottery is setting up the same scenario the lottery is trying to avoid,” said Ron Watson whose client lists includes marijuana businesses. “The department believes a lottery will expedite the process but if someone gets kicked out of the pre-qualifying process, well, they will challenge.”