The state lawyer helping to draft a rule to bring low-THC marijuana to Florida said Friday that the changes to initial the rule were designed to find compromise between the concerns of potential applicants and patient needs.
“Our goal is to get the product to patients as soon as possible,’’ said Jennifer Tschetter, general counsel for the Department of Health which is drafting the rule.
She made the comments Friday at the onset of a second workshop to get feedback from marijuana industry hopefuls about a proposed new rule that will create the framework for the legal cultivation of low-THC, high-CBD marijuana in Florida for medical purposes.
Regulators have heightened the requirements for entrepreneurs who see potential profit in pot but weakened the law that limited cultivation of the crop to 30-year nurseries. The new draft says that the nurseries need only have a 25 percent ownership interest in the dispensary company to apply for a license to cultivate and distribute medical pot.
The change is likely to increase the number of applicants to the state-run lottery, but concerns persist that it could mean less emphasis on growing and extracting a quality product for sick people who qualify to use the drug.
Photo: Paige Figi, mother of Charlotte, the first child to use low-THC marijuana to treat intractable epilepsy.
More than 200 people signed up to speak at Friday's workshop as hundreds of investors flock to Florida and families of people children with intractable epilepsy, people with cancer and suffering from diseases with muscle spasms await the rule to take effect by Jan. 1.
Tschetter said the goal of the agency is that cultivation of low-THC marijuana be completed 75 days after the rule is adopted and dispensing to patients will begin within 150 days.
She also outlined the changes the agency made in the draft rule since its first proposal released a month ago. She said they agreed to compromise to allow each of the five organizations licensed to cultivate and develop the medical marijuana product to distribute their product by truck or van across the state. In return, they have heightened the standards for who will be eligible to apply for the license.
Tschetter emphasized, however, that the state continues to adhere to the principle of choosing the licensees in each of the five regions by lottery, not by the merit of their application.
Several speakers repeated their concerns that the state should decide which applicants could provide the best product to patients most quickly before it choses who will get the license via lottery.
Paige Figi, the mother of Charlotte Figi who is the first child to use low-THC marijuana to treat epilepsy, urged regulators to seek a qualitative review of applicants. "I really hope this is done properly,'' she said.
Tschetter said the decision to allow each dispensing organization to deliver its product by truck was also a compromise to address concerns that limiting each dispensing organization to one site, it was creating a virtual monopoly in each region.
DOH also modified the rule to allow nurseries to partner with other entrepreneurs and investors as long as they have at least 25 percent ownership in the company. The change, Tschetter said, was intended to address a fear by nurseries that they were putting too much of their assets at risk.
“The nursery will be an integral player but need not put all its resources on the line,’’ she said.
Among the new requirements:
- Trucks that distribute the medical marijuana product must log their time, date and travel route.
- Each nursery is eligible to make a single application and may not team up with numerous partners for numerous applications.
- Each application must include a business plan, a quality assurance plan, an emergency management plan and comply with all state and local building codes and requirements.
- The plants must be organically grown in a climate-appropriate environment with odor control and in a place where plants are protected from public view. “We want to make sure we’re pretty clear it’s not the shed out back,’’ Tschetter said.
- The end product will be rigorously tested at a state-approved lab which will test the THC and CBD levels and look for any indication of mold and heavy metals.
- If the testing lab results show that the THC and CBD levels are outside the requirements in the law, the entire batch must be destroyed.
- Each nursery is allowed a single dispensing facility but may transport its product across the state. Each dispensary must post its hours of operation online and at its site.
- Visitors to the nurseries and dispensaries must be accompanied, wear badges and be monitored.
- Businesses may modify their structure, dispensing organization plan and other elements of their application after they receive a license but only with the approval of the department.
Tschetter said the agency rejected several suggestions from the first workshop, mostly because they were not part of the law, contrary to the law or the agency didn’t believe it had the authority.
For example, it rejected the idea that pharmacists be part of the dispensary structure because the Legislature specificially exempted the medical marijuana law from the law that regulates pharmacies, she said. “So it seemed inconsisten to us to re-insert them.”
They decided not to require that companies obtain certain amounts of insurance, have an in-state partner and be prohibited from selling their business within two years of obtaining the license.
Those requirements are “not required by the law and drives up the cost,’’ Tschetter said.
She also hinted that they want to avoid any legal challenges to the final rule. “We are very mindful of getting in rule in place 20 days after its adopted,’’ she said.
The hearing is being broadcast live on the Florida Channel.