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Becoming a Caregiver
Under Florida law, “the qualified patient's legal representative may purchase and possess for the patient's medical use up to the amount of low-THC cannabis or medical cannabis ordered for the patient, but not more than a 45-day supply, and a cannabis delivery device ordered for the patient.” Section 381.986(9)(a), Florida Statutes.
Section 381.986(1)(d) of the Florida Statutes provides that only the following persons can serve as the qualified patient’s “legal representative”:
- a parent;
- a legal guardian acting pursuant to a court's authorization as required under Section 744.3215(4), Florida Statutes;
- a health care surrogate acting pursuant to the qualified patient's written consent or a court's authorization as required under Section 765.113, Florida Statutes; or
- an individual who is authorized under a power of attorney to make health care decisions on behalf of the qualified patient.
The law contemplates that if a patient chooses to act through a “legal representative,” then the representative can participate in all aspects of the process by which a patient obtains medical marijuana, including supplying the requisite informed consent on behalf of the patient (Section 381.986(2)(h), Florida Statutes), and being registered by the physician in the compassionate use registry as the patient’s legal representative (Section 381.986(2)(e), Florida Statutes). In that regard, the Department’s regulations on compassionate use registry confirm that a dispensing organization may provide medical marijuana to a patient’s legal representative who is properly registered in the registry. Fla. Admin. Code r. 64-4.009(4)-(5).
Note on registration cards: Florida law requires the Department of Health “to establish a system for issuing and renewing registration cards for patients and their legal representatives….” Section 381.986(7)(f). Please visit the “Resources” page on the Office of Compassionate Use website for up to date information on the status of development of Rule 64-4.011 in the Department’s regulations, which will address registration cards for patients and their legal representatives. (http://www.floridahealth.gov/programs-and-services/office-of-compassionate-use/resources/index.html).
Becoming a Producer or Provider
Under Florida law, all cultivation, processing and dispensing of medical marijuana must be done by the state-approved “dispensing organizations,” meaning that each dispensing organization must be vertically integrated.
As of July 2016, six dispensing organizations have been authorized by the Department of Health to grow medical marijuana. The Department has also issued regulations governing the approval process and operation of dispensing organizations.
Note: According the website of the Office of Compassionate Use, the Department of Health presently is not accepting any new applications to become a dispensing organization.
Florida law charged the Department of Health with developing a form for applying to become a “dispensing organization.” A copy of that form may be viewed here: http://www.floridahealth.gov/programs-and-services/office-of-compassionate-use/_documents/64-4-application-dh8006.pdf
The requirements for becoming a dispensing organizations are set forth in Section 381.986(5)(b) of Florida Statutes. The law requires, among other things, that a party interested in becoming a provider must be able to cultivate at least 400,000 plants and must have been in business as a registered nursery for at least 30 consecutive years prior to becoming a dispensing organization. Additional application requirements, including application fee, are set forth in Rule 64-4.002 of the Department’s regulations.
Both the statute and the regulations require each dispensing organization to employ a “medical director,” who must be a physician licensed pursuant to Chapters 458 or 459 of the Florida Statutes. To serve as a medical director, the physician is required to take a 2-hour continuing education course and examination, which can be accessed at the following link: http://www.flcannabisce.com/
Renewal/Termination/Suspension of Registration
Each dispensing organization must renew its registration every two years and pay a renewal fee.
The Department may decline to renew a dispensing organization’s approval if the organization commits any of the violations set forth in Section 381.986(7)(g). Any of those violations also provide grounds for revoking or suspending the organization’s approval. Additional grounds for revocation are set forth in Rule 64-4.004 of the Department’s regulations. Specifically, the Department is required to revoke approval if the dispensing organization
- begins cultivating cannabis before obtaining department authorization; or
- knowingly dispenses marijuana products to an individual other than a qualified patient or a qualified patient's legal representative without noticing the department and taking appropriate corrective action.
Manufacturing, Labeling and Dispensing Requirements
Section 381.986(6) sets forth the requirements that dispensing organizations must follow when cultivating, processing and dispensing medical marijuana. Below is a summary of key requirements concerning the operation of dispensing organizations.
In growing medical marijuana, the dispensing organization:
- may only use approved pesticides;
- must grow medical marijuana in enclosed space and separate from any other plants;
- must inspect the seeds and plants for pests and notify the agriculture department within 10 days if a plant is infested or infected;
- must perform fumigation, treatment and removal and destruction in accordance with Chapter 581, Florida Statues.
In processing medical marijuana, the dispensing organization:
- must process medical marijuana in enclosed space and separate from any other plants;
- must test low-THC cannabis to ensure its compliance with statutory limitations on THC content;
- must test all medical marijuana to ensure that it is safe for human consumption;
- must keep records of all testing;
- must contract with an independent laboratory to perform audits of the dispensing organization’s operations;
- must package the products in accordance with U.S. Poison Prevention Packaging Act of 1970 (15 U.S.C. §§ 1471 et seq.)
- must affix a label indicating the origins of the product and that the product is safe for human consumption.
When dispensing medical marijuana, the dispensing organization must ensure that every order being dispensed does not exceed a 45-day supply.
Additionally, at that the time of dispensing, the organization’s employee must (i) enter his name and identifying information into the compassionate use registry at the time of dispensing the product; (ii) verify in the registry that the physician has ordered the specific marijuana product and/or delivery device that the patient has asked to be filled; (iii) record the date, time and quantity and form of the product being filled.
No dispensing activities may take place between the hours of 9 p.m. and 7 a.m.
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