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    DEPARTMENT OF HEALTH

    RULE NO.:RULE TITLE:

    64-4.001Definitions

    NOTICE OF CHANGE

    Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 44 No. 85, May 1, 2018 issue of the Florida Administrative Register.

    These changes are in response to written public comments and comments submitted by the Joint Administrative Procedures Committee staff:

    64-4.001 Definitions.

    For the purposes of Department of Health (the “department”) medical marijuana treatment center rules and regulations, the following words and phrases shall have the meanings indicated:

    (1) Applicant – An individual or entity that meets the requirements of section 381.986(8)(b), F.S., and applies for registration as a medical marijuana treatment center pursuant to section 381.986(8)(a), F.S., excluding subparagraph 1 and sub-subparagraph 2.a.  

    (2) Approval – Written notification from the department to an applicant that its application for registration as a medical marijuana treatment center has been found to be in compliance with the provisions of section 381.986, F.S., and department rules has been selected pursuant to the comparative review process set forth in Rule 64-4.002, F.A.C., and that the department is awaiting notification that the medical marijuana treatment center is prepared to be inspected and authorized to begin cultivation, processing, and dispensing.

    (2)(3) Certified Financials – Financial statements that have been audited in accordance with Generally Accepted Auditing Standards (GAAS) by a Certified Public Accountant, licensed pursuant to Chapter 473, F.S.

    (3)(4) Cultivation – The preparation of any soil or other medium for the planting of marijuana or the tending and care or harvesting of marijuana intended to be dispensed by a medical marijuana treatment center for medical use by a qualified patient.

    (4)(5) Cultivation Authorization – Written notification by the department to a medical marijuana treatment center that it may begin cultivating marijuana.

    (5)(6) Cultivation Facility – Any area designated in the application to be used for cultivation of marijuana.

    (6)(7) Derivative Product – Forms of marijuana suitable for medical use routes of administration.

    (7)(8) Dispensing Authorization – Written notification by the department to a medical marijuana treatment center that it may begin dispensing derivative product.

    (8)(9) Dispensing Facility – Any area designated to be in the application that is accessible by the public and where derivative product and marijuana delivery devices will be are dispensed at retail.

    (9)(10) Employee – Any person whose duties involve any aspect of the cultivation, processing, transportation or dispensing of marijuana whether or not compensated for the performance of such duties. 

    (10)(11) Financial Statements – A presentation of financial data, including accompanying notes, derived from accounting records, that purports to show actual or anticipated financial position and intended to communicate an entity's economic resources or obligations at a point in time, and the results of operations and cash flows for a period of time, in accordance with generally accepted accounting principles or a comprehensive basis of accounting other than generally accepted accounting principles. Financial presentations included in tax returns are not financial statements. The method of preparation (for example, manual or computer preparation) is not relevant to the definition of a financial statement.

    (11)(12) Fulfillment and Storage Facility – Any area designated in the application, which is not open to the public, to be used for order fulfillment, shipping, transportation, or storage of low-THC cannabis, medical marijuana, derivative product or marijuana delivery devices.

    (12)(13) Interests – Any form of ownership in or control of an applicant or a medical marijuana treatment center, including, but not limited to, ownership of stock, membership interests, partnership interests, a sole proprietorship or otherwise which convey to the holder thereof an ownership right or an interest in or right to the profits, capital, or voting with respect to such applicant or medical marijuana treatment center.

    (13)(14) Majority Ownership – Ownership of more than 50% of the interests of an applicant or registered medical marijuana treatment center, such ownership being determined by application of the requirements in paragraph (15)(16) below.

    (14)(15) Manager – Any person with the authority, directly or indirectly, to exercise or contribute to the operational control, direction or management of an applicant or a medical marijuana treatment center or who has direct or indirect authority to supervise any employee of an applicant or a medical marijuana treatment center. The term shall be interpreted broadly and shall include, but not be limited to, all officers, managers, and members of board of directors as well as any other person engaged to undertake management or control of the applicant or a medical marijuana treatment center or any person or persons in control of an entity engaged to undertake management or control of the applicant or medical marijuana treatment center.

    (15)(16) Owner – Any person who, directly or indirectly, owns (actually or beneficially) or controls, a 5% or greater share of interests of the applicant or a medical marijuana treatment center. In the event that one person owns a beneficial right to interests and another person holds the voting rights with respect to such interests, then in such case, both shall be considered the owner of such interests. In determining the owners of the applicant or a medical marijuana treatment center, the attribution of ownership rules set forth in the Treasury Regulations cited as 26 CFR 1.414(c)-4(b) and (c) (4-1-17 edition), incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX, shall apply, but with the following exceptions and additions:

    (a) The use of the term “option” in 26 CFR 1.414(c)-4(b) shall be interpreted broadly to include, but not be limited to, any and all options, warrants, calls, rights of first refusal and any other right to acquire an interest (as defined herein), whether such right is vested or unvested and regardless of whether such right is then exercisable or becomes exercisable at a future date or upon the occurrence of a future event.

    (b) The exception for attribution of a spouse’s interest, as defined in subsection paragraph (132) above and as set forth in 26 CFR 1.414(c)-4(b)(5)(ii), shall not apply.

    (c) The age limitation contained in 26 CFR 1.414(c)-4(b)(6) shall apply only to children who have not attained the age of 18 years. The term “interest” as used in 26 CFR 1.414(c)-4(b)(6) shall have the meaning as set forth in paragraph (132) above. 

    (d) In the event that a person under the age of 18 owns or is deemed an owner of an interest, such person must be disclosed to the department. Persons under the age of 18 shall be required to submit to a background screening unless only in the event that the interest or ownership is was not imputed to another family member or guardian as outlined in paragraph (156)(c) above.

    (e) To the extent that the above alterations to the provisions of 26 CFR 1.414(c)-4 alter the outcome of any of the examples set forth therein, then, in such case, such example does not apply.

    (f) As used in 26 CFR 1.414(c)-4(b)(3), the term “actuarial interest” shall be interpreted broadly and shall include, but not be limited to, the right of a beneficiary of a trust or an estate to receive either income or principal distributions with respect to an interest held by such trust or estate.

    (g) With regard to publicly traded companies with ownership interests in the applicant, any person who holds 10% or more interest in the publicly traded company shall be considered an owner.

    (16)(17) Processing Authorization – Written notification by the department to a medical marijuana treatment center that it may begin processing marijuana to derivative product.

    (17)(18) Processing Facility – Any area designated in the application to be used for processing of derivative product.

    (18)(19) Registration as a Medical Marijuana Treatment Center – Approval and Llicensure as a medical marijuana treatment center pursuant to section 381.986(8), F.S.

    (19)(20) Resident – A person who meets the requirements of section 381.986(5)(b), F.S.

    (20)(21) Routes of Administration – The forms of marijuana and delivery devices, as certified by a qualified physician, as the appropriate method for the derivative product to be taken into the body of the qualified patient, as certified by a qualified physician, but does not include smoking.

    Rulemaking Authority 381.986(8)(b) FS. Law Implemented 381.986 FS. History–New 6-17-15, Amended            .

Document Information

Related Rules: (1)
64-4.001. Definitions