Definitions

 

DEPARTMENT OF HEALTH

RULE NO.:  RULE TITLE:

64ER17-1Definitions

SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC, HEALTH, SAFETY, OR WELFARE:  Pursuant to Chapter 2017-232, § 14, at 45, Laws of Florida, the Department is not required to make findings of an immediate danger to the public, health, safety, or welfare.

REASONS FOR CONCLUDING THAT THE PROCEDURE USED IS FAIR UNDER THE CIRCUMSTANCES:

The Department of Health is directed by Chapter 2017-232, § 14, at 45, Laws of Florida, to adopt emergency rules to implement section 381.986, Florida Statutes.

SUMMARY:  Emergency rule 64ER17-1 (64-4.001) provides the definitions necessary to implement the statutory changes creating medical marijuana treatment centers in Florida.

THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS: Courtney Coppola at [e-mail].

 

THE FULL TEXT OF THE EMERGENCY RULE IS:

 

(Substantial rewording of Rule 64-4.001 follows. See Florida Administrative Code for present text.)

64ER17-1 (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)2.b. and c., F.S.

(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 department rules and regulations 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.

(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.

(4) Contingent licensee – An applicant that has been granted approval contingent upon the initial registration of 100,000 active patients in the Medical Marijuana Use Registry in accordance with section 381.986(8)(a)4., F.S.

(5) Cultivation – Growth of marijuana plant source material.

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

(7) Cultivation facility – Any area designated in the application to be used for cultivation of marijuana

(8) Derivative product – Forms of marijuana suitable for routes of administration.

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

(10) Dispensing facility – Any area designated in the application where derivative product and marijuana delivery devices are dispensed at retail.

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

(12) 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.

(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 and 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. 

(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 subsection (16) below.

(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.  

(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),as incorporated by reference and available at http://www.floridahealth.gov/programs-and-services/office-of-medical-marijuana-use/mmtc-applicants/index.html, 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 (13), as set forth in 26 CFR 1.414(c)-4(b)(5)(ii) is eliminated and shall not apply.

(c) The age limitation contained in 26 CFR 1.414(c)-4(b)(6) is amended to 18 years. The term interest as used in 26 CFR 1.414(c)-4(b)(6) shall have the meaning as set forth in subsection (13). 

(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 only be required to submit to a background screening in the event that the interest or ownership was not imputed to another family member or guardian as outlined in paragraph (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 is deemed eliminated.

(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.

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

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

(19) Registration – Approval and licensure as a medical marijuana treatment center pursuant to section 381.986(8), F.S.

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

(21) Routes of administration – means the path by which a derivative product is ordered by a physician to be taken into the body of the qualified patient, but does not include smoking.

Rulemaking Authority 381.986(8)(b) FS. Law Implemented 381.986 FS. History–New 6-17-15, Amended 9-19-17.

 

THIS RULE TAKES EFFECT UPON BEING FILED WITH THE DEPARTMENT OF STATE UNLESS A LATER TIME AND DATE IS SPECIFIED IN THE RULE.

EFFECTIVE DATE: September 19, 2017