Application Requirements for Medical Marijuana Treatment Centers  

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    DEPARTMENT OF HEALTH

    RULE NO.:  RULE TITLE:

    64ER17-2Application Requirements for Medical Marijuana Treatment Centers

    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 64ER17-2 (64-4.002) provides the application requirements and process necessary to apply and be approved for registration as a medical marijuana treatment center.

    THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS: Courtney Coppola at Courtney.Coppola@flhealth.gov.

     

    THE FULL TEXT OF THE EMERGENCY RULE IS:

     

    (Substantial rewording of Rule 64-4.002 follows. See Florida Administrative Code for present text.)

    64ER17-2 (64-4.002) Application for Registration of Medical Marijuana Treatment Centers.

    Pursuant to section 381.986, F.S., all applicants seeking registration with the department as a medical marijuana treatment center shall comply with the registration process detailed below. The registration process set forth in this regulation does not apply to individuals requesting registration pursuant to section 381.986(8)(a)2.a., F.S.

    (1) Each individual or entity that meets the requirements of section 381.986(8)(b), F.S., desiring to be registered as a medical marijuana treatment center pursuant to section 381.986, F.S., shall submit an application to the department using Form DH8013-OMMU-08/2017, “Application for Medical Marijuana Treatment Center Registration” herein incorporated by reference and available at http://www.floridahealth.gov/programs-and-services/office-of-medical-marijuana-use/mmtc-applicants/index.html. The application must comply with the page limits, blind grading, format, and organization instructions detailed in the application. The application, once submitted to the department, shall be considered final. The department will not accept any amendments or supplements to the initial application. The applicant must include with the application at the time of submission, the following:

    (a) A non-refundable application fee of $60,830.00.

    (b) Written documentation from the Department of State or the Department of Revenue, as applicable under Florida law, demonstrating that the applicant has been registered to do business in Florida for the prior five consecutive years and that the applicant possesses a valid certificate of registration issued by the Department of Agriculture and Consumer Services pursuant to section 581.131, F.S. The name of the applicant as submitted to the department must match the name on any documents provided in accordance with this paragraph.

    (c) A list of all owners, officers, board members, and managers indicating the date of each individual’s most recent Level-2 background screening pursuant to section 381.986(9), F,S, within the calendar year prior to application. Each owner, officer, board member, and manager shall go to the Florida Department of Law Enforcement (FDLE) or one of its approved vendors for fingerprinting and, at such time, shall give to FDLE or the FDLE approved vendor the entity ORI number FL924890Z (DOH – OFFICE OF MEDICAL MARIJUANA USE). The report will be sent directly to the Office of Medical Marijuana Use. To be eligible for registration, all of the applicant’s owners, officers, board members, and managers must have successfully passed a Level-2 background screening.

    (d) For applicants seeking registration pursuant to section 381.986(8)(a)2.b., F.S., the applicant must provide evidence that it is majority-owned by (an) African-American farmer(s) who:

    1. Is a recognized class member of Pigford v. Glickman, 185 F.R.D. 82 (D.D.C. 1999) (Pigford) or In re Black Farmers Discrimination Litigation, 856 F. Supp. 2d 1 (D.D.C. 2011) (BFDL). Examples of acceptable evidence include:

    a. Documentation from Poorman-Douglass Corporation (now Epiq Systems Inc.) that the applicant received a consent decree case number in Pigford;

    b. Documentation that the applicant was granted class status by the Pigford adjudicator;

    c. Court documents or United States Department of Agriculture (USDA) documents showing that the applicant received judgment discharging debt, providing a cash payment, or providing injunctive relief in Pigford;

    d. Documentation that the applicant was determined to be a class member by Epiq Systems Inc. in BFDL;

    e. Documentation that the applicant received a settlement award in BFDL; or

    f. Other court documents or USDA documents demonstrating that the applicant was granted class member status in either Pigford or BFDL.

    2. Is currently a member of the Black Farmers and Agriculturists Association – Florida Chapter.

    3. A letter from the Black Farmers and Agriculturists Association – Florida Chapter certifying that the applicant meets subparagraph 1. and 2. will be accepted as sufficient evidence that the applicant qualifies for registration pursuant to section 381.986(8)(a)2.b., F.S.

    4. Applicants seeking registration pursuant to section 381.986(8)(a)2.b., F.S., are exempt from the evidentiary requirements of paragraph (1)(b) above and therefore, are also exempt from the provisions of paragraph (3)(b) below. However, if an applicant wishes to be considered under both sections 381.986(8)(a)2.b. and 381.986(8)(a)2.c., F.S., the applicant must provide the documentation required in paragraph (1)(b).

    (e) For applicants seeking preference for registration pursuant to section 381.986(8)(a)3., F.S., the applicant must provide evidence that:

    1. The property at issue currently is or was previously used for the canning, concentrating, or otherwise processing of citrus fruit or citrus molasses. In order to demonstrate the property meets this criteria the applicant may provide documentation that the applicant currently holds or has held a registration certificate or a citrus fruit dealer license pursuant to sections 601.40 and 601.55, F.S, respectively. A letter from the Department of Citrus certifying that the property currently is or was previously used for the canning, concentrating, or otherwise processing of citrus fruit or citrus molasses will be accepted as sufficient evidence;

    2. The applicant as an individual holds, in his or her name, or the applicant as an entity holds, in the legal name of the entity the deed to property meeting the criteria set forth in subparagraph 1. above; and

    3. A brief explanation of how the property will be used for purposes of growing, processing or dispensing medical marijuana if the applicant is awarded a license.

    (2) If the applicant intends to claim any exemption from public records disclosure under section 119.07, F.S., or any other exemption from public records disclosure provided by law for any part of its application, it shall indicate on the application the specific sections for which it claims an exemption and the statutory basis for the exemption. The applicant shall submit a redacted copy of the application redacting those items identified as exempt concurrent with the submission of the application for approval under subsection (4) below. Failure to provide a redacted copy of the application at the time of submission, or failure to identify and redact information claimed as trade secret will result in the release of all application information in response to a public records request unless the information falls under another public records exemption. All identified trade secrets are subject to the department review in accordance with section 381.83, F.S.

    (3) Failure to provide the following at the time of submission of the application shall result in the application being denied prior to any scoring as contemplated in subsection (5) of this regulation:

    (a) The $60,830.00 application fee; 

    (b) Documentation required under paragraph (1)(b); or

    (c) The list of owners, officers, board members, and managers required under paragraph (1)(c).

    (4) The department shall publish in the Florida Administrative Register and on its website the date upon which the department will begin accepting applications and the deadline to receive all applications. Applications and all required exhibits and supporting documents shall be hand delivered to the Department of Health at 4052 Bald Cypress Way in Tallahassee, Florida, during normal business hours, but no earlier than 10:00 a.m. (Eastern Time), on the date the department begins accepting applications and no later than 5:00 p.m. (Eastern Time) on the last date upon which the applications are accepted. Applications submitted after 5:00 p.m. Eastern Time on the final day of the application period will be denied. 

    (5) Subject matter experts will substantively and comparatively review, evaluate, and score applications using Form DH8014-OMMU-08/2017, “Scorecard for Medical Marijuana Treatment Center Selection” herein incorporated by reference and available at http://www.floridahealth.gov/programs-and-services/office-of-medical-marijuana-use/mmtc-applicants/index.html.

    (a) The subject matter experts shall have the following qualifications:

    1. Subject matter experts reviewing Sections 1-3 of the application, the cultivation components, shall have at least 2 years of professional experience or advanced degree in one of the following areas: agriculture, horticulture, or agronomy, or comparable field.

    2. Subject matter experts reviewing Sections 4-5 of the application, the processing components, shall have at least 2 years of professional experience or advanced degree in chemistry, biology, or biochemistry.

    3. Subject matter experts reviewing Sections 6-8 of the application, the dispensing components, shall have at least 2 years of professional experience or advanced degree in industrial engineering, supply chain management, or strategic management.

    4. Subject matter experts reviewing Sections 9, 10, 12, and 16 of the application, the compliance components, shall have at least 2 years of professional experience or advanced degree related to operating a business in a highly regulated environment.

    5. Subject matter experts reviewing Section 13 of the application shall have at least 2 years of management experience within a business operating in a regulated industry or at least 2 years of experience working in human resources.

    6. Subject matter experts reviewing Section 11 of the application shall have at least 2 years of management experience within a business operating in the health care industry or an active, unrestricted license as a medical doctor or doctor of osteopathic medicine.

    7. Subject matter experts reviewing Sections 14-15 of the application, the legal and financial components, shall have an active CPA license or an active license to practice law and experience in business structuring.

    Subject matter experts will certify that they do not have a conflict of interest and will evaluate and score each section of the application according to the rubric set forth in DH8014-OMMU-08/2017.

    (b) Scores for each Section of the application will be combined to create an applicant’s total score. The department shall generate a final ranking of the applicants in order of highest to lowest scores. Any application which demonstrates a failure to comply with the minimum statutory requirements for cultivation, processing, dispensing, security, or general operations, as identified in DH8014-OMMU-08/2017, shall be denied and will not be considered in the final ranking of applications. 

    (c) In accordance with section 381.986(8)(a)3., F.S., the two highest scoring applicants that own one or more facilities that are, or were, used for the canning, concentrating, or otherwise processing of citrus fruit or citrus molasses and will use or convert the facility or facilities for the processing or marijuana will receive an additional 35 points to their respective total score.

    (6) Licenses will be awarded, subject to availability, as set forth in s. 381.986(8)(a)2., F.S., based on the highest total score in the following manner:

    (a) The highest scoring applicant that is a recognized member of Pigford or BFDL and a member of the Black Farmers and Agriculturalists Association-Florida Chapter, will receive a license

    (b) The remaining highest scoring applicants, after the addition of the preference for applicants that own citrus and molasses facilities, will receive licenses up to the statutory cap set forth in section 381.986(8)(a)2., F.S.

    (c) The next four highest scoring applicants, after removing any preference points for citrus applicants provided under paragraph (5)(c) above, will receive notification of approval as contingent licensees. The contingent license will not become active until such time as the department provides notification of the registration of 100,000 active patients in the Medical Marijuana Use Registry. The department will provide notification to the contingent licensee of the activation of its license within 30 days of the registration of the first 100,000 active patients.

    (d) In the event of a tie, the following tiebreakers will be applied:

    1. The first tiebreaker shall be the score for Section 14 – Financials: Certified Financial Documents. The applicant with the highest score in Section 14 shall be awarded a license. In the event that this does not resolve the tie:

    2. The second tiebreaker shall be the score for Section 15 – Financials: Business Structure. The applicant with the highest score in Section 15 shall be awarded a license. In the event that this does not resolve the tie:

    3. The third tiebreaker shall be the score for Section 13 – Diversity Plan. The applicant with the highest score in Section 13 shall be awarded a license. In the event that this does not resolve the tie:

    4. The final tiebreaker shall be the score for Section 10 – Accountability: Operations.

    (7) Upon notification that it has been approved as a medical marijuana treatment center as an active license, the applicant shall have 10 business days to:

    (a) Post a performance bond, provide an irrevocable letter of credit payable to the department or provide cash to the department in the amount of $5 million (collectively “financial assurance”) pursuant to section 381.986(8)(b)7., F.S. If a bond is provided, the bond shall:

    1. Be payable to the department in the event the medical marijuana treatment center’s approval is revoked;

    2. Be written by an authorized surety company rated in one of the three highest rating categories by a nationally recognized rating service; and

    3. Be written so that the individual or entity name on the bond corresponds exactly with the applicant name.

    4. The surety company can use any form it prefers for the performance bond as long as it complies with this regulation. For convenience, the surety company can use Form DH8015-OMMU-08/2017, “Florida Medical Marijuana Performance Bond” herein incorporated by reference and available at              http://www.floridahealth.gov/programs-and-services/office-of-medical-marijuana-use/mmtc-applicants/index.html.

    (b) Provide documentation supporting representations related to property ownership and/or leases made in the application.

    (8) If a financial assurance is canceled or revoked in any manner and the medical marijuana treatment center fails to provide new financial assurance to the department in the required amount on or before the effective date of cancellation or revocation, the medical marijuana treatment center’s approval shall be revoked.

    (9) If a selected applicant fails to post the financial assurance or supporting property ownership and/or use documents within the required timeframe, the applicant with the next highest score shall be selected and notified.

    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

Document Information

Effective Date:
9/19/2017
Related Rules: (1)
64ER17-2. Application Requirements for Medical Marijuana Treatment Centers