Department of Health, Departmental

 

DEPARTMENT OF HEALTH

The Department of Health, Office of Compassionate Use hereby provides notice that the regulation development procedure below has been filed for adoption with the Department Agency Clerk and is effective as of June 14, 2017, pursuant to the Department's authority under Article X, Section 29, of the Florida Constitution. This regulation development procedure will be used by the Department to implement its regulation authority under the Florida Constitution. The Department previously provided notice of the proposed procedure in Vol. 43 No. 102, May 25, 2017 issue of the Florida Administrative Register.

 

Office of Compassionate Use

Article X, Section 29, of the Florida Constitution

Regulation Development Procedure

1. Background

In November 2016, Florida voters passed an amendment to Article X of the Florida Constitution establishing provisions for the recommendation, use, and sale of medical marijuana. Under the amendment, the Florida Department of Health is responsible for registering and regulating medical marijuana treatment centers that produce and distribute marijuana for medical purposes, as well as issuing identification cards to patients and caregivers. Regulations promulgated pursuant to constitutional authority are not subject to Chapter 120, Florida Statutes. Because there is public benefit to having uniform procedures that are clearly laid out for such regulations, the Florida Department of Health (Department) establishes the following procedures for implementing Article X, Section 29 of the Florida Constitution.

2. Definitions of Regulations
   1. Regulations are statements of general applicability to guide the conduct or action of the Department, medical marijuana treatment centers, physicians, patients, and caregivers, adopted by the Department to implement its powers and duties. Regulations must be consistent with the law.
   2. Regulations are not subject to the provisions of Chapter 120, Florida Statutes, as they are promulgated pursuant to constitutionally delegated authority and not legislatively delegated authority.
3. Regulation Development Procedures
   1. Notice
      1. Prior to the adoption, amendment, or repeal of any regulation, except an emergency regulation, the Department shall give notice of its intended action. This notice shall be given at least 15 days prior to any proposed adoption or repeal of a regulation. Notice of a proposed regulation, amendment, or repeal shall include publication in the Florida Administrative Register.
   2. Comments
      1. Any person may submit written comments concerning a proposed regulation, amendment, or repeal to the contact person identified in the notice within 3 days after the date of the notice.
      2. In response, the Department may solicit additional written comments, schedule a public hearing, withdraw or modify the regulation, amendment, or repeal in whole or in part after notice, or proceed with adopting the regulation.
   3. Adoption
      1. The Department is responsible for adopting its regulations. Regulations are adopted upon promulgation by the Department.
   4. Filing
      1. Place of Filing, Record and Effective Date
         1. When adopted, the regulation, amendment, or repeal shall be filed with the Agency Clerk and posted in the Florida Administrative Register.
         2. The regulation, amendment, or repeal shall become effective on the date of filing unless the effective date is stated otherwise.
4. Due Process
   1. In implementing regulations that affect the rights of individuals, the Department will honor established due process principles to ensure that applicable due process rights are afforded to affected individuals.
5. Emergency Regulations
   1. An emergency regulation may be adopted if there is an immediate danger to the public health, safety, or welfare under a procedure which is fair under the circumstances. The action taken must be only that necessary to protect the public interest in the emergency. At the time of, or prior to the Department’s action, it must publish in the Florida Administrative Register specific facts and reasons for concluding that the procedure is fair under the circumstances. An emergency regulation shall not be effective for a period longer than 90 days. However, the Department may take identical action under the regular regulation development procedure set forth herein.