Florida Marijuana Manufacturing License

Does Florida Require a Marijuana Manufacturing License to Make Cannabis Products?

Yes, in the State of Florida, pursuant to Florida Statutes Section 381.986 (8)(a)(1), the Florida Department of Health, Office of Medical Marijuana Use (OMMU) licenses marijuana businesses in Florida, primarily Medical Marijuana Treatment Centers (MMTC). These MMTCs perform a variety of marijuana business activities, including manufacturing. The Medical Marijuana Treatment Center license authorizes registered marijuana business entities to cultivate, manufacture, transport, and dispense medical cannabis, low-THC cannabis, and cannabis delivery devices. Florida does not have a well-defined license for marijuana manufacturing and processing. The Medical Marijuana Treatment Center license is an unrestricted license that covers marijuana manufacture, cultivation, transportation, and distribution.

Does Florida Require Licensed Cannabis Manufacturers to Have Cultivation Licenses?

In Florida, an entity involved in cannabis manufacturing is required to obtain a Medical Marijuana Treatment Center license. This license authorizes them to engage in various forms of marijuana businesses, which also include the cultivation of marijuana. However, such businesses must adhere to the rules on cultivation set by the Florida Department of Health, Office of Medical Marijuana Use. There are no cultivation-specific licenses required to be obtained by marijuana-producing or processing establishments. A licensed Medical Marijuana Treatment Center that engages in manufacturing can contract with a single entity to process, cultivate, transport, and dispense marijuana and marijuana delivery devices.

How Does Florida Classify Marijuana Manufacturing Licenses?

Florida does not classify marijuana manufacturing licenses. A Medical Marijuana Treatment Center license is an unrestricted license that permits all marijuana manufacturing procedures regardless of the methods used by manufacturing establishments, types of chemicals used for extraction and post-processing. The same license is also used whether the establishments are in shared or single-use facilities.

What are the Different Types of Cannabis Manufacturing Licenses in Florida?

The Medical Marijuana Treatment Center license is the only type of license that authorizes marijuana manufacturing in Florida.

Does Florida Require a Separate License to Manufacture Edibles?

There is no separate license issued to marijuana business entities that authorize them to manufacture edibles. However, there are certain requirements that these entities must pass before they are allowed to manufacture edibles. These include:

• A medical marijuana treatment center that manufactures or processes edibles must hold a permit to enable them to run a food establishment in accordance with the Florida Food Safety Act, Chapter 500.
• A medical marijuana treatment center that manufactures or processes edibles must fulfill all the requirements and rules for food establishments contained in Food Safety Act, Chapter 500.
• A medical marijuana treatment center that manufactures or processes edibles must adhere to the sanitation rules that provide the standards and requirements for storing, displaying, or dispensing edibles.
• Edibles must only have a maximum potency variance of 15%.
• The tetrahydrocannabinol in edibles must not be more than 200 milligrams and one single serving portion of an edible must not exceed 10 milligrams of tetrahydrocannabinol.
• Edibles must not be attractive to children, manufactured in the shape of humans, cartoon characters, or animals; or in any form that resembles products available for consumption by children, such as commercially available candy. It must also not contain any color additives. \ The Health Department, OMMU does not permit children to consume edibles. Hence, the department dictates the shapes, forms, and ingredients permitted and prohibited for edibles by rule.

How to Get a Cannabis Manufacturing License in Florida

The Florida Department of Health, Office of Medical Marijuana Use manages the issuance and regulation of Medical Marijuana Treatment Center licenses in the state. The department has provided a document showing the process involved in the Application for Medical Marijuana Treatment Center Registration. The application process is divided into three parts, including:

Part I

The applicant is required to provide the OMMU with basic information about themselves and the application, including the applicant’s:

• Name (The name must not be different from the name registered with the state)
• Department of Agriculture Certificate Address, including street address, city, and ZIP code
• Mailing Address, including street address, city, and ZIP code (if different)
• Contact Name
• Email Address
• Phone Number

It should also contain the Medical Director’s:

• Name

• Mailing Address, including street address, city, and ZIP code

• Florida MD or DO License Number

• Email Address

• Phone Number \ Some of the required documents in Part I are:

  • Certified documentation from the Florida Department of Revenue or Florida Department of State, appropriate under Florida law, showing that the applicant has been registered to do business in Florida for a minimum of five consecutive years preceding the present time.
  • A certified copy of an original certificate of registration used by the Department of Agriculture and Consumer Services under Section 581.131, Florida Statutes
  • A list of all owners, board members, managers, and officers specifying the date of each individual's most recent level-2 background screening. The list should include each party’s name and their respective positions or proposed positions in the proposed MMTC.

• Note that other required information and the questionnaire in Part I can be found on page 5 of the Application for Medical Marijuana Treatment Center Registration.

  \ **Part II \ **The applicant is required to provide the OMMU with accurate items to demonstrate the ability to run an MMTC as specified in the table below:

Detailed instructions for the completion of Part II are listed on pages 2-3 of the Application for Medical Marijuana Treatment Center Registration. An applicant is required to properly organize their application for an MMTC registration when submitting it. This means that each document submitted with the application should be labeled correctly with the section number of the corresponding application. Applicants must also not exceed the page limits for each section. Pages that exceed the page limit will be removed from the application before evaluation. Applicants can find guidelines on necessary information for Part II of the application on pages 6-13 of the Application for Medical Marijuana Treatment Center Registration.

Part Ill

After the application has been completed and all necessary documentation has been provided, the applicant may hand-deliver the completed application, which should include the applicant’s signature page, and required application fee. The application package may be delivered to:

Florida Department of Health

4052 Bald Cypress Way

Tallahassee, FL 32399

The application should be submitted during regular business hours, but no earlier than 10:00 a.m., Eastern Time, on the day the Department of Health begins accepting applications. On the final day of the application period, applications must be submitted no later than 5:00 p.m., Eastern Time. Any applications submitted later than 5:00 p.m. Eastern Time on the last day of the application will be denied.

Note that an applicant must submit the completed application and supporting documents on a thumb drive. The department will deny any applications submitted in hard copy form. The applicant will also be required to provide a list of all materials for which they claim public records exemption, including a precise legal citation to the exemption. The applicant may also provide a full proposed redacted version of the application, if applicable.

In addition to the requirements listed in the application procedure, an entity applying for licensure as a medical marijuana treatment center must show:

• The technical and technological ability to cultivate and manufacture marijuana and marijuana products like low-THC cannabis
• A premises located in a good location within the state to dispense marijuana to registered qualified patients regionally or across the state as determined by the department
• The capacity to secure the premises, resources, and personnel required to operate as a medical marijuana treatment center
• That all owners, board members, officers, and managers have passed the required background screening
• That the entity can maintain accountability of all raw materials, finished products, and any byproducts to prevent diversion or illegal access to or acquisition of these substances
• The financial power to continue operations for the period of the two-year approval cycle and the provision of approved financial statements to the department.
  • If an application is approved, the applicant is required to post a $5 million performance bond issued by an authorized surety insurance company. The company must be rated in one of the three highest rating categories by a nationally recognized rating service. However, a medical marijuana treatment center that serves a minimum of 1,000 qualified patients is only expected to maintain a $2 million performance bond.
  • As a substitute for the performance bond required, the applicant may provide cash to the department or present an irrevocable letter of credit payable to the department. If provided with cash in this case, the department will deposit the cash in the Grants and Donations Trust Fund under the Department of Health. It shall be subject to the same conditions as the bond concerning requirements for the applicant to lose ownership of the funds. If the funds deposited under this sub-subparagraph generate interest, the department will use the amount generated for the administration of this section.
• A diversity plan that recommends and guarantees the participation of minority persons and minority business enterprises, as defined in section 288.703, or veteran business enterprises, as defined in section 295.187, in employment, ownership, and management. A licensure renewal applicant must show the potency of the diversity plan by including the following in their application for renewal:
  • Representation of minority persons and veterans in the workforce of the medical marijuana treatment center
  • A record of contracts for services with veteran business enterprises and minority business enterprises
  • Efforts to employ minority persons and veterans

Within 12 months after a medical marijuana treatment center has been licensed, it must demonstrate to the department that all its processing facilities have passed inspection by a Food Safety Good Manufacturing Practice, like the Global Food Safety Initiative. An equivalent nationally accredited certifying body for inspection may also suffice. Any facility of a medical marijuana treatment center that fails to pass this inspection must immediately stop processing until it demonstrates to the department that such facility has met this requirement.

How Much Does a Cannabis Manufacturing License Cost in Florida?

In addition to submitting an application and fulfilling the requirements, the Florida Department of Health, Office of Medical Marijuana Use requires applicants for medical marijuana treatment centers to pay a non-refundable $146,000 application fee. The fee should be paid in the form of a cashier's check made payable to the Florida Department of Health. Licensure for a marijuana treatment center is expected to be renewed every 2 years at least 30 days, but not more than 60 days before the license expires. Florida raised the renewal fee for an MTC license to $1.33 million in December 2022.

To renew a license, the applicant must complete the Application and Instructions for MMTC License Renewal and submit it together with the biennial renewal fees to:

Physical Address:

Florida Department of Health

Office of the General Counsel

ATTN: Agency Clerk

2585 Merchants Row Boulevard, Suite 110

Tallahassee, FL 32399

Mailing Address:

Florida Department of Health

Office of the General Counsel

ATTN: Agency Clerk

4052 Bald Cypress Way, Bin A-02

Tallahassee, FL 32399

Individuals may email questions regarding fees and application renewal to the OMMU at OMMULicenseOperation@flhealth.gov. The OMMU typically responds to emails within 48 hours during normal business hours.