Ohio Administrative Code › Title 3796:3 - Processors › Chapter 3796:3-1 - Generally › Section 3796:3-1-02 - Processor provisional license application

Current through all regulations passed and filed through July 1, 2024
(A)
								The department
			 shall provide advance notice to the public indicating the commencement date and
			 time period for accepting applications. The director shall have the right to
			 amend the notice prior to the deadline for submitting an application. The
			 director shall publish such amended notice in the same manner as the original
			 notice. The director shall also have the right to cancel a notice of open
			 application prior to the award of a processor provisional
			 license.
(B)
								The provisional license application shall be submitted
			 in accordance with Chapter 3796. of the Revised Code and this chapter. The
			 application will include instructions for completion and submission. An
			 applicant for a processor provisional license shall submit, in accordance with
			 the application instructions, the following:
(1)
									A non-refundable
			 application fee as set forth in rule
			 3796:5-1-01 of the
			 Administrative Code;
(2)
									A business plan, which, at a minimum, shall
			 include:
(a)
										The
			 legal name of the applicant;
(b)
										The type of
			 business organization of the applicant, such as individual, corporation,
			 partnership, limited liability company, association or cooperative, joint
			 venture, or any other business organization;
(c)
										Confirmation that
			 the applicant is registered with the secretary of state as the type of business
			 submitted pursuant to paragraph (B)(2)(b) of this rule, a certificate of good
			 standing issued by the secretary of state, and a copy of the applicable
			 business documents governing the operations and administration of the
			 business;
(d)
										The proposed physical address of the applicant's
			 facility;
(e)
										An organizational chart of the company, including name,
			 address, and date of birth of each principal officer and board member of the
			 processor, provided that all those individuals shall be at least twenty-one
			 years of age;
(f)
										Experience with the manufacture of medical marijuana,
			 agricultural, or horticultural products;
(g)
										All persons
			 subject to the criminal records checks shall submit both an Ohio bureau of
			 criminal identification and investigation criminal records check and a federal
			 bureau of criminal investigation criminal records check pursuant to division
			 (B) of section 3796.12 of the Revised
			 Code;
(h)
										Any instance in which a business that any person
			 associated with the applicant had managed or served on the board of the
			 business and was convicted, fined, censured, or had a registration or license
			 suspended or revoked in any administrative or judicial
			 proceeding;
(i)
										Evidence that the applicant owns the property on which
			 the proposed processor will be located, has executed a lease for the property
			 that does not contain any use restrictions that would otherwise prevent the
			 processor from operating pursuant to Chapter 3796. of the Revised Code and the
			 rules promulgated in accordance with Chapter 3796. of the Revised Code, or has
			 secured the ability to purchase or lease the property that does not contain any
			 use restrictions that would otherwise prevent the processor from operating
			 pursuant to Chapter 3796. of the Revised Code and the rules promulgated in
			 accordance with Chapter 3796. of the Revised Code;
(j)
										A location area
			 map of the area surrounding the proposed processor that establishes the
			 facility is at least five hundred feet from the boundaries of a parcel of real
			 estate having situated on it a prohibited facility, as measured under rule
			 3796:5-5-01
			 of the Administrative Code;
(k)
										For any instance
			 in which an applicant or any person associated with the applicant is currently
			 or was previously licensed or authorized in another state or jurisdiction to
			 cultivate, produce, test, dispense, or otherwise deal in the distribution of
			 medical marijuana in any form, the following:
(i)
											A copy of each
			 such licensing or authorizing document verifying licensure in that state or
			 jurisdiction;
(ii)
											A statement granting permission to contact the
			 regulatory agency that granted the license, accompanied by the contact
			 information, to confirm the information contained in the application;
			 and
(iii)
											If the license, authorization, or application was ever
			 warned, fined, denied, suspended, revoked, or otherwise sanctioned, a copy of
			 documentation so indicating, or a statement that the applicant was so licensed
			 and was never sanctioned; and
(l)
										Documentation
			 that the applicant is currently in compliance, or will be in compliance prior
			 to the issuance of a certificate of operation, with all building, fire, safety,
			 and zoning statutes, local ordinances, and rules and regulations adopted by the
			 locality in which the applicant's property is located, which are in effect at
			 the time of the application, including but not limited to building department
			 approval demonstrating compliance with rules adopted by the board of building
			 standards pursuant to Chapters 3781. and 3791. of the Revised Code and any
			 applicable zoning considerations.
(3)
									An operations
			 plan that establishes policies and procedures that the applicant will implement
			 for the safe, secure, sustainable, and proper processing of medical marijuana,
			 which, at a minimum, shall include:
(a)
										Processing and extraction techniques;
(b)
										A list of medical
			 marijuana products proposed to be manufactured with estimated cannabinoid
			 profiles, if known, including varieties with high cannabidiol
			 content;
(c)
										Facility specifications, designating the areas in the
			 facility where the extraction and processing activities will occur, and
			 evidencing that the applicant will comply with the requirements of Chapter
			 3796. of the Revised Code and will operate in accordance with the rules
			 promulgated pursuant to Chapter 3796. of the Revised Code;
(d)
										The
			 implementation of standards and guidelines for processing of plant material,
			 refining of medical marijuana extracts, and manufacturing of medical marijuana
			 products, including safety protocols and equipment; and
(e)
										Facility staffing
			 and employment matters, which, at minimum, shall include:
(i)
											Employee training
			 standards for the safe operation and maintenance of any and all equipment that
			 will be used for processing medical marijuana conducted on an annual
			 basis;
(ii)
											Employee training standards for the safe use, handling,
			 storage and disposal of any and all chemicals that will be used for processing
			 medical marijuana, in accordance with OSHA protocols, conducted on an annual
			 basis;
(iii)
											Employee training standards for the safe and sanitary
			 execution of any applicable post-extraction refining protocols, conducted on an
			 annual basis;
(iv)
											Employee training standards for the safe and sanitary
			 execution of any applicable manufacturing processes, including any applicable
			 food safety standards under Chapter 901:3-1 of the Administrative Code
			 conducted on an annual basis; and
(v)
											Employee
			 compliance with Chapter 3796. of the Revised Code and the rules promulgated in
			 accordance with Chapter 3796. of the Revised Code;
(4)
									A
			 quality assurance plan that establishes policies and procedures for a safe,
			 consistent supply of medical marijuana, which, at a minimum, shall
			 include:
(a)
										Intended use and sourcing of extraction equipment and
			 associated solvents for the extraction of medical marijuana, or, in the case of
			 non-solvent extraction, the intended physical methods and
			 equipment;
(b)
										Intended use and sourcing of all non-marijuana
			 ingredients utilized in the manufacture of medical marijuana products,
			 including methods to verify or ensure the safety and integrity of those
			 ingredients, as well as their potential to be allergens or to contain allergens
			 as a result of their specific manufacturing;
(c)
										Compliance with
			 Chapter 901:3-1 of the Administrative Code in the production of edible medical
			 marijuana products;
(d)
										Best practices for the packaging and labeling of
			 medical marijuana, such that it maintains medicinal integrity for the expected
			 shelf-life;
(e)
										Implementation and compliance with the inventory
			 tracking system;
(f)
										An inventory control plan;
(g)
										Standards for the
			 disposal of medical marijuana waste and other wastes; and
(h)
										Recall policies
			 and procedures in the event of contamination, expiration, or other
			 circumstances that render the medical marijuana unsafe or unfit for
			 consumption, including at a minimum, identification of the products involved,
			 notification to the dispensary or others to whom the product was sold or
			 otherwise distributed, and how the products will be disposed of if returned to
			 or retrieved by the applicant.
(5)
									A security plan
			 that establishes policies and procedures to prevent theft, loss, or diversion
			 from a processor and protect facility personnel, which, at a minimum, shall
			 include:
(a)
										Record keeping policies and procedures that will ensure the
			 facility complies with rule
			 3796:3-2-08
			 of the Administrative Code;
(b)
										A security plan
			 in accordance with rule
			 3796:3-2-05 of
			 the Administrative Code;
(c)
										Transportation policies in accordance with rule
			 3796:5-3-01
			 of the Administrative Code; and
(d)
										A plot plan of
			 the processing facility drawn to a reasonable scale that designates the
			 different areas of operation, including, but not limited to, the marijuana
			 extraction and production areas, with the mandatory access restrictions.
(i)
											If the building
			 is in existence at the time of the application, the applicant shall submit
			 plans and specifications drawn to scale for the interior of the
			 building.
(ii)
											If the building is not in existence at the time of
			 application, the applicant shall submit a plot plan and a detailed drawing to
			 scale of the interior and the architect's drawing of the building to be
			 constructed.
(6)
									A financial plan,
			 which, at a minimum, shall include:
(a)
										The identity and ownership interest of every person,
			 association, partnership, other entity, or corporation having a financial
			 interest, direct or indirect, in the processor with respect to which licensure
			 is sought;
(b)
										A cost breakdown of the applicant's anticipated costs
			 in building the facility and implementing the policies and procedures submitted
			 as part of the application and the source of funding for the associated
			 costs;
(c)
										Documentation acceptable to the department that the
			 individual or entity filing the application has sufficient liquid assets for a
			 processor provisional license, which are unencumbered and can be converted
			 within thirty days after a request to liquidate such assets. Documentation
			 acceptable to the department includes a signed statement from an Ohio licensed
			 certified public accountant attesting to proof of the required amount of liquid
			 assets under the control of an owner or the entity applying, if such a
			 statement is available at the time of application. The documentation must be
			 dated within thirty calendar days before the date the application was
			 submitted. The following shall be considered sufficient liquid assets:
(i)
											Two hundred fifty
			 thousand dollars for a processor provisional license; or
(ii)
											One hundred
			 thousand dollars for a processor provisional license, if at the time of
			 application, the applicant has previously been issued a cultivator provisional
			 license or cultivator certificate of operation and the processor will be
			 located in the cultivator's existing facility;
(d)
										Information
			 verifying that the applicant will be able to conform to the financial
			 responsibility requirements under rule
			 3796:3-1-05
			 of the Administrative Code; and
(e)
										A record of tax
			 payments in the form of tax summary pages for individuals and businesses at the
			 state and federal level in this state and in all jurisdictions in which an
			 applicant has operated as a business and for every person with a financial
			 interest of one percent or greater in the applicant for the five years before
			 the filing of the application, unless the department determines that
			 documentation should be submitted for all individuals and
			 entities.
(7)
									Any other information requested in the application
			 instructions that the department deems necessary to evaluate and determine the
			 applicant's suitability to operate as a processor.