Mo. Code Regs. tit. 19 § 100-1.170

Current through Register Vol. 49, No. 20, October 15, 2024

Section 19 CSR 100-1.170 - Manufacturing Facilities

PURPOSE: Under Article XIV, Sections 1 and 2 of the Missouri Constitution, the Department of Health and Senior Services has the authority to regulate and control medical and marijuana facilities. This rule explains what regulations apply to facilities that manufacture marijuana product.

(1) Manufacturing facilities, generally.

(A) A manufacturing licensee's authority to engage in the process of manufacturing marijuana-infused products includes the ability to-

1. Acquire and transfer marijuana from a cultivation facility;

2. Acquire and transfer marijuana product from another manufacturing facility to further process;

3. Acquire and transfer marijuana product from a dispensary facility;

4. Process and store (on- or off-site) marijuana product;

5. Manufacture and package marijuana-infused products and prerolls;

6. Transfer marijuana product to or from its own warehouse storage facility, another manufacturing facility, cultivation facility, or dispensary facility;

7. Transfer marijuana product to a testing facility; and

8. Sell marijuana product to another manufacturing facility, cultivation facility, dispensary facility, or testing facility.

(2) Manufacturing licensee requirements. In addition to this chapter's requirements for licensed facilities and licensees, manufacturing licensees shall also comply with the following:

(A) Manufacturing licensees must mitigate odors from all odor sources by-

1. Developing, implementing, and maintaining an odor control plan, which shall address odor mitigation practices such as system design and operational processes;

2. Engaging a professional engineer or certified industrial hygienist to review the odor control plan and certify that the plan is sufficient to effectively mitigate odors from all odor sources prior to commencing operations; and

3. Maintaining compliance with local ordinances related to odor;

(B) Marijuana product shall not be transferred to a dispensary facility until the marijuana product has been tested by a testing licensee, according to the provisions of this chapter, and the manufacturing licensee has received verification from the testing licensee that the marijuana product passed mandatory testing;

(C) Manufacturing licensees that produce ingestible marijuana-infused products shall comply with the applicable food safety standards set forth in 19 CSR 20 and any relevant statutes controlling food safety standards. Such licensees are prohibited from producing frozen desserts or acidified foods, as defined by 19 CSR 20;

(D) Manufacturing licensees that use volatile solvents shall install air-handling systems and other controls designed to minimize the risks of explosions and fires. These controls should include systems to prevent ignition; Volatile Solvent Standard Operating Procedures; plans for safe storage, use, and disposal of solvents; and policies for continuous staff monitoring of all processes involving volatile solvents;

(E) Any tetrahydrocannabinol, such as THC-A, Delta-8, or Delta-10, in a marijuana product manufactured by a manufacturing licensee shall only be derived from marijuana cultivated in Missouri by a licensed cultivator; and

(F) Manufactured product may not contain chemical modification, conversion, or synthetic derivation of cannabinoids to produce intoxicating cannabinoid isomers, including those created by heat or other process during use by a patient or consumer, and all cannabinoids acquired from entities other than marijuana facilities for purpose of inclusion in marijuana product must be accompanied by a Certificate of Analysis at time of acquisition that identifies the testing lab that tested the product and lists the product's ingredients.

(G) Manufacturing licensees shall track all ingredients used in any given manufactured product.

19 CSR 100-1.170

Adopted by Missouri Register March 1, 2023/Volume 48, Number 5, effective 2/3/2023

Amended by Missouri Register June 15, 2023/Volume 48, Number 12, effective 7/31/2023