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• TITLE 310. Oklahoma State Department of Health TITLE 310. Oklahoma State Department of Health CHAPTER 681. Medical Marijuana Control Program [OAR Docket #18-639] AGENCY NOTE: The Board of Health adopted new emergency rules on August 1, 2018, to supersede all rules identified in this rulemaking action. The new superseding Chapter was approved by the Governor on August 6, 2018, and will be published in a later edition of the Oklahoma Register. RULEMAKING ACTION: EMERGENCY adoption RULES: Subchapter 1. General Provisions [NEW] Subchapter 2. Medical Marijuana Licenses [NEW] Subchapter 3. Transportation License [NEW] Subchapter 4. Medical Research License [NEW] Subchapter 5. Commercial Establishments [NEW] Subchapter 6. Commercial Facilities [NEW] Subchapter 7. Labeling [NEW] Subchapter 8. Testing Standards for Marijuana [NEW] Appendix A. Supporting Tables for Subchapter 8 (Relating to Testing Standards for Marijuana) [NEW] AUTHORITY: Oklahoma State Board of Health; Title 63 O.S. Section 1-104, and Title 63 O.S. § 420 et seq. ADOPTION: July 10, 2018 EFFECTIVE: Immediately upon Governor's approval or August 25, 2018, whichever is later. APPROVED BY GOVERNOR: July 11, 2018 EXPIRATION: Effective through September 14, 2019, unless superseded by another rule or disapproved by the legislature. SUPERSEDED EMERGENCY ACTIONS: "n/a" INCORPORATION BY REFERENCE: Incorporated standards: National Institute of Standards and Technology (NIST) Handbook 130 (2017), "Uniform Packaging and Labeling Regulation" US Food and Drug Administration's "Bacterial Analytical Manual", 2016 US Food and Drug Administration's "Guidelines for the Validation of Chemical Methods for the FDA FVM Program", 2nd Edition, 2015. AOAC International's "Official Methods of Analysis for Contaminant Testing of AOAC International", 20th Edition, 2016 United States Pharmacopeia and the National Formulary's "Methods of Analysis for Contaminant Testing", 2016 Incorporating rules: 310:681-7-1(d)(2)(B) 310:681-8-5(b)(A) 310:681-8-5(b)(B) 310:681-8-5(b)(C) 310:681-8-5(b)(D) Availability: 8:00 a.m. to 5:00 p.m., Monday through Friday, Oklahoma State Department of Health, 1000 NE 10th St., Oklahoma City, OK 73117. FINDING OF EMERGENCY: Pursuant to Title 75 O.S. Section 253, the Department seeks Emergency adoption of the proposed rules. Emergency rulemaking is sought pursuant to the passage of State Question 788 and as codified at 63 O.S. § 420 et seq. Title 63 O.S. § 420(C) states: "A regulatory office shall be established under the Oklahoma State Department of Health which will receive applications for medical license recipients, dispensaries, growers, and packagers within sixty (60) days of the passage of this initiative." Title 63 O.S. § 423(C) states: "within sixty (60) days of passage of this initiative, make available a set of standards which will be used by licensed processors in the preparation of edible marijuana products." The language requires the Department to create a process to receive, review and issue patient license applications, within approaching timeframes given the recent passage of State Question 788 on June 26, 2018. Delay in adoption of rules, until the forthcoming legislative session would cause the Department to fail to comply with state law, therefore satisfying a finding of an emergency pursuant to 75 O.S. § 253(A)(1)(c). This Emergency rulemaking action is necessary to promulgate rules to implement the provisions in the new law pertaining to regulations on medical marijuana products, and individual and commercial licensees. GIST/ANALYSIS: These proposed rules will implement the agency's requirements from the passage of State Question 788 and as codified at 63 O.S. § 420 et seq.. The proposed regulations set forth the Department's definitions and requirements for the approvals of medical marijuana patient, caregiver, dispensary, laboratory, grower and packager licenses. CONTACT PERSON: Kim Bailey, Chief Operating Officer, Oklahoma State Department of Health, 1000 N.E. 10th Street, Oklahoma City, OK 73117-1207; phone (405) 271-4200, e-mail: [email protected]. PURSUANT TO THE ACTIONS DESCRIBED HEREIN, THE FOLLOWING EMERGENCY RULES ARE CONSIDERED PROMULGATED UPON APPROVAL BY THE GOVERNOR AS SET FORTH IN 75 O.S., SECTION 253(F), AND EFFECTIVE UPON APPROVAL BY THE GOVERNOR OR AUGUST 25, 2018, WHICHEVER IS LATER: [OAR Docket #18-639; filed 7-25-18] SUBCHAPTER 1.General Provisions 310:681-1-1. Purpose The purpose of this Chapter is to ensure the health and safety of all Oklahomans and provide reasonable and orderly regulation of medical marijuana as authorized by the lawful passage of State Question 788. This regulatory authority shall be known as the "Oklahoma Medical Marijuana Authority" and shall be a division of the Oklahoma State Department of Health. Only the powers enumerated under this Chapter shall be proper. Any power not specifically enumerated is prohibited. 310:681-1-2. Regulatory program established (a) All license applications, inquiries, and other correspondence shall be directly electronically received, processed, and regulated by the Oklahoma State Department of Health by the "Oklahoma Medical Marijuana Authority" division or its designee. (b) All applications provided for under this Chapter are available on the Oklahoma State Department of Health's Oklahoma Medical Marijuana Authority website at http://omma.ok.gov/ (c) The Oklahoma State Department of Health is located at 1000 N.E. 10th Street, Oklahoma City, Oklahoma, 73117. All approval and rejection letters shall be sent to the applicant through U.S. Mail. 310:681-1-3. Limitations of licenses All licenses and rights granted under this Chapter and under Title 63 O.S. § 420 et seq. shall only be valid in the State of Oklahoma, excluding any tribal trust or tribal restricted land or federal lands in the state. 310:681-1-4. Definitions The following words and terms, when used in this Chapter, shall have the following meaning, unless the context clearly indicates otherwise: "Acquire" or "Acquisition" means coming to possess marijuana by means of any legal source herein authorized, from an authorized source, and in accordance with Title 63 O.S. § 420 et seq. and the rules of this Chapter. "Applicant" means the natural person in whose name a license would be issued, with the exception of a patient license, or any entity the natural person represents or on whose behalf the application is being submitted. All applicants under these provisions must be at least twenty-five years of age to be eligible to be an applicant. "Approved Laboratory" means a laboratory that is accredited by The NELAC Institute (TNI), ANSI/ASQ National Accreditation Board or other accrediting organization that has developed and maintained an independent system, based upon International Organization for Standardization and International Electrotechnical Commission (ISO/IEC) 17025 standards or other appropriate ISO/IEC standards as determined by the Department, for providing laboratories with an impartial review of laboratory operations. "Batch" means, with regard to usable marijuana, a homogenous, identified quantity of usable marijuana, no greater than ten (10) pounds, that is harvested during a specified time period from a specified cultivation area, and with regard to oils, vapors and waxes derived from usable marijuana, means an identified quantity that is uniform, that is intended to meet specifications for identity, strength, and composition, and that is manufactured, packaged and labeled during a specified time period according to a single manufacturing, packaging and labeling protocol. "Batch Number" means a unique numeric or alphanumeric identifier assigned prior to testing to allow for inventory tracking and traceability. "Cannabidiol ("CBD")" means a cannabinoid and the primary non-psychoative ingredient found in marijuana, Chemical Abstracts Service Number 13956-29-1. "Cannabidiolic Acid ("CBDA")" means one of the primary cannabinoids produced on the stems, leaves and flowers of some varieties of marijuana plants. "Cannabinoid" means any of the diverse chemical compounds that can act on cannabinoid receptors in cells and alter neurotransmitter release in the brain, including phytocannabinoids that are produced naturally by marijuana and some other plants. "Clone" means a non-flowering plant cut from a mother plant that is no taller than eight inches and is capable of developing into a new plant. "Commercial Establishment" ("Establishment") means an entity licensed under this Chapter as a medical marijuana dispensary, grower, processor or researcher. "Commercial License" means a license issued to a medical marijuana dispensary, grower, processor or researcher. "Commissioner" means the Commissioner of Health of the Oklahoma State Department of Health. "Complete Application" means a document prepared in accordance with the rules and the forms and instructions provided by the Department, including any supporting documentation required by the Department and the license fee. "Control Number" means the tracking number issued with a license to purchase medical marijuana. "Department" means the Oklahoma State Department of Health or its agent or designee. "Dispense" means the selling of medical marijuana or a medical marijuana product to a qualified patient or the patient's designated caregiver that is packaged in a suitable container appropriately labeled for subsequent administration to or use by a qualifying patient. "Dispensary" means an entity that has been licensed by the Department pursuant to Title 63 O.S. § 421 and this Chapter, which allows the entity
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