HAR 11-850 — MEDICAL CANNABIS DISPENSARIES (Subchapter 1 to 11)

(a) A dispensary licensee shall ensure that all cannabis and manufactured cannabis products it dispenses are safe for use or consumption by qualifying patients and qualifying out-of-state patients. (b) A dispensary licensee shall comply with State and county health, safety, and s…

(a) The management of a medical cannabis production center shall ensure that all individuals who produce cannabis or manufactured cannabis products are qualified to perform their assigned duties. (b) Each individual engaged in production of cannabis or manufactured cannabis produ…

(a) Grounds. The grounds about a production center under the control of the dispensary shall be kept in a condition that will protect against the contamination of cannabis or manufactured cannabis products. The methods for adequate maintenance of grounds shall include: (1) Proper…

(a) General maintenance. Buildings, fixtures, and other physical facilities shall be maintained in a clean and sanitary condition and shall be kept in repair adequate to prevent cannabis or manufactured cannabis products from becoming contaminated. Cleaning and sanitizing of uten…

Each medical cannabis production center shall be equipped with adequate sanitary facilities and accommodations including: (1) Water supply. The water supply shall be adequate for the operations intended and shall be derived from an adequate source. Any water that contacts cannabi…

(a) All medical cannabis production center equipment and utensils used in production and storage of cannabis or manufactured cannabis products shall be so designed and of such material and workmanship as to be adequately cleanable and shall be adequately maintained to protect aga…

(a) General. (1) All operations in the production and storage of cannabis, manufactured cannabis products, and components shall be conducted in accordance with adequate sanitation principles. (2) Appropriate quality control operations shall be employed to ensure that cannabis and…

Storage and transportation of cannabis, manufactured cannabis products, and components shall be under conditions that will protect against allergen cross-contact and against biological, chemical (including radiological), and physical contamination of cannabis, manufactured cannab…

Notes Haw. Code R. §§ 11-850-118 to 11-850-120 Res 2/24/2022 Res 4/29/2022 Res 11/17/2022 Res 12/6/2024

(a) An application for a dispensary license shall include both an individual applicant and an applying entity and they shall apply to the department on a form and in a manner prescribed by the department. (b) The department shall establish an open application period for available…

(a) A medical cannabis dispensary shall establish written processing and control standard operating procedures for the production of cannabis and manufactured cannabis products (for example, formulations, processing procedures, in-process control methods, packaging procedures, pr…

(a) Production records shall document, for each batch of cannabis or manufactured cannabis product:(1) Review of ingredient records to determine if ingredients are adequately controlled; (2) Ingredients (name, code, batch number, quantity, etc.) added to the batch; (3) Production…

(a) A dispensary shall establish and follow written standard operating procedures and assign specific staff persons as quality control personnel to fulfill the requirements of this section. (b) Quality control personnel shall conduct a review and make a disposition decision if: (…

(a) Standard operating procedures. A dispensary shall establish and follow written standard operating procedures to fulfill the requirements of this section. (b) Quarantine and investigation of production processes. Returned cannabis or manufactured cannabis products shall be ide…

(a) A dispensary shall establish and follow written procedures to fulfill the requirements of this section. (b) Review and investigation of product complaints. A qualified person shall: (1) Review all product complaints to determine whether the product complaint involves a possib…

(a) A dispensary shall establish and follow written procedures to fulfill the requirements of this section. (b) A dispensary licensee shall notify the department within forty-eight hours after learning of an adverse event associated with cannabis or a manufactured cannabis produc…

(a) A dispensary shall establish a written recall plan for cannabis and for each manufactured cannabis product. (b) The written recall plan shall include procedures that describe the steps to be taken, and assign responsibility for taking those steps, to perform the following act…

(a) A medical cannabis dispensary shall establish and maintain the following records documenting compliance with this subchapter: (1) Written procedures for quality control operations, including:(A) Conducting a review and making a disposition decision; (B) Approving or rejecting…

(a) As permitted by section 11-850-135 (h) (1), a batch of cannabis or manufactured cannabis products may be remediated and submitted a certified laboratory for reanalysis in accordance with the following procedures: (1) The dispensary licensee shall submit the sampling plan, cer…

An individual applicant shall: (1) Be not less than twenty-one years of age; (2) Be a legal resident of the State for not less than five years preceding the date of application; (3) Not have any felony convictions or any other disqualifying background history in accordance with t…

Notes Haw. Code R. § 11-850-130 Res 2/24/2022 Res 4/29/2022 Res 11/17/2022 Res 12/6/2024

(a) A dispensary licensee shall not dispense cannabis or manufactured cannabis products unless a laboratory certified by the department pursuant to this chapter has analyzed a representative sample of the cannabis or manufactured cannabis products and the samples meet the require…

(a) No laboratory is authorized to handle or analyze cannabis or manufactured cannabis products unless that laboratory is certified by the department as specified in this subchapter, except as provided in subsection (d). (b) The department may grant a certification to a laborator…

(a) To apply for a laboratory certification to analyze cannabis and manufactured cannabis products, a laboratory shall submit to the department on forms and in a manner prescribed by the department:(1) An application; (2) All information and documents required by the department, …

(a) Upon being certified by the department, a laboratory shall: (1) Display a copy of the certification in a prominent location on the laboratory premises; (2) Obtain department approval of the laboratory's employee qualifications, quality assurance plan, and standard operating p…

(a) A certified laboratory shall develop and follow a statistically valid sampling plan to collect representative samples from each batch of cannabis or manufactured cannabis product in accordance with section 11-850-131. A certified laboratory shall analyze a representative samp…

(a) A certified laboratory or a laboratory seeking certification shall provide the department access to inspect the laboratory facility, interview laboratory personnel, or review, inspect, evaluate, and audit records and documents related to the analyses of dispensary licensee sa…

(a) A laboratory aggrieved by a suspension or revocation made pursuant to section 11-850-136 may request a reconsideration of the action. (b) A request for reconsideration shall be submitted to the department within five business days after the date of notification; provided that…

Notes Haw. Code R. §§ 11-850-138 to 11-850-140 Res 2/24/2022 Res 4/29/2022 Res 11/17/2022 Res 12/6/2024

(a) An individual applicant shall provide the following required information and documents: (1) Legal name, date of birth, legal residence, last four digits of the applicant's social security number, mailing address, and principal residence address if different from the mailing a…

A dispensary licensee shall not post any signage visible from the exterior other than one or two signs, each no greater than one thousand six hundred square inches, that bear only the business or trade name in text without any pictures or illustrations; provided that if any appli…

(a) A dispensary licensee shall use packaging for cannabis and manufactured cannabis products that:(1) Meets the requirements for child-resistant special packaging for the number of openings and closings customary for the package size and contents, specified in Title 16 C.F.R. pa…

(a) Each package of cannabis or manufactured cannabis product shall be labeled using only black lettering on a white background with no pictures or graphics. (b) Except as provided in subsection (f), every package of cannabis or manufactured cannabis product shall be labeled with…

(a) All ingredients shall be listed on the label in order of prominence by weight and shall be preceded by the word "Ingredients". (b) The common or usual name of ingredients shall be consistent with the names standardized in: (1) For ingredients that are botanicals (including fu…

(a) A dispensary licensee shall not engage in advertising in any media including but not limited to:(1) Broadcast or electronic media: (A) Radio; (B) Television; (C) Internet; and (D) Social media; (2) Print media: (A) Newspaper; (B) Magazine; (C) Billboards; and (D) Placards on …

Notes Haw. Code R. §§ 11-850-146 to 11-850-150 Res 2/24/2022 Res 4/29/2022 Res 11/17/2022 Res 12/6/2024

An applying entity shall: (1) Be organized under the laws of the State; (2) Have a Hawaii tax identification number; (3) Have a department of commerce and consumer affairs business registration division number and suffix; (4) Have a federal employer identification number; (5) Not…

(a) If the director determines that any person is violating any provision of this chapter, chapter 329D, HRS, or the person's license, the director may have that person served with a notice of violation and an order. The notice shall specify the alleged violation. The order may:(…

(a) Upon suspension of a dispensary license pursuant to section 329D-21 and this subchapter, the licensee shall immediately do any or all of the following as ordered by the director:(1) Cease dispensing or manufacturing cannabis and manufactured cannabis products, or both; (2) Ce…

(a) An applying entity shall provide the following required information and documents: (1) Name of the applying entity and any other name under which the applying entity does business; street address, telephone number, facsimile number, email address; date the applying entity was…

(a) The following are subject to background checks conducted by the department or its designee: (1) The individual applicant or licensee; (2) All officers, directors, members of a limited liability corporation, shareholders with at least twenty-five per cent ownership interest in…

(a) Each application for a dispensary license shall include a non-refundable application fee of $5,000 by certified check or cashier's check payable to State of Hawaii Department of Health, delivered or mailed by certified mail, return receipt requested, to: Department of Health,…

(a) After receipt of an application, the department shall verify that the application and supporting documentation is complete, and the information submitted in the application is true and valid, and meets the requirements of section 329D-3, HRS. (b) Applications that meet the re…

As used in this chapter: "Accreditation body" means an impartial organization that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement for Testing and which requires laboratories to conform to ISO/IEC 17025, the general r…

(a) The department shall consider the following criteria based on merit to evaluate applications verified pursuant to section 11-850-19: (1) Ability to operate a business, including but not limited to education, knowledge, and experience with: (A) Regulated industries; (B) Agricu…

(a) Within seven days of receiving written notice of selection from the department, the selected applicant shall submit to the department a dispensary license fee of $75,000 by certified or cashier's check made payable to: State of Hawaii Department of Health. (b) If the dispensa…

(a) Upon award of a license pursuant to section 11-850-21, a dispensary licensee shall apply to the department of public safety narcotics enforcement division (NED) and obtain a certificate to possess and handle cannabis and manufactured cannabis products. (b) A dispensary licens…