20,160 sections across 1,928 Iowa regulatory chapters.
R.641—154.21 Manufacturer and dispensary security requirements
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154.21(1) Restricted access. A manufacturer or dispensary shall limit entrance to all restricted areas by completing all of the following: a. Mark restricted access areas with signs that state: “Do Not Enter—Restricted Access Areas Access Limited to Authorized Personnel Only”. b.…
R.641—154.22 Advertising and marketing
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154.22(1) Permitted marketing and advertising activities. A manufacturer or dispensary must include medical cannabidiol pricing and hours of operation on its website and may do the following: a. Display the manufacturer or dispensary’s business name and logo on medical cannabidio…
R.641—154.23 Sales and inventory tracking system. The department shall establish and maintain a
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secure, electronic system that is available 24 hours per day, seven days per week to track: 1. Inventory of plant material and medical cannabidiol; 2. Transport of plant material and laboratory samples; 3. Application and use of crop inputs and other solvents and chemicals; 4. Sa…
R.641—154.24 Financial transactions
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154.24(1) A manufacturer or dispensary shall maintain records that reflect all financial transactions and the financial condition of the business. 154.24(2) The following records shall be maintained for at least five years and made available for review upon request of the departm…
R.641—154.25 Inspection by department or independent consultant. A manufacturer or dispensary
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is subject to reasonable inspection by the department, a department-approved consultant, or another agency pursuant to Iowa Code chapter 124E and these rules and as authorized by laws and regulations. 154.25(1) Types of inspections. Inspections may include: a. Aspects of the busi…
R.641—154.26 Manufacturer operations
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154.26(1) Operating documents. a. A manufacturer shall maintain operating documents that accurately reflect the manufacturer’s standard operating procedures. Unless otherwise noted, a manufacturer shall make the operating documents available to the department upon request, throug…
R.641—154.27 Recordkeeping requirements
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154.27(1) Manufacturer sales and distribution. A manufacturer shall maintain complete and accurate electronic sales transaction records in the department’s secure sales and inventory tracking system, including: a. The date of each sale or distribution; b. The item number, product…
R.641—154.28 Recall of medical cannabidiol products. Medical cannabidiol products may be
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recalled in the following ways: 154.28(1) Voluntarily by a licensed manufacturer. 154.28(2) By the department. If the department determines, based on an evaluation, that there is a reasonable probability that use of, or exposure to, a violative medical cannabidiol product will ca…
R.641—154.29 Quality assurance and control
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154.29(1) Quality control program. A manufacturer shall develop and implement a written quality assurance program that assesses the chemical and microbiological composition of medical cannabidiol. Assessment includes a profile of the active ingredients, including stability studie…
R.641—154.3 Medical cannabidiol registration card—application and issuance to patient
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154.3(1) The department may issue a registration card to a patient who meets the criteria listed at Iowa Code section 124E.4(1). The application form is available on the department’s website. The department shall not approve an application that does not include the information re…
R.641—154.30 Packaging and labeling
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154.30(1) Trade names. A manufacturer’s medical cannabidiol trade names shall comply with the following: a. Names shall be limited to those that clearly reflect the form’s medical cannabidiol nature; b. Any name that is identical to, or similar to, the name of an existing nonmedi…
R.641—154.31 Transportation of medical cannabidiol and plant material
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154.31(1) Transport of medical cannabidiol or plant material. A manufacturer is authorized to transport medical cannabidiol or plant material to and from: a. Dispensaries; b. A laboratory for testing; c. A waste facility for disposal; d. A manufacturer licensed by the department …
R.641—154.32 Disposal of medical cannabidiol and plant material
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154.32(1) Return of medical cannabidiol from dispensaries and laboratory. A manufacturer may collect at no charge medical cannabidiol waste from dispensaries. A manufacturer that chooses to collect medical cannabidiol waste may use it for research and development or retained samp…
R.641—154.33 Production requirements
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154.33(1) Cultivation and processing. a. All phases of production shall take place in designated, restricted access areas in accordance with rule 641—154.21(124E). b. The production process shall be designed to limit contamination. c. Each production area shall allow for access, …
R.641—154.34 Supply and inventory
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154.34(1) Reliable and ongoing supply. A manufacturer shall provide a reliable and ongoing supply of medical cannabidiol to medical cannabidiol dispensaries. 154.34(2) Inventory controls and procedures. A manufacturer shall establish inventory controls and procedures for conducti…
R.641—154.35 Duties of the department
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154.35(1) Inspection of dispensaries. The department or its agents shall conduct regular inspections of dispensaries and their facilities. 154.35(2) Establishment and maintenance of a secure sales and inventory tracking system. The department shall establish and maintain a secure…
R.641—154.36 Dispensary operations
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154.36(1) Operating documents. a. A dispensary shall maintain operating documents that accurately reflect the dispensary’s standard operating procedures. Unless otherwise noted, a dispensary shall make the operating documents available to the department upon request, through secu…
R.641—154.37 Recordkeeping requirements
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154.37(1) Dispensary sales. Within one business day of sale, a dispensary shall record complete and accurate electronic sales transaction records in the secure sales and inventory tracking system, including: a. The name of the patient and, if purchase is made by the primary careg…
R.641—154.38 Storage
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154.38(1) Storage of saleable medical cannabidiol. a. A dispensary shall store medical cannabidiol to prevent diversion, theft, or loss, including ensuring that: (1) Medical cannabidiol is kept in a secure and monitored location within the dispensary; and (2) Cabinets or storage …
R.641—154.39 Dispensing
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154.39(1) Access to all forms of product. A dispensary shall provide access to all medical cannabidiol forms produced by each licensed manufacturer. 154.39(2) Dispensing to a patient or primary caregiver. Prior to dispensing any medical cannabidiol to a patient, a dispensary shal…
R.641—154.4 Medical cannabidiol registration card—reciprocity. A medical cannabidiol
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registration card shall hold reciprocity with other states pursuant to Iowa Code section 124E.18. 154.4(1) A patient with a valid registration card from another state or jurisdiction shall maintain the affirmative defense for possession of medical cannabidiol, provided the form o…
R.641—154.40 Transportation of medical cannabidiol. A dispensary is not authorized to transport
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medical cannabidiol, unless approved by the department. Any approved transport shall be logged in the secure sales and inventory tracking system. [ARC 8124C, IAB 7/10/24, effective 8/14/24]
R.641—154.41 Disposal of medical cannabidiol
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154.41(1) Identification of excess, expired, or damaged medical cannabidiol. Dispensaries shall identify unused, excess, expired, or damaged medical cannabidiol. 154.41(2) Return of medical cannabidiol from a patient or primary caregiver to a dispensary. a. A dispensary shall acc…
R.641—154.42 Inventory
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154.42(1) Inventory controls and procedures. A dispensary shall establish inventory controls and procedures for conducting inventory reviews to prevent and detect any diversion, theft, or loss in a timely manner. 154.42(2) Real-time inventory required. A dispensary shall use the …
R.641—154.43 Quality assurance and control. A dispensary shall cooperate with manufacturers
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and the department on quality assurance and control procedures, including participating in stability-testing studies, developing sampling strategies, and returning medical cannabidiol that has been recalled. [ARC 8124C, IAB 7/10/24, effective 8/14/24] MEDICAL CANNABIDIOL BOARD…
R.641—154.44 Purpose and duties of board. The purpose of the board is to administer the
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provisions of Iowa Code section 124E.5. [ARC 8124C, IAB 7/10/24, effective 8/14/24]
R.641—154.45 Organization of board and proceedings
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154.45(1) Membership. The board shall be composed of members as set forth in Iowa Code section 124E.5. The appointments, unless provided otherwise by law, shall be for three-year staggered terms that shall expire on June 30. Board members shall be knowledgeable about the use of m…
R.641—154.46 Petitions for the addition or removal of medical conditions, medical treatments
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or debilitating diseases. Pursuant to Iowa Code section 124E.5(3)“a,” the board shall accept and review petitions to modify the list of debilitating medical conditions for the medical use of cannabidiol. The petition shall be in accordance with 441—Chapter 4, except that the capt…
R.641—154.47 Requirements of the department
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154.47(1) Laboratory testing requirements and acceptance criteria. The department shall work with manufacturers and laboratories to create and maintain a document describing required sampling methodology, acceptance criteria, stability-testing procedures, and other guidance for m…
R.641—154.48 Requirements of a laboratory
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154.48(1) Minimum testing requirements. A laboratory shall establish and implement test methods and corresponding standard operating procedures for the analyses of cannabinoids, residual solvents and processing chemicals, pesticides, microbiological impurities, and metals and oth…
R.641—154.49 Requirements of a manufacturer
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154.49(1) Assuming costs. A manufacturer shall assume the costs for all laboratory testing pertaining to verification studies on new products, the cost of standard testing protocols as outlined in a Laboratory Acceptance and Criteria Document and other tests as requested by the d…
R.641—154.5 Medical cannabidiol registration card—application and issuance to primary
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caregiver. 154.5(1) For a patient in a primary caregiver’s care, the department may issue a registration card to a primary caregiver who meets the criteria listed at Iowa Code section 124E.4(3). The application form is available on the department’s website. The department shall n…
R.641—154.50 Content testing
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154.50(1) Cannabinoids. a. For each unique lot of medical cannabidiol, and if asked to do so by a requester for other medical cannabis goods, a laboratory shall, at minimum, test for and report measurements for the following cannabinoid analytes: (1) THC; (2) THCA; (3) CBD; and (…
R.641—154.51 Reporting requirements
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154.51(1) Reporting test results. The laboratory shall generate a certificate of analysis for each primary sample that it tests and make the certificate of analysis available to the manufacturer and the department. 154.51(2) Tentatively identified analytes. A laboratory shall rep…
R.641—154.52 Recordkeeping requirements
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154.52(1) Data package. A laboratory shall create a data package for each analytical batch of primary samples that the laboratory analyzes. The data package shall contain at minimum the following information: a. The name and address of the laboratory that performed the analytical…
R.641—154.53 Quality control. The laboratory shall have quality control protocols that include the
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following elements: 154.53(1) Quality control samples required. a. The laboratory shall run quality control samples with every analytical batch of samples for chemical and microbiological analysis. b. For microbiological analysis, the laboratory shall develop procedures for quali…
R.641—154.54 Security requirements
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154.54(1) Security policy requirement. A laboratory shall maintain a security policy to prevent the loss, theft, or diversion of medical cannabidiol samples. The security policy shall apply to all staff and visitors at a laboratory facility. 154.54(2) Restricted access. A laborat…
R.641—154.6 Denial and cancellation. The department may deny an application for a registration
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card, or may cancel a registration card, for any of the following reasons: 1. Information contained in the application is illegible, incomplete, falsified, misleading, deceptive, or untrue. 2. The department is unable to verify the identity of the applicant from the photo identif…
R.641—154.7 Appeal
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154.7(1) Written notice of denial or cancellation. If the department denies an application for or cancels a registration card, the department shall inform the applicant or cardholder of the denial or cancellation, state the reasons for the denial or cancellation in writing, and s…
R.641—154.8 Duplicate card
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154.8(1) Lost, stolen, or destroyed card. To replace a registration card that is lost, stolen, or destroyed, a cardholder shall present to the department the cardholder’s valid photo identification that was provided at the time of application. 154.8(2) Change in card information …
R.641—154.9 Renewal. A registration card shall be valid for one year from the date of issuance,
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unless canceled. Renewal of a registration card will follow the application and issuance rules of this chapter. [ARC 8124C, IAB 7/10/24, effective 8/14/24]
R.641—155.1 Definitions. Unless otherwise indicated, the following definitions apply to the
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specific terms used in these rules: “Accredited opioid treatment program” means an opioid treatment program that is the subject of a current, valid accreditation from an accreditation body approved by the Substance Abuse and Mental Health Services Administration (SAMHSA). “Addict…
R.641—155.10 Grounds for denial of license. The department may deny an application for a
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license for any of the following reasons: 155.10(1) The application is not complete, is not timely or otherwise does not meet the requirements of these rules. 155.10(2) The applicant fails to achieve the minimum licensure weighting report rating required for a 270-day initial lic…
R.641—155.11 Denial, suspension or revocation of a license. The department may deny an
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application for a license. The department may suspend or revoke a license for any of the grounds for discipline pursuant to subrule 155.10(4). 155.11(1) Initial notice from the department. When the department determines to deny, suspend or revoke a one-, two-, or three-year licen…
R.641—155.12 to 155.14
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R.641—155.15 Issuance of a license after denial, suspension or revocation. After denial,
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suspension, or revocation of a license, the former applicant or licensee shall not have a license issued within one year of the effective date of the denial, suspension or revocation. After one year, the former applicant or licensee may submit an application for a 270-day initial…
R.641—155.16 Complaints and investigations
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155.16(1) Complaints. Any person may file a complaint with the department against any program licensed pursuant to this chapter. The complaint shall be made in writing and shall be emailed, mailed or delivered to the department. The complaint shall include the name and address of…
R.641—155.17 License revision. A licensee shall submit a written request to the department to
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revise a license at least 30 days prior to any change of address, executive director, clinical oversight staff, facility, or licensed program service. The department will determine if the requested revision can be approved or if the change is significant enough to require the sub…
R.641—155.18 Deemed status
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155.18(1) Accreditation. The department will approve a license under deemed status for an applicant accredited by a recognized national accreditation body when it determines that the accreditation is for the same licensed program services as those addressed by these rules and whe…
R.641—155.19 Funding. The issuance of a license shall not be construed as a commitment on the
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part of either the state or federal government to provide funds to such licensee. [ARC 9499C, IAB 8/20/25, effective 10/1/25]