Iowa Admin. Code r. 641-154.41

Current through Regsiter Vol. 46, No. 26, June 12, 2024

Rule 641-154.41 - Dispensary operations

(1)Operating documents. The operating documents of a dispensary shall include all of the following:

a. Procedures for the oversight of the dispensary, including descriptions of operational and management practices regarding:

(1) The forms and quantities of medical cannabidiol products that will be stored and dispensed at the dispensary;

(2) The estimated forms and quantities of medical cannabidiol waste to be generated or collected;

(3) The disposal methods for all waste materials;

(4) Employee training methods for the dispensary employees;

(5) Strategies for identifying and reconciling discrepancies in inventory of medical cannabidiol;

(6) Procedures to ensure the dispensary does not dispense more than a patient's certified cap of total tetrahydrocannabinol to a patient and the patient's primary caregiver(s) in a 90-day period;

(7) Medical cannabidiol labeling procedures;

(8) Procedures for recall or market withdrawal of medical cannabidiol;

(9) Plans for responding to a security breach at the dispensary facility;

(10) A business continuity plan; and

(11) Other information requested by the department.

b. Procedures to ensure accurate record keeping.

c. Procedures for the implementation of appropriate security measures to deter and prevent the theft of medical cannabidiol and unauthorized entrance into areas of the dispensary facility containing medical cannabidiol.

(2)Prohibited activities.

a. A person or entity shall not own or operate a dispensary unless the person or entity is licensed by the department pursuant to Iowa Code chapter 124E and these rules.

b. A dispensary shall not:

(1) Dispense medical cannabidiol in any location except in those areas approved by the department;

(2) Sell, receive, transport, or distribute medical cannabidiol from any location except its dispensary;

(3) Sell, receive, or distribute medical cannabidiol from any entity other than a manufacturer licensed by the department;

(4) Sell or distribute medical cannabidiol to any person other than an approved patient or primary caregiver;

(5) Sell or distribute more than 4.5 grams of total tetrahydrocannabinol to a patient and the patient's primary caregiver(s) in a 90-day period, unless the patient's health care practitioner has certified a higher total tetrahydrocannabinol cap;

(6) Transport or deliver medical cannabidiol to any location, unless approved by the department;

(7) Sell medical cannabidiol that is not packaged and labeled in accordance with rules 641-154.21 (124E) and 641-154.46 (124E);

(8) Repackage medical cannabidiol or remove the manufacturer's label;

(9) Sell medical cannabidiol in any form or quantity other than a form or quantity approved by the department and adopted by rule;

(10) Permit any person to consume medical cannabidiol on the property of the dispensary;

(11) Employ a person who is under 18 years of age or who has been convicted of a disqualifying felony offense.

(3)Criminal background checks.

a. An owner of a dispensary shall not have been convicted of a disqualifying felony offense and shall be subject to a background investigation conducted by the department of public safety, including but not limited to a national criminal history background check.

b. An employee of a dispensary shall not have been convicted of a disqualifying felony offense and shall be subject to a background investigation conducted by the department of public safety, including but not limited to a national criminal history background check.

c. An applicant or licensed dispensary shall respond within 30 days to a request from the department or the department of public safety for more information to complete a background investigation and national criminal history background check on an owner, investor, or employee.

(4)Relationship to health care practitioners. A dispensary shall not share office space with, refer patients to, or have any financial relationship with a health care practitioner.

(5)Employment of a pharmacist or pharmacy technician. A medical cannabidiol dispensary shall employ a pharmacist or pharmacy technician licensed or registered pursuant to Iowa Code chapter 155A for the purpose of making dosing recommendations.

Iowa Admin. Code r. 641-154.41

Adopted by IAB January 31, 2018/Volume XL, Number 16, effective 3/7/2018

Amended by IAB June 5, 2019/Volume XLI, Number 25, effective 7/10/2019

Amended by IAB October 7, 2020/Volume XLIII, Number 8, effective 11/11/2020