reglab/statecodes huggingface dataset:
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.18 - Suspension or Revocation of a Manufacturing or Dispensary License

Current through Register Vol. 47, No. 3, July 24, 2024
(1) The
			 department may suspend or revoke a manufacturer or dispensary license upon any
			 of the following grounds:
a. Submission of
			 false, inaccurate, misleading, or fraudulent information to the department in
			 the application or inspection processes.
b. Failure to submit required reports and
			 documents.
c. Violation of Iowa
			 Code chapter 124E or these rules, or violation of state or local law related to
			 operation of the licensee.
d.
			 Conduct or practices detrimental to the safety, health, or welfare of a
			 patient, primary caregiver, or the public.
e. Criminal, civil, or administration action
			 taken against a license or registration in this or another state or country
			 related to manufacturing or dispensing medical cannabidiol.
f. False, misleading, or deceptive
			 representations to the department, another state or federal agency, or a law
			 enforcement agency.
g.
			 Discontinuance of operation for more than 30 days, unless the department
			 approves an extension of such period for good cause shown.
h. Failure to maintain effective controls
			 against diversion, theft, or loss of medical cannabidiol.
i. Failure to correct a deficiency within the
			 time frame required by the department.
j. Failure of a manufacturer or dispensary's
			 business owner or investors to have a satisfactory result in a background
			 investigation or national criminal history background check as determined by
			 the department.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.19 - Location

Current through Register Vol. 47, No. 3, July 24, 2024
All of a manufacturer's manufacturing, cultivating, harvesting,
				packaging, processing, and storage of medical cannabidiol shall take place in
				one secured manufacturing facility location at a physical address provided to
				the department during the licensure and application processes.
(1)
Proximity to dispensary.
A manufacturer shall not operate a manufacturing facility at the same physical
			 location as a medical cannabidiol dispensary.
(2)
Proximity to school.
A
			 manufacturer shall not operate a manufacturing facility in any location,
			 whether for manufacturing, possessing, cultivating, harvesting, transporting,
			 packaging, processing, storing, or supplying, within 1,000 feet of a public or
			 private school existing before the date of the manufacturer's licensure by the
			 department.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.19 - Assessment of Penalties

Current through Register Vol. 47, No. 3, July 24, 2024
The department shall assess to a manufacturer a civil penalty
				of up to $1,000 per violation of Iowa Code chapter 124E or these rules in
				addition to other applicable penalties.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.20 - Advertising and Marketing

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Permitted marketing and
			 advertising activities.
a. A
			 manufacturer may:
(1) Display the
			 manufacturer's business name and logo on medical cannabidiol labels, signs,
			 website, and informational material provided to patients. The name or logo
			 shall not include:
1. Images of cannabis or
			 cannabis-use paraphernalia;
2.
			 Colloquial references to cannabis;
3. Names of cannabis plant strains or
			 varieties;
4. Unsubstantiated
			 medical claims; or
5. Medical
			 symbols that bear a reasonable resemblance to established medical associations.
			 Examples of established medical organizations include the American Medical
			 Association or American Academy of Pediatrics. The use of medical symbols is
			 subject to approval by the department;
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.20 - Closure of Operations

Current through Register Vol. 47, No. 3, July 24, 2024
(1) A
			 manufacturer or dispensary shall notify the department at least six months
			 before the closure of the manufacturing facility.
(2) If a manufacturer or dispensary ceases
			 operation, the manufacturer or dispensary shall work with the department to
			 verify the remaining inventory of the manufacturer or dispensary and ensure
			 that any plant material, plant material waste, medical cannabidiol products, or
			 combination thereof are destroyed at a waste facility or returned to a
			 manufacturer.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.21 - Packaging and Labeling

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Medical cannabidiol
			 packaging.
A manufacturer shall package all medical cannabidiol
			 intended for distribution according to the following standards:
a. The manufacturer shall properly package
			 medical cannabidiol in compliance with the United States Poison Prevention
			 Packing Act regarding child-resistant packaging and exemptions for packaging
			 for elderly patients.
b. The
			 manufacturer shall label packaged medical cannabidiol as described in subrule
			 154.21(3).
c. The manufacturer
			 shall use medical containers that are:
(1) Of
			 sufficient size to accommodate a separate dispensary label containing the
			 information described in rule
			 641-154.46 (124E);
(2) Designed to maximize the shelf life of
			 the contained medical cannabidiol;
(3) Tamper-evident; and
(4) Child-resistant.
d. Medical cannabidiol packaging shall not
			 bear a reasonable resemblance to commonly available nonmedical commercial
			 products.
e. The manufacturer shall
			 package medical cannabidiol in a manner that minimizes the package's appeal to
			 children.
f. The manufacturer
			 shall not depict images other than the manufacturer's business name or logo on
			 the packaging.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.21 - Manufacturer and Dispensary Security Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
(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. Use a
			 controlled access system that:
(1) Limits
			 access to authorized individuals;
(2) Maintains a log of individuals with
			 approved access, including dates of approvals and revocations;
(3) Tracks times of personnel entry to and
			 exit from the facility;
(4) Stores
			 data for retrieval for a minimum of one year; and
(5) Limits access to authorized individuals
			 in the event of a power failure.
c. If the controlled access system cannot
			 electronically record visitors, visitors to restricted access areas sign
			 manifests with name, date, and times of entry and exit. These manifests shall
			 be kept and stored for a minimum of one year.
d. Visitors wear badges that are visible at
			 all times and identify them as visitors.
e. If requested by the department, submit
			 stored controlled access system data to the department within five business
			 days.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.22 - Transportation of Medical Cannabidiol and Plant Material

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Transport of medical
			 cannabidiol.
A manufacturer is authorized to transport medical
			 cannabidiol to and from:
a.
			 Dispensaries;
b. A laboratory for
			 testing;
c. A waste facility for
			 disposal;
d. A manufacturer
			 licensed by the department under Iowa Code chapter 124E;
e. Other sites only with departmental
			 approval.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.22 - Advertising and Marketing

Current through Register Vol. 47, No. 3, July 24, 2024
(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 cannabidiol labels, signs,
			 website, and informational material provided to patients. The name or logo
			 shall not include:
(1) Images of cannabis or
			 cannabis-use paraphernalia;
(2)
			 Colloquial references to cannabis;
(3) Names of cannabis plant strains or
			 varieties;
(4) Unsubstantiated
			 medical claims; or
(5) Medical
			 symbols that bear a reasonable resemblance to established medical
			 associations.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.23 - Disposal of Medical Cannabidiol and Plant Material

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Return
			 of medical cannabidiol from dispensaries and laboratory.
a. A manufacturer shall collect at no charge
			 medical cannabidiol waste from dispensaries. A manufacturer shall:
(1) Collect medical cannabidiol waste from
			 each dispensary on a schedule mutually agreed upon by the manufacturer and
			 dispensary;
(2) Dispose of medical
			 cannabidiol waste as provided in subrule 154.23(2); and
(3) Maintain a written record of disposal
			 that includes:
1. The tracking number assigned
			 at the time of the dispensing, if available, or the name of the patient, if the
			 tracking number is unavailable, when the medical cannabidiol was returned to
			 the dispensary from a patient or primary caregiver;
2. The date the medical cannabidiol waste was
			 collected;
3. The quantity of
			 medical cannabidiol waste collected; and
4. The type and lot number of medical
			 cannabidiol waste collected.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.23 - Sales and Inventory Tracking System

Current through Register Vol. 47, No. 3, July 24, 2024
The department shall establish and maintain a 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.
			 Sales of medical cannabidiol to dispensaries;
5. Sales of medical cannabidiol from
			 dispensaries to patients and primary caregivers.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.24 - Record-keeping Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
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 name and description, and quantity of medical cannabidiol sold
			 or otherwise distributed; and
c.
			 The sale price.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.24 - Financial Transactions

Current through Register Vol. 47, No. 3, July 24, 2024
(1) A
			 manufacturer or dispensary shall maintain records that reflect all financial
			 transactions and the financial condition of the business.
(2) The following records shall be maintained
			 for at least five years and made available for review upon request of the
			 department:
a. Purchase invoices, bills of
			 lading, sales records, copies of bills of sale, and any supporting documents,
			 including the items or services purchased, from whom the items were purchased,
			 and the date of purchase;
b. Bank
			 statements and canceled checks for all business accounts;
c. Accounting and tax records; and
d. Records of all financial transactions,
			 including contracts and agreements for services performed or services
			 received.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.25 - Production Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Cultivation and
			 processing.
a. Only a licensed
			 manufacturer is authorized to produce and manufacture medical
			 cannabidiol.
b. All phases of
			 production shall take place in designated, restricted access areas that are
			 monitored by a surveillance camera system in accordance with rule
			 641-154.18 (124E).
c. The production process shall be designed
			 to limit contamination. Examples of contamination include mold, fungus,
			 bacterial diseases, rot, pests, nonorganic pesticides, and mildew.
d. Each production area shall allow for
			 access, observation, and inventory of each plant group.
e. Biosecurity measures shall be in effect as
			 described in the operating documents pursuant to subrule 154.17(1).
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.25 - Inspection by Department or Independent Consultant

Current through Register Vol. 47, No. 3, July 24, 2024
A manufacturer or dispensary 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.
(1)
Types of inspections.
Inspections may include:
a. Aspects of the business
			 operations;
b. The manufacturing
			 facility or the physical location of a dispensary, including any storage
			 facility;
c. Vehicles used for
			 transport or delivery of medical cannabidiol or plant material;
d. Financial information and inventory
			 documentation;
e. Physical and
			 electronic security alarm systems;
f. Health and sanitary inspection;
			 and
g. Other inspections as
			 determined by the department.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.26 - Quality Assurance and Control

Current through Register Vol. 47, No. 3, July 24, 2024
(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
			 shelf life, and the presence of inactive ingredients and contaminants. A
			 manufacturer shall use these testing results to determine appropriate storage
			 conditions and product expiration dates.
(2)
Sampling protocols.
A
			 manufacturer shall develop and follow written procedures for sampling medical
			 cannabidiol that require the manufacturer to:
a. Conduct sample collection in a manner that
			 provides analytically sound and representative samples;
b. Document every sampling event and provide
			 this documentation to the department upon request;
c. Describe all sampling and testing plans in
			 written procedures that include the sampling method and the number of units per
			 lot to be tested;
d. Ensure that
			 random samples from each lot are:
(1) Taken in
			 an amount necessary to conduct the applicable test;
(2) Labeled with the lot number;
			 and
(3) Submitted for
			 testing;
e. Retain the
			 results from the random samples for at least five years; and
f. Notify the department at least two
			 business days prior to sample collection and allow the department or its
			 designees to be present to observe the sampling procedures when the samples are
			 to be sent to a laboratory for testing.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.26 - Manufacturer Operations

Current through Register Vol. 47, No. 3, July 24, 2024
(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, through secure
			 means.
b. The operating documents
			 of a manufacturer shall include all of the following:
(1) Procedures for the oversight of the
			 manufacturer, including descriptions of operational and management practices
			 regarding:
1. The forms and quantities of
			 medical cannabidiol products that are produced at the manufacturing
			 facility;
2. The methods of
			 planting, harvesting, drying, and storing cannabis. A manufacturer may make
			 operating documents for these procedures available on site only;
3. The estimated types and amounts of all
			 crop inputs used in the production of medical cannabidiol;
4. The disposal methods for all waste
			 materials;
5. Employee training
			 methods for the specific phases of production. A manufacturer may make
			 operating documents for these procedures available on site only;
6. Biosecurity measures and standard
			 operating procedures used in the production and manufacturing of medical
			 cannabidiol. A manufacturer may make operating documents for these procedures
			 available on site only;
7.
			 Strategies for identifying and reconciling discrepancies in inventory of plant
			 material or medical cannabidiol;
8.
			 Sampling strategy and quality testing for labeling purposes. A manufacturer may
			 make operating documents for these procedures available on site only;
9. Medical cannabidiol packaging and labeling
			 procedures;
10. Procedures for
			 recall of medical cannabidiol;
11.
			 Plans for responding to a security breach at a manufacturing facility or while
			 medical cannabidiol is in transit to a dispensary. A manufacturer may make
			 operating documents for these procedures available on site only;
12. A business continuity plan. A
			 manufacturer may make this operating document available on site only;
13. Records relating to all transport
			 activities; and
14. Other
			 information requested by the department.
(2) Procedures to ensure accurate
			 recordkeeping.
(3) Procedures for
			 the implementation of appropriate security measures to deter and prevent the
			 theft of medical cannabidiol and unauthorized entrance into areas containing
			 medical cannabidiol. A manufacturer may make operating documents for these
			 procedures available on site only.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.27 - Supply and Inventory

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Reliable and ongoing supply.
A manufacturer shall provide a
			 reliable and ongoing supply of medical cannabidiol to medical cannabidiol
			 dispensaries.
(2)
Inventory
			 controls and procedures.
A manufacturer shall establish inventory
			 controls and procedures for conducting inventory reviews to prevent and detect
			 any diversion, theft, or loss in a timely manner.
(3)
Inventory tracking
			 required.
A manufacturer shall use the department-approved secure
			 sales and inventory tracking system to track medical cannabidiol production
			 from seed or plant cutting through distribution of medical cannabidiol to a
			 dispensary. The manufacturer shall use the system to maintain a record of the
			 manufacturer's inventory of plant material and medical cannabidiol to include:
a. The quantity and form of medical
			 cannabidiol maintained by the manufacturer at the manufacturing facility on a
			 daily basis;
b. The amount of
			 plants being grown at the manufacturing facility on a daily basis;
			 and
c. Other information deemed
			 necessary and requested by the department.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.27 - Recordkeeping Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
(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 name and
			 description, and quantity of medical cannabidiol sold or otherwise distributed;
			 and
c. The sale price.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.28 - Inspection by Department or Independent Consultant

Current through Register Vol. 47, No. 3, July 24, 2024
A manufacturer is subject to reasonable inspection by the
				department, a department-approved consultant, or other agency pursuant to Iowa
				Code chapter 124E and these rules and as authorized by laws and
				regulations.
(1)
Types of
			 inspections.
Inspections may include:
a. Aspects of the business
			 operations;
b. The manufacturing
			 facility;
c. Vehicles used for
			 transport or delivery of medical cannabidiol or plant material;
d. Financial information and inventory
			 documentation;
e. Physical and
			 electronic security alarm systems; and
f. Other inspections as determined by the
			 department.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.28 - Recall of Medical Cannabidiol Products

Current through Register Vol. 47, No. 3, July 24, 2024
Medical cannabidiol products may be recalled in the following
				ways:
(1) Voluntarily by a licensed
			 manufacturer.
(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 cause a serious adverse health consequence or death,
			 the department may require a manufacturer to recall such violative medical
			 cannabidiol products from dispensaries. An evaluation of the health hazard
			 presented by medical cannabidiol being considered for recall shall be conducted
			 by an ad hoc committee of scientists appointed by the department and shall
			 consider, but need not be limited to, each of the following factors:
a. Whether any disease or injuries have
			 already occurred from the product.
b. Whether any existing conditions could
			 contribute to a clinical situation that could expose humans to a health hazard.
			 Any conclusion shall be supported as completely as possible by scientific
			 documentation, statements, or both that the conclusion is the opinion of the
			 individual(s) making the health hazard determination.
c. A holistic assessment of the hazard and
			 its present and future potential consequences.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.29 - Assessment of Penalties

Current through Register Vol. 47, No. 3, July 24, 2024
The department shall assess to a manufacturer a civil penalty
				of up to $1,000 per violation of Iowa Code chapter 124E or these rules in
				addition to other applicable penalties.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.29 - Quality Assurance and Control

Current through Register Vol. 47, No. 3, July 24, 2024
(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 studies, and the presence of inactive ingredients and contaminants. A
			 manufacturer shall use these testing results to determine appropriate storage
			 conditions and product expiration dates.
(2)
Sampling protocols.
A
			 manufacturer shall develop and follow written procedures for sampling medical
			 cannabidiol that require the manufacturer to:
a. Conduct sample collection in a manner that
			 provides analytically sound and representative samples;
b. Document every sampling event and provide
			 this documentation to the department upon request;
c. Describe all sampling and testing plans in
			 written procedures that include the sampling method and the number of units per
			 lot to be tested;
d. Ensure that
			 random samples from each lot are:
(1) Taken in
			 an amount necessary to conduct the applicable test;
(2) Labeled with the lot number;
			 and
(3) Submitted for
			 testing;
e. Retain the
			 results from the random samples for at least five years; and
f. Notify the department at least two
			 business days prior to sample collection and allow the department or its
			 designees to be present to observe the sampling procedures when the samples are
			 to be sent to a laboratory for testing.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.30 - Suspension or Revocation of a Manufacturer License

Current through Register Vol. 47, No. 3, July 24, 2024
(1) The department
			 may suspend or revoke a manufacturer license upon any of the following grounds:
a. Submission of false, inaccurate,
			 misleading, or fraudulent information to the department in the application or
			 inspection processes.
b. Failure to
			 submit required reports and documents.
c. Violation of Iowa Code chapter 124E or
			 these rules, or violation of state or local law related to operation of the
			 licensee.
d. Conduct or practices
			 detrimental to the safety, health, or welfare of a patient, primary caregiver,
			 or the public.
e. Criminal, civil,
			 or administration action taken against a license or registration in this or
			 another state or country related to manufacturing or dispensing medical
			 cannabidiol.
f. False, misleading,
			 or deceptive representations to the department, another state or federal
			 agency, or a law enforcement agency.
g. Discontinuance of operation for more than
			 30 days, unless the department approves an extension of such period for good
			 cause shown.
h. Failure to maintain
			 effective controls against diversion, theft, or loss of medical
			 cannabidiol.
i. Failure to correct
			 a deficiency within the time frame required by the department.
j. Failure of a manufacturer's business owner
			 or investors to have a satisfactory result in a background investigation or
			 national criminal history background check conducted by the department of
			 public safety and as determined by the department.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.30 - Packaging and Labeling

Current through Register Vol. 47, No. 3, July 24, 2024
(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 nonmedical cannabidiol
			 product is prohibited;
c. Any name
			 that is identical to, or similar to, the name of an unlawful product or
			 substance is prohibited; and
d. Any
			 name that contains language that suggests using medical cannabidiol for
			 recreational purposes or for a condition other than a qualifying debilitating
			 medical condition is prohibited.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.31 - Closure of Operations

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Notice.
A manufacturer
			 shall notify the department at least six months before the closure of the
			 manufacturing facility.
(2)
Procedures.
If a manufacturer ceases operation, the
			 manufacturer shall work with the department to verify the remaining inventory
			 of the manufacturer and ensure that any plant material, plant material waste,
			 and medical cannabidiol are destroyed at a waste facility as provided in
			 subrule 154.23(2).
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.31 - Transportation of Medical Cannabidiol and Plant Material

Current through Register Vol. 47, No. 3, July 24, 2024
(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
			 under Iowa Code chapter 124E;
e.
			 Other sites only with departmental approval.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.32 - Disposal of Medical Cannabidiol and Plant Material

Current through Register Vol. 47, No. 3, July 24, 2024
(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 samples, but the manufacturer shall not introduce medical cannabidiol
			 returned from a laboratory into lots of products intended for sale.
			 Notwithstanding this provision, a manufacturer shall:
a. Dispose of medical cannabidiol waste;
			 and
b. Maintain a written record of
			 disposal.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.33 - Production Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
(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, observation, and inventory of each
			 plant group.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.34 - Supply and Inventory

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Reliable and ongoing supply.
A manufacturer shall provide a
			 reliable and ongoing supply of medical cannabidiol to medical cannabidiol
			 dispensaries.
(2)
Inventory
			 controls and procedures.
A manufacturer shall establish inventory
			 controls and procedures for conducting inventory reviews to prevent and detect
			 any diversion, theft, or loss in a timely manner.
(3)
Inventory tracking
			 required.
A manufacturer shall use the secure sales and inventory
			 tracking system to track medical cannabidiol production from seed or plant
			 cutting through distribution of medical cannabidiol to a dispensary.
(4)
Reconciliation.
No less
			 often than every two calendar weeks, a manufacturer shall reconcile its
			 physical inventory with the inventory recorded in the secure sales and
			 inventory tracking system.
a. Reconciliation
			 shall include:
(1) Plant material at the
			 manufacturing facility and in transit; and
(2) Medical cannabidiol at the manufacturing
			 facility.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.35 - Duties of the Department

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Inspection of dispensaries.
The department or its agents shall
			 conduct regular inspections of dispensaries and their facilities.
(2)
Establishment and maintenance of
			 a secure sales and inventory tracking system.
The department shall
			 establish and maintain a secure, electronic system that is available 24 hours
			 per day, seven days per week to track:
a.
			 Inventory of medical cannabidiol and waste material;
b. Sales of medical cannabidiol from
			 dispensaries to patients and primary caregivers;
c. Total tetrahydrocannabinol purchased in
			 the last 90 days by a patient and the patient's primary caregiver.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.36 - Dispensary Operations

Current through Register Vol. 47, No. 3, July 24, 2024
(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 secure
			 means.
b. The operating documents
			 of a dispensary shall include all of the following:
(1) 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 limit 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 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.
(2) Procedures to ensure accurate
			 recordkeeping.
(3) 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.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.37 - Recordkeeping Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
(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 caregiver, the name of the primary
			 caregiver;
b. The date and time of
			 each sale;
c. The item number,
			 product name and description, and quantity of medical cannabidiol
			 sold;
d. The sale price;
e. Other information required by the
			 department.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.38 - Storage

Current through Register Vol. 47, No. 3, July 24, 2024
(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 containers inside the
			 secure and monitored area are locked at the end of a business day.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.39 - Dispensing

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Access to all forms of product.
A dispensary shall provide
			 access to all medical cannabidiol forms produced by each licensed
			 manufacturer.
(2)
Dispensing to a patient or primary caregiver.
Prior to
			 dispensing any medical cannabidiol to a patient, a dispensary shall do all of
			 the following:
a. Verify the patient or
			 primary caregiver's identity using acceptable photo identification and that the
			 patient or primary caregiver is over 18 years of age. Acceptable photo
			 identification includes:
(1) A valid Iowa
			 driver's license;
(2) A valid Iowa
			 nonoperator's identification card;
(3) A U.S. passport;
(4) A U.S. military ID or veteran ID;
			 or
(5) A tribal ID
			 card/document;
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.40 - Duties of the Department

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Interagency agreements.
The department may enter into any interagency agreements with other state
			 agencies for technical services or other assistance related to the regulation
			 or inspection of dispensaries.
(2)
Notice to law enforcement.
The department shall notify local
			 law enforcement agencies and the department of public safety of the locations
			 of dispensaries. If the department has sufficient cause to believe that there
			 is a threat to public safety, the department shall notify local law enforcement
			 agencies and the department of public safety of any conditions that pose a
			 threat to public safety including but not limited to:
a. Loss or theft of medical
			 cannabidiol;
b. Diversion or
			 potential diversion of medical cannabidiol;
c. Unauthorized access to the secure sales
			 and inventory tracking system or other patient and caregiver information system
			 or file; or
d. Other violations of
			 law.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.40 - Transportation of Medical Cannabidiol

Current through Register Vol. 47, No. 3, July 24, 2024
A dispensary is not authorized to transport medical
				cannabidiol, unless approved by the department. Any approved transport shall be
				logged in the secure sales and inventory tracking system.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.41 - Dispensary Operations

Current through Register Vol. 47, No. 3, July 24, 2024
(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.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.41 - Disposal of Medical Cannabidiol

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Identification of excess,
			 expired, or damaged medical cannabidiol.
Dispensaries shall identify
			 unused, excess, expired, or damaged medical cannabidiol.
(2)
Return of medical cannabidiol
			 from a patient or primary caregiver to a dispensary.
a. A dispensary shall accept at no charge
			 medical cannabidiol waste from any patient or primary caregiver. A dispensary
			 may provide all medical cannabidiol waste to the manufacturer for
			 disposal.
b. The dispensary shall
			 enter the following information into the secure sales and inventory tracking
			 system for medical cannabidiol returned from a patient or primary caregiver
			 being returned to the manufacturer:
(1) The
			 tracking number assigned at the time of the dispensing, if available, or the
			 name of the patient, if the tracking number is unavailable;
(2) The date the medical cannabidiol was
			 returned;
(3) The quantity of
			 medical cannabidiol returned; and
(4) The type and lot number of medical
			 cannabidiol returned.
c.
			 A dispensary shall store medical cannabidiol returned from patients and primary
			 caregivers.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.42 - Security Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
The department may request assistance from the department of
				public safety in ensuring dispensaries meet the security requirements in this
				rule.
(1)
Restricted
			 access.
A dispensary shall have a controlled access system to limit
			 entrance to all restricted access areas of the dispensary facility. Visitors to
			 restricted access areas shall sign manifests with name, date, and times of
			 entry and exit, if the controlled access system cannot electronically record
			 visitors. Visitors shall wear badges that are visible at all times and identify
			 them as visitors.
a. The controlled access
			 system shall do all of the following:
(1)
			 Limit access to authorized individuals;
(2) Maintain a log of individuals with
			 approved access, including dates of approvals and revocations;
(3) Track times of personnel entry to and
			 exit from restricted access areas;
(4) Store data for retrieval for a minimum of
			 one year; and
(5) Limit access to
			 authorized individuals in the event of a power failure.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.42 - Inventory

Current through Register Vol. 47, No. 3, July 24, 2024
(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.
(2)
Real-time inventory
			 required.
A dispensary shall use the secure sales and inventory
			 tracking system to maintain a real-time record of the dispensary's inventory of
			 medical cannabidiol to include:
a. The
			 quantity and form of saleable medical cannabidiol maintained at the dispensary
			 on a daily basis;
b. The amount of
			 damaged, expired, or returned medical cannabidiol being held at the dispensary
			 for return to a manufacturer; and
c. Other information deemed necessary and
			 requested by the department.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.43 - Location

Current through Register Vol. 47, No. 3, July 24, 2024
All dispensing of medical cannabidiol shall take place in an
				enclosed facility at one physical address provided to the department during the
				licensure process.
(1)
Proximity to manufacturers.
A dispensary shall not operate at
			 the same physical location as a manufacturer.
(2)
Proximity to schools.
A
			 dispensary shall not operate in any location within 1,000 feet of a public or
			 private school existing before the date of the dispensary's licensure by the
			 department.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.43 - Quality Assurance and Control

Current through Register Vol. 47, No. 3, July 24, 2024
A dispensary shall cooperate with manufacturers 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.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.44 - Advertising and Marketing

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Permitted marketing and
			 advertising activities.
a. A
			 dispensary may:
(1) Display the dispensary's
			 business name and logo on medical cannabidiol labels, signs, website, and
			 informational material provided to patients. The name or logo shall not
			 include:
1. Images of cannabis or
			 cannabis-use paraphernalia;
2.
			 Colloquial references to cannabis;
3. Names of cannabis plant strains or
			 varieties;
4. Unsubstantiated
			 medical claims; or
5. Medical
			 symbols that bear a reasonable resemblance to established medical associations.
			 Examples of established medical organizations include the American Medical
			 Association or American Academy of Pediatrics. The use of medical symbols is
			 subject to approval by the department.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.45 - Storage

Current through Register Vol. 47, No. 3, July 24, 2024
(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 containers inside the
			 secure and monitored area are locked at the end of a business day.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.45 - Organization of Board and Proceedings

Current through Register Vol. 47, No. 3, July 24, 2024
(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
			 medical cannabidiol. The medical practitioners appointed to the board shall be
			 licensed in Iowa and be nationally board-certified in their area of
			 specialty.
(2)
Vacancies.
Vacancies shall be filled in the same manner in
			 which the original appointments were made for the balance of the unexpired
			 term.
(3)
Absences.
Three consecutive unexcused absences shall be
			 grounds for the governor to consider dismissal of a board member and to appoint
			 another. Department staff is charged with providing notification of absences to
			 the governor's office.
(4)
Board meetings.
a. Board
			 meetings shall be conducted in accordance with the open meetings requirements
			 of Iowa Code chapter 21.
b. The
			 department's bureau of cannabis regulation shall schedule the time, date and
			 location of meetings.
c. A majority
			 of the members shall constitute a quorum for conducting business of the
			 board.
d. An affirmative vote of a
			 majority of the board members present at a meeting is required for a motion to
			 pass.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.46 - Dispensing

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Access to all forms of product.
A dispensary shall provide
			 access to all medical cannabidiol forms produced by each licensed
			 manufacturer.
(2)
Dispensing to a patient.
a.
			 Prior to dispensing any medical cannabidiol to a patient, a dispensary shall do
			 all of the following:
(1) Verify the
			 patient's identity using a valid photo ID. Acceptable photo identification
			 includes:
1. A valid Iowa driver's
			 license,
2. A valid Iowa
			 nonoperator's identification card,
3. A U.S. passport,
4. A U.S. military ID or veteran
			 ID,
5. A tribal ID
			 card/document;