reglab/statecodes huggingface dataset:
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.46 - Petitions for the Addition or Removal of Medical Conditions, Medical Treatments or Debilitating Diseases

Current through Register Vol. 47, No. 3, July 24, 2024
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 caption
				should read "Petition for Addition or Removal."
(1)
Inquiries.
Inquiries
			 concerning the status of a petition may be made to the bureau of cannabis
			 regulation at the department's address.
(2)
Additional information.
The board may request that the petitioner submit additional information
			 concerning the petition. The board may also solicit comments from any person on
			 the substance of the petition. Comments on the substance of the petition may be
			 submitted to the board by any person.
(3)
Presentation to the
			 board.
The board may request or allow the petitioner to make an oral
			 presentation of the contents of a petition at a board meeting following
			 submission of the petition.
(4)
Board response.
The board shall notify the petitioner in
			 writing of the decision within six months after the filing, unless the
			 petitioner agrees to a time extension. If the petition is granted, the board
			 will recommend addition or removal of the medical condition, medical treatment
			 or debilitating disease to the board of medicine. If the petition is denied,
			 the board will provide the rationale for the denial. Notification occurs when
			 the board mails the writing to the petitioner.
(5)
Denials.
Denial of a
			 petition because it does not substantially conform to the required form does
			 not preclude the filing of a new petition on the same subject that seeks to
			 eliminate the grounds for the agency's rejection of the petition.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.47 - 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 641-154.47 - Requirements of the Department

Current through Register Vol. 47, No. 3, July 24, 2024
(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 manufacturers and laboratories on testing procedures. The
			 department shall provide manufacturers and laboratories no less than 14 days in
			 which to comment on proposed revisions to the document, and the department
			 shall provide no less than 30 days' notice before a revision takes effect. The
			 document shall:
a. Describe the minimum
			 number of sample units and reserve samples required for testing by the
			 laboratory;
b. Describe an option
			 for manufacturers to reduce the amount of testing conducted by allowing
			 compositing of sample units or other techniques that reduce the number of tests
			 required without compromising the safety of the products once a manufacturer
			 has satisfactorily completed a control study for a specific extraction or
			 production process;
c. Describe the
			 minimum requirements for sample size and testing intervals for stability
			 testing; and
d. Be available on the
			 department's website (hhs.iowa.gov).
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.48 - Disposal of Medical Cannabidiol

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Identification of excess,
			 expired, or damaged medical cannabidiol.
a. Dispensaries shall identify unused,
			 excess, expired, or damaged medical cannabidiol for return to
			 manufacturers.
b. Unused, excess,
			 expired, or damaged medical cannabidiol shall be stored as described in subrule
			 154.45(2).
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.48 - Requirements of a Laboratory

Current through Register Vol. 47, No. 3, July 24, 2024
(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 other analyses as requested by the
			 department.
(2)
Level of
			 quantitation.
A laboratory shall be able to demonstrate that its level
			 of quantitation (LOQ) is below any action level established by the
			 department.
(3)
Inventory
			 tracking.
A laboratory shall record the following:
a. The receipt of medical cannabidiol from a
			 manufacturer for testing.
b. The
			 return of medical cannabidiol or waste to a manufacturer.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.49 - Record-keeping Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Sales.
A dispensary
			 shall maintain complete and accurate electronic sales transaction records in
			 the department's 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 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 641-154.49 - Requirements of a Manufacturer

Current through Register Vol. 47, No. 3, July 24, 2024
(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 department. A manufacturer shall provide any necessary
			 reference materials to the laboratory at no cost.
(2)
Obtaining approval for sampling
			 protocols.
A manufacturer shall obtain approval from the department
			 for the manufacturer's sampling protocols prior to submitting samples for
			 laboratory testing related to content and contamination.
(3)
Obtaining approval for
			 stability-testing procedures.
A manufacturer shall obtain approval
			 from the department for the manufacturer's stability-testing procedures prior
			 to submitting samples for laboratory testing related to stability testing and
			 product-expiration-date studies.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.50 - 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 or withdrawn from the
				market.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.50 - Content Testing

Current through Register Vol. 47, No. 3, July 24, 2024
(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
(4) CBDA.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.51 - 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 department-approved 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 641-154.51 - Reporting Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
(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.
(2)
Tentatively
			 identified analytes.
A laboratory shall report on the certificate of
			 analysis any tentatively identified analytes detected during the analysis of
			 the primary sample. When a laboratory identifies additional analytes in a
			 primary sample, the laboratory shall:
a.
			 Notify the department of the additional analytes detected.
b. Refrain from issuing a final certificate
			 of analysis until given approval to do so by the department.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.52 - Inspection by Department or Independent Consultant

Current through Register Vol. 47, No. 3, July 24, 2024
A dispensary is subject to reasonable inspection by the
				department, a department-approved consultant, or other agency as authorized by
				Iowa Code chapter 124E and these rules or state or local laws and
				regulations.
(1)
Types of
			 inspections.
Inspections may include:
a. Aspects of the business
			 operations;
b. The physical
			 location of a dispensary, including any storage facilities;
c. Financial information and inventory
			 documentation;
d. Physical and
			 electronic security alarm systems; and
e. Other aspects or areas as determined by
			 the department.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.52 - Recordkeeping Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
(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 procedures;
b. The names, functions, and signatures
			 (electronic or handwritten) of the laboratory personnel who performed the
			 primary sample preparation, analyzed the primary samples, and reviewed and
			 approved the data;
c. All primary
			 sample and analytical batch quality control sample results;
d. Raw data for each primary sample
			 analyzed;
e. Instrument raw data,
			 if any was produced;
f. Instrument
			 test method with parameters;
g.
			 Instrument tune report, if one was created;
h. All instrument standard calibration
			 data;
i. Test-method worksheets or
			 forms used for primary sample identification, characterization, and
			 calculations, including chromatograms, sample-preparation worksheets, and final
			 datasheets;
j. The quality control
			 report with worksheets, forms, or copies of laboratory notebook pages
			 containing pertinent information related to the identification and traceability
			 of all reagents, reference materials, and standards used for
			 analysis;
k. The analytical batch
			 sample sequence;
l. The field
			 sample log; and
m. The
			 chain-of-custody form.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.53 - Assessment of Penalties

Current through Register Vol. 47, No. 3, July 24, 2024
The department shall assess to a dispensary 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 641-154.53 - Quality Control

Current through Register Vol. 47, No. 3, July 24, 2024
The laboratory shall have quality control protocols that
				include the following elements:
(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 quality control
			 requirements for each analytical batch of samples.
c. The laboratory shall analyze the quality
			 control samples in exactly the same manner as the test samples to validate the
			 laboratory testing results.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.54 - Suspension or Revocation of a Dispensary License

Current through Register Vol. 47, No. 3, July 24, 2024
(1) The department
			 may suspend or revoke a 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 dispensary's business owner
			 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 641-154.54 - Security Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
(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.
(2)
Restricted access.
A laboratory shall limit entrance to all
			 restricted areas by completing all of the following:
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 when personnel enter and exit the laboratory;
(4) Track times of personnel movement between
			 restricted access areas;
(5) Store
			 data for retrieval for a minimum of one year; and
(6) Remain operable in the event of a power
			 failure.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.55 - Closure of Operations

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Notice.
A dispensary
			 shall notify the department at least six months before the closure of the
			 dispensary.
(2)
Procedures.
If a dispensary ceases operation, the dispensary
			 shall work with the department to verify the remaining inventory of the
			 dispensary and ensure that any medical cannabidiol is returned to a
			 manufacturer.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.60 - Purpose and Duties of Board

Current through Register Vol. 47, No. 3, July 24, 2024
(1) The purpose of the board is to administer
			 the provisions of Iowa Code section
			 124E.5.
(2) Responsibilities of the board include but
			 are not limited to:
a. Accepting and reviewing
			 petitions to add medical conditions, medical treatments, or debilitating
			 diseases to the list of debilitating medical conditions for which the medical
			 use of cannabidiol would be medically beneficial under Iowa Code chapter
			 124E.
b. Making recommendations to
			 the board of medicine relating to the removal or addition of debilitating
			 medical conditions to the list of allowable debilitating medical conditions for
			 which the medical use of cannabidiol under Iowa Code chapter 124E would be
			 medically beneficial.
c. Working
			 with the department regarding the requirements for the licensure of
			 manufacturers and dispensaries, including licensure procedures.
d. Advising the department regarding the
			 location of manufacturers and dispensaries throughout the state.
e. Making recommendations to the board of
			 medicine relating to the form and quantity of allowable medical uses of
			 cannabidiol.
f. Submitting an
			 annual report to the general assembly detailing the activities of the board no
			 later than January 1.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.61 - Organization of Board and Proceedings

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Membership.
The board
			 shall be composed of nine members appointed by the governor pursuant to Iowa
			 Code section
			 124E.5.
			 The appointments, unless provided otherwise by law, shall be for three-year
			 staggered terms which 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. The board shall convene at least twice per
			 year.
b. Board meetings shall be
			 conducted in accordance with the open meetings requirements of Iowa Code
			 chapter 21.
c. The department's
			 office of medical cannabidiol shall schedule the time, date and location of
			 meetings.
d. A majority of the
			 members shall constitute a quorum for conducting business of the
			 board.
e. 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 641-154.62 - Official Communications

Current through Register Vol. 47, No. 3, July 24, 2024
All official communications, including submissions, petitions
				and requests, may be addressed to the Medical Cannabidiol Board, Office of
				Medical Cannabidiol, Lucas State Office Building, 321 E. 12th Street, Des
				Moines, Iowa 50319-0075.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.64 - Public Meetings

Current through Register Vol. 47, No. 3, July 24, 2024
Members of the public may be present during board meetings
				unless the board votes to hold a closed session. Dates and location of board
				meetings may be obtained through the Iowa department of public health's website
				(idph.iowa.gov/mcarcp) or directly from the board office.
(1)
Exclusion of
			 participants.
The person presiding at a meeting of the board may
			 exclude a person from an open meeting for behavior that obstructs the
			 meeting.
(2)
Recording of
			 meetings.
Cameras and recording devices may be used at open meetings,
			 provided the cameras or recording devices do not obstruct the meeting. If the
			 user of a camera or recording device obstructs the meeting by the use of such
			 device, the presiding department staff member at the meeting may request the
			 user to discontinue use of the camera or device.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.65 - Petitions for the Addition or Removal of Medical Conditions, Medical Treatments or Debilitating Diseases

Current through Register Vol. 47, No. 3, July 24, 2024
Petitions for the addition or removal of medical conditions,
				medical treatments, or debilitating conditions for which the medical use of
				cannabidiol would be medically beneficial under Iowa Code chapter 124E may be
				submitted to the board pursuant to this rule.
(1)
Petition form.
Any
			 person or entity may file a petition to add or remove medical conditions,
			 medical treatments or debilitating diseases with the board. A petition is
			 deemed filed when it is received by the medical cannabidiol office. The board
			 must provide the petitioner with a file-stamped copy of the petition if the
			 petitioner provides the board an extra copy for this purpose. The petition must
			 be typewritten or legibly handwritten in ink and must substantially conform to
			 the following form:
Click here to
				view Image
The petition must provide the following information:
a. A statement of the specific medical
			 condition, medical treatment or debilitating disease the petitioner is seeking
			 to add to or remove from the list of debilitating medical conditions for which
			 the medical use of cannabidiol would be medically beneficial.
b. A brief summary of the petitioner's
			 arguments in support of the action urged in the petition.
c. A brief summary of any data or scientific
			 evidence supporting the action urged in the petition.
d. A list of reference material supporting
			 the petition.
e. A list of subject
			 matter experts who are willing to testify in support of the petition. The list
			 of subject matter experts must contain names, credentials (if applicable),
			 email addresses, telephone numbers, and mailing addresses.
f. The names and addresses of other persons,
			 or a description of any class of persons, known by petitioner to be affected
			 by, or interested in, the proposed action which is the subject of the
			 petition.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.69 - Requirements of the Department

Current through Register Vol. 47, No. 3, July 24, 2024
(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 manufacturers and laboratories on testing procedures. The
			 department shall provide manufacturers and laboratories no less than 14 days in
			 which to comment on proposed revisions to the document, and the department
			 shall provide no less than 30 days' notice before a revision takes effect. The
			 document shall:
a. Describe the minimum
			 number of sample units and reserve samples required for testing by the
			 laboratory;
b. Describe an option
			 for manufacturers to reduce the amount of testing conducted by allowing
			 compositing of sample units or other techniques that reduce the number of tests
			 required without compromising the safety of the products once a manufacturer
			 has satisfactorily completed a control study for a specific extraction or
			 production process;
c. Describe the
			 minimum requirements for sample size and testing intervals for stability
			 testing;
d. Be available on the
			 department's website
(
www.idph.iowa.gov
)
.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.70 - Requirements of a Laboratory

Current through Register Vol. 47, No. 3, July 24, 2024
(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.
(2)
Additional tests upon
			 request.
A laboratory shall establish and implement test methods and
			 corresponding standard operating procedures for other analyses as requested by
			 the department.
(3)
Level
			 of quantitation.
A laboratory shall be able to demonstrate that its
			 LOQ is below any action level established by the department.
(4)
Inventory tracking.
a. A laboratory shall use the department's
			 secure sales and inventory tracking system, if available, or a manifest system
			 to record the receipt of medical cannabis goods from a manufacturer for
			 testing.
b. A laboratory shall use
			 the department's secure sales and inventory tracking system, if available, or a
			 manifest system to record the return of medical cannabis goods or waste to a
			 manufacturer.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.71 - Requirements of a Manufacturer

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Assuming costs.
A
			 manufacturer shall assume the costs for all laboratory testing requested by the
			 department or laboratory for medical cannabis goods produced by the
			 manufacturer.
(2)
Sample
			 waste retrieval.
A manufacturer shall retrieve analyzed samples and
			 waste containing medical cannabis goods from the laboratory at a duration and
			 frequency approved by the department.
(3)
Obtaining approval for sampling
			 protocols.
A manufacturer shall obtain approval from the department
			 for the manufacturer's sampling protocols pursuant to subrule 154.26(2) prior
			 to submitting samples for laboratory testing related to content and
			 contamination.
(4)
Obtaining approval for stability-testing procedures.
A
			 manufacturer shall obtain approval from the department for the manufacturer's
			 stability-testing procedures pursuant to subrule 154.26(4) prior to submitting
			 samples for laboratory testing related to stability testing and
			 product-expiration-date studies.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.72 - Content Testing.

Current through Register Vol. 47, No. 3, July 24, 2024
(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
(4) CBDA.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.73 - Reporting Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
(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 who ordered the tests and the department through the department's
			 secure sales and inventory tracking system, if available, or another laboratory
			 information management system.
(2)
Tentatively identified analytes.
A laboratory shall report on
			 the certificate of analysis any tentatively identified analytes detected during
			 the analysis of the primary sample. When a laboratory identifies additional
			 analytes in a primary sample, the laboratory shall:
a. Notify the department of the additional
			 analytes detected.
b. Refrain from
			 issuing a final certificate of analysis to a manufacturer until given approval
			 to do so by the department.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.74 - Record-keeping Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
(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 procedures;
b. The names, functions, and signatures
			 (electronic or handwritten) of the laboratory personnel that performed the
			 primary sample preparation, analyzed the primary samples, and reviewed and
			 approved the data;
c. All primary
			 sample and analytical batch quality control sample results;
d. Raw data for each primary sample
			 analyzed;
e. Instrument raw data,
			 if any was produced;
f. Instrument
			 test method with parameters;
g.
			 Instrument tune report, if one was created;
h. All instrument standard calibration
			 data;
i. Test-method worksheets or
			 forms used for primary sample identification, characterization, and
			 calculations, including chromatograms, sample-preparation worksheets, and final
			 datasheets;
j. The quality control
			 report with worksheets, forms, or copies of laboratory notebook pages
			 containing pertinent information related to the identification and traceability
			 of all reagents, reference materials, and standards used for
			 analysis;
k. The analytical batch
			 sample sequence;
l. The field
			 sample log; and
m. The
			 chain-of-custody form.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.75 - Quality Control

Current through Register Vol. 47, No. 3, July 24, 2024
The laboratory shall have quality control protocols that
				include the following elements:
(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 quality control
			 requirements for each analytical batch of samples.
c. The laboratory shall analyze the quality
			 control samples in exactly the same manner as the test samples to validate the
			 laboratory testing results.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.76 - 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 a laboratory meets the security requirements in this
				rule.
(1)
Security policy
			 requirement.
A laboratory shall maintain a security policy to prevent
			 the loss, theft, or diversion of medical cannabis goods and samples. The
			 security policy shall apply to all staff and visitors at a laboratory
			 facility.
(2)
Visitor
			 logs.
Visitors to a laboratory facility shall sign visitor manifests
			 with name, date, and times of entry and exit, and shall wear badges that are
			 visible at all times and that identify them as visitors.
(3)
Restricted access.
A
			 laboratory shall use a controlled access system and written manifests to limit
			 entrance to all restricted access areas of its laboratory facility and shall
			 retain a record of all persons who entered the restricted access areas.
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;
(4)
			 Track times of personnel movement between restricted access areas;
(5) Store data for retrieval for a minimum of
			 one year; and
(6) Remain operable
			 in the event of a power failure.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 155 - Licensure Standards for Substance Use Disorder and Problem Gambling Treatment Programs › Rule 641-155.2 - Licensing

Current through Register Vol. 47, No. 3, July 24, 2024
In accordance with Iowa Code section
				125.13,
				a person shall not maintain or conduct a substance use disorder program without
				having first obtained a license for the program from the department, and in
				accordance with Iowa Code section
				135.150,
				a person shall not maintain or conduct a problem gambling treatment program
				funded by the department unless the person has obtained a license for the
				program from the department. The provision of treatment to a patient through
				any electronic means, regardless of the location of the program or facility,
				shall constitute the practice of treatment in the state of Iowa and shall be
				subject to regulation in accordance with Iowa Code chapter 125, Iowa Code
				section
				135.150,
				and these rules. An applicant shall apply for one license only. The department
				shall award one license only to an applicant or licensee.
(1)
Program licenses.
The
			 department shall offer the following program licenses:
a. A substance use disorder assessment and
			 OWI evaluation-only program license.
b. A substance use disorder treatment program
			 license.
c. A problem gambling
			 treatment program license.
d. A
			 substance use disorder and problem gambling treatment program
			 license.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 155 - Licensure Standards for Substance Use Disorder and Problem Gambling Treatment Programs › Rule 641-155.3 - Types of Licenses

Current through Register Vol. 47, No. 3, July 24, 2024
(1) The
			 department may issue an initial license for 270 days to a new applicant scoring
			 a minimum rating of 70 percent in each standards category on the licensure
			 weighting report. An initial license shall expire in 270 days and shall not be
			 extended or renewed.
(2) The
			 department may issue a license subsequent to an initial license for one, two,
			 or three years based on the applicant's rating on the licensure weighting
			 report.
a. An applicant achieving a rating of
			 95 percent or higher in each standards category may qualify for a three-year
			 license.
b. An applicant achieving
			 a rating of less than 95 percent but not less than 90 percent in each standards
			 category may qualify for a two-year license.
c. An applicant achieving a rating of less
			 than 90 percent but not less than 70 percent in each standards category may
			 qualify for a one-year license.
d.
			 A license for one, two, or three years shall expire on the date noted on the
			 license and shall not be extended but may be renewed upon
			 application.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 155 - Licensure Standards for Substance Use Disorder and Problem Gambling Treatment Programs › Rule 641-155.4 - Nonassignability

Current through Register Vol. 47, No. 3, July 24, 2024
(1) A license
			 issued by the department for the operation of a program applies both to the
			 licensee and the facility in which the program is operated. A license is not
			 transferable.
(2) A closing program
			 is one which intends to cease providing licensed program services. The licensee
			 shall notify the division 30 days before ceasing service provision. The
			 licensee shall be responsible for the transition of patients to another program
			 and for the preservation of all records. The licensee shall include in its
			 notice to the division its plan to transition patients and locate records. When
			 a program closes, the program's license is void on the date the program ceases
			 providing licensed program services, and the license shall be returned to the
			 department.
(3) A closed program is
			 one which has ceased providing licensed program services. The licensee shall
			 notify the division immediately of ceased service provision. The licensee shall
			 be responsible for the transition of patients to another program and for the
			 preservation of all records. The licensee shall include in its notice to the
			 division its plan to transition patients and locate records. When a program is
			 closed, the program's license is void on the date the program ceased providing
			 licensed program services, and the license shall be returned to the
			 department.
(4) A person, facility
			 or legal entity acquiring a licensed, closing or closed program for the purpose
			 of operating a program shall apply for a license.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 155 - Licensure Standards for Substance Use Disorder and Problem Gambling Treatment Programs › Rule 641-155.5 - Application Procedures

Current through Register Vol. 47, No. 3, July 24, 2024
The division shall provide license application forms on the
				department's Web site and at its office. An applicant shall submit application
				materials to the division. The division will proceed with inspection of the
				applicant upon receipt of a complete application. To be complete, an
				application must include all required materials and be responsive to all
				licensure standards, as described in these rules.
(1)
Application information.
An applicant shall submit application materials on the forms provided and in
			 the required format. Application materials shall include, but may not be
			 limited to:
a. The name and address of the
			 applicant and, if the applicant is part of a larger organization, the name and
			 address of the larger organization.
b. The name and address of the applicant's
			 executive director and, if the applicant is part of a larger organization, the
			 name and address of the executive director of the larger
			 organization.
c. The names, titles,
			 dates of employment, education, and years of current job-related experience of
			 the applicant's staff; and the table of organization. If the applicant is part
			 of a larger organization or has multiple organizational components and physical
			 facilities, the relationships between the larger organization, organizational
			 components and physical facilities must be shown on the table of organization,
			 with the applicant and applicant's staff positions clearly
			 delineated.
d. The names and
			 addresses of members of the applicant's governing body, sponsors, and advisory
			 boards; and the current articles of incorporation and bylaws.
e. The names and addresses of individuals,
			 facilities, organizations, and legal entities with which the applicant has a
			 contractual or affiliation agreement pertaining to licensed program services.
f. A description of the licensed
			 program services to be provided by the applicant and a calendar showing program
			 services each week.
g. For each
			 physical facility, copies of reports substantiating compliance with federal,
			 state and local laws, rules and regulations, to include appropriate Iowa
			 department of inspections and appeals rules, state fire marshal rules and fire
			 ordinances, and local health, fire, occupancy, and safety
			 regulations.
h. Information
			 required for programs admitting juveniles as described under Iowa Code section
			 125.14A.
i. Fiscal management information, to include
			 a recent audit or opinion of auditor and program board minutes to reflect
			 approval of the program's budget and insurance.
j. Insurance coverage related to professional
			 and general liability, building, workers' compensation, and fidelity
			 bond.
k. The address of each
			 physical facility.
l. The written
			 policies and procedures manual that covers all the requirements of these
			 rules.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 155 - Licensure Standards for Substance Use Disorder and Problem Gambling Treatment Programs › Rule 641-155.6 - Technical Assistance

Current through Register Vol. 47, No. 3, July 24, 2024
The division may provide technical assistance to an applicant
				or licensee.
(1) An applicant may
			 request technical assistance regarding these rules and the licensure
			 process.
(2) A licensee may request
			 technical assistance regarding these rules and the licensure process or to
			 bring areas of noncompliance with these rules into compliance.
(3) The division may require a licensee to
			 receive technical assistance to bring areas of noncompliance with these rules
			 into compliance.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 155 - Licensure Standards for Substance Use Disorder and Problem Gambling Treatment Programs › Rule 641-155.7 - Inspection of Applicants

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Inspection of applicants.
The division shall inspect each
			 applicant. Inspection shall include review of the complete application and may
			 include, but may not be limited to, review of patient records, review of
			 applicant data reporting, and interviews with staff and patients. Inspection
			 shall include on-site inspection unless specifically waived as allowed under
			 these rules. The division will send the applicant a report of inspection
			 findings within 30 business days of the inspection.
(2)
On-site inspection.
The
			 division will schedule an on-site inspection of an applicant within 60 business
			 days of receipt of the applicant's complete application.
a. The division may waive on-site inspection
			 of an applicant that is:
(1) A licensee
			 applying to renew a license when the applicant's licensed program services are
			 limited to substance use disorder assessment and OWI evaluation services only,
			 outpatient treatment, or intensive outpatient treatment.
(2) An applicant applying for a license under
			 deemed status.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 155 - Licensure Standards for Substance Use Disorder and Problem Gambling Treatment Programs › Rule 641-155.8 - License-approval

Current through Register Vol. 47, No. 3, July 24, 2024
The department shall issue a license upon approval of an
				application for a license by the committee. The license shall become effective
				on the date approved by the committee.
(1)
Committee meeting
			 preparation.
The division shall prepare an inspection findings report
			 with a license recommendation for presentation at a committee meeting held
			 within 60 business days from the date of the inspection findings report.
a. The division will provide public notice of
			 committee meetings in accordance with Iowa Code section
			 21.4.
b. The division shall provide committee
			 members with the inspection findings report and license recommendation for each
			 application to be acted upon at each committee meeting.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 155 - Licensure Standards for Substance Use Disorder and Problem Gambling Treatment Programs › Rule 641-155.9 - Written Corrective Action Plan

Current through Register Vol. 47, No. 3, July 24, 2024
A program approved for a license shall submit a written
				corrective action plan to the division within 30 days following the committee
				meeting to bring any area of noncompliance with these rules into
				compliance.
(1) The written corrective
			 action plan shall include, but may not be limited to:
a. Any area of noncompliance specified in the
			 inspection findings report;
b. The
			 corrective measures to be taken by the program for each area of noncompliance;
			 and
c. The completion date for each
			 corrective measure.
Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 155 - Licensure Standards for Substance Use Disorder and Problem Gambling Treatment Programs › Rule 641-155.11 - Denial, Suspension or Revocation of a License

Current through Register Vol. 47, No. 3, July 24, 2024
The committee may deny an application for a license. The
				committee may suspend or revoke a license for any of the grounds for discipline
				pursuant to paragraph 155.10(1)
"d. "
(1)
Initial notice from
			 committee.
When the committee determines to deny, suspend or revoke a
			 one-, two-, or three-year license or a license under deemed status, the
			 division shall notify the applicant or licensee by certified mail, return
			 receipt requested. Such notice shall provide the applicant or licensee the
			 opportunity to submit a written corrective action plan or written objections to
			 the division.
(2)
Submission of corrective action plan or objections.
An
			 applicant notified of denial of a one-, two-, or three-year license or a
			 license under deemed status or a licensee notified of suspension or revocation
			 of a license may submit a written corrective action plan or written objections
			 to the division within 20 days after receipt of the notice.
a.
Written corrective action
			 plan.
The written corrective action plan must meet the requirements of
			 paragraphs 155.9(1)"a" to
"c."
If the applicant or licensee
			 submits a written corrective action plan, the applicant or licensee shall have
			 90 days from the date of submission within which to show compliance with the
			 plan. The applicant or licensee shall submit any information to the committee
			 that the committee requests or that the applicant or licensee deems pertinent
			 to show compliance with the plan. The department may inspect the licensee,
			 including on-site inspection, to review the implemented corrective measures and
			 report to the committee.
b.
Objections.
If the applicant or licensee submits written
			 objections, the applicant or licensee shall submit to the committee any
			 information that the committee or the applicant or licensee deems pertinent to
			 support the applicant's or licensee's defense.