Iowa Administrative Code
Agency 641 - Public Health Department
Chapter 154 - Medical Cannabidiol Program
Rule 641-154.27 - Recordkeeping Requirements
Universal Citation: IA Admin Code 641-154.27
Current through Register Vol. 47, No. 6, September 18, 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.
(2) Manufacturer operations and inventory reporting other records.
a. A manufacturer or dispensary shall
maintain the following for at least five years, unless otherwise noted, and
provide to the department upon request:
(1)
All personnel records;
(2) Records
of any theft, loss, or other unaccountability of any medical cannabidiol or
plant material;
(3) Transportation
manifests and incident reports; and
(4) Records of all samples sent to a testing
laboratory and the quality assurance test results.
b. A manufacturer or dispensary shall
maintain for at least one year and provide to the department upon request its
controlled access system data and visitor manifests.
(3) Manufacturer entry into the secure sales and tracking system.
a.
A manufacturer or dispensary shall use the secure sales and inventory tracking
system to maintain the following:
(1) Batch
and harvest records;
(2) Crop input
and additive records;
(3)
Extraction and production records;
(4) Transportation records;
(5) Inventory records;
(6) Solvent and processing chemical records;
and
(7) Other records as determined
by the department.
b.
Unless otherwise provided in these rules, a manufacturer shall adhere to the
following schedule for entering data into the secure sales and inventory
tracking system. A manufacturer shall enter data in real time for data related
to:
(1) Transport of medical cannabidiol,
plant material, and laboratory samples;
(2) Sales of medical cannabidiol to
dispensaries;
(3) The creation of
process lots containing a unique identifier; and
(4) The creation of package lots containing a
unique identifier.
c. A
manufacturer shall enter inventory reports on key inventory events into the
secure sales and inventory tracking system within five business days in which
the event occurred. These inventory reports include but are not limited to:
(1) Batch reports;
(2) Crop input and additive
reports;
(3) Harvest
reports;
(4) Extraction
reports;
(5) Solvent and processing
chemical reports;
(6) Package lot
reports;
(7) Certificates of
analysis from a laboratory;
(8)
Other records as determined by the department.
d. State of Iowa manufacturer API guide. The
department shall maintain a document describing the IT requirements and
acceptance criteria for reporting information to the secure sales and inventory
tracking system. The department shall provide manufacturers 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 include:
(1) The
schedule and means of data reporting;
(2) Integration requirements for third-party
vendors; and
(3) Be available on
the department's website (hhs.iowa.gov).
Disclaimer: These regulations may not be the most recent version. Iowa may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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