Iowa Admin. Code r. 641-154.27

Current through Register Vol. 47, No. 6, September 18, 2024

Rule 641-154.27 - Recordkeeping requirements

(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).

Iowa Admin. Code r. 641-154.27

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

Amended by IAB October 10, 2018/Volume XLI, Number 8, effective 11/14/2018

Amended by IAB June 15, 2022/Volume XLIV, Number 25, effective 7/20/2022

Adopted by IAB July 10, 2024/Volume XLVII, Number 1, effective 8/14/2024