Iowa Admin. Code r. 641-154.28

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

Rule 641-154.28 - Recall of medical cannabidiol products

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 Admin. Code r. 641-154.28

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

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