Iowa Admin. Code r. 641-154.49

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

Rule 641-154.49 - Requirements of a manufacturer

(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 Admin. Code r. 641-154.49

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

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