§158.165 Description of formulation process.

The applicant must provide information on the formulation process of the product (unless the product consists solely of a technical grade of active ingredient), as required by the following sections:

(a) Section 158.162(b)(2), pertaining to characterization of the process.

(b) Section 158.162(b)(4), pertaining to ingredients used in the process.

(c) Section 158.162(b)(5), pertaining to process equipment.

(d) Section 158.162(b)(6), pertaining to the conditions of the process.

(e) Section 158.162(b)(8), pertaining to quality control measures.