Code of Federal Regulations Title 21. Food and Drugs § 21.111.210 What must the master manufacturing record include?

(a) The name of the dietary supplement to be manufactured and the strength, concentration, weight, or measure of each dietary ingredient for each batch size;

(b) A complete list of components to be used;

(c) An accurate statement of the weight or measure of each component to be used;

(d) The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement;

(e) A statement of any intentional overage amount of a dietary ingredient;

(f) A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made;

(g) A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label;

(h) Written instructions, including the following: