R590-287-5. WAC History

The reported WAC history shall include the following information: (1) the name of the manufacturer; (2) the drug product's NDC; (3) a description of the drug product that includes the; (a) name; (b) strength; (c) dosage form; and (d) package size; (4) the FDA classification of the drug product as brand or generic; (5) the effective date of the WAC increase for the drug product; (6) the amount of the WAC increase for the drug product; (7) the WAC resulting from the reported cost increase for the drug product; (8) the WAC one calendar year prior to the effective date of the reported cost increase of the drug product; (9) the WAC two calendar years prior to the effective date of the reported cost increase of the drug product; (10) a written description, suitable for public release, of the factors that led to the increase in the WAC of the drug product and the significance of each factor; and (11) the manufacturer's aggregate company-wide research and development costs for the most recent year for which final audit data is available.