Utah Admin. Code R590-287-5 - WAC History

The reported WA C 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 WA C increase for the drug product;

(6) the amount of the WA C 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 WA C 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 WA C 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.

Notes

Utah Admin. Code R590-287-5

Adopted by Utah State Bulletin Number 2022-11, effective 5/11/2022