(a) For each drug product wholesale acquisition cost increase for which a notice was required pursuant to Section 96065, a manufacturer shall file a report with the Department.
(b) The report shall include the following information:
(1) The NDC. The NDC shall be reported in numeric form.
(2) A description of the drug product to include the following:
(A) The drug product name.
(B) The drug product strength.
(C) The drug product dosage form.
(D) The drug product package size.
(3) Effective date of wholesale acquisition cost increase.
(4) Amount of wholesale acquisition cost increase.
(5) The wholesale acquisition cost resulting from the reported cost increase.
(6) If the drug is under patent, the patent expiration date. For a drug under multiple patents, the patent expiration date shall be the date on which all of the patents will have expired.
(7) Indicate whether the drug product is one of the following as defined in subparagraph (A) of paragraph (7) of subdivision (k) of Section 1396r-8 of Title 42 of the United States Code:
(A) An innovator multiple source drug;
(B) A noninnovator multiple source drug; or
(C) A single source drug.
(8) Total volume of gross sales in United States dollars of the drug product sold in the United States during the one year period prior to the effective date of the cost increase.
(9) A narrative description of the specific financial and nonfinancial factors used to make the decision to increase the wholesale acquisition cost of the drug product and to decide on the amount of the increase. The description shall include, but shall not be limited to, an explanation of how these factors explain the increase in the wholesale acquisition cost of the drug product.
(10) A narrative description of the change or improvement in the drug product, if any, that necessitates the price increase.
(11) A schedule of wholesale acquisition cost increases for the drug product for any period during the previous five year period in which the drug product was manufactured by the reporting manufacturer. The schedule shall list the date of each wholesale acquisition cost increase, the amount of each wholesale acquisition cost increase, and the wholesale acquisition cost resulting from each wholesale acquisition cost increase.
(12) If the drug product was acquired by the manufacturer within the previous five year period, all of the following information:
(A) The name of the company from which the drug product was acquired.
(B) The date acquired.
(C) The purchase price.
(D) The wholesale acquisition cost of the drug product at the time of acquisition.
(E) The wholesale acquisition cost of the drug product one year prior to the date of acquisition.
(F) The year the drug product was introduced to market.
(G) The wholesale acquisition cost of the drug product at the time it was introduced to market.
(c) A manufacturer may limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.
(d) A manufacturer may append comments to any information described in subdivision (b).
Credits
Note: Authority cited: Section 127685, Health and Safety Code. Reference: Section 127679, Health and Safety Code.
