Section 96075 - New Drug Notice(a) When a manufacturer introduces a new prescription drug to market at a wholesale acquisition cost that exceeds the threshold set for a specialty drug under the Medicare Part D program (Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173)), the manufacturer shall file a notice with the Department.(b) The notice shall include the following information; (1) The NDC. The NDC shall be reported in numeric form.(2) The date the new prescription drug was, or will be, introduced to market.(3) The wholesale acquisition cost of the new prescription drug as of the introduction to market date.(c) The notice shall be filed with the Department within three days after the day the drug was introduced to market. If the drug is expected to be introduced to market within three days of approval by the federal Food and Drug Administration, a notice may be filed pending that approval.Cal. Code Regs. Tit. 22, § 96075
Note: Authority cited: Section 127685, Health and Safety Code. Reference: Section 127681, Health and Safety Code.
Note: Authority cited: Section 127685, Health and Safety Code. Reference: Section 127681, Health and Safety Code.
1. New article 3 (sections 96075-96077) and section filed 11-29-2018; operative 1/1/2019 (Register 2018, No. 48).
2. Amendment of subsections (a) and (c) filed 12-21-2023; operative 4/1/2024 (Register 2023, No. 51).