California Health and Safety Code

§ 127681

HSC § 127681 Effective Jul 27, 2021Div. 107 · Part 2 · Ch. 9

Statute text

(a)A manufacturer of a prescription drug shall notify the department in writing if it is introducing 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 notice shall be provided in writing within three days after the release of the drug in the commercial market. A manufacturer may make this notification pending approval by the federal Food and Drug Administration, if commercial availability is expected within three days of approval.

(b)No later than 30 days after notification pursuant to this section, a manufacturer shall report all of the following information to the department in a format prescribed by the department:

(1)A description of the marketing and pricing plans used in the launch of the new drug in the United States and internationally.

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Legislative history

Amended by Stats. 2021, Ch. 143, Sec. 112. (AB 133) Effective July 27, 2021.