§ 109310 Post-Approval Drug Reporting

In the case of any drug, medicine, compound or device for that an approval of an application filed pursuant to this article and Article 1 (commencing with Section 109250) is in effect, the applicant shall establish and maintain the records, and make the reports to the board, of data relating to clinical experience and other data or information, received or otherwise obtained by the applicant with respect to the drug, medicine, compound, or device, as the board may prescribe on the basis of a finding that the records and reports are necessary in order to enable the board to determine, or facilitate a determination, whether there is or may be ground for suspension of the application. Every person required under this section to maintain records, and every person in charge of custody thereof, shall, upon request of an agent of the board, permit the agent at all reasonable times to have access to and copy and verify the records. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)