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Health & Saf. Code, § 109310 · Article 2. Prohibitions and Enforcement

Health & Saf. Code, § 109310

Verbatim from the official edition

Text — As published in the Legislative Counsel's database, tables dated October 18, 2026 (pubinfo_2025.zip)

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.

Notes and commentary — not statutory text

History

Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.

Source of truth

Edition
As published in the Legislative Counsel's database, tables dated October 18, 2026 (pubinfo_2025.zip)
Official file
https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=HSC&sectionNum=109310.
Text hash
sha256 18b073b1239f008fdf3534f6013ee1b8156f7766cd0c7c144ad2a22b9ad12359
Composed by
compose_ca.py 2026-10-22: the Legislative Counsel's CAML content files read by a tokenizer (caml_readers.reader_a); an independent xml.etree reading (caml_readers.reader_b) agrees on every section

This section cites

Provisions in this library that the text above cites, as it prints each citation. A range cited as “ss. 61.13-61.16” links its first and last provisions.

Procedural information only. Not legal advice and not a substitute for the advice of an attorney. Confirm the current text with the official publisher before relying on it.