Health & Saf. Code, § 111550 · Article 5. New Drugs or Devices
Health & Saf. Code, § 111550
Text — As published in the Legislative Counsel's database, tables dated October 18, 2026 (pubinfo_2025.zip)
No person shall sell, deliver, or give away any new drug or new device unless it satisfies either of the following:
(a) It is one of the following:
(1) A new drug, and a new drug application has been approved for it and that approval has not been withdrawn, terminated, or suspended under Section 505 of the federal act (21 U.S.C. Sec. 355).
(2) A new biologic product for which a license has been issued as required by the federal Public Health Service Act (42 U.S.C. Sec. 262).
(3) A device that is reported under Section 510(k) of the federal act (21 U.S.C. Sec. 360(k)), or is a device exempted pursuant to subsection (l) or (m) of Section 360 of Title 21 of the United States Code, or it is a new device for which a premarket approval application has been approved, and that approval has not been withdrawn, terminated, or suspended under Section 515 of the federal act (21 U.S.C. Sec. 360e).
(b) The department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended. Any person who files a new drug or device application with the department shall submit, as part of the application, all of the following information:
(1) Full reports of investigations that have been made to show whether or not the new drug or device is safe for use and whether the new drug or device is effective in use under the conditions prescribed, recommended, or suggested in the labeling or advertising of the new drug or device.
(2) A full list of the articles used as components of the new drug or device.
(3) A full statement of the composition of the new drug or device.
(4) A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the new drug, or in the case of a new device, a full statement of its composition, properties, and construction, and the principles of its operation.
(5) Samples of the new drug or device and of the articles used as components of the drug or device as the department may require.
(6) Specimens of the labeling and advertisements proposed to be used for the new drug or device.
Notes and commentary — not statutory text
History
Amended by Stats. 2012, Ch. 688, Sec. 1. (AB 1277) Effective January 1, 2013.
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§ionNum=111550.
- Text hash
- sha256 fbb7c06820b14c116f1059a998e7c773300b8bd2caa588cdb5bf72fe0116be8f
- 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
Cited by 13 provisions
Provisions in this library whose text cites Health & Saf. Code, § 111550. Each shows the citation as that text prints it.
Business and Professions Code
Health and Safety Code
- Health & Saf. Code, § 110405Printed as Section 111550
- Health & Saf. Code, § 111470Printed as Section 111550
- Health & Saf. Code, § 111485Printed as Sections 111350 and 111550
- Health & Saf. Code, § 111548.2Printed as Section 110280, 111520, or 111550
- Health & Saf. Code, § 111555Printed as Section 111550
- Health & Saf. Code, § 111560Printed as Section 111550
- Health & Saf. Code, § 111570Printed as Section 111550
- Health & Saf. Code, § 111590Printed as Section 111550
- Health & Saf. Code, § 111595Printed as Section 111550
- Health & Saf. Code, § 111605Printed as Section 111550
- Health & Saf. Code, § 111610Printed as Section 111550
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.