Health & Saf. Code, § 111375 · Article 3. Misbranded Drugs or Devices
Health & Saf. Code, § 111375
Text — As published in the Legislative Counsel's database, tables dated October 18, 2026 (pubinfo_2025.zip)
Any drug or device is misbranded unless its labeling bears all of the following information:
(a) Adequate directions for use.
(b) Such adequate warnings against use in pathological conditions or by children where its use may be dangerous to health.
(c) Adequate warning against unsafe dosage or methods or duration of administration or application.
Warnings shall be in a manner and form as are necessary for the protection of users.
If the department determines that any requirement of subdivision (a), as applied to any drug or device, is not necessary for the protection of the public health, the department may adopt regulations exempting the drug or device from these requirements.
Any drug or device exempted under Section 502(f) of the federal act (21 U.S.C. Sec. 352(f)) is exempt from the requirement of this section. The department, however, may adopt any regulation including a drug or device within, or excluding a drug or device from the requirements of this section, whether or not the inclusion or exclusion of the drug or device is in accord with the federal act.
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§ionNum=111375.
- Text hash
- sha256 dd18b88770a3ed5c9cc10e60e1f495ce3680abf8418b7c64877680a2cb624643
- 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 1 provision
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