California Legal Codes and Statutes

§ 111375

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

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.

Cite this section

Cal. Health & Saf. Code § 111375 (2026)
https://ca.codecond.com/codes/hsc/division-104-environmental-health/part-5-sherman-food-drug-and-cosmetic-laws/chapter-6-drugs-and-devices/article-3-misbranded-drugs-or-devices/section-111375

Other sections in Article 3 - Misbranded Drugs or Devices

§ 111330§ 111335§ 111340§ 111345§ 111355§ 111360§ 111365§ 111375§ 111376§ 111380…§ 111465§ 111470§ 111475§ 111480§ 111485§ 111490§ 111495§ 111500§ 111505§ 111510

This content is for reference, learning, and study purposes only. All legal text should be verified against the official California Legislative Information website, which is the authoritative source for California law. Data last processed: February 8, 2026.