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HomeHealth and Safety CodeDiv. 104Pt. 5Ch. 6Art. 3§ 111365 Prescription Drug Labeling Requirements

§ 111365 Prescription Drug Labeling Requirements

Health and Safety Code·California
AI Summary·Official Text·Key Terms·Related Statutes·References
AI SummaryVerified

§ 111365 Prescription Drug Labeling Requirements

Key Takeaways

  • •If a drug has a brand name, the real drug name must be on the label too.
  • •The real drug name must be at least half as big as the brand name.
  • •The government can make exceptions if they think it's safe.

Example

You buy a painkiller called 'SuperRelief' at the store.

The label must also say 'Ibuprofen' in big letters, at least half the size of 'SuperRelief', so you know what's really in it.

AI-generated — May contain errors. Not legal advice. Always verify source.

Official Source
View on CA.gov

§ 111365 Prescription Drug Labeling Requirements

Any drug subject to Section 111470 is misbranded unless the established name of the prescription drug or prescription drug ingredient is printed on the label prominently and in type at least half as large as that used for the proprietary name or designation on the label, labeling, or advertising. The department may, by regulation, establish exemptions from the requirements of this section when compliance with this section is not considered necessary for the protection of health and safety. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)

Last verified: January 23, 2026

Key Terms

misbrandedestablished nameproprietary nameexemptions

Related Statutes

  • § 111360 Drug Advertising Labeling Requirements
  • § 111510 Drug Code Imprint Requirements
  • § 111330 Misbranded Drug Labeling
  • § 111335 Drug Device Labeling Requirements
  • § 111340 Drug Labeling Requirements

References

  • Official text at leginfo.legislature.ca.gov
  • California Legislature. Health and Safety Code. Section 111365.
View Official Source