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HomeHealth and Safety CodeDiv. 104Pt. 5Ch. 6Art. 3§ 111385 Drug Device Deterioration Labeling

§ 111385 Drug Device Deterioration Labeling

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

§ 111385 Drug Device Deterioration Labeling

Key Takeaways

  • •If a medicine or medical tool can go bad, it must be packed and labeled the right way to keep people safe.
  • •The label must tell you how to store it or use it so it doesn’t get ruined.
  • •The government can’t make these rules for medicines already listed in official books unless they’ve asked the book people first and they didn’t fix it in time.

Example

You buy cough syrup at the store, and the bottle says 'Keep in a cool, dry place.'

The label tells you how to store it so the medicine doesn’t go bad and make you sick. If it didn’t have this warning, the medicine would be misbranded, and the store could get in trouble.

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

Official Source
View on CA.gov

§ 111385 Drug Device Deterioration Labeling

Any drug or device is misbranded if the department determines that the drug or device is liable to deterioration, unless it is packaged in that form and manner and its label bears a statement of the precautions, as the department, by regulation, may require as necessary for the protection of public health. Such regulations shall not be established for any drug or device recognized in an official compendium, unless the department has informed the appropriate body, charged with the revision of the official compendium, of the need for that packaging or labeling requirements and that body has not prescribed the requirements in a reasonable length of time. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)

Last verified: January 23, 2026

Key Terms

misbrandeddeteriorationpackaginglabelingpublic healthofficial compendium

Related Statutes

  • § 111335 Drug Device Labeling Requirements
  • § 111330 Misbranded Drug Labeling
  • § 111345 Drug Labeling Conspicuity Requirements
  • § 111380 Drug Labeling Compliance
  • § 111400 Misbranded Dangerous Drugs

References

  • Official text at leginfo.legislature.ca.gov
  • California Legislature. Health and Safety Code. Section 111385.
View Official Source