§ 111260 Drug Device Manufacturing Standards

Health and Safety Code·California

AI SummaryVerified

Key Takeaways

•Medicines and medical tools must be made carefully to be safe.
•The places and ways they are made must follow good rules to keep them clean and strong.
•If they don’t follow these rules, the medicine or tool is considered bad or unsafe.

Example

A company makes painkillers but doesn’t keep their factory clean.

The medicine could get dirty or weak, making people sick instead of helping them. This breaks the rule because the factory didn’t follow good making practices.

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

Official Source

View on CA.gov

§ 111260 Drug Device Manufacturing Standards

Any drug or device is adulterated if the methods, facilities, or controls used for its manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with current good manufacturing practice to assure that the drug or device meets the requirements of this part as to safety and has the identity and strength, and meets the quality and purity characteristics that it purports or is represented to possess. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)

Last verified: January 23, 2026

Key Terms

adulterated current good manufacturing practice safety identity strength quality purity

References

Official text at leginfo.legislature.ca.gov
California Legislature. Health and Safety Code. Section 111260.

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Key Takeaways

Example

Key Terms

Related Statutes

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