CA AB1277

Exempts new biologic products with a federal license from state approval requirements under the Sherman Food, Drug, and Cosmetic Law.

Allows manufacturers to submit documentation of valid federal licenses or compliance with quality standards instead of undergoing pre-licensure state inspection by the Department of Public Health.

Limits state inspections of licensed drug and device manufacturers to situations involving public health risks, complaints, federal recall requests, or FDA enforcement assistance.

Requires the department to provide official copies of valid licenses upon request from licensed manufacturers.