Public health: federal regulation.

The Sherman Food, Drug, and Cosmetic Law regulates the packaging, labeling, and advertising of drugs and devices, and is administered by the State Department of Public Health. The law prohibits the sale, delivery, or giving away of any new drug or new device unless either the department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended under specified provisions of the federal Food, Drug, and Cosmetic Act, or it is a new device for which a premarket approval application has been approved, and that approval has not been withdrawn, terminated, or suspended under the federal act. Existing law exempts a drug or device intended solely for investigational use of a drug or device if the investigation is conducted in accordance with specified provisions of the federal act. Existing law prohibits the production of human whole blood or human whole blood derivatives unless the person is licensed and the human whole blood or human whole blood derivative is collected, prepared, labeled, and stored, as specified. Existing law exempts the production of biologics other than human whole blood and human whole blood derivatives if the biologics are produced in a federally licensed facility. This bill would exempt the production of human whole blood and human whole blood derivatives and other biologics at a clinical trial site, as specified, if the biologics are intended solely for investigation use and the investigation is conducted in accordance with specified provisions of the federal Food, Drug, and Cosmetic Act. Existing law requires every tissue bank operating in California to have a current and valid tissue bank license, unless a tissue bank falls under a specified exemption. This bill would additionally exempt the storage or preparation for patient administration of tissue performed at a clinical trial site that is intended solely for investigation use and the investigation is conducted in accordance with specified provisions of the federal Food, Drug, and Cosmetic Act. The Sherman Food, Drug, and Cosmetic Law, until January 1, 2023, exempts a licensed home medical device retail facility business from annual inspection, if it is accredited, as specified, by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services and authorizes the department to inspect only upon a complaint about the licensee. For a licensee that is not so accredited, existing law requires the department to conduct an inspection at least annually. This bill would extend these provisions until January 1, 2028.