Sherman Food, Drug, and Cosmetic Law.

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department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended or a new drug application has been approved for it and that approval has not been withdrawn, terminated, or suspended under specified provisions of the Federal Food, Drug, and Cosmetic Act, or it is a new device for which a premarket approval application has been approved, and that approval has not been withdrawn, terminated, or suspended under the federal act. The Sherman Food, Drug, and Cosmetic Law requires the department to adopt regulations to establish the application form and set the fee for licensure and renewal of a drug or device license. This bill would revise the above-described prohibition to exempt a new biologic product for which a license has been issued under federal law. Existing law also requires the department to inspect the place of business of each licensed manufacturer of a drug or device in the state prior to issuance of the license and, thereafter, once every 2 years, unless the United States Food and Drug Administration inspected the place of business within the previous 2 years. This bill would, instead, require each place of business to submit to the department documentation that evidences ownership and that the place of business is operating pursuant to a valid biologics license, establishment registration, or approved investigational new drug or investigational device exemption issued by the United States Food and Drug Administration, as prescribed, or is in compliance with audits conducted pursuant to specified standards, prior to the department issuing the place of business a license. If the business does not provide this documentation, the bill would require the department to inspect the place of business prior to licensure. This bill would authorize the business to request an official copy of the valid license. Existing law authorizes any authorized agent of the department to enter and inspect specified locations, as prescribed, for purposes of enforcement of the Sherman Food, Drug, and Cosmetic Law. This bill would require, for any place of business where a drug or device is manufactured and its manufacturer has received a license, the department to make investigations or inspections only under specified circumstances, including when the department makes a determination that the health and safety of the public is at risk, notification has been sent by the United States Food and Drug Administration to the department requesting assistance regarding a specified recall action, or when the United States Food and Drug Administration has requested assistance for enforcement activities.