This California law outlines requirements for facilities that mix medications without a specific patient in mind, known as outsourcing facilities. Such facilities need a special license if they ship medications to California. They can't double as sterile compounding pharmacies at the same spot. The board can make rules to enforce this. They must also keep an eye on federal guidelines to stay current. If a facility makes custom prescriptions for individual patients, it doesn't need a regular pharmacy license but must follow the same rules as pharmacies.

If an outsourcing facility, which makes sterile and nonsterile drugs, is located in California and already licensed by the FDA, it must also get a state license to operate here. This license needs a yearly renewal and can't be transferred to someone else. The facility must follow certain rules set by both the federal and state authorities for drug manufacturing. Before the facility can get or renew its license, the state board must inspect it and review its procedures and reports from other inspections. The facility must also inform the board quickly about any issues, like disciplinary actions, recalls, or complaints about its products.

This law states that outsourcing facilities located outside California but inside the U.S. must have a special license to send their drug products into California. They need to follow California regulations and federal manufacturing practices for both sterile and nonsterile drugs. The license must be renewed every year and requires a board inspection. A facility must show its compounding procedures and previous inspection reports. They also have to inform the board quickly about issues like recalls, complaints, disciplinary actions, or adverse effects involving their products.

This law required a report on nonresident outsourcing facilities to be submitted by January 1, 2018, detailing the board's activities in inspecting and licensing these facilities, assessing if fee revenues cover costs, and reviewing federal law changes impacting these facilities. Recommendations for any necessary changes to protect public health were also to be included. The obligation to report ended on January 1, 2022.

If a state board believes a facility making drugs is dangerous to the public, it can order the facility to stop immediately. This stop order can last up to 30 days. The board must inform the facility owner about the reasons and the laws involved. The owner has 15 days to request a hearing to challenge the order, and this hearing must happen within five business days. If the board decides against the owner, they can appeal. Not obeying the stop order is considered misconduct.

This law states that if someone breaks the rules outlined in this article or related regulations, they can be fined up to $5,000 for each time they violate it. The fine is issued through a citation by the board.

This section allows the board to issue a temporary license to an outsourcing facility if it's in the public interest. This temporary license requires a fee and can last up to 180 days if needed for public safety. The board can end the temporary license if it was given by mistake or the permanent license application is denied. The holder of a temporary license does not have guaranteed rights to keep it, and this won't affect any disciplinary proceedings.

If a facility that prepares medications sends out a recall for a drug because it's dangerous, they must inform the pharmacy, doctor, or patient who received the drug within 24 hours. They also need to tell the state board. The quick notification is required if the drug could cause serious health issues or death, and if it was used or meant to be used in California. If the drug was given to a doctor, the doctor needs to tell the patient. If it was given to a pharmacy, the pharmacy has to inform the doctor or patient, and the doctor must tell the patient if they are informed.