Drugs.

(1) Existing federal law, the Federal Food, Drug, and Cosmetic Act, regulates, among other matters, the manufacture, distribution, and sale of prescription drugs in interstate commerce and is administered by the United States Food and Drug Administration. Existing law, the federal Drug Supply Chain Security Act, provides for the development of a system that will require, among other things, manufacturers, wholesale drug distributors, repackagers, and dispensers in the drug supply chain to provide specified transaction information about a drug product, and prohibits a state or political subdivision of a state from continuing in effect any requirements for tracing products through the distribution system, including any requirements with respect to electronic pedigree systems, that are inconsistent with, more stringent than, or in addition to, any requirements of federal law. Existing law, the Pharmacy Law, provides for the licensure and regulation of the practice of pharmacy and the sale of dangerous drugs or dangerous devices by the California State Board of Pharmacy. Existing law, commencing July 1, 2016, prohibits a wholesaler or repackager from selling, trading, or transferring a dangerous drug at wholesale without providing a pedigree, as defined, and from acquiring a dangerous drug without receiving a pedigree. Existing law imposes parallel requirements with respect to pharmacies commencing July 1, 2017. Existing law makes these pedigree requirements inoperative upon the effective date of federal law addressing pedigree or serialization measures for dangerous drugs, or as otherwise specified in the event of a conflict with federal law. This bill would repeal the pedigree requirements and make related conforming changes. (2) Existing 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. Existing law makes it unlawful to manufacture, sell, deliver, hold, or offer for sale, any drug that is misbranded, and provides that a drug or device is misbranded if its labeling is false or misleading in any particular. A violation of this law is a misdemeanor. This bill would provide that any foreign dangerous drug that is not approved by the United States Food and Drug Administration or that is obtained outside of the licensed supply chain regulated by the United States Food and Drug Administration, California State Board of Pharmacy, or State Department of Public Health is misbranded, except as specified. Because a violation of this provision would be a crime, the bill would impose a state-mandated local program. The bill would provide that any person, except as specified, who purchases or sells a foreign dangerous drug or medical device, or an illegitimate product or suspect product, as those terms are defined pursuant to federal law, that is not approved or otherwise authorized by the United States Food and Drug Administration or that is obtained outside of the licensed supply chain regulated by the United States Food and Drug Administration, California State Board of Pharmacy, or State Department of Public Health is guilty of a misdemeanor and subject to imprisonment for not more than one year in a county jail, a fine of not more than $10,000 per occurrence, or both the imprisonment and fine. By creating new crimes, the bill would impose a state-mandated local program. (3) The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason.