What is the legal framework governing the importation of drugs?

The legal framework governing the importation of drugs into California is determined by the federal government. The California Department of Public Health (CDPH) is responsible for enforcing the federal laws and regulations governing the importation of drugs in the state. The federal laws that are enforced in California include the Federal Food, Drug, and Cosmetic Act (FD&C Act). This act requires that drug manufacturers comply with certain standards for safety and efficacy when producing and distributing drugs. Additionally, the Prescription Drug Marketing Act (PDMA) regulates the distribution of prescription drugs and requires that only authorized distributors may distribute drugs within the state. The California Pharmacy Law and the California Board of Pharmacy are responsible for ensuring that imported drugs are properly approved and stored, and that foreign manufacturers follow applicable federal laws. The California Board of Pharmacy requires that foreign manufacturers be registered with the state and that certified copies of all imported drugs be provided to the state. Additionally, the California Health & Safety Code Sections 111550-111565 prohibit the sale or distribution of adulterated, misbranded, or unapproved drugs. This ensures that only drugs that meet the standards of the state are distributed throughout the state. In summary, the legal framework governing the importation of drugs into California is determined by the federal government, with the oversight of the CDPH and the California Board of Pharmacy. This framework is designed to protect Californians by ensuring that imported drugs meet high standards of safety and efficacy.

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What is the legal framework governing the importation of drugs?

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