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註釋The laws and regulations governing the pharmaceutical industry were adopted to protect the consuming public by attempting to provide drugs of constituent quality, purity, and efficacy. The Food, Drug and Cosmetic Act (the Act) is a living document in that it is amended frequently and interpreted constantly. The act may be imperfect, but careful attention to its provisions plus an effort of good faith by all persons concerned with drug manufacturing can produce the type of product for which the Act and its regulations strives. Even though the applicable laws and regulations may change with regard to specifics, there are, nonetheless, many constant applicable generally. This book serves an overview of the more significant laws, regulations and Acts. This text book describes the Food, Drug and Cosmetic Act, treats briefly regulations bearing on pharmaceutical manufacturing, looks at the structure, powers, and duties of the Food and Drug administration (FDA), describes state and local laws and regulations, and finally, covers the protection of industrial property and product liability.