modern pharmacology with clinical application 5th edition.verified

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modern pharmacology with clinical application 5th edition.verified Before the twentieth century,most government controls were concerned not with drugs but with impure and adulterated foods. Medicines... were thought to pose problems similar to those presented by foods. Efficacy was questioned in two respects: adulteration of active medicines by addition of inert fillers and false claims made for the so-called patent (secret) medicines or nostrums. Indeed, much of the development of the science of pharmacy in the nineteenth century was standardizing and improving prescription drugs. A landmark in the control of drugs was the 1906 Pure Food and Drug Act. Food abuses, however, were the primary target. Less than one quarter of the first thousand decisions dealt with drugs, and of these, the majority were concerned with patent medicines. The 1906 law defined drug broadly and governed the labeling but not the advertising of any substance used to affect disease.This law gave the Pharmacopoeia and the National Formulary equal recognition as authorities for drug specifications. In the first contested criminal prosecution under the law, action was taken against the maker of a headache mixture bearing the beguiling name of Cuforhedake-Brane-Fude. In 1912, Congress passed an amendment to the Pure Food and Drug Act that banned false and fraudulent therapeutic claims for patent medicines. Prescription drugs also were subject to control under the 1906 law. In fact, until 1953 there was no fixed legal boundary between prescription and nonprescription medications. Prescription medications received a lower priority, since food and patent medicine abuses were judged to be the more urgent problems. For the next 30 years, drug control was viewed primarily as a problem of prohibiting the sale of dangerous drugs and tightening regulations against misbranding. Until the 1930s, new drugs posed little problem because there were few of them. MODERN DRUG LEGISLATION The modern history of United States drug regulation began with the Food, Drug and Cosmetic Act of 1938, which superseded the 1906 Pure Food and Drug Act. The 1938 act was viewed as a means of preventing the marketing of untested, potentially harmful drugs. An obscure provision of the 1938 act was destined to be the starting point for some of the most potent controls the Food and Drug Administration (FDA) now exercises in the drug field. This provision allowed the prescription drug to come under special control by requiring that it carry the legend “Caution—to be used only by or on the prescription of a physician.” A major defect of the generally strong 1938 law was its inadequate control of advertising. Regulations now require that the “labeling on or within the package from which the drug is to be dispensed” contain adequate information for the drug’s use; this requirement explains the existence of the package insert. If the pharmaceutical manufacturer makes claims for its product beyond those contained in an approved package insert, the FDA may institute legal action against the deviations in advertising. The 1938 act required manufacturers to submit a New Drug Application (NDA) to the FDA for its approval before the company was permitted to market a new drug. Efficacy (proof of effectiveness) became a requirement in 1962 with the Kefauver-Harris drug amendments.These amendments established [Show More]

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