Drug labelling

Drug labelling is also referred to as prescription labelling, is a written, printed or graphic matter upon any drugs or any of its container, or accompanying such a drug. Drug labels seek to identify drug contents and to state specific instructions or warnings for administration, storage and disposal. Since 1800s, legislation has been advocated to stipulate the formats of drug labelling due to the demand for an equitable trading platform, the need of identification of toxins and the awareness of public health. Variations in healthcare system, drug incidents and commercial utilization may attribute to different regional or national drug label requirements. Despite the advancement in drug labelling, medication errors are partly associated with undesirable drug label formatting. In the US, early regulations of food and drug quality were predominantly fostered by fair competition between entrepreneurs and drug labelling was not legally mandatory until 1966. In 1906, the adoption of Food and Drugs Act in the US outlawed the business involving mislabeled, tainted or adulterated food, drinks, and drugs. The Sherley Amendment was later introduced to prohibit fabricated medical claims in drug labels. In 1937, misadventure of 107 persons as a consequence of tainted Elixir Sulfanilamide prescription initiated the requirement for prescription only medications. Walter G. Campbell, one of the pioneers in the regulations of drug safety, launched the legal process against spurious drugs and took the stewardship in Food and Drug Administration (FDA) in 1940. In 1950, a ruling in the U.S. Court of Appeals indicated the requirement of listing drug indication in drug labels. In 1962, a drug tragedy in Europe, thousands of defective infants as a result of the administration of thalidomide in pregnant women, dramatized the demand of drug safety profile prior to commercialization. Thousands of prescription medications were retreated as devoid of clinical evidence on effectiveness; and drug labels were required to reflect known medical facts according to the Fair Packaging and Labeling Act in 1966.