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The Fair Packaging and Labeling Act is a U.S. law that applies to labels on many consumer products. It requires the label to state: The identity of the product; The name and place of business of the manufacturer, packer, or distributor; and; The net quantity of contents. The contents statement must include both metric and U.S. customary units.
Drug labelling, 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.
In 1960, the Food and Drug Administration (FDA), in association with the American Medical Association (AMA), drafted what became known as the Hazardous Substances Labeling Act. This law stated that certain products, identified as "hazardous substances" within the meaning of the law, had to carry on their labels specific statements of caution. [1]
The Directive ceased to be in force on 31 May 2015 and was repealed by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text ...
anon, Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics, May 1999, Food and Drug Administration, Center for Drug Evaluation and Research, Lockhart, H., and Paine, F.A., "Packaging of Pharmaceuticals and Healthcare Products", 2006, Blackie, ISBN 0-7514-0167-6
The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product. The other sections are as follows:
Mandatory labelling is mandated in most developed nations and increasingly also in developing nations, especially for food products, e.g. "Grade A" meats. With regard to food and drugs, mandatory labelling has been a major battleground between consumer advocates and corporations since the late 19th century.
The CLP Regulation [1] (for "Classification, Labelling and Packaging" [2]) is a European Union regulation from 2008, which aligns the European Union system of classification, labelling and packaging of chemical substances and mixtures to the Globally Harmonised System (GHS). It is expected to facilitate global trade and the harmonised ...