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  2. Drug labelling - Wikipedia

    en.wikipedia.org/wiki/Drug_Labelling

    In the US, early regulations of food and drug quality were predominantly fostered by fair competition between entrepreneurs [1] 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. [ 2 ]

  3. Boxed warning - Wikipedia

    en.wikipedia.org/wiki/Boxed_warning

    In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize it is of ...

  4. Food and Drug Administration - Wikipedia

    en.wikipedia.org/wiki/Food_and_Drug_Administration

    The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...

  5. Regulation of food and dietary supplements by the U.S. Food ...

    en.wikipedia.org/wiki/Regulation_of_food_and...

    The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.

  6. DailyMed - Wikipedia

    en.wikipedia.org/wiki/DailyMed

    The documents published use the HL7 version 3 Structured Product Labeling (SPL) standard, [1] which is an XML format that combines the human readable text of the product label with structured data elements that describe the composition, form, packaging, and other properties of the drug products in detail according to the HL7 Reference ...

  7. Structured Product Labeling - Wikipedia

    en.wikipedia.org/wiki/Structured_Product_Labeling

    Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.

  8. History of warning labels in the United States - Wikipedia

    en.wikipedia.org/wiki/History_of_warning_labels...

    The history of warning labels in the United States began in 1938 when the United States Congress passed a law mandating that food products have a list of ingredients on the label. [1] In 1966, the Federal government mandated that cigarette packs have a warning on them from the surgeon general. In 1973, Congress decided that products containing ...

  9. Medication package insert - Wikipedia

    en.wikipedia.org/wiki/Medication_package_insert

    In the United States, the Food and Drug Administration (FDA) determines the requirements for patient package inserts. In the United States, the FDA will occasionally issue revisions to previously approved package inserts, in much the same way as an auto manufacturer will issue recalls upon discovering a problem with a certain car.

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