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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. Title 21 of the Code of Federal Regulations - Wikipedia

    en.wikipedia.org/wiki/Title_21_of_the_Code_of...

    Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration

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

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

    The Pure Food and Drug Act of 1906 was the first of a series of significant consumer protection laws enacted by the Federal Government in the twentieth century and led to the creation of the Food and Drug Administration. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it ...

  5. 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 ...

  6. 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.

  7. Boxed warning - Wikipedia

    en.wikipedia.org/wiki/Boxed_warning

    The FDA can require a pharmaceutical company to place a boxed warning. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of preventable, serious or even life-threatening adverse effects. [2] [3]

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