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    Packaging Requirements for New Drug Applications

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    The regulatory responsibilities of the Food and Drug Administration and the Consumer Product Safety Commission, under the Federal Food, Drug, and Cosmetic Act and the Poison Prevention Packaging Act of 1970, as they pertain to safety packaging, are reviewed. Details are given on container information required in a new drug application. The importance of the requirement for adequate stability testing of drug products in their containers is stressed. Sources of various public standards pertaining to testing of drug packaging and component parts are listed.


    packaging, drugs, plastics industry, drug industry, quality control, containers, standards, polyvinyl chloride, Food and Drug Administration, Federal Food, Drug, and Cosmetic Act, Poison Prevention Packaging Act

    Author Information:

    Kumkumian, CS
    Assistant associate director for new drug evaluation (chemistry), Bureau of Drugs, Food and Drug Administration, Rockville, Md.

    Committee/Subcommittee: D10.32

    DOI: 10.1520/STP27866S