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FDA Barcode Requirements

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    • As of 2004, the FDA requires certain drugs to have bar codes.Comstock/Comstock/Getty Images

      As a protector of public health, the Food and Drug Administration (FDA) is responsible for making sure Americans receive safe, effective medical devices, drugs and more. As of 2004, the FDA ruled certain drugs have bar codes to help reduce the amount of medical mistakes made in hospitals and other health facilities. This ruling allows patients to receive the right drug in the right dose and in the correct way and time.

    National Drug Code

    • The FDA ruled in February 2004 that drugs and biological products manufactured on or after April 26, 2006, have a bar code that at least has the National Drug Code (NDC) of the drug. The NDC contains 10 numeric digits, divided into three segments. The labeler code has four to five digits and represents the manufacturer. The product code has three to four digits and identifies the product. The third and last segment has one to two digits and represents the package code, containing the package type and size. The NDC also has an asterisk, which the FDA uses internally. The bar code on the label, for example, will not reveal the asterisk.

    Bar Code Location

    • The FDA requires the bar code location to be on the outside container of the drug or on the wrapper. If the bar code cannot be seen or read through the outside container or wrapper, the bar code must be on the container itself. The overwrap should also contain the bar code if the bar code scanner cannot read the bar code through it, which means health care professionals must scan the bar code before removing the overwrap.

    Blood and Blood Components

    • Blood and blood component labels must also have bar code information. As of October 2010, the FDA recognizes Codabar and ISBT 128.3 for bar code scanning. Each blood and blood component label must have at least a product code, a facility identifier, a donor lot number and the donor's ABO and Rh. The ABO represents the donor's blood types A, B or O (and AB), and Rh, which stands for substances on the red blood cells surface that causes individuals who do not have the substances to produce antibodies.

    Bar Code Required Drugs

    • Drugs that must have bar code requirements set by the FDA include prescription drugs unless these drugs are medical gases, prescription drug samples, intrauterine contraceptive devices (IUDs) and allergenic extracts. Biological products and drugs used commonly in hospitals with labels stating for hospital use also must have bar codes.

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