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The NDC( National Drug Code) System was originally established as an essential part of an out-of-hospital drug reimbursement program under Medicare. The NDC serves as a universal product identifier for human drugs.
The Drug Listing Act of 1972, amending the Federal Food, Drug, and Cosmetic Act, became effective February 1, 1973. Its purpose is to provide the Commissioner of the Food and Drug Administration (FDA) a current list of all drugs manufactured, prepared, propagated, compounded, or processed by a drug establishment registered under the Federal Food, Drug, and Cosmetic Act. The act requires submission of information on commercially marketed drugs and is used in the enforcement of the Federal Food, Drug, and Cosmetic Act.
The directory consists of prescription and selected over-the-counter, insulin, domestic, and foreign drug products that are in commercial distribution in the United States. The products have been listed in accordance with the Drug Listing Act and applicable Code of Federal Regulations for submitting drug product information to the FDA.
There are a number of reasons why products may not be included in the directory (and be in your medicine cabinet): the firm has not submitted the listing information to the FDA; the firm has notified the FDA that the product is no longer being marketed; the firm has not complied fully with the listing process so the product is considered pending until complete information is provided in accordance with 21 CFR 207.
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