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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.
The list of 1997 drug labelling changes can be found on the FDA's website, here. The first patient package insert required by the FDA was in 1968, mandating that isoproterenol inhalation medication must contain a short warning that excessive use could cause breathing difficulties.
Drug labelling is also referred to as prescription labelling, is a written, printed or graphic matter upon any drugs or any of its container, or accompanying such a drug. Drug labels seek to identify drug contents and to state specific instructions or warnings for administration, storage and disposal.
The national drug code (NDC) is a unique product identifier used in the United States for drugs intended for human use. The Drug Listing Act of 1972 [ 1 ] [ 2 ] requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed ...
DailyMed is a website operated by the U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a "package insert") to health care providers and the general public. The contents of DailyMed is provided and updated daily by the U.S. Food and Drug Administration (FDA). The FDA in turn collects this ...
202-203 Drug advertising and marketing; 210 et seq. cGMPs for pharmaceuticals; 310 et seq. Requirements for new drugs; 328 et seq. Specific requirements for over-the-counter (OTC) drugs. The 500 series are regulations for animal feeds and animal medications: 510 et seq. New animal drugs; 556 Tolerances for residues of drugs in food animals
Drugs subject to USP standards include both human drugs (prescription, over-the-counter, or otherwise) and animal drugs. USP-NF standards also have a role in US federal law ; a drug or drug ingredient with a name recognized in USP-NF is considered adulterated if it does not satisfy compendial standards for strength, quality, or purity.
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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