An SPL (Structured Product Label) is an electronic format for submitting product information to the FDA (Food and Drug Administration) and is used to standardize the way product information is presented and communicated. SPL is a format that is based on the HL7 Health Level Seven Clinical Document Architecture (CDA) standard and is used to electronically submit information about human drug products and biological products.
An SPL is a way to submit the labeling of a product in a machine-readable format, including all the information found in the package insert, carton or container label, and the label affixed to the drug product itself. The SPL is also used for submitting the information for certain biological products. The SPLs provide useful information for the healthcare providers and patients, such as the product name, active ingredients, dosage form, routes of administration, warnings and precautions, etc.
FDA's SPL is intended to improve the effectiveness of the labeling by making it more current, accurate, and easily accessible. By using SPL, the FDA can more quickly and easily access the latest labeling information for a drug, which can be used to identify potential safety issues, update drug labels with new information, and ensure that healthcare providers and patients have access to the most current information.
The use of SPL format is mandatory for most of the drug and biological products applications, submissions, and approvals, it's also recommended for over-the-counter drugs and supplements.
In summary, an SPL is an electronic format used by the FDA to standardize the way product information is presented and communicated. SPL is used for submitting the labeling of drug and biological products, in machine-readable format, to improve the effectiveness of the labeling by making it more current, accurate, and easily accessible for the healthcare providers and patients.
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