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The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.
importers about the proper labeling of their food products. This guidance is a summary of the required statements that must appear on food labels under these laws and their regulations.
For more information on labeling, including Physician Labeling Rule (PLR) requirements, guidances, presentations, sample templates and format tools, and established pharmacologic class (EPC ...
What's new in food labeling and nutrition, including label claims, nutrition labeling for restaurants, and links to industry guidance.
FDALabel: FDA’s web-based application designed to perform customizable searches of over 140,000 labeling for human prescription drug; nonprescription drugs; and labeling for other products (e.g ...
Standards of Identity for Food. The FDA began establishing Standards of Identity (SOI) in 1939, and since then, the agency has established more than 250 SOIs. Products like milk, milk chocolate ...
Labeling Requirements for Radiation Emitting Devices and Products; Quality System Regulation Labeling Requirements
Questions regarding these SPL Xforms should be sent to SPL@fda.hhs.gov. Stay informed! - To be notified of updates to these SPL Xforms, request for your e-mail address to be added to the SPL ...
This guidance is intended to assist applicants of human prescription drug and biological products in determining the appropriate placement and content of drug interaction (DI) information in labeling.