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GUIDANCE DOCUMENT

Indexing Structured Product Labeling June 2008

Final

Indexing Structured Product Labeling

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance explains that FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) will index the content of labeling for human drug and biological products using SPL (Structured Product Labeling). Indexing refers to the insertion of machine-readable tags, which do not appear in actual printed labeling, that enable users with clinical decision support tools and electronic prescribing systems to rapidly search and sort product information. This guidance also describes how applicants can participate in the SPL indexing process. Having consistently and accurately indexed content of labeling is an important step toward the creation of a fully automated health information exchange system.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.