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GUIDANCE DOCUMENT

Indexing Structured Product Labeling June 2008

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2007-D-0364
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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2007-D-0364.

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