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Structured Product Labeling (SPL)
The Food and Drug Administration (FDA) now
requires drug manufacturers to submit prescription drug label
information to FDA in a new electronic format. This electronic format
will allow healthcare providers and the general public to more easily
access the product information found in the FDA-approved package
inserts ("labels") for all approved medicines in the United States.
- FDA Announces the Use of New Electronic Drug Labels to Help
Better Inform the Public and Improve Patient Safety.
FDA
News
-
Structured
Product Labeling Resources
- Draft SPL Release 2 Implementation Guide for Highlights [Word]
or [PDF] (5/10/2006)
- Introduction to SPL Changes with the Physician Labeling Rule [PowerPoint]
or [PDF] (3/20/2006)
- SPL Implementation Guide for FDA Content of Labeling Submissions [Word]
[PDF] (1/12/2006, updated 2/27/2006)
- Companion Document for SPL Implementation, Version 1 [Word]
[PDF] (1/11/2006)
- Electronic Labeling Information Processing System (ELIPS)
Validation and Conformance Rules [Word]
[PDF] (1/10/2006)
- SPL Standard for Content of Labeling Technical Questions and
Answers
[HTML] or [PDF]
or [Word] (12/8/2005)
- SPL Data Element Examples [Word]
or [PDF] (12/28/2005,
updated 2/27/2006)
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Electronic Regulatory Submissions and Review
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Date created: May 10, 2006 |
