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Label Review Training: Module 3: Special Issues, Page 19

Section 4: How should I review directions for use?

Key Points

  • When reviewing directions for use, it is critical to distinguish between statements that are intended to be enforceable and those that are included for informational purposes.
  • Suggested formats for directions for use include bulleted format, tabular format, and modified paragraph format.
  • The Directions for Use Checklist includes questions to ask when conducting a label review.
  • Label reviewers should use policy documents along with the applicable laws to make case-by-case determinations on the acceptability of label language.  

 Progress Check

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