GUIDANCE DOCUMENT
Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors April 2013
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2013-D-0401
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and Research
The purpose of this guidance is to help prescription drug and biologic product manufacturers minimize medication errors 2associated with their products. This guidance focuses on safety aspects of the container label3 and carton labeling design, and provides a set of principles and recommendations for ensuring that critical elements of a product’s container labels and carton labeling are designed to promote safe dispensing, administration, and use of the product.
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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2013-D-0401.