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Drug Dispensing Errors Get FDA Focus in Labeling Guidelines

May 17, 2022, 4:32 PM

Drugmakers should make sure their product labels are easy to read and prominently display dosing information to prevent dispensing errors, the FDA said in finalized guidance.

The guidance, filed Tuesday in the Federal Register, aims to help makers of pharmaceutical and biologic products know what factors to consider to ensure that their labeling is “designed to promote safe dispensing, administration, and use of the product,” the Food and Drug Administration said.

The recommendations, which build on 2013 draft guidance, could help prevent common mistakes that may make it difficult for health-care providers or patients to locate and understand a ...