Glossary

Labelling

All written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce. Note: Labeling includes the container labels, package insert (or professional labeling), the patient package insert, medication guides, instructions for use, risk management materials and promotional labeling.

Source: 21 CFR 1.3(a)

Resources

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