ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Label

(USP) Document physically attached directly to the packaging materials that are in direct contact with the excipient, drug substance, or drug product.

Publication Source: ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities (First Edition)

Publication Date: 2012

Label

A display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of the Federal Food, Drug, and Cosmetic Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.

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