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Clarifying “repackaging”

February 7, 2012

When do you use the labelling requirements in Standard 21 (repackaging) versus those in Standard 7 (dispensing)?

The intent of the Standard 21 is to provide direction for labelling of drugs or blood products that were not packaged in a package intended for dispensing. To help clarify requirements, ACP council approved the following interpretation of repackaging.

Repackaging means breaking up a manufacturer’s original package of a drug or blood product for the purpose of dividing and assembling the drug in larger or smaller quantities

a) in preparation for dispensing, or

b) for redistribution or sale by retail, and

does not include packaging of a drug or blood product for dispensing to a patient pursuant to a prescription as per Standard 7.