Expiration dating of repackaged medications

07-Dec-2017 12:54

These containers should meet all the applicable requirements in this chapter, pertinent sections in general test chapters refers to a container–closure system that yields the same, or better, moisture vapor transmission rate (MVTR), oxygen transmission, and light transmission as the original market container.

These values may be determined by the repackager, or they may be obtained from the container–closure vendor for the specific container–closure system under consideration.

The expiration date of a drug is estimated using stability testing under good manufacturing practices as determined by the Food and Drug Administration (FDA).

Drug products marketed in the US typically have an expiration that extends from 12 to 60 months from the time of manufacturer.

Because the packaging practice relates to packaging, processing, or holding a drug product intended for administration to humans or animals, the repackager is expected to comply with regulations such as those relating to the sections pertaining to quality control, personnel qualifications, building and facilities, equipment, production and process controls, packaging and labeling controls, laboratory controls, master production record, batch records and reprints, distribution records, storage control records, and complaint files.

is one who purchases and removes a drug product from the manufacturer's market container or bulk dosage container and places the product into a different container for distribution for human or animal use.

In the absence of stability data, where a repackager repackages a product into a unit-dose or multiple-unit container without conducting appropriate stability studies to support expiration dates used, the period of use of the product is limited by the BUD for the repackaged product, which must be less than the expiration date.

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Stability studies are performed on the drug product in the original manufacturer's containers to establish an expiration date.

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