This chapter is intended to provide guidance to those engaged in repackaging of drug products in accordance with 21 CFR 10.90.
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Currently under construction at the Fincantieri shipyard in Marghera, Italy, Carnival Horizon will offer indoor and outdoor dining, bar, entertainment and activity options that debuted on Carnival Vista.
Included is a groundbreaking bike-ride-in-the-sky attraction called Sky Ride, an IMAX Theatre and a massive Waterworks aqua park featuring a water tube slide called Kaleid-o-slide.
A repackager should provide appropriate labeling of the product identical to the manufacturer's approved market container.
All repackaged products should be labeled with an appropriate BUD in the absence of stability data, or with an expiration date in cases where suitable stability studies, determined in CFR 211.166 (for recommended conditions see ), have been performed on the product using the repackager's container.
A repackager is engaged in the repackaging of drugs (see also is one who is contracted by original drug manufacturers to package or repackage their product into a single- or multi-unit container chosen by the manufacturer.