FDA Allows Outsourcing Facilities to Extend Beyond-Use Date for Repackaged Avastin

February 2, 2018: By Joan McKenna

Avastin is repackaged into smaller doses for IVT use.

The US FDA will allow outsourcing facilities to extend the beyond-use date (BUD) for repackaged Avastin if additional sterility testing is undertaken, the agency announced Jan. 19.

The FDA released the policy change in two published final guidance documents on compounding.

In response, the American Society of Cataract and Refractive Surgery said it was working with the ophthalmic community to identify the cost and time associated with the test and the opinions of outsourcers on the final guidance.

The current BUD for repackaged Avastin is 90 to 180 days, according to a Minnesota retina specialist.

Draft guidance released in February 2015 called for a BUD of no more than five days for biologics repackaged at 503B outsourcing facilities. The clock would start once the package was opened at an outsourcing facility for repackaging.

Critics said the short timetable would make it impossible for Avastin to be repackaged, labeled, shipped, handled, and used by a surgeon, much less tested for sterility.

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