If you receive product prior to the point in the manufacturing process in which the
drug is first packaged in a container/closure system specified in the “How
Supplied” section of an approved ANDA and you package that product into such a
container/closure system for the first time, you are a packager for purposes of
GDUFA. Every ANDA specifies the forms in which the approved drug product
may be distributed in the “How Supplied” section. For example, if you receive bulk
drugs and package them into the containers in which they are marketed, you are a
packager.
You also are a packager if you receive product in a container/closure specified in
the “How Supplied” section of an approved ANDA, and apply the FDA-approved
prescription package labeling to that product for the first time.