Postapproval Changes to Semisolid Drugs

To ensure continuing product quality and performance characteristics of the semisolid topical formulations, regulatory approvals are required for changes to 

Site of manufacture of a semisolid formulation during the postapproval period 

Recommended chemistry, manufacturing, and controls tests to support each level of change 

In most cases, except those involving scale up, stability data from pilot scale batches will be acceptable to support the proposed change. 

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