The drug will not be "essentially a duplicate" of a number of marketed medicines (as described uniquely in part 503B, notably far more broadly and with narrower exclusions than for "standard" compounding) Compounding medicine while in the absence of GMPs improves the prospective for planning errors. When compounding is carried https://mytopfiles.s3.amazonaws.com/CompoundingPharmacySydneyAndItsImportance.html