Hello,
I have come across some ANDAs that were approved with raw material specifications meeting both USP and EP requirements. The products made with these excipients are for US distribution only. My question is: Would removing the EP tests and using only the USP tests be considered a Prior Approval? Or since we are removing the non-applicable tests and wanting to use straight USP, could this be a lower reporting category (Changes guidance VIII.C.1.e or D.1)? Has anyone removed EP testing from raw material specs?
Any help is greatly appreciated!
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Lisa Apolis
Director of RA
BLU Pharmaceuticals
Franklin KY
United States
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