New Section 804 Drug Import Rule Does Not Allow Foreign Versions of FDA-Approved Drugs
Pharmacy Checkers
NOVEMBER 12, 2020
But the Canadian drug includes a different binder or filler as inactive ingredients. There’s a different inactive ingredient. In this case, a drug sold in Canada carries the same active ingredient and formulation as an FDA-approved drug. The Canadian drug is now deemed a foreign version of an FDA-approved drug.
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