3. FDA_Import_2011_2[1]

3. FDA_Import_2011_2[1] - FDA IMPORT INSPECTION PROGRAM...

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1 FDA IMPORT INSPECTION PROGRAM http://www.fda.gov Gary Dykstra [email protected] UGA College of Pharmacy This presentation has been revised by the UGA RA Dept. to reflect recent reorganizational changes at the FDA. FDA IMPORT PROGRAM FDC Act (21 USC Section 331) prohibits the interstate shipment (includes importation) of unapproved new drugs. Unapproved new drugs are any drugs that lack FDA approval including foreign made versions of U.S. approved drugs and have not been manufactured in accordance with FDA approval. 2
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2 FDA IMPORT PROGRAM Under the FDC Act, FDA may refuse import admission to any drug that “appears” to be unapproved which places the burden on the importer to prove that the drug which is being imported is approved by FDA. 3 FDA IMPORT PROGRAM Absent evidence that the drugs being imported have been manufactured in accordance with a New Drug Application, such drugs would be considered unapproved and subject to regulatory action.
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