Update April, 99 #2

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Update April, 99 #2

FDA Update - Exports: Notification and Recordkeeping Requirements Fed.. Reg. Announcement - 4/4/99 Docket - 98N-0583

The FDA has drafted and is waiting for comments by June 16, 1999 concerning notification and recordkeeping for companies that are exporting human drugs, biologics, devices, animal drugs, foods and cosmetics.

The records that will be required are:

1) the product meets the foreign purchaser's specifications
2) the product does not conflict with the laws of the importing country
3) the labeling of the product has "for export only"
4) documentation that product is not offered for sale in the US

US exports will also have to send notification to the FDA of such shipments.

The US export will also have to keep trace of where the shipment were sent for at least 5 years from the site from where they were shipped.

This new regulations will meet the FDA's obligation concerning the FDA Export Reform and Enhancement Act, 1996.

If you want more information on these regulations and to whom you should make comments please go to the FDA's website at www.FDA.gov to contact mdi directly. We will send you a copy of the Fed. Reg. Announcement and discuss the ramifications with you.

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