FDA Instituting Testing Program for Imported Heparin

-FDA News

03/18/2008 -  As regulators worldwide are increasingly concerned that the supply of heparin active pharmaceutical ingredient (API) might be contaminated, the FDA is implementing a program to test all heparin entering the U.S.

Under the program, companies marketing heparin sodium in the U.S., which include APP Pharmaceuticals and Hospira, have the option to enter into an agreement with the agency to employ more advanced identity tests on crude heparin or API, CDER Director Janet Woodcock said. In exchange, entry of their products into the U.S. will not be delayed.

Five unidentified companies — representing a substantial portion of the market — have agreed. These companies use both domestic and foreign sources of crude heparin or API, Woodcock said.

For companies not participating, imported crude heparin and API will be held and tested by the FDA to ensure that the products are not adulterated. Contaminated product will be refused entry into the U.S. and likely destroyed.

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