miércoles, 23 de diciembre de 2015

CDER Alert: FDA Warns of Potential Contamination of Drug Shipments from Explosions in Tianjin City

FDA Division of Drug Information: Know the Moment It Happens
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
On December 22, 2015, FDA alerted drug compounders and manufacturers that drug shipments from Tianjin, China may be at risk of chemical contamination. FDA increased surveillance of drug shipments following two massive explosions at Tianjin Dongjiang Port Ruihai International Logistics Co., a chemical warehouse, in August 2015. 
The increased surveillance resulted in the detection of hydrogen cyanide contamination in two shipments of drugs from Tianjin Tianyao Pharmaceuticals Co., Ltd. (Tianjin Tianyao) located in Tianjian, approximately 30 kilometers (18 miles) from the explosion site. Tianjin Tianyao also sent two other drug shipments to the U.S., since the explosion, that were tested and released after hydrogen cyanide was not detected in the shipments. The shipments appear to have been intended for use in pharmacy compounding.
The contaminated shipments have been stopped and will not be allowed into the United States. The FDA is working with the Chinese Food and Drug Administration (CFDA) on this issue.
FDA’s increased monitoring is intended to prevent the import into the U.S. of drugs that may be contaminated by toxic chemicals associated with the explosions. While information related to the explosion is limited, more than 40 different types of chemicals were discovered at the blast site. 
It is the responsibility of companies that obtain drugs - including finished drug products, active pharmaceutical ingredients (APIs) and excipients - from the Tianjin City region to take appropriate precautions to ensure the quality of these products before they are distributed and/or used to further manufacture or compound drugs or drug products. 
Manufacturers and compounders obtaining drug ingredients must know the source of the ingredients. Companies in the U.S. with questions about the drug ingredients they order or receive, particularly from the Tianjin City area, should contact the foreign manufacturer for information. Companies must remain vigilant to ensure that all shipments are free from contamination associated with the explosion and not contaminated in any way.
To learn more, please visit: Tianjin drug shipments

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