Contamination with China Drug Shipments
Thursday, December 31, 2015 @ 12:12 PM gHale
Drug shipments from Tianjin, China may be at risk of chemical contamination, federal officials said.
That means drug compounders and manufacturers need to be on alert because the Food and Drug Administration (FDA) increased surveillance of drug shipments following two massive explosions at Tianjin Dongjiang Port Ruihai International Logistics Co., a chemical warehouse, this past August.
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, 30 kilometers (18 miles) from the explosion site.
Tianjin Tianyao also sent two other drug shipments to the U.S., since the explosion, that ended up tested and released after officials did not find hydrogen cyanide in the shipments. The shipments were for use in pharmacy compounding.
The contaminated shipments ended up stopped and will not be able to come into the United States. The FDA is working with the Chinese Food and Drug Administration (CFDA) on this issue.
The goals of the FDA’s increased monitoring is to prevent the import into the U.S. of contaminated drugs that may have toxic chemicals associated with the explosions. While information related to the explosion remains limited, more than 40 different types of chemicals ended up 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 end up 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 all shipments are free from contamination associated with the explosion and not contaminated in any way.