Contaminated Compounding Drug Shipments Coming from China, FDA Warns

The FDA is cautioning drug compounders and manufacturers about a potential risk of chemical contamination stemming from Chinese shipments.

After 2 explosions at a chemical warehouse this summer in Tianjin, China, the FDA increased surveillance of drug shipments.

Investigators discovered hydrogen cyanide contamination in 2 shipments from Tianjin Tianyao Pharmaceuticals Co Ltd, about 18 miles from the explosion site. The FDA stopped these contaminated shipments from entering the United States.

Meanwhile, the Tianjin pharmaceutical company had sent 2 other shipments “intended for use in pharmacy compounding” to the United States since the explosion, but the shipments were not found to contain hydrogen cyanide.

The FDA stated that its goal was to prevent drugs contaminated with toxic chemicals associated with explosions from entering the country.

“It is the responsibility of companies that obtain drugs, including finished drug products, active pharmaceutical ingredients, 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,” the FDA stated in a press release.

The agency also stressed that compounders should know where their drug ingredients come from, and if they have questions, they 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,” the FDA stated.