FDA发布对天津市爆炸引起的药品污染警讯

julia朱玉姣

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

CDER警讯：FDA警示天津市爆炸对药品运输的潜在污染

On December 22, 2015, FDA alerted drugcompounders and manufacturers that drug shipments from Tianjin, China may be atrisk of chemical contamination. FDA increased surveillance of drug shipmentsfollowing two massive explosions at Tianjin Dongjiang Port Ruihai InternationalLogistics Co., a chemical warehouse, in August 2015.

2015年12月22日，FDA警示药房和生产商，提示来自中国天津的货物可能有被化学品污染的风险。在2015年8月，中国天津东疆保税港区瑞海国际物流有限公司所属危险品仓库发生两次爆炸后，FDA加强了对其运输的药物货品的监管。

The increased surveillance resulted in thedetection of hydrogen cyanide contamination in two shipments of drugs fromTianjin Tianyao Pharmaceuticals Co., Ltd. (Tianjin Tianyao) located inTianjian, approximately 30 kilometers (18 miles) from the explosion site.Tianjin Tianyao also sent two other drug shipments to the U.S., since theexplosion, that were tested and released after hydrogen cyanide was notdetected in the shipments. The shipments appear to have been intended for usein pharmacy compounding.

强化监管后，从天津天药制药有限公司（天津天药）发出的两次货运中检出了氢氰酸。该公司位于天津，距爆炸地约30公里（18英里）。天津天药在爆炸发生后，还发了两次货到美国，那两次发运的货品中未检出氢氰酸，在检测后被放行。所运输的货品显示被用于药房药物配制。

The contaminated shipments have beenstopped and will not be allowed into the United States. The FDA is working withthe Chinese Food and Drug Administration (CFDA) on this issue.

被污染的货品已被停运，不会被允许进入美国。FDA正与中国药监局为此事商讨对策。

FDA’s increased monitoring is intended toprevent the import into the U.S. of drugs that may be contaminated by toxicchemicals associated with the explosions. While information related to theexplosion is limited, more than 40 different types of chemicals were discoveredat the blast site.

FDA加强监管是为了防止可能与爆炸有关的被有毒化学物污染的药品进口到美国。由于爆炸有关的资料有限，在爆炸现场发现了超过40种不同类的化学物。

It is the responsibility of companies thatobtain drugs - including finished drug products, active pharmaceuticalingredients (APIs) and excipients - from the Tianjin City region to takeappropriate precautions to ensure the quality of these products before they aredistributed and/or used to further manufacture or compound drugs or drugproducts.

从天津市地区 获取药品----包括制剂、原料药（API）和辅料----的公司有责任采取预防措施，确保这些产品的质量，然后才可以销售和/或用于进一步加工或配制药物。

Manufacturers and compounders obtainingdrug ingredients must know the source of the ingredients. Companies in the U.S.with questions about the drug ingredients they order or receive, particularlyfrom the Tianjin City area, should contact the foreign manufacturer forinformation. Companies must remain vigilant to ensure that all shipments arefree from contamination associated with the explosion and not contaminated inany way.

获取药品成分的生产商和药房必须知道这些成分的来源。对所订购或收到的药品成分来源有疑问的美国公司，尤其是来自天津市区域的药品，应联系其国外生产商获得相关资料。公司必须保持警觉，确保所有货运不会受到爆炸事件相关的污染影响，未受到任何形式的污染。

To learn more, please visit: [url=http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTUxMjIyLjUzMDk4OTUxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE1MTIyMi41MzA5ODk1MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MjQxODA4JmVtYWlsaWQ9emh1eXVqaWFvMTk3MkBob3RtYWlsLmNvbSZ1c2VyaWQ9emh1eXVqaWFvMTk3MkBob3RtYWlsLmNvbSZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&100&&&http://www.fda.gov/Drugs/DrugSaf ... _source=govdelivery]Tianjin drug shipments[/url]

更多信息，请参见天津药品货运。

道路漫长黑暗

对比一下CFDA的简讯，这个信息量确实大了不少，天津港爆炸后FDA加强了运输的药物货品的监管、发现了问题，CFDA就只能等着被人家打上门来，愁。

Doitasyoulike

这应该是货物包装表面发现了其他化学物质

北重楼

这FDA明显是有备而来