Extremely Important News effecting Worldwide Clinical Trial Logistics

New regulations have just been issued by the International Air Transport Association (IATA), which will dramatically change the way Infectious Substances and Diagnostic Specimens are transported by air on a worldwide basis. The new regulations will be in effect as of January 1, 2005.

Specimens being transported for "investigational purposes" that contain Risk Group 2 and 3 pathogens will be shipped as Diagnostic Specimens under the new IATA/ICAO regulations. A diagnostic specimen is not described as an infectious substance unless the source patient or animal has or may have a serious human or animal disease from a Risk Group 4 pathogen.

Infectious clinical samples in Risk Groups 2 and 3 must be shipped as: Diagnostic Specimen Packed in Compliance with IATA Packing Instruction 650." The package must be marked with these words and "UN 3373" (the new UN number), as well as the net quantity of material being shipped inside the box. There is no need to utilize Class 6.2 packaging, and there are no hazard labels to be placed on the package. Importantly, there is no Shipper's Declaration required. However, Dry Ice package marking and labeling requirements remain the same.

For up-to-the-minute information on regulatory changes, email us at: statwebsales@qintl.com or contact your local QuickSTAT representative.