Transporting human blood products across the border between Mexico and the United States

The Chief of the Public Health Laboratory in San Diego County (Patricia McVay, PHM, MA, MD; attribution used with permission) reports that since pandemic (novel H1N1) flu started, her Laboratory has had great difficulty transporting diagnostic specimens across the border between Mexico and the United States, in order to perform clinical testing on Mexican patients' blood, urine, sputum, nasopharyngeal swabs and other swab specimens for the purpose of treatment and surveillance of flu, HIV, hepatitis, West Nile Virus and tuberculosis. Dr. McVay comments that ten years ago such specimens could easily be transported across the border twice a week; now the access is limited to twice a month. She says that presently, the diagnostic specimens must now be managed by a customs broker and pass thru HazMat gates in Mexico and in the USA. The HazMat gates are only open a total of three hours a week and there is a lengthy wait for inspections. The diagnostic specimens are properly packaged for shipping in SafTPak boxes. The HazMat requirements with the three hour weekly window were added only after pandemic flu arrived.

Having shared the aforementioned situation, Dr. McVay wonders if human blood for transfusion can be transported across the US Mexican border. If so, is the transportation of human blood products across the border as complicated as it is for diagnostic specimens? Dr. McVay realizes that human blood for transfusion is reasonably safe from viral contamination, with the exception of autologous units which have a significantly greater risk of viral infection compared to allogeneic units.

The following comments have been received in response.

ADDENDA Aug. 18, 2009

According to a compliance officer at a university medical center in Southern California, the FDA's Center for Biologics Evaluation and Research (CBER) is responsible for the regulation of biologically-derived products including blood intended for transfusion. Information related to importing CBER-regulated products into the United States is available at the page on the FDA website entitled, Importing CBER-Regulated Products into the United States Questions and Answers.

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