It may have taken three years since the heparin-contamination tragedy, but the Food and Drug Administration is apparently close to issuing its guidance for the tracking and tracing of medicines. http://www.securingpharma.com/40/articles/403.php
Joshua Sharfstein, FDA deputy commissioner, said Thursday that the guidance will set “a standard for unique identification for prescription drug packages, which ultimately will help in identifying the whereabouts and authenticity of drug packages and distinguish them from counterfeits.”
He made his remarks before a House Energy and Commerce health subcommittee meeting, which was called “Drug Safety: An Update From The FDA.”
Coming up with a better system of tracking drugs is crucial, especially when about 80 percent of all active pharmaceutical ingredients used by U.S. drug makers come from overseas, according to a 1998 U.S. General Accounting Office study.
During his testimony, Sharfstein claimed that the FDA has made great progress beefing up the oversight of foreign-made drug ingredients that are coming into the United States, For example, it has opened offices in several countries and now has information-sharing deals with foreign regulatory agencies.
Sharfstein also cited the calamity involving Chinese-made heparin, which he said caused the deaths at least 80 Americans, during his comments to the subcommittee.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
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