FDA now has expanded authority over global supply chain. FDASIA has been given FDA administrative detention authority over drugs, which previously includes only device and tobacco products. Meanwhile, FDA has more tools for inspection and related enforcement, allowing FDA to destroy counterfeit or adulterated imported products, bar entry of imported drugs, consider results of inspection conducted by foreign counterpart authorities, etc. FDA will bar entry of imported drugs from establishment that has delayed, limited or denied an FDA inspection. FDASIA established current good manufacturing practice requirements (cGMP) that apply to manufacture, processing, packing, or holding drugs. It created uniform national standard to govern product traceability and pre-empt state law requirements. In addition, FDASIA requires the manufacturer of a drug that is life-supporting, life-sustaining, or intended for use in a debilitating disease to notify FDA of a permanent discontinuance or interruption in the drug supply at least six months ahead of time. It also expressly grants FDA extraterritorial federal jurisdiction for violations of the FDCA, so long as the product was intended for import into the US or if any act in furtherance of an FDCA violation occurred in the US.
For our attorney Dr. Susie Cheng's new article on expanded FDA authority over global supply chain, please see http://web.yyjjb.com:8080/html/2013-09/16/content_199074.htm (in Chinese).
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