Posted by Sandy Donchess on June 03, 1999 at 18:56:08:
FDA proposes requiring registration of foreign imports of drugs, biological products and devices
In order to implement section 417 of the Food and Drug Administration Modernization Act of 1997 (FDAMA), the Food and Drug Administration (FDA) has proposed new regulations requiring foreign establishments that import human or animal drugs, biological products (in particular, blood and blood products) and devices into the United States to register with the FDA and to identify the U.S. agent for the establishment.
The proposed amendments to FDA regulations are detailed in the May 14 Federal Register, Vol. 64, No. 93, pp. 26,330-26,334.
Before the enactment of FDAMA, foreign establishments were required to list their products with the FDA, but were not required to register.
This practice generated confusion and resulted in such establishments not complying with the listing requirement, FDA notes in the Federal Register. "Moreover, in some cases, the lack of registration information on foreign establishments made it difficult to determine the source of specific imported products, particularly products that were impure, counterfeit products or products whose safety or efficacy had not been established," FDA adds.
In contrast, all domestic establishments are required to register with FDA, unless specifically exempted, and to list their products.
FDAMA specifically requires all foreign establishments "engaged in the manufacture, preparation, propagation, compounding or processing of a drug or a device that is imported or offered for import into the United States" to register and to list their products.
The proposed rule would not affect veterinary biologics, which are regulated by the U.S. Department of Agriculture.