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December 5, 2001
NEW RULE REQUIRES FOREIGN IMPORTERS TO REGISTER WITH FDA
FDA has published a final rule that requires foreign establishments whose products are imported or offered for import into the United States to register with FDA and to identify a U.S. agent. This final rule, that was published in the November 27, 2001, Federal Register, implements Section 417 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) for human drugs, animal drugs, biological products, and devices. This rule is effective February 11, 2002.
Generally speaking, before FDAMA's enactment, foreign establishments could, but were not required to, register with FDA. Through its regulations, FDA did require foreign establishments to list their products regardless of whether the foreign establishment was registered.
This difference in registration and listing requirements confused some foreign establishments and led some to not comply with the listing requirement. Additionally, the lack of registration information on foreign establishments sometimes 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.
FDAMA changed this situation by requiring 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 U.S. to register. It also emphasized that foreign establishments must list their products and required, for the first time, foreign establishments to identify a United States agent.
Comments on this rule may be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted to http://www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm. The comments should include Docket No. 98N-1215.
Additional information on this rule is available in the Federal Register of November 27, 200 and from Philip L. Chao, Office of Policy, Planning, and Legislation (HF-23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3380.
Issued by:
FDA, Center for Veterinary Medicine,
Office of Management and Communications, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (301) 827-3800 FAX: (301) 827-4065
Internet Web Site: http://www.fda.gov/cvm