July 15, 2002

 

 Final rule on foreign animal drug establishments - July 15, 2002

Posted on July 1, 2002

 

According to a new rule from the Food and Drug Administration, owners of foreign animal drug establishments must now designate a United States agent for purposes of registration and drug listing. Companies must send a letter on company letterhead to the FDA identifying their agent. Letters should be signed by a company official and sent to FDA/CDER/Drug Reg. and Listing, 5600 Fishers Lane (HFD-095), Rockville, MD 20857.

Individuals can obtain additional information about the final rule, which took effect Feb. 11, in the Nov. 27, 2001 Federal Register, www.fda.gov/OHRMS/DOCKETS/98fr/112701a.htm, and in a Dec. 5, 2001 "CVM Update," www.fda.gov/cvm/index/updates/foreignup.htm.

Additional information on animal drug registration may be obtained from Lowell Fried, FDA Center for Veterinary Medicine, HFV-212, 7500 Standish Place, Rockville, MD 20855. Individuals can also call (301) 827-0165 or e-mail lfried@cvm.fda.gov.