September 1, 1999
PIPERAZINE GUIDANCE AVAILABLE
FDA's Center for Veterinary Medicine (CVM) has released a guidance document entitled "Manufacture and Distribution of Unapproved Piperazine Products" (Guidance Document #102.) This guidance document explains that in the April 29, 1999, Federal Register, FDA announced the approval of a supplemental new animal drug application (NADA) filed by Fleming Laboratories, Inc. for the use of piperazine in chickens, turkeys, and swine for treatment of certain parasitic infections. In this same Federal Register notice, FDA provided that firms without approved NADAs for piperazine for use in food-producing animals could continue to manufacture and distribute piperazine only until August 27, 1999.
The Guidance Document says that in order to provide for an orderly phase-out, FDA would not object to distribution of this product until December 31, 1999. After that date, unapproved piperazine products may be subject to regulatory action. Firms that currently manufacture and distribute piperazine for use in food-producing animals without an approved NADA are urged to submit their NADA to FDA as soon as possible.
Copies of this guidance document may be obtained from our Guidelines and Guidance Page or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755.
Comments and suggestions you wish to make officially to the Agency regarding this document should be sent to: Policy & Regulations Team, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855.
Further information and clarification of this document is available from Barbara A. Rodgers, Center for Veterinary Medicine (HFV-235), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1785.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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