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GUIDANCE DOCUMENT

CVM GFI #102 Manufacture and Distribution of Unapproved Piperazine Products August 1999

Final
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
CENTER FOR VETERINARY MEDICINE

Guidance for Industry

This document supersedes the guidance of the same name published earlier this month.

Manufacture and Distribution of Unapproved Piperazine Products

REVISED

This document is intended to provide guidance on the manufacture and distribution of unapproved piperazine products in food-producing animals. It represents the agency's current thinking on this issue. It does not create or confer any rights for or on any person and does not operate to bind the FDA or public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations or both.

Comments and suggestions regarding this document should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.

For further information regarding this document, contact Linda Benjamin, Center for Veterinary Medicine, (HFV-222), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855,240-453-6855, e-mail: linda.benjamin@fda.hhs.gov.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine (CVM)
August 27, 1999

Manufacture and Distribution of Unapproved Piperazine Products

REVISED

A supplemental new animal drug application (NADA) filed by Fleming Laboratories, Inc., was approved effective March 23, 1999, for the use of piperazine in chickens, turkeys, and swine for treatment of certain parasitic infections. Notification of this approval was published in the April 29, 1999, Federal Register.

In this same notification, 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. However, 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.

Attached is a copy of the April 29, 1999, Federal Register document, which further explains this matter. If you are marketing a piperazine product covered by this notification, please advise Barbara A. Rodgers of your intentions regarding further marketing of piperazine. Responses may be forwarded to Ms. Rodgers' attention at: Food and Drug Administration, Center for Veterinary Medicine, Division of Compliance, HFV-235, 7500 Standish Place, MPN II, Rockville, Maryland 20855.

Attachment

Additional Information


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002