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U.S. Department of Health and Human Services

Animal & Veterinary

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Final Guidance On Stability Testing For Medicated Premixes Available

March 16, 2000

The Food and Drug Administration (FDA) announced in the March 14, 2000, Federal Register, the availability of a final guidance for industry (#91) entitled "Stability Testing for Medicated Premixes" (VICH GL8.) This guidance document was developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

Guidance #91 on stability testing is an annex to the parent VICH guidance entitled "Stability Testing of New Veterinary Drug Substances and Medicinal Products." Guidance document #91 addresses the recommendations for stability testing of veterinary medicinal Type A medicated articles (referred to as medicated premix drug products in the final guidance) intended for submission for approval to the European Union, Japan, and the United States.

This guidance represents current thinking and does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use alternative methods as long as they satisfy the requirements of the applicable statute and regulation.

Copies of this document may be obtained from CVM's Guidelines and Guidances Page on the Internet 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.

Interested persons may submit written comments and suggestions on the guidance document at any time, to Dr. Carol Haley, Policy and Regulations Team (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855. Comments should be identified with the full title of the guidance document and with Docket number 99D-2249.

Further information about this guidance document is contained in a March 14, 2000, Federal Register notice. Information on guidance document #91 is also available from William G. Marnane (HFV-140), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6966, e-mail: wmarnane@cvm.fda.gov.

Further information on VICH is available from Dr. Sharon R. Thompson (HFV-3), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1798, e-mail: sthompso@cvm.fda.gov, or from Dr. Robert C. Livingston, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place (HFV-1), Rockville, MD 20855, 301-594-5903, e-mail: rlivings@cvm.fda.gov .

 

Contact FDA

240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855