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Guidance for Industry 

STABILITY TESTING OF NEW VETERINARY 

DOSAGE FORMS

VICH GL4 

FINAL GUIDANCE 

(October 28, 2010, this guidance document was revised to update contact information and broken 

internet links)

 

This guidance is an annex to the VICH parent guidance entitled “Stability Testing of New Veterinary 

Drug Substances and Medicinal Products” (VICH GL3). It addresses the recommendations on what should 

be submitted regarding stability of new dosage forms by the new animal drug applicant, after the original 

submission of stability information has been made in a new animal drug application. 

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. 

Comments and suggestions regarding the document should be submitted to Division of Dockets 

Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 

20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified 

with the Docket No. FDA-2006-D-0299 (Legacy Docket No. 1998D-0566.)

For questions regarding this document, contact Norman Gregory, Center for Veterinary Medicine, (HFV143), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8253, e-mail: 

norman.gregory@fda.hhs.gov. 

U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Veterinary Medicine 

September 1999 
Contains Non-Binding Recommendations 

VICH GL4 (STABILITY 2) 

May 1999 

For implementation at Step 7 

STABILITY TESTING FOR

NEW VETERINARY DOSAGE FORMS 

Recommended for Implementation 

at Step 7 of the VICH Process 

on 20 May 1999 

by the VICH Steering Committee 

THIS GUIDANCE HAS BEEN DEVELOPED BY THE APPROPRIATE VICH EXPERT WORKING GROUP ON THE 

BASIS OF THE ICH GUIDANCES ON THE SAME SUBJECT AND HAS BEEN SUBJECT TO CONSULTATION BY THE 

PARTIES, IN ACCORDANCE WITH THE VICH PROCESS. AT STEP 7 OF THE PROCESS THE FINAL DRAFT IS 

RECOMMENDED FOR ADOPTION TO THE REGULATORY BODIES OF THE EUROPEAN UNION, JAPAN AND USA. 

Page 2
Contains Non-Binding Recommendations 

Page 3

STABILITY TESTING FOR NEW VETERINARY DOSAGE FORMS

Recommended for Implementation at Step 7 of the VICH Process 

on 20 May 1999 by the VICH Steering Committee 

GENERAL 

This document is an annex to the VICH parent stability guidance, Stability Testing of New Veterinary Drug 

Substances and Medicinal Products (VICH GL3) and addresses the recommendations on what should be 

submitted regarding stability of new dosage forms by the owner of the original application, after the 

original submission for new drug substances and products. 

NEW DOSAGE FORMS 

A new dosage form is defined as a drug product which is a different pharmaceutical product type, but 

contains the same active substance as included in the existing drug product approved by the pertinent 

regulatory authority. 

Such pharmaceutical product types include products of different administration route (e.g., oral to 

parenteral), new specific functionality/delivery systems (e.g., immediate release tablet to modified release 

tablet) and different dosage forms of the same administration route (e.g. capsule to tablet, solution to 

suspension). 

Stability protocols for new dosage forms should follow the guidance in the parent stability guidance in 

principle. However, a reduced stability database at submission time may be acceptable in certain justified 

cases.