74 
 
  
Guidance for Industry 
 
 
S N V
TABILITY TESTING OF  EW  ETERINARY 
D F  
OSAGE  ORMS
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, (HFV-
143), 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 
 
 
 
 
 
 
S T  
TABILITY  ESTING FOR
N V D F  
EW  ETERINARY  OSAGE  ORMS
 
 
 
 
 
 
 
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 
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. 
 
 
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