91 
 
Guidance for Industry 
 
STABILITY TESTING FOR                                
MEDICATED PREMIXES 
VICH GL8 
 
FINAL GUIDANCE
 
       
This guidance document is an annex to the parent guidance VICH GL3, Stability 
Testing of New Veterinary Drug Substances and Medicinal Products.  It addresses the 
recommendations for stability testing of new veterinary medicinal Medicated Premix 
products intended for submission for approval to the European Union, Japan and the 
United States. 
 
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.  
 
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.  
 
Additional copies of this final guidance document may be requested from the 
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug 
Administration, 7519 Standish Place, Rockville, MD 20855, and may be viewed on the 
Internet at 
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIn
dustry/default.htm. 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
March 2000  VICH GL8 (STABILITY PREMIXES) 
 
 
 
 
 
 
S T  
TABILITY  ESTING
M P  
FOR  EDICATED  REMIXES
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THIS GUIDANCE HAS BEEN DEVELOPED BY THE APPROPRIATE VICH EXPERT WORKING GROUP 
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. 
Pag e 2 STABILITY TESTING FOR MEDICATED PREMIXES 
 
1. General  
The VICH Harmonized Tripartite Guidance covering the Stability Testing of New Veterinary 
Drug Substances and Medicinal Products (hereafter referred to as the parent guidance) 
references an annex for Medicated Premixes. This document is an annex to the parent 
guidance and addresses the recommendations for stability testing of veterinary medicinal 
Medicated Premix drug products. The parent guidance (VICH GL3) provides a general 
indication of the information on product stability generated, but the annex for Medicated 
Premixes leaves sufficient flexibility to encompass a variety of different practical and 
scientific considerations that are specific to the characteristics of the drug products being 
evaluated. Other stability studies which might be important to consider like stability in 
relation to conditioning and pelleting, segregation and homogeneity studies are not within 
the scope of this guidance.  
2. Preamble  
The guidance primarily addresses the generation of acceptable stability information for 
submission in Registration Applications for medicated premix drug products containing new 
molecular entities. Medicated Premixes are intended for oral administration following 
incorporation into animal feed. The guidance only pertains to Medicated Premixes, and 
does not currently seek to cover information required for products manufactured from 
medicated premixes. Stability studies carried out with a medicated premix should be in line 
with the parent guidance. However, the application of the parent guidance may be limited in 
some instances. This guidance therefore describes those areas where there may be 
differences in the stability data package for medicated premixes.  
3. Storage Test Conditions and Test Parameters  
Medicated Premixes are recommended to be tested at 25C 2C / 60% RH5% (long-term 
testing) and 40C 2C / 75% RH5% (accelerated testing) and with the same schedule 
intervals as described in the Parent Guidance for drug product. Other storage conditions 
are allowable if justified. Where "significant change" occurs due to accelerated testing, 
additional testing at an intermediate condition e.g., 30C 2C / 60% RH5% should be 
conducted. "Significant change" at the accelerated condition is defined as failure to meet 
specifications. Evidence is necessary to demonstrate the stability of the Medicated Premix 
before incorporation into an additional feed. The shelf-life specification of a Medicated 
Premix should include necessary stability indicating test parameters.  
4. Packaging Materials  
The testing should be carried out in the final packaging proposed for marketing when 
practicable. The use of smaller comparable containers simulating the actual market 
packaging may be justified.  
Pag e 3 5. Glossary  
Carrier - An edible material to which drug substances are added to facilitate uniform 
incorporation into feed.  
 
Medicated Premix (Type A Medicated Article) - A Medicated Premix is a veterinary 
medicinal product consisting of a mixture of one or more drug substances, generally with a 
carrier, that is prepared to facilitate oral administration of the drug to animals when mixed 
with feed.  
 
For additional definitions, please refer to regional guidance or regulations. 
 
Pag e 4