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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) 

STABILITY TESTING FOR MEDICATED PREMIXES

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. 

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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 25°C ±2°C / 60% RH±5% (long-term 

testing) and 40°C ±2°C / 75% RH±5% (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., 30°C ±2°C / 60% RH±5% 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. 

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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.