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.

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 Carol Haley, Policy & Regulations Team, Center for Veterinary Medicine, (HFV-6), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855.

For questions regarding this final document, contact William G. Marnane, Center for Veterinary Medicine, (HFV-140), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6966, E-mail: wmarnane@cvm.fda.gov.

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.

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.