FDA Guidance for Industry 
Drug Stability Guidelines

I. INTRODUCTION

The guideline is to be used as an aid in designing and conducting studies to establish drug stability in support of original, abbreviated or supplements to new animal drug applications (NADAs/ANADAs). The guideline will provide a framework within which stability studies can be conducted to provide meaningful and sufficient data. The concept of the guidelines is applicable to studies on drug substances and the actual dosage form. The guideline is not intended to restrict experimentation. The guideline applies to pharmaceutical dosage forms and medicated feed products.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required. 

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Guidance for Industry Drug Stability Guidelines

FDA Guidance for Industry Drug Stability Guidelines: