Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages

Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages

Guidance for Industry - Final Guidance
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March 2010

TABLE OF CONTENTS
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I. INTRODUCTION

II. BACKGROUND
A. Food and Drug Administration Amendments Act of 2007
B. Scope of this Guidance

III. STANDARDIZED NUMERICAL IDENTIFIERS
A. What should be designated as a package-level SNI for most prescription drugs?
B. What should be designated as a package-level SNI for certain biological products?
C. Does the SNI include expiration date and/or lot or batch number?
D. Why did FDA select the serialized NDC for package-level SNI for most prescription drugs?
E. Should the SNI be in human- and machine-readable forms?
F. Is the SNI that FDA is recommending compatible with international standards?

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http://www.fda.gov/RegulatoryInformation/Guidances/ucm125505.htm