FDA Draft Guidance - Drug Supply Chain and SNIs

I'm glad to see these new proposed standards. With the presence of drug counterfeiting, diversion, and quality issues, I'm hopeful these standards can bring greater safety and confidence to the supply chain. This FDA Guidance for Industry Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages - Draft Guidance is the first of several guidances and regulations that the FDA may issue to implement Section 913 of the Food and Drug Administration Amendments Act of 2007. This guidance recommends the standards that industry should use for the identification of individual packages containing prescription drugs. These standards will facilitate the adoption of a uniform electronic track and trace system for prescription drugs to further improve their safety and security. The details of the draft guidance follow . . .

TABLE OF CONTENTS
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?
B. Does the SNI include expiration date and/or lot or batch number?
C. Why did FDA select the serialized NDC for package-level SNI?

Do you agree with the direction this FDA draft guidance is taking us?

Related Posts:
FDA Draft Guidance On Good Importer Practices
FDA - Global Drug Supply Chain Needs Better Oversight
CA E-Pedigree - Pedigree and Serialization

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