FDA Draft Guidance - Drug Supply Chain and SNIs

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Updated October 24, 2022:

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Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages - Draft Guidance is the first of several guidances and regulations that the FDA may issue to implement Section 913 of the Food and Drug Administration Amendments Act of 2007.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 The details of the draft guidance follow .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 Do you agree with the direction this FDA draft guidance is taking us? 

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FDA - Global Drug Supply Chain Needs Better Oversight

Updated August 3, 2024

The original link broke.

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Office of Global Policy and Strategy - FDA.gov

---  the original post follows below  ---

We're still reeling from the tainted heparin situation, and I suspect that it's only the tip of the iceberg. A rising percentage of drugs are coming from China and India, reports this ASHP News article, "World's Drug Supply Chain Needs Better Oversight, FDA Says." The associate commissioner for policy and planning at FDA is quoted, and here's a small sample of highlights . . .

• "where there are economic incentives and/or there is lax regulatory oversight, there is going to be greater opportunity for risky or criminal behavior"
• "If we have good behavior, we want to facilitate compliance. If we have risky behavior, we want to provide deterrence. And with criminal behavior, we need rapid detection and aggressive enforcement. And electronic track and trace can play an important role in it."

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