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FDA Publishes DSCSA Guidance Plans for 2016
January 22, 2016
The FDA has published its official 2016 program plan for DSCSA Guidance documents. These documents outline the FDA's expectations and recommendations for implementation of various areas of DSCSA regulations.
The schedule for DSCSA Guidance publications include:
- Products Eligible for Grandfather Status (products in the supply chain after serialization deadlines without product identifiers)
- Standards for Interoperable Exchange of Information for Prescription Drugs
- Verification Systems for Prescription Drugs (verification of TH / TI information during suspect product scenarios)
- Waivers, Exceptions, and Exemptions from Product Tracing Requirements (waivers for economic hardship, exceptions from serialization due to packaging/labeling, exemptions for certain products and transactions)
- Annual Reporting by Wholesale Distributors and 3PLs
- Product Identifier for Prescription Drugs (barcode data carriers, serialization information such as the SNI, etc.)
You can review the FDA's full 2016 Guidance plan for DSCSA and other programs here. The DSCSA-related items are under the "Procedural" heading.
As the various Guidance documents are released, TraceLink will provide insight on those rules and their impact on companies across the pharma supply chain.
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