FDA Publishes DSCSA Guidance Plans for 2017

The FDA has published its official 2017 agenda for DSCSA guidance documents. These documents outline the FDA's expectations and recommendations for implementation of various areas of DSCSA regulations.

The schedule of DSCSA guidance publications this year includes:

• Annual Reporting by Prescription Drug Wholesale Distributors and 3PLs: Questions and Answers (published 1/10/17, read more here).    
• Grandfathering Policy for Packages and Homogeneous Cases of Product Without a Product Identifier (products in the supply chain after serialization deadlines without product identifiers).          
• Identifying Trading Partners Under the Drug Supply Chain Security Act.          
• Product Identifier Requirements under the Drug Supply Chain Security Act – Compliance Policy.          
• Standardization of Data and Documentation Practices for Product Tracing.          
• The Product Identifier for Human, Finished, Prescription Drugs: Questions and Answers (such as barcode data carriers, serialization information like the SNI).
• Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs (verification of TH / TI information during suspect product scenarios).           
• Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act (waivers for economic hardship, exceptions from serialization due to packaging/labeling, exemptions for certain products and transactions). 

There were no big surprises in what the program outlines, especially considering it contains several items that are holdovers from the 2016 agenda that were not delivered. 

As the various guidance documents are released, TraceLink will provide insight on those rules and their impact on companies across the pharma supply chain.

See the full FDA 2017 guidance plan for DSCSA and other programs here. The DSCSA-related items are under the "Procedural" category.