FDA Releases DSCSA Guidance Plan for 2016

The FDA has released their guidance plan for what guidance documents they will release in 2016.  Let’s examine each one:

1. Annual Reporting by Prescription Drug Wholesale Distributors and Third- Party Logistics Providers. *This pertains to reporting requirements and procedures.

2. Products Eligible for Grandfather Status. *Products in the supply chain before the deadline.

3. Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs.  *Interoperable standards to support the exchange of information in regards to tracing for Rx products.

4. The Product Identifier for Human, Finished, Prescription Drugs .*Barcode label information, standards, SNI etc.

5. Verification Systems for Prescription Drugs. *Verification of T3 data, quarantine etc.

6. Waivers, Exceptions and Exemptions from Product Tracing Requirements. *Exemptions for certain products and scenarios.

When will these guides be released? They don’t say. Sometime in 2016. Rest assured, TrackTraceRx will provide you with each guidance information as it is released.


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