The FDA has released theirguidance planfor 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,TrackTraceRxwill provide you with each guidance information as it is released.
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