The Differences Between The DSCSA, FDA Rules and Guidance – RxTrace

How To Approach, Read, and Interpret the DSCSA
Another great educational snippet from Dirk Rodgers (RxTrace). Follow the link below to read his full article.

“So let’s apply that to the exchange of Transaction Information TI, Transaction History TI, and Transaction Statements TS that all U.S. pharma supply chain trading partners must do beginning on January 1 of next year (dispensers don’t have to do it until July 1 of next year) (see “DQSA: How Should Transaction Data Be Exchanged?”).  First, the DSCSA that contains this requirement is a law, which means non-exempt trading partners are obligated to follow those requirements or be exposed to penalties.

The DSCSA also obligates the FDA to take certain actions on a particular schedule (see “Decoding The FDA’s DSCSA Timeline”).  Two of those actions are the publication of guidance on identification of suspect product and termination of notifications of illegitimate product, which is due by next Monday, and the publication of draft guidance establishing standards for interoperable exchange of TI, TH and TS in paper or electronic format, which is due on or before November 27 of this year.  Both of these are guidance, which means they will contain non-binding information that represents the current thinking of the FDA on those topics.”  via The Differences Between The DSCSA, FDA Rules and Guidance.

Go to The Designated Representative and Exemptee Training Website

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