HDA Traceability Seminar Recap – FDA Update

Hello Everyone,

The TrackTraceRx team spent last week at the HDA Traceability Seminar in Washington D.C. and found it very informative and beneficial. Thank you everyone who stopped by our booth and signed up to see our launch of the TrackTraceRx Suite. The demand has been amazing as companies see the benefits of having a fully integrated solution versus a single service solution.

 

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About the Conference

The HDA Traceability Seminar had a record breaking registered attendee of 450 (WOW!)… an amazing turnout. The HDA also covered their salable returns pilots and issued their report here:

http://www.hdmanet.org/~/media/pdfs/industry-relations/hda-pilots-scenario-brochure.ashx

The report covers different scenarios of handling how distributors must process serialized saleable pharmaceutical returns from customers.  According to an HDA member survey, saleable pharmaceutical returns comprise 2 to 3 percent — or nearly 59 million units — of total sales annually.

Out of the nine different scenarios in the report, two of the live pilot scenarios were determined to be the most cost-effective and viable approaches to achieving compliance. In the first recommended option, a manufacturer sends aggregated product identifier information only for the products purchased to each individual distributor; when the distributor processes a saleable return, the distributor references an internal database to verify the product identifier information from the manufacturer.

The second option employs a verification router service. In this scenario, the manufacturer stores all of its product identifier information locally, which is connected to a third-party routing service. Upon receiving a saleable return, the distributor captures the product data and sends the data to this third-party router service, which then routes the query to the appropriate manufacturer’s database.

FDA

Dr. Connie Jung from the FDA spoke about all respective DSCSA updates, and here is what we got:

The DSCSA text offers a grandfathering of current products clause for manufacturers and nothing for downstream trading partners. So the question remains on how downstream trading partners which receive products will handle grandfathering. It was implied that trading partners may possibly be able to take advantage of being able to grandfather these products also. TrackTraceRx will be able to confirm this as soon as the FDA releases more guidance on grandfathering products. When asked when this guidance would be issued all we got from the Dr. Connie Jung was “soon”.

Compounded drugs are exempt from the DSCSA.

The smallest saleable unit sold to the pharmacy must be serialized not the pill.

The FDA will not hold pilots but will look for the industry partner pilots.

Charitable organizations are not exempt from the DSCSA only company inter-transfer shipments are exempt.

All in all the event was amazing! Be sure that TrackTraceRx will be sponsoring the HDA’s next event as well at the: 2017 Distribution Management Conference and Expo (March 5-8). We hope to see you there!

-Chris

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

 

VRS

Return Saleable gets future-ready! Learn the secret

The future of VRS is here! Product verification on returns gets 60% faster and profitable with advanced technology and precision platform-the Traceability suite. Track, trace and create audit reports, all at a single go with agile solutions that are time bound and result-oriented. So, are you future-ready?

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