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WDSrx Offers Complete DSCSA Compliance For Non-Serialized Products

September 19, 2017; Boca Raton, FL — When manufacturer clients were faced with the prospect of significant costs to meet the impending deadline for DSCSA compliance, WDSrx – Woodfield Distribution, LLC, a logistics services provider, recommended that they do nothing.

The reason?  Many pharmaceutical manufacturers choose not to make the significant investment to upgrade hardware, software, equipment and training for pharmaceutical serialization requirements.  WDSrx advised multiple clients facing similar issues to entrust the logistics firm with their serialization programs.  WDSrx President Adam Runsdorf states, “Our serialization-ready warehouses, packaging and labeling lines are ready to assist manufacturers regardless of their level of DSCSA compliance.”

Prescription drug products requiring serialization are received at WDSrx and serialized for compliant fulfillment within the United States and Europe.

According to Michael Venters, Chief Executive Officer at Cameron Pharmaceuticals, LLC, “At Cameron, we stress fiscal responsibility.  The cost of complying with the DSCSA serialization requirements is a material expense for a generic pharma company still in the emergent phase of its life cycle like Cameron.  We wanted to ensure that we chose a serialization provider that gave us an exemplary level of service and met the DSCSA requirements but did not require a material up-front cash outlay that could negatively impact available cash for growth opportunities.  WDSrx provided the solution we were looking for at reasonable cost and with full DSCSA compliance.”

The manufacturers in the WDSrx Serialization-As-A-Service program solve different problems but all save time, increase efficiency, minimize the burden of compliance and reduce cost.  The complete program includes WDSrx receiving non-serialized product, disassembling original packaging, then re-packaging and re-labeling with serial numbers from the manufacturer’s own Level 4 repository set up by WDSrx and managed for the client on their behalf.  Woodfield is not only providing serialization, but also managing the trading-partner data transfers that will be part of later DSCSA compliance requirements.

Printers on the packaging lines imprint a unique 2D barcode on each bottle revealing a National Drug Code (NDC), a GS1-standard Global Trade Item Number (GTIN), an individual Serial Number, Lot Number and Expiration Date.

In addition to the reduced program cost, the program appeals to manufacturers with a limited number of products that fall within DSCSA requirements and also for manufacturers working with contract manufacturers that are at risk of non-compliance after the legal deadline of November 27, 2017.  In such cases, product can be shipped to WDSrx for compliant labeling and distributed directly by WDSrx to client accounts in the United States and throughout Europe.

Another program benefit for manufacturers is that the Level 4 repository created for clients by WDSrx is owned by the client compared with many contract manufacturing firms that own their repository and contract serial numbers out to their accounts.  With WDSrx, brand owners maintain constant ownership of their products within the pharmaceutical supply chain and minimize any potential complications when tracing issues arise.

The WDSrx Serialization-As-A-Service program was developed with TraceLink, creator of the TraceLink Life Sciences Cloud, the world’s largest pharmaceutical track and trace network.  The collaboration with WDSrx is the first undertaken by TraceLink with a third party logistics provider.

TraceLink Board Member Jack M. Cooper (l) with TraceLink President and CEO Shabbir Dahod (c) and WDSrx Marketing Manager Larry Hotz at TraceLink NEXUS ’17 held June 7-8 in Barcelona Spain

Adds Runsdorf of WDSrx, “WDSrx serialization services address a significant need in the marketplace for small and mid-size manufacturers who don’t want to spend the money to serialize themselves but who also want to maintain business operations in a post-serialization environment.”

For further information about WDSrx Serialization Services, pharmaceutical warehousing and other value-added programs contact Larry Hotz (561) 998-3885 x304 or lhotz@wdsrx.com.

Are any Controlled Substances (CII) included in your return? If so, please press "Yes" and complete the DEA 222 Request Form. You can also contact Jason Solomon at jsolomon@wdsrx.com or (561) 998-3885 x316.