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Serialization Solutions For DSCSA-Challenged Manufacturers

Procedures are detailed in Standard Operating Procedures (SOP) documents that are precisely executed.

In recent years, the pharmaceutical industry has acted like a student who is not sure whether he or she has studied the proper material for an upcoming exam.  The deadline for the next phase of DSCSA serialization compliance passes on November 27, 2017.  It’s too late to cram for the test.

HIDDEN HEROES

Manufacturers that delayed studying up till now won’t catch up no matter how many all-nighters they put in until November, unless they get a study partner to help achieve serialization.  The best partners to maintain business operations before, during and after the DSCSA deadline are ready and willing to help:  pharmaceutical third party logistics providers.

Reputable pharmaceutical 3PL companies including WDSrx, based in Boca Raton, FL have been conscientiously preparing to achieve DSCSA compliance prior to the November deadline.  Their position within the pharmaceutical supply chain, working upstream and downstream with manufacturers and dispensers, requires installation of flexible serialization solutions to work seamlessly with multiple parties at various stages of serialization readiness.

WDSrx also performs contract packaging and labeling for solid and liquid dosage forms from their on-site packaging suites at their Boca Raton, FL headquarters and at an affiliated site in Houston, TX.  For serialization-deficient manufacturers, this provides a one-stop end-to-end serialization solution from receipt of product in the warehouse to primary and secondary packaging and labeling and on to sending serialized orders with compliant data transmission to their shipping destination.

SERIALIZE NOW.  OR NEVER.

It is important for manufacturers to take action now to solve for serialization.  Small to mid-size manufacturers and brand owners are particularly vulnerable to having non-serialized shipments rejected at the loading dock after November 27, 2017.  The transition to full serialization will be challenging and wholesalers willing to work through the transition with larger partners may not extend the same consideration to smaller players.

The Act states that by the November 27 deadline, manufacturers must put a unique product identifier on certain prescription drug packages and must have a procedure for verification of the product at the package level including the standardized numerical identifier, or NDC.  Adam Runsdorf, President of WDSrx, advises clients to beware of creating a false sense of confidence by completing this single requirement.  “Previous communications from large wholesalers makes it clear that they expect serialized products with compliant data transmission in order to be received.”

Another reason for WDSrx recommendation to clients for comprehensive serialization services is due to confusion by brand owners who believe their products are serialized because their contract manufacturer applied a compliant serial number to each unit.  Brand owners are often surprised when told that in most of these cases, the serial number is owned by the CMO and not by the brand owner.

According to Rob Gerstein, WDSrx Vice-President, “We hear from clients regularly who say their contract manufacturer can add serial numbers and we explain that brand owners enabling their CMO to add serial numbers to their product are forfeiting a degree of control over their product because the numbers are being generated by a system that belongs to another party.” The serial number is a link in a complex chain that involves systems to integrate equipment and information technology assets with product tracing, verification and end-to-end serialization, also known as Level IV enterprise compliance.

 THREE SOLUTIONS FOR DSCSA COMPLIANCE TODAY

Level 4 services at WDSrx are being provided by TraceLink, creator of the TraceLink Life Sciences Cloud, the world’s largest pharmaceutical track and trace network.  According to Brian Daleiden, TraceLink Co-Founder and VP of Industry Marketing, “Requirements for DSCSA compliance mandate a flexible track and trace system that can handle complex data management and compliance processing for information on lot-level and serialized products that is generated and exchanged among parties that manufacture, distribute or dispense pharmaceutical products in the United States.”

WDSrx offers a customizable serialization program that provides manufacturers with the correct solution to fit their needs and maintain operations.

1. Manufacturers with a limited number of products requiring DSCSA compliance may choose to outsource the entire serialization process to WDSrx because the financial investment to meet compliance is too great. For companies with no serialization plans, WDSrx undertakes the responsibility to convert their inventory into DSCSA-compliant products.

The process begins with WDSrx serialization experts establishing a Level 4 data repository with TraceLink that is controlled by the client.  The repository gathers serial number generation requests from packaging lines and produces DSCSA-compliant serial numbers and related data.

The repository handles exchange and transmission of serialized data aggregation, commission and shipping events between packaging and distribution systems and manages communication between upstream and downstream parties to verify transactions, check for saleable returns and recognize suspect products to minimize diversion and counterfeiting.

After the repository is established for the client, products are packaged and labeled with DSCSA-compliant barcodes on each unit, package and pallet.  From the packaging line, products are moved to the on-site warehouse for storage as required where orders are fulfilled to downstream recipients.

As Gerstein notes, “DSCSA requirements add an additional layer of information exchange resulting in the information flow not matching the product flow.  For example, the Law requires serialization data to be transmitted initially from the CMO to the brand owner and then on to the third party logistics provider.  The actual product moves directly from the CMO to the third party logistics provider, creating two separate tracks for information and product.

2.The second level of serialization support services offered by WDSrx address manufacturers that have DSCSA-compliant serial numbers on each item. In this case WDSrx establishes a Level 4 repository on behalf of the client.  The CMO that created the serial numbers transmits the information to the client repository.  At that point, each serial number can be aggregated and shipping events and transactions may be exchanged to upstream and downstream partners.

3. The third scenario for support addresses manufacturers with multiple contract manufacturing sites. During regular audits, manufacturers may determine some of their sites will not be compliant by the deadline.

Any product from those locations can be shipped to WDSrx for serialization services to avoid unnecessary delay and potential supply chain disruption.  European manufacturers may find the same problem with their production facilities in the U.S.  WDSrx can serialize according to EU protocols utilizing the TraceLink platform and ship compliant product overseas as directed

AVOID REJECTION

With the November 27 deadline approaching for the next phase of DSCSA compliance, time has already run out for companies that are not already well underway with their serialization implementation program.  WDSrx was an early adapter of comprehensive serialization solutions for their third party logistics operations and their on-site pharmaceutical packaging and labeling capabilities.

Although a unique serial number on each item will satisfy the Law by the deadline date, WDSrx recommends clients take a more comprehensive approach for several reasons:  current FDA rules are open to interpretation; smaller manufacturers are at a disadvantage compared to global players; manufacturers with limited product requiring serialization have a high cost/benefit to investing in implementation.

DSCSA compliance has created an opportunity for companies within the pharmaceutical supply chain including WDSrx to initiate discussions with trading partners and share information about the process of serialization.  This dialogue is improving communication between parties and will result in greater collaboration and understanding about the benefits of a comprehensive serialization program.

For further information contact:  Larry Hotz, (561) 998-3885 x304  lhotz@wdsrx.com

About WDSrx

WDSrx – Woodfield Distribution, LLC provides integrated pharmaceutical third party logistics services and value-added solutions empowering the Life Sciences industry.  Supply chain operations include Pharmaceutical Warehousing, Storage, Fulfillment, Transportation Management, Temperature Regulated Environments, Reverse Logistics and Regulatory Compliant Product Disposition.  Value-added solutions include on-site Pharmaceutical Packaging and Labeling, Clinical Trial Support and Kitting, Customer Service, Patient Assistance Programs, E-Commerce Solutions and Financial Services Management.

State licensed nationally, WDSrx operates from secure facilities in Boca Raton, Florida and Sugar Land, Texas.  Operations are licensed to meet cGMP, FDA, DEA, EPA, DOT, VAWD and Federal, State and Regulatory Agency requirements for handling of Over-The-Counter, Prescription and Controlled Substance (CII-CV) pharmaceutical products.

WDSrx DSCSA-compliant operations utilize the international GS1 barcode standard that creates a single platform to identify, capture and share authorized information with other businesses and regulatory authorities.

WDSrx is a proud member of the HDA, Specialty Pharma Association, BioFlorida, BioHouston, BioNJ and NACDS.

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.