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Pharmaceutical Serialization

Progress in the implementation of DSCSA regulations is highly variable across the industry.  Pharmaceutical manufacturers, distributors, 3PL providers, re-packagers and dispensers take different approaches to achieve DSCSA compliance.  As the conduit between manufacturers and dispensers, 3PL logistics service providers face unique implementation challenges requiring fundamental changes to their operations.

Quality Assurance and Compliance professionals rely on their logistics providers to place the highest priority on regulatory issues.  It is the responsibility of LSPs to share with clients their action plan to achieve full compliance with DSCSA regulations.

Operations executives at pharmaceutical manufacturers may seek out alternative trading partners with early compliance timetables in order to assure an uninterrupted supply chain and eliminate risk of non-compliance due to serialization delays with current packaging and labeling partners.

At WDSrx, we implement a variety of strategies and solutions to achieve full compliance with DSCSA regulations prior to deadline dates.

We Rely On Transparent Serialization Methods

Title II of the Drug Quality Security Act (DQSA) requires the development of an electronic system to verify the legitimacy of pharmaceutical drug products down to the package level.  The program mandates compliance at several stages over a ten-year period until full implementation by 2024. Drug manufacturers, wholesale drug distributors, re-packagers, dispensaries and Third Party Logistics pharmaceutical providers are all affected by this drive for transparency.

The initial process selected to achieve the high level of transparency outlined in the DSCSA within the pharmaceutical supply chain is known as serialization.  By 2018, manufacturers must utilize a standardized method to individually identify the Smallest Salable Unit (SSU) available for purchase by authorized pharmacies or other dispensers.

The pharmaceutical serialization method involves placing 2-D barcodes and a unique identifier containing product ID, serial number, expiration date and lot number on each SSU. Additional individual barcodes must be placed on standard shipping configurations including cases and pallets.  By 2023, the technology, called Track and Trace, will be able to follow each bottle or package in the U.S. and internationally back through the supply chain to the original manufacturer.

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; and manufacturers with a limited number of products requiring serialization may choose to outsource the entire process more economically compared with the significant capital investment required to achieve compliance themselves.

As a logistics services provider with contract packaging capabilities, WDSrx is completing modifications to fully utilize new 2D technology in warehousing, fulfillment and packaging and labeling operations.  Current linear 1D barcode technology uses a single code in parallel lines to convey a limited amount of product information.  With pharmaceutical serialization, each pallet, case and bottle will have their own unique 2D barcodes for improved tracking at every point within the supply chain.  The 2D barcodes hold the increased amount of data required to implement Track and Trace capabilities.  The technology upgrades are designed to minimize procedural changes on the warehouse floor, however some of these practices will also be modified.

The legal requirement for pharmaceutical serialization raises the business necessity for aggregation.  Aggregation enables a single scan to capture the unique identifiers on each of the smallest salable units within a large shipment.

Three Phases of DSCSA Compliance

The Federal Drug Administration is responsible for the implementation and monitoring of the Drug Supply Chain Security Act.  The FDA examined the components of the law and separated them into three phases. Each phase addresses specific issues with specific deadlines for completion.

Although the FDA continues to refine requirements, the three phases of DSCSA compliance are the approved guidelines currently followed by the pharmaceutical industry.

Phase I: Lot Level Management and FDA Registration – The FDA required all 3PL providers to provide product tracing information, known as T3 Compliance Data, on documents for all outgoing shipments and to register on the FDA portal by May 15, 2015.

In addition to updating paper packing slips and ASN forms, the handheld and desktop scanners at WDSrx are being upgraded to read 2D barcodes required by DSCSA regulations (right-hand scanner and top box pattern), as well as conventional 1D barcodes to accommodate clients that have not yet adopted the new format (left-hand scanner and bottom box line pattern).

Phase II: Item Serialization — When serialization is implemented, the process of receiving, storing and fulfilling orders will change significantly for 3PL providers.  The most significant changes will occur in the technology backbone to enable electronic communications within and between systems to allow for exchange of extensive data captured on new 2D barcodes.

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.

As a logistics services provider with contract packaging capabilities, WDSrx is completing modifications to fully utilize the new 2D technology in warehousing, fulfillment and packaging and labeling operations.  Current linear 1D barcode technology uses a single code in parallel lines to convey a limited amount of product information.  With serialization, each pallet, case and bottle will have their own unique 2D barcodes for improved tracking at every point within the supply chain.  The 2D barcodes hold the increased amount of data required to implement Track and Trace capabilities.

The legal requirement for pharmaceutical serialization raises the business necessity for aggregation.  Aggregation enables a single scan to capture the unique identifiers on each of the smallest salable units within a large shipment.  Aggregation solutions are often undertaken during Phase II with Item Serialization programs.

Phase III: Serialized Item-Level Traceability – By November 2023, the completed serialization program will combine with comprehensive information exchange to mine, analyze and evaluate data about the movement of pharmaceutical drug products to minimize counterfeit, diversion, manufacturing and supply chain issues.  It will be illegal to buy, sell or handle products without product identifiers.  Enhanced product tracing at the package level will be implemented.  The FDA is expected to issue details in the future detailing the architecture of the enhanced product tracing system.

Our Implementation Strategy

The requirements of the DSCSA represent the greatest overhaul of the U.S. pharmaceutical supply chain since The Federal Food, Drug and Cosmetic (FDC) Act of 1938.   The implementation of new and upgraded equipment, enhanced training and development programs and technology systems re-engineering affect the entire supply chain and will fundamentally change the way companies conduct business.

The requirements and associated deadlines to achieve DSCSA compliance demand a pro-active response from all affected parties to implement the important changes.  Logistics services providers must address issues related to their internal procedures while accommodating the various solutions being implemented on either side of the supply chain.  On the receiving side of the LSP, pharmaceutical manufacturers require their 3PL partners to adapt to their desired solutions.  On the fulfillment side of the LSP, the three largest wholesalers in the country demand that their trading partners follow their requirements in order to receive goods.

WDSrx long-range strategy for pharmaceutical serialization was initiated prior to the passage of the DQSA into law.  Our plans include budgeting for the significant financial investment and human resources required to achieve compliance while maintaining operational efficiency.

As a Third Party Logistics (3PL) provider that also has active packaging lines, WDSrx is making a considerable investment in its packaging operations, distribution centers, IT infrastructure, training and quality assurance to meet current and future DQSA/DSCSA requirements.

The WDSrx Information Technology team is responsible for the overall program implementation and integration with the WDSrx Footprint® Warehouse Management System (WMS) by Datex Corporation.  The WDSrx Quality Assurance and Regulatory Affairs Department will be deeply involved in training and documentation during this process.

WDSrx Action Plan and Completion Status

Pharmaceutical logistics services providers operate at a critical point between manufacturers and dispensers within the pharmaceutical supply chain.  The movement of these critically important products depends on comprehensive regulations created and administered by government and other regulatory authorities.

Although the DSCSA requirements will further protect the pharmaceutical supply chain from diversion and counterfeit products, the patient will probably not notice any difference in the way prescription drugs are delivered.   The minimal effect to patients contrasts with the significant resources being invested to achieve objectives and maintain compliance prior to deadlines.

The WDSrx solutions strategy currently being implemented involves five (5) levels of technology provided by three (3) vendors integrating with our current Datex Warehouse Management System (WMS).

The most effective and comprehensive pharmaceutical serialization solutions connect the shop floor and plant levels with the enterprise level.

Hardware including printers, desktop device readers, cameras and scanners are upgraded or replaced on individual lines in the Packaging and Labeling operations on Level 1.

The software programs required to control data, serial number management and aggregation on separate production lines for Level 1 devices are the objective of Level 2 services provided by Optel Vision.

Level 3 involves installation of software governing all production lines in the packaging operations.  Optel Vision will build on their Level 2 program by enabling Level 3 capabilities.

At Level 4, further software development is implemented incorporating the international GS1 standard including EPCIS (Electronic Product Code Information Service).  This programming controls connectivity throughout the entire company by interfacing with the Warehouse Management System built on the Datex FootPrint platform.  At Level 4, systems are activated to integrate equipment and information technology assets with product tracing, verification and end-to-end serialization, also known as enterprise compliance.

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.

Manufacturers Seek Early Compliance Schedules From Trading Partners

Manufacturers must ensure all trading partners are in compliance with DSCSA guidelines or risk penalties. Forward-thinking supply chain executives must consider that packaging and labeling vendors promising item serialization compliant facilities by the FDA-imposed deadline may be delayed.  Searching for alternative solutions from firms promising compliance in advance of the deadline date are in the best interest of manufacturers to maintain supply chain integrity and uninterrupted distribution.

A recent study by the Healthcare Distribution Alliance, an industry trade group, revealed that 66% of branded manufacturers and 67% of generic manufacturers expect to have 100% of their products serialized by the deadline.  The substantial gap between current readiness and full compliance is compelling manufacturers to seek options to continue full operations post-deadline.

With complete pharmaceutical serialization capabilities installed in our facilities, WDSrx offers manufacturers at any stage of compliance three types of programs that provide 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 involves WDSrx setting up a Level 4 repository on the client’s behalf.  The repository acts as the nerve center to achieve pharmaceutical serialization compliance. It gathers serial number generation requests from packaging lines and produces DSCSA-compliant serial numbers and related data.  The repository also 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.

Client products are then 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.

2. Manufacturers working with contract manufacturers that place compliant serial numbers on primary packaging should be made aware that in some of these cases, the serial number is owned by the CMO and not by the brand owner.

When products with DSCSA-compliant serial numbers are shipped to WDSrx, the pharmaceutical serialization services team 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. Manufacturers auditing their contract manufacturers to determine their serialization readiness are able to ship product from ‘at-risk’ facilities directly to WDSrx for compliant packaging, labeling, warehousing and fulfillment.

Post-Implementation Performance

The upgrades to hardware and software implemented for DSCSA compliance affect the procedures carried out by warehouse personnel.  WDSrx operations continue to handle non-serialized products while also managing new serialized products with their enhanced track and trace requirements.

Training and documentation are updated regularly according to cGMP guidelines to address changes to procedures in warehousing, fulfillment, packaging and labeling operations brought about by new technology and reporting.  To achieve pre-serialization efficiency levels in a post-serialization environment, WDSrx leads the industry with a pro-active approach to addressing serialization impact.  By leveraging data and analytics, the company is developing fresh insights for new best practices that increase efficiency and reduce cost for partners and clients.

WDSrx Packaging and Labeling solutions include printing 2D barcodes with GS1-standard data to meet DSCSA serialization regulations.  If required, WDSrx 3PL services receive, store and fulfill orders to dispensers at client request.

Your Leader for Pharmaceutical Serialization

Pharmaceutical logistics services providers operate at a critical point between manufacturers and dispensers within the pharmaceutical supply chain.  The movement of these critically important products depends on comprehensive regulations created and administered by government and other regulatory authorities.

The Drug Supply Chain Security Act is the catalyst for sweeping changes throughout the industry.  WDSrx takes a pro-active and strategic approach to assure compliance with DSCSA requirements.  Upgrades to equipment, training and information technology infrastructure will be complete prior to November 2017 at all WDSrx facilities in Boca Raton, FL and in Sugar Land, TX.

For more information call at Larry Hotz (561) 998-3885 x304 or contact us online now.

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.