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rfxcel, Part of Antares Vision Group, and MVC Sign Agreement with Lebanese Republic to Deploy End-to-End Pharmaceutical Traceability Hub

The agreement continues the partners’ success in the Middle East, where they recently launched the first GS1-compliant Traceability Hub in the Kingdom of Bahrain.

Reno, Nevada, Sept. 22, 2021 (EINPRESSWIRE). rfxcel, part of Antares Vision Group and a global leader in digital supply chain traceability solutions, today announced that it signed a five-year cooperative agreement with the Lebanese Republic’s Ministry of Public Health to provide a GS1-compliant Traceability Hub to secure the country’s entire pharmaceutical supply chain. The company will implement the system with its partner Medical Value Chain (MVC), the Bahrain subsidiary of U.S.-based AVC Global.

The announcement comes only a few months after rfxcel and MVC were selected by Bahrain’s National Health Regulatory Authority and Supreme Council of Health to provide the first GS1-compliant system to track the Kingdom’s entire pharmaceutical supply chain on a blockchain platform.

The Lebanon Traceability Hub will deliver end-to-end visibility into every aspect of the country’s pharmaceutical supply chain, from the manufacturer of origin, importers, wholesalers, and distributors to pharmacies, clinics, and hospitals — all the way to individual patients. It will integrate with the Ministry of Public Health’s MediTrack system for domestic manufacturers.

The Hub is designed to achieve the following:

  • Lower the cost of pharmaceuticals
  • Provide patients with only authentic, safe medications
  • Combat drug counterfeiting and smuggling
  • Ensure access to pharmaceuticals subsidized by the Banque du Liban, the central bank of Lebanon
  • Prevent hoarding of medicines

“The Hub is all about leveraging leading-edge technology to secure Lebanon’s pharmaceutical supply chain and safeguard patients and consumers,” rfxcel CEO Glenn Abood said. “Security and safety — these are the very reasons I founded rfxcel almost 20 years ago. We’re eager to begin our work with MVC in Lebanon, and we’ll continue to focus on bringing Traceability Hubs to other countries in the Middle East and beyond.”

MVC Co-Founder and President Leo Giacometto said, “The MVC technology platform with blockchain revolutionizes the delivery and integrity of pharmaceutical supply chains in Lebanon. We are excited and honored to deploy our platform in partnership with the Ministry of Public Health in the Republic of Lebanon.”

Emidio Zorzella, Antares Vision Group CEO, said, “We’re all eager to start working with the Ministry of Public Health and gratified that everything has come together so well. When we unveiled the Bahrain Traceability Hub in June, I said we’d be announcing national hubs in other countries. Here we are today, continuing our vision of protecting products and people, and making supply chains safer and more efficient.”

About rfxcel

Part of Antares Vision Group, rfxcel provides leading-edge software solutions to help companies build and manage their digital supply chain, lower costs, protect their products and brand reputations, and engage consumers. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s Traceability System to power end-to-end supply chain solutions in track and trace, environmental monitoring, regulatory compliance, serialization, and visibility. Founded in 2003, the company is headquartered in the United States and has offices in the United Kingdom, the EU, Latin America, Russia, India, Japan, the Middle East, and the Asia-Pacific region.

About Antares Vision Group

Antares Vision Group protects products, people, and brands with inspection systems featuring 6,500 quality controls, track and trace software solutions for end-to-end transparency and visibility in digital supply chains, and smart data management tools for maximum operational efficiency, from raw materials to final consumers. It provides solutions to five primary industries: pharmaceuticals and life sciences (medical devices and hospitals), food and beverage, cosmetics, and consumer packaged goods. Active in more than 60 countries, Antares Vision Group has seven production facilities and three Innovation and Research Centers in Italy, 22 foreign subsidiaries, and a global network of more than 40 partners. Today, 10 of the world’s 20 leading pharmaceutical companies use its solutions to secure their production and supply chain operations; worldwide, it has deployed more than 25,000 inspection systems and more than 3,500 serialization modules. Antares Vision Group has been listed on the Italian Stock Exchange’s AIM Italia market since April 2019 and in the STAR Segment of the Mercato Telematico Azionario (MTA) since May 2021.

For further information

Antares Vision S.P.A.

Via Del Ferro, N. 16

25039 – Travagliato (BS)

Alessandro Baj Badino, Investor Relator

Tel.: +39 030 72 83 500

E-mail: Investors@antaresvision.com

Herb Wong, rfxcel Vice President of Marketing and Strategic Initiatives

Tel.: +1 925-791-3235

E-mail: hwong@rfxcel.com

FDA Official Says DSCSA 2023 Interoperability Deadline Will Not Change

The Food and Drug Administration (FDA) appears to be digging in its heels and insisting pharma stakeholders be ready to comply with interoperability requirements by November 27, 2023, the deadline mandated in the U.S. Drug Supply Chain Security Act (DSCSA).

Leigh Verbois, director of FDA’s Office of Drug Security, Integrity, and Response, indicated there would be no delays during a Healthcare Distribution Alliance (HDA) webinar on August 9.

As reported by Regulatory Focus, Verbois said, “It is FDA’s goal that we not extend the November deadline for interoperability … We have been working at a full tilt to make sure that we can make our goal of an interoperable system by 2023.”

Verbois also said that the FDA was continuing to develop a framework for interoperability, adding that the Agency knew there were “a number of important issues” to address and that regulators had been “working to understand the interplay between the elements that are necessary to build a system.”

Director Verbois’ comments at the HDA webinar come just two months after the FDA published draft and final guidance on key aspects of the DSCSA: product identifiers, suspect and illegitimate products, and enhanced drug distribution security.

  1. Product Identifiers under the Drug Supply Chain Security Act: Questions and Answers (final guidance)
  2. Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry (final guidance)
  3. Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry (revised draft guidance)
  4. Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (new draft guidance)

What are the DSCSA interoperability requirements?

The DSCSA requires pharma supply chain trading partners to exchange transaction information (TI) “in a secure, interoperable, electronic manner in accordance with the standards established [through FDA guidance].”

Trading partners must provide TI and a transaction statement (TS) to the subsequent owner of a product “prior to, or at the time of, each transaction.” TI must “include the product identifier at the package level for each package included in the transaction.”

What’s changing in 2023?

Right now, TI and TS are being electronically exchanged at the lot-level, which is usually done with an advance ship notice (ASN).

In 2023, however, TI must include the product identifier, which includes serial numbers and expiration dates. This means the U.S. pharmaceutical supply chain will be fully serialized, and the Electronic Product Code Information Services (EPCIS) appears to be the standard the industry will use to enable this exchange.

The transition from ASN to EPCIS is one of the “four pillars” of the regulations that we talked about in our three-part DSCSA 2023 webinar series in June, which you can view and download here. We also hosted a “Plan for DSCSA Readiness” webinar in March that you can view here.

DSCSA 2023 Four Pillars

Final thoughts

As we reported in our blog, the FDA has twice delayed enforcement of the DSCSA Saleable Returns Requirement. Now, the table seems to be set for November 2023: No more delays, no more extensions.

The pace will only intensify. In just about two years, you’ll have to be up and running in a fully serialized U.S. pharmaceutical supply chain. Now, the question we’ve been asking for so long is even more critical: Will you be ready?

In terms of interoperability, ask yourself these questions:

  • Can you send and receive serialized data?
  • Can you send and receive aggregated data?
  • Do you have procedures and training in place to support serialized data exchange?

Contact us today if you need to know more. Our supply chain and DSCSA experts are here to help.

 

 

 

3 Benefits of Supply Chain Traceability for Your Business

Imagine for a minute that you get the phone call all companies dread. It’s the “I am dissatisfied with my product” call, direct from a customer. You take the call, help the customer, and move on, right? You’re feel good about solving the problem — and are definitely not thinking about supply chain traceability.

A few days go by, then you’re flooded with more complaints, none of which seem to be related. You scramble to identify the root cause of all your problems, but you don’t know where to look. What should you do?

This is when you should be thinking about supply chain traceability. It is the key to having total insight into how your products get made, where they’ve been, and where they’re going. By employing supply chain traceability, you can:

  • Assure your brand and customers are protected
  • Maintain regulatory compliance
  • Pinpoint common problems, such as counterfeits and diversion

Let’s take a deeper look into each of these benefits.

1. Supply chain traceability for brand protection and customer satisfaction

Customers grade a brand on both the quality of its products and how it responds when an issue arises. Brands build loyalty with their customers by being transparent and demonstrating consistent product and service quality. Brands lose customers by failing to respond to complaints and recalls.

Response to complaints and recalls

Supply chain traceability is helpful when investigating a customer complaint. It is also essential when assessing a potential recall or managing an actual recall.

All the products you make and sell must have identification that traces back their source. Manufacturers and retailers can follow a problematic unit backward through its life cycle. Information collected through traceability includes:

  • Date and time of manufacturing
  • Equipment used for manufacturing and packaging
  • Personnel involved in manufacturing and packaging
  • Raw materials and components
  • Physical locations of inventory throughout its life

In a best-case scenario, the complaint is an isolated incident that’s easy to fix. But if the complaint means there’s been a breakdown somewhere or a product has been compromised, a recall may be triggered.

Recalls happen for any number of reasons. For example, you might discover a material that is out of specification. Once identified, it is necessary to trace all usage of that material. Another example is contamination, especially in the food supply chain.

A recall of any size can have a significant impact on your business. Having a supply chain traceability system will speed recalls, improve cooperation with regulators and other authorities, enable better information-sharing with your customers, and reduce damage to your brand reputation. Faster batch recalls are possible only when there is a robust supply chain traceability system.

Transparency about sourcing

A study conducted by the Consumer Goods Forum found that “70 percent of consumers are most interested in transparency about products.” Customers want to know where the materials used in their products came from and how they were sourced.

Some companies are publishing reports to make their supply chains and operations more transparent — and to make their brand more appealing to consumers. In addition to how they source materials, they’re sharing information about things such as:

  • Origins and purposes of raw ingredients
  • Manufacturing processes
  • Safe handling practices along the supply chain
  • The brand’s mission and values

This type of “transparency marketing” is effective in the food and consumer packaged goods industries, as it entices consumers to make a purchase because they’re getting the product information they demand.

A 2016 study by Label Insight indicated that 94 percent of consumers are not only likely to be loyal to a brand that offers complete transparency but are willing to pay more for products that meet such standards. This has powerful implications for brands; it shows that transparency made possible with supply chain traceability inspires product and brand loyalty.

2. Supply chain traceability is key to compliance

Being able to track material movement and consumption is critical for regulatory compliance.

The ISO 9000 Standards Series is the basis for most industries’ standards and provides expectations to help companies structure their quality management systems. Within these standards, traceability is defined as “The ability to trace the history, application, use and location of an item or its characteristics through recorded identification data.”

To meet this standard, it’s critical to be able to identify individual product units. Also, you must collect information about subcomponents. This information will allow for the tracing of parts of products throughout your supply chain.

Serialization makes supply chain track and trace easier

Serialization is the process of assigning unique identifiers to outbound and inbound materials. This makes the parts of products easier to track and trace throughout your processes. Utilizing software such as our Serialization Processing solution will save you time and effort in managing your supply chain.

Collecting supply chain data on your materials and finished products can also help to identify problems before they become an issue. This empowers you to be proactive and assess what works well (or what does not work well) throughout your entire supply chain process, which allows you to standardize your work processes and cut out waste.

Prove your product claims

Marketing claims must be substantiated, not only to consumers but also to regulatory agencies. Claims about sustainable sourcing, organic certifications, and other attributes can be demonstrated with supply chain traceability. Safe and compliant handling of products is also best demonstrated with traceability. Many retailers and manufacturers have routine audits to assure that they have processes to trace a product’s life cycle. In some industries, the results of these audits are available as public information.

Regulations evolve over time

Regulatory requirements for the documentation of traceability are constantly evolving. For example, the U.S. Food and Drug Administration (FDA) published the “Proposed Rule for Food Traceability,” which called for additional traceability records for certain foods. The FDA is encouraging the voluntary adoption of these new practices for all food products. These new requirements will affect all who manufacture, process, pack, or hold foods.

We’ve written extensively about the FDA’s push for traceability in modern food supply chain. For example, check out “Food Traceability Regulations in the United States: A Timeline.”

rfxcel is prepared to help you comply with all current and future requirements in any industry, including food and beverage, life sciences/pharmaceuticals, government, and consumer goods. We track industry regulations and guidance documents for upcoming and proposed legislation. We have software solutions that take the guesswork out of compliance no matter where you do business.

3. Combat counterfeits and diversion/theft by identifying supply chain weak spots

One of the worst things that can happen to any business is having their products counterfeited or stolen.

Counterfeits not only result in a direct loss of sales, but your customers might lose faith in your brand. If a person winds up with an inferior counterfeit product with your name and logo on it, there’s a good chance they will be dissatisfied with your brand and take their business somewhere else. And if your products are diverted or stolen, then you’re losing money and might have a much larger supply chain problem on your hands.

Supply chain traceability is like a forensic tool to help fight counterfeits and diversion — and host of other problems. Here’s how it works:

  • You know the origin of your ingredients. You can verify that all ingredients or components are legitimate. You can see the history of any ingredient, including its origin and when it was combined with other ingredients to make a finished product.
  • You can trace a product’s every move. Traceability means you can see everywhere a product has been before, during, and after it was harvested or manufactured. You can see every case or box, every pallet, every delivery vehicle, every stop along the supply chain (e.g., a warehouse, a retail store, a pharmacy or hospital). Even after a product has been unloaded from the delivery vehicle and taken out of cases or boxes, you see where individual units have been right up to the time the consumer takes possession (check-out at the cash register, dispensation at a clinic, etc.).
  • You can pinpoint where a product might have been harmed or compromised. Traceability data will show if a shipment strayed from its prescribed route, which could indicate theft or other mischief that could harm your bottom line and brand. Serialization, compliance, real-time monitoring, and other supply chain traceability solutions create a provenance that can demonstrate the legitimacy and purity of every product.

Final thoughts

We hope you have a better idea of how supply chain traceability can help your brand and business. Traceability is a crucial aspect of managing your business operations.

Are you ready to get started? Setting up your own supply chain traceability system might seem daunting, but rfxcel is here to help. We have easy-to-use, scalable solutions for all of your track and trace needs, no matter what industry you’re in.

Contact us today if you would like to see a short demo of how we can help you to build an effective traceability system. Together, we can protect your brand, ensure regulatory compliance, and fight counterfeits and theft.

DSCSA ATPs: Top Authorized Trading Partner Questions, Answered

What’s being discussed to ensure interoperability of different credentialing solutions for authorized trading partners (ATPs)? Is GS1 going to set standards for ATP credentialing solutions? If a solution provider supports DSCSA compliance and customers will aggregate serial numbers, why do users need to do anything else? 

These were the Top 3questions from “Authorized Trading Partners: The OCI Solution,the third and final presentation in the “DSCSA 2023” webinar series we hosted last month. rfxcel Global Executive Advisor Brian Files was hosting that day, and we share his answers below.

We also shared our answers to the top questions from the two other webinars, The Verification Router Service: Aligning to the Standardand ASN to EPCIS: Industry Change, Your Challenge.” There’s a lot of good information there, so be sure to check them out!

Our “DSCSA 2023” webinars were part of our ongoing efforts to keep the pharma industry updated about the DSCSA and help all stakeholders be ready for the full serialization of the U.S. pharma supply chain in November 2023. If you have other questions or want more details about DSCSA 2023, contact us today. You can also watch the webinars and download the presentation slides here.

What’s being discussed to ensure interoperability of different ATP credentialing solutions?

The same industry stakeholders are involved in developing the different solutions, whether it’s the Open Credentialing Initiative (OCI), .MED, or XATP. It’s important to have systems that connect and exchange information. The HDA has been hosting meetings with the three ATP providers to determine how/if interoperability can be achieved. Great progress has been made in a short time but there are still many open issues to be resolved as of mid-July 2021.

Is GS1 going to set standards for ATP credentialing solutions?

GS1 is not setting the standards; however, as part of the HDA effort to ensure interoperability, the teams are keeping GS1 updated on their efforts to ensure any GS1 specifications are updated/clarified as needed. For example, ATP will leverage the VRS messaging standards, which may need to be updated/clarified to include ATP.

If a solution provider supports DSCSA compliance and customers will aggregate serial numbers, why do users need to do anything else? 

For DSCSA 2023, the onus is on companies to ensure they’re getting their data in the proper format. Just having a DSCSA solution will not make you compliant. You have to go through your operational protocols and procedures and design your internal systems so they’ll be DSCSA-compliant.

Some companies have been working with solution providers since the early days of the DSCSA rollout, but have yet to optimize how their compliance software works with their internal systems, how they work with their provider, and, critically, how they communicate with their trading partners. Companies need to optimize internally to get the most out of their solutions — and to ensure compliance.

More DSCSA 2023 resources from rfxcel

Supply Chain Traceability Systems Make Your Business Better

One of the best ways to get more people to buy your products is to inspire consumer confidence. And one of the best ways to increase consumer confidence is to insist on airtight food safety protocols, which absolutely should include supply chain traceability systems.

Are there some areas where your food safety can improve? It’s always a good idea to periodically reflect on what you and your team are doing. This will allow you to improve on weak spots in your food supply chain. Supply chain traceability systems are a huge help.

Most important, the ability to trace everything in your supply chain ensures you are delivering safe food to your customers — and building consumer confidence. It also helps ensure compliance with regulations. So, if you don’t have traceability in your supply chain, you should consider implementing a system as soon as possible.

Let’s take a closer look at the benefits supply chain traceability systems can bring to your business.

What are supply chain traceability systems?

Supply chain traceability systems are a powerful tool for any industry. They give you the ability to know where your ingredients and finished products have been and where they’re going as they move through your supply chain, through the “life cycle” of your business. They are particularly helpful with maintaining product safety and minimizing and proactively managing issues that could harm your business, such as a recall.

Advantages of supply chain traceability

There’s no doubt supply chain traceability systems will save your company time, money, and effort. But what specifically can they do for you? Let’s look further into the benefits of implementing a food safety program with supply chain traceability.

Effective recall management

Supply chain traceability is a key part of recall management. The food industry is one of the most vulnerable to recalls. A recent example is Tyson Chicken. On July 3, 2021, the food giant had to recall almost 9 million pounds of ready-to-eat chicken in the United States. Thanks to supply chain traceability, however, Tyson could work quickly and effectively with the U.S. Department of Agriculture, pinpointing when the products were made and what labels were on the packaging, notifying consumers, and mitigating further troubles.

Needless to say, a recall of any size can hurt profitability and brand reputation. But supply chain traceability systems help manage damage. As we’ve discussed before, having the proper systems in place for effective recall management is paramount for protecting your business’ profitability and your brand reputation.

Regulatory compliance

Another advantage of implementing supply chain traceability systems is meeting regulatory requirements. The FDA keeps a watchful eye over food supply chain processes in the United States. And, with much of our food traveling far and wide before it reaches our plates, those processes require many moving parts. Being aware of where your food has been, where it is now, where it’s going, who is handling it, and how long it’s been in transit are all helpful metrics to keep your operation in compliance with the FDA and other regulatory agencies.

The FDA is pushing hard for more traceability standards, and consumers are more aware of where their food is coming from and demanding more information about what they eat. This is yet another reason why traceability is so important today.

Maximized efficiency

Being able to trace (and track) your products as they move through your supply chain also allows you to identify inefficiencies and bottlenecks. In other words, end-to-end traceability maximizes operational efficiency. It will enable you to see which processes are working well and which ones aren’t.

Supply chain traceability systems also help you cut costs. If you have rich data that quantifies that a particular process (or trading partner) is inefficient, you can take steps to improve it or remove it from your supply chain process.

Consumer engagement

Believe it or not, traceability will also help your sales. Customers love stories — and they’re demanding more information about the products they buy. Smart companies will use their supply chain traceability systems as part of their marketing, connecting with consumers by telling their story and sharing information about their products.

You see this all of the time in the food industry. In commercials, companies highlight how far their products have traveled and how much care goes into making, packaging, and shipping them. This kind of advertising paints a picture of the journey the products take to arrive in a customer’s home and emphasizes the qualities people want (e.g., salmon from Alaska or peaches from Georgia). Being able to “play up” the source and the journey will make your food products more appealing to shoppers.

Communicating with stakeholders

You always need to consider input from stakeholders. Supply chain traceability is an effective way to keep them happy. Making stakeholders aware of this information is known as supply chain transparency.

Supply chain transparency is an important part of your business. While food safety and quality are important, you also need to keep your trading partners in the loop. Any effective supply chain transparency plan has three main components.

The first component is the “what” of your supply chain traceability. What information are you going to share with your stakeholders? You’re also going to want to determine what format you’re going to use to display the information.

The next step is to decide the “who. Who needs to see this information? Several different groups might need it, such as internal stakeholders, vendors, suppliers, clients, and consumers. You’ll also want to consider why they need to have it.

Last, you’ll want to consider the “when. When are your people going to get this information? And how often?

You’ll also need to decide how often to update your information. Today, the trend is toward real-time updates. This is the ideal scenario, but it can be a challenge to attain. Supply chains involve a lot of moving parts and have many different nodes or tiers. Providing real-time updates in this complex framework requires efficient, streamlined operations utilizing supply chain traceability systems.

Supply chain mapping

Supply chain mapping — the process of mapping every tier of your supply chain with easy-to-follow imagery — is an effective way to keep all your stakeholders happy. A supply chain map doesn’t show every person involved in the process; instead, it shows all of the players within each tier of the supply chain.

One of the benefits of supply chain mapping is that it presents an opportunity for risk assessment. Seeing your supply chain clearly mapped out allows your management team to decide which areas need to be carefully monitored. You can also analyze your supply chain with a “bird’s-eye view” and decide if you need to make adjustments for greater efficiency.

Safer, healthier food

Today, grocery stores are full of food that’s touted as being locally sourced, sustainably caught, and so on. How can companies make and prove these claims? With end-to-end supply chain traceability data. Making these types of claims requires companies to make sure they are tracking the right metrics to support them. Companies also need to leverage the correct technology to support these initiatives.

Examples of how supply chain traceability systems work

How do companies achieve end-to-end supply chain traceability? Keeping track of your products and all the important metrics requires modern technology.

One of the ways companies are doing this is by putting QR codes and 2D Data Matrix codes on their packaging. These codes contain important information and can be scanned as products move through the supply chain. This allows vendors, suppliers, and people responsible for transport to “check the food in” at various points throughout the process and add important data, including critical tracking events (CTEs) and key data elements (KDEs).

Leveraging this technology is a critical aspect of today’s supply chain traceability systems. It helps companies keep track of where their products are at all times, throughout all nodes of the supply chain. For more information about it all works, download our new white paper, Traceability in the Food Supply Chain.

A quick word about blockchain

As technology moves forward, supply chain traceability systems also continue to evolve. One of the newest technologies with traceability applications is blockchain.

Most people probably associate blockchain with cryptocurrencies such as Bitcoin. One of the reasons Bitcoin is so valuable is because it can be traced across the internet via the blockchain. Investors and computer programmers can map each Bitcoin to its proper place on a global digital ledger.

This and other characteristics give blockchain tremendous functionality in a wide array of industries. For food in particular, blockchain can help companies achieve a “locked down” supply chain, providing indisputable, verified data and a level of security not possible with other technologies.

What do you think tracking food products in the same manner as cryptocurrency would do for supply chain traceability systems? It’s still in the early stages, but blockchain could revolutionize traceability. It’s a complicated subject, so we encourage you to download our white paper, Blockchain-Based Supply Chain Traceability.

Final thoughts

Supply chain traceability systems are an essential part of any business. But they’re especially important in the food industry. The safety and quality of your product is the most important part of your business. Consumers’ health depends on it. Your brand reputation depends on it. Your bottom line depends on it.

rfxcel can help. We have the software solutions you need for your business — for supply chain traceability, regulatory compliance, serialization, monitoring, and even vaccine track and trace.

Contact us today if you have any questions about supply chain traceability systems or would like to see a short demo of how our solutions can help you build your business, no matter what your business is.

 

DSCSA VRS: Top Verification Router Service Questions, Answered

When do I need to implement the DSCSA VRS? Are there any new developments the industry should be aware of? What are some of the “sticking points” with the VRS today?

These were just a few of the questions asked during the first of three “DSCSA 2023” webinars that we held last month. In “The Verification Router Service: Aligning to the Standard,rfxcel VP of Marketing and Strategic Initiatives Herb Wong and Global Executive Advisor Brian Files answered these and other questions about the DSCSA VRS. Below, we give their answers to the most-asked questions.

Check back throughout the week, because we’ll be posting the top questions from the other two webinars in the series, “ASN to EPCIS: Industry Change, Your Challenge” and “Authorized Trading Partners: The OCI Solution.

The webinars were part of our ongoing efforts to keep pharma stakeholders up to date with the DSCSA and help the industry prepare for the full serialization of the U.S. pharma supply chain in November 2023. If you have other questions or want more details about DSCSA 2023, contact us today. You can also watch the webinars and download the presentation slides here.

When do I need to implement the DSCSA VRS?

Manufacturers and wholesalers/distributors should be implementing right now. VRS is a cornerstone of the DSCSA; it’s not going away. As you go through the 2020 to 2023 period, working with your partners is going to be critical. You should also be working with your solution provider — or finding one if you don’t already have one. Keep your eyes on the November 27, 2023, deadline and always be working toward it so you’ll be ready and compliant. Dispensers should be looking carefully at the benefits of VRS and requirements for validating saleable returns. (See response to next question.)

Are there any new developments the industry should be aware of?

VRS is the first interoperable system in the DSCSA. Error management and handling the complexities involved with the enormous volume of returned products contributed to its delay until 2023. (Read our articles about the FDA’s decision to delay enforcement of the DSCSA saleable returns requirement.) Downstream partners only add to the volume and complexity the VRS must handle in sub-second time. So, it will be important for the industry to determine exactly how the VRS will be used and what type of volume controls and error management it will have. You must also consider what type of outcomes your partners will need, as well as what you need for your own business model.

What are some of the “sticking points” with the VRS today?

The Healthcare Distribution Alliance (HDA) collected feedback from the industry about optimizations/improvements it would like to see in the VRS network and presented its findings to solution providers on June 11, 2021. We’re now in the process of evaluating the feedback to determine next steps.

The “sticking points” fall into six categories, as shown in the graphic below. The most predominant concern is how to deal with data synchronization issues. The process for resolving all these issues needs to be streamlined among service providers.

Industry Feedback on DSCSA VRS

What’s the current implementation rate and use of VRS?

That depends on which part of the supply chain you are referring to. There is no accurate estimate of this across the industry, but based on our observations, this is what we’re seeing: Manufacturers and distributors have the highest “implementation rate.” Approximately 70-80 percent of our manufacturers can support VRS and 80-90 precent of wholesalers/distributors are VRS ready. The numbers further down the supply chain are lower, but are increasing quickly as dispensers become more aware of the benefits of VRS.

My wholesale distributor takes care of VRS for me. What is my responsibility? Am I covered if I were to be audited?

This is a little tricky, because there’s a lot of information circulating about what wholesale distributors will and will not do in the VRS ecosystem.

Wholesale distributors are doing a lot of heavy lifting with VRS, but they’re not completely responsible for your DSCSA transactions. They’re responsible for your information that’s being plugged into the VRS, but they are not responsible if there are any problems with a returned product.

The simple truth is that every stakeholder is responsible for their own DSCSA compliance. Your wholesale distributor should be there to help coordinate to the extent of the arrangement and partnership you have, but they are not responsible for your compliance. It’s not their job to “take care of VRS” for you. As we get into 2023, you’re going to need hardware, software, and system updates ready to go, and you can’t “pass the buck” for VRS to your wholesale distributor — or any other trading partner.

More DSCSA 2023 resources from rfxcel

Traceability in the Food Supply Chain

Traceability has always been an important part of the food supply chain. It helps ensure food safety, speeds recalls and investigations, and makes the food supply chain faster and more efficient. In recent years, however, there has been a stronger push for traceability from regulators and consumers alike.

Regulators, notably the U.S. Food and Drug Administration, have developed new traceability requirements for food products, including rules governing specific types of food (i.e., those that are more prone to contamination), guidance for stakeholders to collect more data at every node of the food supply chain, and modern, digital systems to optimize safety and efficiency and aid recall management.

Similarly, consumers are demanding more information about the foods they eat. They want a demonstrable provenance of what they’re taking home to their families, “on-demand data” that demonstrates that foods are exactly what companies say they are. And if they don’t get this, they’re only too happy to take their business somewhere else — and let other people know that Brand XYZ isn’t living up their expectations of quality and transparency.

Every stakeholder in the food supply chain, from manufacturers and processors to distributors and retailers, has to think about traceability. If they don’t, they’re risking problems with regulators, alienating consumers, damaging their brand reputations, and, ultimately, putting their business in jeopardy.

This rfxcel white paper covers the fundamentals of traceability in the food supply chain. It describes how critical tracking events (CTEs) and key data elements (KDEs) build “digital assets” that can be traced (and tracked) from farm to fork. It takes an in-depth look at the FDA’s initiatives to modernize the U.S. food supply chain using digital technology, including the Food Safety Modernization Act (FSMA), the “New Era of Smarter Food Safety,” the “Food Traceability List,” and the pending “Requirements for Additional Traceability Records for Certain Foods,” also known as the Proposed Rule. It also describes the many benefits of food traceability, which include better consumer engagement and brand protection.

 

Saudi Arabia’s Traceability Requirements for Imported Food

The Kingdom of Saudi Arabia imports about 80 percent of its food, according to a June 2020 report from the U.S. Department of Agriculture. To prevent food-borne illnesses and increase visibility in the food supply chain, the Saudi Food and Drug Authority (SFDA) strictly regulates imported food.

Let’s take a look at what food companies must do to comply with SFDA regulations when shipping their products to Saudi Arabia.

Saudi Arabia’s requirements for imported food

The Department of Agriculture report lists the following import procedures. First, companies must create an “E-account” with the SFDA and register their food products. They must have a Commercial Register, which includes imports and distribution of food
products. They must also submit an original invoice certified by a chamber of commerce in their home country. Last, depending on the product being imported, the may be asked to present some of following certificates:

  • Certificate of origin (copy)
  • Halal certificate (original). A Halal certificate is proof that the product meets Islamic Law requirements and is acceptable for consumption in Muslim-majority countries, as well as Western countries with a large Islamic population.
  • Certificate of slaughtering for meat and poultry (original)

Other requirements for imported food items

The GCC Standardization Organization (GSO) was established in 2001 and began operations in 2004. It is exactly what its name says: a standards organization for Gulf Cooperation Council (GCC) members. GSO requirements for Saudi Arabia’s imported foods are listed below. Many of these regulations also apply to domestic food items.

GCC Standards Organization (GSO) 9/2007

Since the end of 2010, Saudi Arabia has enforced the Gulf Standard 9/2007. Per this standard, all prepackaged and domestic foods must at minimum contain the following data points:

  • Product name
  • Packer’s name
  • Country of origin or manufacture
  • Listing of ingredients
  • Instructions for use (if applicable)
  • Shelf life

GSO 2233/2018 requirements for nutritional labeling

In 2013, the SFDA began enforcing GSO 2233/2012, a regulation from the GSO that requires labels to clearly disclose a product’s nutritional information (e.g., calories, carbohydrates, proteins, and fats) that may affect its nutritional value and consumers’ health or safety. The labels must list the ingredients, and nutritional information must be presented in a standardized, easy-to-read table so customers can readily understand what they’re purchasing. The labeling is also designed to increase people’s nutritional education to improve overall health. Some products are exempt from labeling, including bottled water, fresh fruits and vegetables, one-nutrient foods such as rice and coffee, and foods for special dietary uses, including infant formula.

Final thoughts

Keeping up with food traceability and regulations in Saudi Arabia — or any market — is a challenge. But rfxcel can help. Our solutions for food and beverage cover everything from farm to fork, from compliance to environmental monitoringContact us to book a demo of our award-winning rfxcel Traceability System and see how this  customizable, scalable platform will simplify and accelerate all of your supply chain operations.

DSCSA 2023: The Future of Pharmaceutical Traceability in the United States

Welcome to the third and final installment of our DSCSA 2023 series. The first two parts talked about DSCSA authorized trading partners — manufacturers, wholesale distributors, repackagers, third-party logistics providers, and dispensers. If you’re not a DSCSA authorized trading partner, it will be difficult to do business in the United States, so be sure to read Part 1 and Part 2.

Today, we’re focusing on the day we’ve all been preparing for: November 27, 2023, the 10th anniversary of the DSCSA. Per Section 582(g)(1) of the DSCSA (Title II of the Drug Quality and Security Act):

“On the date that is 10 years after the date of enactment of the Drug Supply Chain Security Act … interoperable, electronic tracing of product at the package level requirements shall go into effect.”

So, in a little more than 2 years and 8 months from now, the U.S. pharmaceutical supply chain will be fully serialized. Let’s take a closer look at what this means for the pharma industry and its authorized trading partners.

A quick clarification

This blog post looks at “the letter of the law” — the language in Section 582(g)(1) that lays out six requirements for DSCSA 2023.

For its part, the pharma industry has tended to see the DSCSA as having four pillars, as illustrated below. These pillars encompass the six requirements we’re talking about today.

DSCSA 2023 Four Pillars

Our own Herb Wong, VP of marketing and strategic initiatives, recently hosted a webinar about DSCSA 2023 readiness that included an overview of the four pillars. It’s a great follow-up to what you’ll read below and a valuable resource for every pharma supply chain stakeholder. If you missed it or want to watch it again, Herb’s webinar is here.

DSCSA 2023: six key requirements

To date, the DSCSA has focused on lot-level traceability, or exchanging information about every package of medication so supply chain stakeholders can see exactly where each has been. DSCSA 2023 is all about complete unit-level serialization through the use of product identifiers, meaning stakeholders will have to electronically track products at the individual package level. Here are the six requirements for DSCSA 2023 laid out in Section 582(g)(1):

  1. Authorized trading partners must exchange transaction information (TI) and a transaction statement (TS) in a secure, interoperable, electronic manner.

TI includes the product name; its strength and dosage form; its National Drug Code; container size and number of containers; lot number; transaction date; shipment date; and the name and address of the businesses from which and to which ownership is being transferred. The TS is an attestation by the business transferring ownership of the product that it has complied with the DSCSA.

Trading partners must maintain all transaction data for 6 years.

The law requires the standards for interoperable exchange of TI to “comply with a form and format developed by a widely recognized international standards development organization.” Right now, EPCIS 4 (Electronic Product Code Information Services) is the only standard that meets this requirement; however, the industry is investigating alternatives.

  1. TI must include the product identifier (PI) at the package level for each package included in the transaction.

The upshot of this requirement is unit-level traceability (i.e., serialization). A PI is a standardized graphic that contains the product’s standardized numerical identifier (SNI), a lot number, and an expiration date. The SNI comprises two data points: the National Drug Code and a unique alphanumeric serial number. PIs must be human- and machine-readable.

  1. Authorized trading partners must have systems and processes to verify products at the package level, including the SNI.

According to the definition in Section 581 of the DSCSA, “verification” or “verify” means determining if the PI “affixed to, or imprinted upon, a package or homogeneous case corresponds to the SNI or lot number and expiration assigned to the product by the manufacturer or the repackager.”

  1. Authorized trading partners must have the systems and processes to promptly respond with the TI and TS for a product upon a request by the Secretary (or other appropriate federal or state official) in the event of a recall or for the purposes of investigating a suspect or illegitimate product.

The “Secretary” here is the commissioner of the U.S. Food and Drug Administration (FDA). Suspect and illegitimate products include drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution.

This requirement dovetails with the FDA’s push for modernization of the U.S. food supply chain, including recall processes.

  1. Authorized trading partners must have the systems and processes necessary to promptly facilitate gathering the information necessary to produce the TI for each transaction going back to the manufacturer.

This requirement is similar to No. 4 in that authorized trading partners must provide this information to the FDA commissioner or other federal or state officials; however, goes a step further by adding trading partners. The law says these systems and processes

“shall be required in the event of a request by an authorized trading partner, in a secure manner that ensures the protection of confidential commercial information and trade secrets, for purposes of investigating a suspect product or assisting the Secretary (or other appropriate Federal or State official) with a request described in clause.”

  1. Each person accepting a saleable return must have systems and processes in place to allow acceptance the product(s). Furthermore, they may accept saleable returns only if they can associate the returned product(s) with its TI and TS.

This has to do with the DSCSA saleable returns verification requirement and the Verification Router Service (VRS). Supply chain stakeholders must verify saleable returns before they can be reintroduced to the supply chain; they do this by verifying the drug’s PI. The VRS is the system they use to rapidly verify PIs.

rfxcel is the industry leader in the VRS. We led an FDA-approved pilot to extend testing of the VRS and continue to focus on making it ready for DSCSA 2023. Here a few of our resources to answer any questions you may have:

Final thoughts

As we said in Part 1, we’ve been covering the DSCSA for a long, long time. We’ve done webinars, written white papers, and been active in industry initiatives, particularly the VRS and the Open Credentialing Initiative (OCI) to meet the requirements for DSCSA authorized trading partners.

We’ve also been helping pharma companies comply with the DSCSA and other pharma regulations around the world. From our rfxcel Serialization Processing and Compliance Management solutions to the full-scale power of our rfxcel Traceability System, we ensure compliance no matter your role in the supply chain.

So contact us with your questions about DSCSA 2023 or the DSCSA in general. Our supply chain experts can give you a short demonstration of our solutions, share their insights and knowledge, and work with you to ensure you’re compliant today, tomorrow — always.

 

 

 

 

 

 

DSCSA 2023: Understanding DSCSA Authorized Trading Partners, Part 2

Welcome to Part 2 of our discussion about DSCSA authorized trading partners. The 10-year rollout of the U.S. Drug Supply Chain Security Act — the DSCSA — is scheduled to conclude on November 27, 2023, so now’s a good time to take stock of where we are and what to expect over the coming months.

As we said in Part 1, everybody’s talking about DSCSA authorized trading partners — manufacturers, wholesale distributors, repackagers, third-party logistics providers (3PLs), and dispensers. From now until November 2023, it’s really all about ensuring these supply chain actors are ready to comply with the regulations.

Remember, under the DSCSA, authorized trading partners may engage in transactions only with other authorized trading partners. In other words, if you’re not a DSCSA authorized trading partner, your access to the U.S. pharma supply chain will be severely restricted or denied altogether.

Below, we finish our discussion of DSCSA authorized trading partners by defining who qualifies as a repackager, a 3PL, and a dispenser.

Repackagers

Repackagers own or operate an establishment that repacks and relabels a product or package for further sale or distribution without a further transaction.

Generally, dispensers (specifically pharmacies) are not considered repackagers. By this definition, a dispenser/pharmacy only packs and labels a product for dispensation to a person who has a valid prescription for that product; they do not do “bulk” repackaging.

Repackagers are considered trading partners if they accept or transfer direct ownership of a product from or to a manufacturer, another repackager, a wholesale distributor, or a dispenser. To be a DSCSA authorized trading partner, repackagers, like manufacturers, must be registered with the U.S. Food and Drug Administration (FDA) in accordance with Section 510 of the Food, Drug, and Cosmetics Act (FD&C Act), “§360. Registration of producers of drugs or devices.”

3PLs

The DSCSA defines a 3PL as an “entity that provides or coordinates warehousing or other logistics services with regard to a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.”

3PLs are considered trading partners if they accept or transfer direct possession of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser. Returns processors and reverse logistics providers are considered 3PLs. There are two reasons for this:

  1. They provide other logistics services for other trading partners in a facility they own, rent, or lease.
  2. They do not take ownership of the product and do not direct the sale or disposition of the product.

Generally, brokers, solution providers, common carriers, and logistics or administrative services contractors are not considered 3PLs because they don’t provide or coordinate warehousing and don’t accept or transfer direct possession of the product. These stakeholders do not have to be licensed.

To be a DSCSA authorized trading partner, 3PLs must have a valid license under state law or FD&C Act Section 584(a)(1), “National Standards for Third-Party Logistics Providers,” in accordance with Section 582(a)(7), “Requirements, Third-party logistics provider licenses”, as amended by the DSCSA and in compliance with reporting requirements under Section 584(b).

Dispensers

To be considered a dispenser, you must meet one of three criteria:

  1. You’re a retail pharmacy, a hospital pharmacy, or a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor.
  2. You’re a person legally authorized to dispense or administer prescription drugs.
  3. You’re an affiliated warehouse or distribution center of a dispenser under common ownership and control that does not act as a wholesale distributor.

A dispenser is considered a trading partner if they accept or transfer direct possession of a product from or to a manufacturer, repackager, wholesale distributor, or another dispenser. To be a DSCSA authorized trading partner, a dispenser must have a valid state license.

Generally, veterinarians are not considered dispensers, per FD&C Act Section 512(a)(5).

Final thoughts

The table below summarizes everything we’ve laid out above and in Part 1 of our DSCSA authorized trading partners series. It’s adapted from an August 2017 FDA publication.

As you’re reading, remember that all of our stakeholders are considered to be trading partners if they accept or transfer direct ownership of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser. To be an DSCSA authorized trading partner, however, they must meet the criteria explained in the table.

There’s one last installment of our “DSCSA 2023” series coming soon. In it, we’ll talk about the key requirements for 2023 and the future of traceability in the pharma supply chain. While you’re waiting for that, take a moment to check out our webinars, white papers, pharmaceutical compliance solutions, and other resources about the DSCSA. If you feel inspired, contact us to schedule a demo to see our solutions in action.

DSCSA Authorized Trading Partners

DSCSA Authorized Trading Partners