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Brazil ANVISA Update: Manufacturers, Distributors, and Dispensers Must Meet April 2022 Serialization Deadline

The Brazilian Health Regulatory Agency (ANVISA) has approved its final Normative Instruction (NI 100), meaning the April 28, 2022, deadline for meeting serialization, reporting, and traceability requirements is officially set in stone. Let’s take a look at what supply chain stakeholders can expect with Brazil ANVISA when the law goes into effect just six months from now.

Key Brazil ANVISA requirements for April 28, 2022

The pharma industry has been aware of the Brazil ANVISA requirements since December 2016, when the National Medicine Control System (SNCM) was signed into law (Law No. 13.410/2016), establishing serialization requirements and timelines for Brazil’s pharmaceutical supply chain.

There are three key requirements for April 2022:

  1. All prescription medicines must be serialized.
  2. All manufacturers and importers must have a “serialization plan” in the SNCM portal.
  3. All supply chain stakeholders must submit product event reports to the SNCM.

To meet serialization requirements, all products must have a GS1 2D Data Matrix barcode that houses a Global Trade Item Number (GTIN), a 13-digit ANVISA Medicine Registry Number, a unique 13-digit serial number, an expiration date (in the MM/YY format for human-readable form), and a lot/batch number (up to 20 alphanumeric characters).

The ANVISA Medicine Registry Number, serial number, expiration date, and lot/batch number make up the Unique Medicine Identifier (Identificador Único de Medicamentos), or IUM, which must be printed on every product. Compliant labeling might look something like this:

Brazil ANVISA IUM

For their serialization plans in the SNCM portal, manufacturers and importers must provide information about their relevant product lines and medicines. Furthermore, manufacturers must submit a serialization plan that includes all steps and actions they will take to become compliant by April 2022.

Final thoughts

What’s the most important takeaway for Brazil ANVISA? The clock is ticking and you have to be prepared. You should be coordinating with your supply chain partners. You should be registering your products with ANVISA. You should have access to the SNCM portal and be uploading the required reporting data.

You should also register for our “SNCM-ANVISA Serialization and Traceability Compliance” webinar on Wednesday, Nov. 17, 8:30 – 9:15 a.m. Eastern Time. Thiago Alegreti, director of our Latin American operations, will discuss the latest SNCM updates and let you know what you need to be doing to be ready for April 2022.

rfxcel has fine-tuned our traceability software to help manufacturers operating in the Brazilian market comply with the SNCM requirements, and we have an experienced team on the ground in Brazil that can help make sure you’re ready for the regulations. Register for the webinar and contact us today if you have any questions or want more information.

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 2023: Top EPCIS Questions, Answered

When will companies start sending EPCIS? If a solution provider supports DSCSA compliance, why do users need to do anything other than ensure their products are aggregated? 

These were among the questions people asked at our second “DSCSA 2023” webinar last month, “ASN to EPCIS: Industry Change, Your Challenge.Herb Wong, rfxcel VP of Marketing and Strategic Initiatives, was the host, and we share his answers to the most-asked questions below.

Check back tomorrow, because we’ll be posting the top questions from the third and final webinar in the series, “Authorized Trading Partners: The OCI Solution.” You can also read our answers to the top questions from the first webinar, The Verification Router Service: Aligning to the Standard.

If you have other questions or want more details about DSCSA 2023, contact us today. Oh, and you can watch the entire “DSCSA 2023” webinar series and download the presentation slides here.

When will companies start sending EPCIS?

It has already started. However, the industry hasn’t achieved the volume it will need for 2023 (or right now, for that matter). There aren’t exact figures of the current volume of returns supply chain stakeholders (e.g., manufactures and wholesale distributors) are generating, but we do have anecdotal information from one of the Big 3 that they’re getting only about 10 percent. That data is a few months old, though, and that number could have increased. But overall, the industry needs to continue boosting the volume.

If a solution provider supports DSCSA compliance and industry (e.g., HDA) requirements, why do users need to do anything other than ensure their products are aggregated? 

A DSCSA solution should ensure you’re compliant and adhering to industry standards. But there’s more to it than that. For example, a solution provider needs permission from a manufacturer to send its serialized data; however, some manufacturers have chosen not to send this data, even though they have the means to do so. Right now, it’s important to be sending this data so solution providers can continue to work with the industry to ensure that all the data entering the system is clean and the VRS is working well.

So, it’s not that a solution provider can’t handle this for you. The issue is that providers need their customers to agree to send the information and communicate with their trading partners to make sure everyone’s on the same page. This needs to occur throughout the supply chain (e.g., as manufacturers send data to wholesale distributors and wholesale distributors send data to dispensers). Also, dispensers need to be able to receive the data. It’s all about communication and coordination.

What is the vision for the Center of Excellence? Will membership be open to everyone in the industry at no cost, or will membership be limited to certain organizations?

The current vision is that there will be no fees. The intention is to facilitate broader coordination among all participants to encourage data to flow through the system and to build an optimal method for resolving issues. As for membership, the reality is there has to be coordination with certain groups, because it will be difficult to succeed without some sort of organization to “rally around.” In all likelihood, the Center of Excellence will probably be coordinated through the Healthcare Distribution Alliance (HDA). But even if you’re not an HDA member, that shouldn’t preclude you from participating.

What about transformation of events of inbound to outbound serial numbers for 2023 requirements?

Here, “transformation” means, for example, sending a pallet to a wholesale distributor who then “transforms” it by opening a case and sending individual products downstream (e.g., to a dispenser). The vision is to have each entity that transforms — unpacks and repacks — products to manage that process inside their own organization. The role of EPCIS is to handle the actual communication of every transformation. It’s important for the industry to understand and be able to verify every transformation event, and EPCIS is the tool that makes this possible.

In terms of repackaging, an example would be if a company puts different medicines (with different SKUs) together in a new configuration, or package, that meets a certain need (e.g., a combination of pills to treat a specific condition). In that process, the repackager must issue a new serial number that would have to be DSCSA-compliant in terms of EPCIS data flow.

These are the kinds of scenarios the industry needs to flesh out and be ready for by 2023.

More DSCSA 2023 resources from rfxcel

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

Dairy Traceability in 2021: The FDA, the Industry, and the Future

It’s June, and it’s definitely ice cream season! It was 96°F (35°C) at our headquarters in Reno, Nevada, yesterday. Naturally, when we think of ice cream, we think about dairy traceability. Dairy traceability ensures consumer safety and keeps vital supply chains moving.

Most of our readers can probably assume that their food was manufactured, processed, transported, and stored safely and in accordance with quality standards and safety regulations. But the World Health Organization estimates that 600 million people are sickened from contaminated food products every year — and as many as 420,000 die. Dairy products are among the biggest culprits, as they can carry pathogens that cause foodborne illnesses.

The implications are significant. And they illustrate why dairy traceability is so important. Let’s take a look at where we are with dairy traceability in 2021.

Dairy traceability: the industry perspective

Dairy traceability has been on the industry’s radar for quite some time. For example, the Innovation Center for U.S. Dairy has been an advocate since at least 2009, when its Globalization Report noted that traceability was, in so many words, the future of the dairy supply chain.

In 2013, the Center published Guidance for Dairy Product Enhanced Traceability. Now in its third iteration (July 2020), it addresses much of what the FDA wants, including establishing and maintaining records with key data elements (KDEs) associated with critical tracking events (CTEs). There’s also a 21-point Dairy Traceability Checklist that manufacturers can use to evaluate if they follow enhanced dairy traceability best practices.

Last, the Center created the U.S. Dairy Traceability Commitment, “designed by processors, for processors, to increase global competitiveness, help satisfy future requirements of the Food Safety Modernization Act (FSMA) and, in the rare event of a safety issue, quickly isolate products to protect public health and prevent brand damage.”

Dairy traceability: the FDA perspective

Traceability — including dairy traceability — and modernization have also been on the FDA’s radar. We’ve written about this before, so we won’t drill down into the details today. In a nutshell:

The new requirements, also known as the Food Traceability Proposed Rule, apply to many popular cheeses, including brie, camembert, feta, mozzarella, Monterey Jack, cottage cheese, ricotta, and queso fresco.

Dairy traceability in 2021

Just about a year after the FDA announced its New Era of Smarter Food Safety Blueprint and the Innovation Center for U.S. Dairy updated its Guidance for Dairy Product Enhanced Traceability, it’s clear the dairy industry and the FDA are trying to get on the same page.

Generally, the industry has been receptive to the FDA’s efforts. The International Dairy Foods Association, for example, supports the New Era of Smarter Food Safety Blueprint. Still, many in the industry say the Food Traceability Proposed Rule isn’t necessary because supply chain stakeholders have been modernizing and building traceability systems without a government mandate.

With that in mind, the International Dairy Foods Association submitted comments to the FDA asking it to revise the recordkeeping requirements, arguing that doing so would support more widespread adoption of dairy traceability across the industry, to the ultimate benefit of the public. The Association is also working with the FDA to ensure dairy manufacturers have the proper direction and tools that support more efficient food safety practices and dairy traceability protocols.

Final thoughts

This quick sketch of dairy traceability makes two things clear. First, the FDA is all-in on modernization and traceability. Second, the industry understands the need for dairy traceability and has shown its willingness to commit to maintaining a modern, traceable supply chain.

In this environment, rfxcel’s traceability solutions will help dairy companies in any market modernize their food safety protocols, facilitate end-to-end traceability in a digital supply chain, comply with evolving regulations, and maintain trust with customers. Contact us for more information about how we can help, and check back soon for more about traceability in the food supply chain.

 

rfxcel DSCSA 2023 Webinar Series: Sneak Peek #3

Our first DSCSA 2023 webinar is today, June 15, at noon Eastern Time! Registration is still open, so sign up now!

For the next three days, our Executive Global Advisor Brian Files, an expert on U.S. and international pharmaceutical compliance, will present key aspects of the DSCSA and answer your questions.

  1. TODAY, JUNE 15: The Verification Router Service: Aligning to the Standard
  2. Wednesday, June 16: ASN to EPCIS: Industry Change, Your Challenge
  3. Thursday, June 17: Authorized Trading Partners: The OCI Solution

We’ve already done sneak peeks about today’s Verification Router Service webinar and Thursday’s presentation about authorized trading partners. Here’s our last sneak peek about “ASN to EPCIS.” Enjoy! And remember to sign up for the series. All registrants can download the webinars starting next week.

What is the DSCSA?

The DSCSA went into effect on November 27, 2013. It calls for product tracing, product identifiers (PIs), authorized trading partners, and verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers (pharmacies). Full serialization will begin on November 27, 2023.

DSCSA requirements for electronic data exchange

Trading partners must provide transaction information (TI) and a transaction statement (TS) to the subsequent owner of a product “prior to, or at the time of, each transaction.” This information must “be exchanged in a secure, interoperable, electronic manner in accordance with the standards established [through FDA guidance].”

In 2023, TI must include product identifiers (PIs), which include serial numbers and expiration dates. This is part of the full serialization of the U.S. pharmaceutical supply chain.

The FDA puts a premium on these requirements, saying, “electronic, interoperable exchange of TI is … foundational to achieving electronic interoperable tracing and verification … .”

What is ASN?

An advanced shipping notice (ASN) tells what’s being shipped (e.g., number of items, shipment date, number of boxes, shipment weight, description of packaging) and how it’s being shipped (e.g., land, sea, air).

Why are people talking about ASN? Because it does not currently support DSCSA 2023 requirements for including PIs. What are the ramifications?

What is EPCIS?

The Electronic Product Code Information Service (EPCIS) is a global GS1 standard for exchanging Electronic Product Code (EPC) information and enables automatic communication and exchange of authenticated data.

Right now, it seems to be the pharma industry’s preference for meeting DSCSA requirements — but will it remain the frontrunner, or will another standard gain favor?

Final thoughts

Again, head over to our registration page so you can join Brian today, tomorrow, and Thursday. All the webinars begin at noon Eastern Time and will last up to 45 minutes (depending on how long our Q&A goes).

See you at the webinars!

DSCSA 2023 Webinar_June 15-17

 

rfxcel DSCSA 2023 Webinar Series: Sneak Peek #2

Full serialization of the U.S. pharmaceutical supply chain is coming on November 27, 2023. To help make sure you have the latest information and are doing everything you can to be prepared, we’re hosting the rfxcel DSCSA 2023 webinar series on June 15, 16, and 17.

Our Executive Global Advisor Brian Files, an expert on U.S. and international pharmaceutical compliance, will present three key aspects of the DSCSA and answer your questions. Sign up today!

  1. Tuesday, June 15: The Verification Router Service: Aligning to the Standard
  2. Wednesday, June 16: ASN to EPCIS: Industry Change, Your Challenge
  3. Thursday, June 17: Authorized Trading Partners: The OCI Solution

Here’s a sneak peek about DSCSA authorized trading partners (ATPs). Check back for one last sneak peek before Brian kicks off the webinars on June 15!

What is the DSCSA?

The DSCSA went into effect on November 27, 2013. In addition to ATPs, it calls for product tracing, product identifiers (PIs), and verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers (pharmacies). As we said above, full serialization is scheduled to begin on November 27, 2023.

What are ATPs?

Under the DSCSA, manufacturers, wholesale distributors, repackagers, third-party logistics providers (3PLs), and dispensers are ATPs. They may engage in transactions only with other ATPs.

In other words, these supply chain actors and their trading partners must be ATPs. (In broad terms, a trading partner is an entity that accepts or transfers direct ownership of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser.) If you are not an ATP, your access to the U.S. pharma supply chain will be severely restricted or denied altogether.

ATP requirements at a glance

To be considered an ATP,  manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers must meet the criteria presented in the table below, which we’ve adapted from an August 2017 FDA publication.

ATP Requirements

Final thoughts

Be sure to join us on June 15, 16, and 17 for our DSCSA 2023 webinar series. Register today and submit your questions for Brian. You can also contact us to talk with one of our supply chain experts and see how our award-winning rfxcel Traceability System can ensure you comply with all DSCSA requirements.

See you on June 15!

DSCSA 2023 Webinar_June 15-17