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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

Mandatory Dairy Product Labeling in Russia to Begin in Two Months

It’s going to be a busy year for dairy product labeling in Russia. (If you missed our earlier overview, be sure to check it out.) In fact, it’s going to be a busy year for product labeling in Russia generally. A quick look at our blog reveals that the National Track and Trace Digital System, or Chestny ZNAK, is not relenting on its goal of transforming Russia’s supply chain by 2024:

But let’s stay focused on dairy product labeling, which is scheduled to commence on June 1 for two product categories, then will be phased in for two other categories later in the year.

Dairy product labeling in Russia: background

The Chestny ZNAK pilot for dairy product labeling from July 15, 2019, to December 31, 2020. The dairy supply chain has a unique configuration because Chestny ZNAK will share track and trace duties with the “Mercury” electronic veterinary certification system, which tracks animal products in Russia.

Dairy product labeling requires a DataMatrix code containing four data points: a 14-digit Global Trade Item Number (GTIN), a 13-digit serial number, a 4-digit verification key, and an expiration date.

Other dairy product labeling requirements include the following:

  • Product packaging must have a blank field up to 15×15 mm to accommodate the DataMatrix code.
  • Caps on PET bottles must be able to accommodate either printing or labeling with a laser.
  • Manufacturers can have unusually shaped cartons or bottles tested to determine if the form factor affects dairy product labeling and scanning accuracy/reliability.
  • Aggregation is required; the parent-child relationship must be maintained between the aggregation and the individual units within it.

If you want to learn more about Russian dairy product labeling, download our “Russia Chestny ZNAK and the Dairy Industry” white paper. It’s fully updated for 2021 and really drills down into the details.

While we’re at it, if you want to learn about product labeling and serialization for all of the industries regulated in Russia, download our “Overview of Chestny ZNAK Compliance for Key Industries.” This is also fully updated for 2021 and is our most comprehensive publication about Russian supply chain compliance.

The June 1 dairy labeling requirements

Mandatory dairy product labeling begins June 1 for cheeses and ice cream and other edible ice with or without cocoa. Only serialized products can be sold after this date. However, products produced or imported into Russia before June 1 may be sold until the product’s expiration date.

Companies were permitted to begin labeling these cheese and ice cream products as early as January 20, 2021. They were also allowed to transfer dairy product labeling data to the Government Information System for Marking (GIS MT), which catalogs all labeled goods in Russia’s supply chain. To transfer data to GIS MT, you must be registered with Chestny ZNAK.

The table below shows Russia’s product classification codes (OKPD2) and the corresponding Eurasian Economic Union (EAEU) Combined Nomenclature of Foreign Economic Activity (TN VED) codes for labeling these products. This information comes from Chestny ZNAK.

Russia Dairy Product Labeling

 

Final thoughts

rfxcel is the leader in Chestny ZNAK compliance. Not just for dairy product labeling — for labeling requirements in all regulated industries. We know these regulations can be tough to decipher. To help, we have useful resources, like the stories we linked above, our Chestny ZNAK refresher course, our white papers, and our webinars.

These are great places to start, but the best way to ensure you’re prepared to comply with Russia dairy product labeling requirements is to talk with us directly. When we say we’re the leader in Russian compliance, consider our credentials:

  • We’re an official integration, software, and tested solution partner with the Center for Research in Perspective Technologies (CRPT), which operates Chestny ZNAK.
  • We were recently accredited as an IT company by the Ministry of Digital Development, Communications, and Mass Media.
  • We’re one of the few providers with active implementations in Russia.
  • We’ve tripled our workforce in Russia over the last year.
  • Our Moscow-based team provides our clients, which include major global consumer goods and pharmaceutical companies, the quickest time to market while fully automating their compliance reporting.

We’ve also demonstrated that our solutions, including our signature rfxcel Traceability System (rTS), Compliance Management (rCM), and Serialization Processing (rSP), can meet the stringent Russia dairy serialization requirements and ensure you stay compliant. In fact, we had to prove this to the CRPT to be named an official partner. rTS works seamlessly with Chestny ZNAK, including a Russian-language user interface that makes integration and startup much quicker.

So contact us today learn more about how we can help you with dairy product labeling and other Chestny ZNAK compliance. No matter how far along you are in your preparations to comply, you should talk to us — even if you’re already working with another provider. Our powerful software ensures companies in any industry remain compliant with Russia’s complex regulations.

 

 

 

 

Russia Chestny ZNAK Bottled Drinking Water Pilot Ending Soon

A year ago today — April 1, 2020 — Russia started its Chestny ZNAK bottled drinking water pilot. Chestny ZNAK is Russia’s National Track and Trace Digital System, which is transforming how the country runs and regulates the supply chain for everything from pharmaceuticals to fur. It’s managed by the Center for Research in Perspective Technologies (CRPT).

If all goes as planned, the Chestny ZNAK bottled drinking water pilot will wrap up on June 1. Let’s take a quick look at the pilot and what we can expect going forward.

The Chestny ZNAK bottled drinking water pilot

As we said, the pilot (or “experiment,” as these projects are called in Russia) began on April 1, 2020, and is scheduled to end just two months from now, on June 1. The bottled drinking water category includes mineral and carbonated waters, waters without sweeteners or other flavoring, and non-carbonated water. The table below shows the Eurasian Economic Union Combined Nomenclature of Foreign Economic Activity (TN VED) code for the products that must be labeled, as provided by Chestny ZNAK.

 

BOTTLED DRINKING WATER

Pilot: April 1, 2020–June 1, 2021

TN VED CodeDescription
2201Beverages and spirits and vinegar: waters, including natural or artificial mineral waters and aerated (i.e., carbonated) waters, not containing added sugar or other sweetening matter nor flavored; ice and snow

 

Like pilots for other industries, the Chestny ZNAK bottled drinking water pilot tests end-to-end tracking and tracing of marked goods from manufacturing sites or import/customs locations to final sale to consumers. It’s also designed to determine the best approaches for marking and tracing products, including testing methods of applying codes to different types of packaging, such as PET bottles and bottles with irregular shapes.

Chestny ZNAK, which is now in its fourth year of operation, generally requires products to be labeled with a 2D DataMatrix code containing four data points: a Global Trade Item Number (GTIN), a serial number, a verification key, and a verification code (i.e., crypto code).

The DataMatrix codes being used in the Chestny ZNAK bottled drinking water pilot must contain three data points: a 14-digit GTIN, a 13-character serial number, and a 4-character verification code. An optional fourth data point can include information such as the minimum retail price and expiration date. Product packaging is required to have a blank field up to 15×15mm to accommodate the code.

The pilot’s goals include the following:

  • Supply chain actors order DataMatrix codes and apply them to products.
  • All labeling information is transferred electronically to Chestny ZNAK.
  • Products in shipping packages are aggregated; codes for each unit in the aggregation are also aggregated.
  • Marked products enter circulation.
  • Products are tracked and traced in the supply chain, and stakeholders exchange Universal Transfer Documents (UTDs) to record transfer of codes.
  • Consumers purchase goods, which are withdrawn from circulation at checkout via point-of-sale cash registers and scanning devices.

Final thoughts

The CRPT has not announced when mandatory marking of bottled water products will begin. If the pilot ends on schedule, there will likely be a final report and review period, so it could be late 2021 or even early 2022 before you’ll have to comply.

Regardless, the time to think about compliance is now. If you want more details about the Chestny ZNAK bottled drinking water pilot — or any of the regulated industries — start by downloading our white papers. We’ve updated all of our Russia white papers for 2021 and included even more details about what you need to know and do to be compliant.

You should also contact us. We’ve been prepared for Russia’s regulations since 2018. Here a just a few of the reasons why we’re the leader in Chestny ZNAK compliance:

  • We are an official software and integration partner of the CRPT.
  • We’re accredited as an IT company by the Ministry of Digital Development, Communications, and Mass Media.
  • We are one of only a few providers with in-country implementations; clients include global consumer goods and pharma companies.
  • Our powerful software ensures companies in any industry will remain compliant while mastering their supply chains with end-to-end traceability and rich, actionable data mined right down to the unit level.

We’ll be posting more about what to expect with Chestny ZNAK requirements in 2021. There’s definitely a lot going on — including pilots for biologically active food additives and beer getting under way now — so check back often.

Food Traceability Gets Precise: The State of the Art

In recent years, the food industry has been under increasing pressure to trace products from farm to table. When COVID came onto the scene, the need for food traceability only intensified, as consumers wanted assurance from retailers and their supply chain partners that they could rely on the safety of their food.

Food traceability, however, is only as good as the degree to which it is executed up and down the supply chain. In order to improve supply chain management, facilitate feedback for food quality and safety, and differentiate your food product from your competitors’, you need to get precise in your traceability efforts.

Precision food traceability

Precision food traceability refers to the in-depth tracing of supply chain data and critical tracking events (CTEs) backward (to the source of the product) and forward (everywhere a food product has been used) to facilitate the quick and effective review of every action taken related to a product at each stage. With the ability to pinpoint a particular food product’s movement and characteristics, precision traceability not only offers detailed information about a product’s freshness, nutritional values, and logistics, it also supports proactive, informed decision-making should a food safety event occur.

Serialization is an essential tool in a precision food traceability system. The process of creating a unique code for each product, serialization delivers granular data about the food product to provide significantly more end-to-end visibility. With the ability to track the product at every stage, item-level traceability makes it easy to capture key data elements (KDEs), which could be used to trigger an investigation and reduce traceback time in the event of a food safety issue.

For example, let’s say you want to track a harvest operator’s location beyond the primary farmer and farm. Serialization gives you access to data down to the person who picked a vegetable, and from which row, ranch, or plot. For meat products, you can quickly trace back to not just the exact animal, but also to its pen location, feed, and even medicines.

With the ability to track outcomes (e.g., quality inspections and safety test results) and associate them to the product beyond the original facility, you can look back at any event in a product’s lifecycle even after it’s been shipped from the original facility. Precision food traceability makes it possible to track customer feedback and connect it to supply chain data points to deliver a complete picture of the product’s safety and performance. You can also evaluate how you’re doing on a sustainability front by tracking post-consumer activity, such as recycling and waste.

Specific uses for precision food traceability

On its journey from farm to table, a food product may be exposed to disease-causing organisms and food safety hazards. As the volume of international trade expands, so does the potential for transmission of pathogens or chemical contamination.

We all know problems can arise anywhere in the supply chain. Containing ingredients — perhaps from all over the world — and processed in different facilities and handled by wholesalers, retailers, and transportation companies, a food item is handled by many actors before ending up on the consumer’s plate. A precision food traceability system is paramount to ensuring food safety and minimizing the impact should an event arise.

Precision food traceability makes it easy to investigate food safety issues, identify the source of contamination, assess the scope of impact, and resolve the problem quickly. With the ability to trace back to the health of the animal, feed production, rearing, transportation, and more, you can quickly identify the source of infection or prohibited additives and take preventive and control measures to avoid the introduction of the contaminant.

Beyond safety, precision traceability also supports profitability. With detailed food traceability data, you can intelligently evaluate your operations, optimize efficiencies, analyze yield, and even apply consumer feedback to measure return on production investment. Precision traceability can also reduce food waste by tracking and recording data through every stage of the supply chain.

Final thoughts

Maintaining food safety is critical to your overall success and, more important, consumer health. The better and more precise your tracing system, the better equipped you will be to isolate the source of an issue and address quality control problems, quickly and efficiently. By minimizing the production and distribution of substandard and perhaps even illegal products, you reduce the risk of recalls, negative publicity, and liability, and have a “firewall” to protect your brand in the process.

Keeping tabs on every event related to your food supply can seem daunting but rfxcel can help. Offering the most complete and flexible raw materials and finished goods traceability solution in the food and beverage industry, we can help optimize your supply chain operations, meet compliance requirements, track products, and increase business value.