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What Does the EU COVID-19 Vaccine Distribution Plan Look Like?

The EU announced its COVID-19 vaccine strategy on June 17, 2020. Among other things, it called for ensuring the quality, safety, and efficacy of vaccines, securing quick access to vaccines, and ensuring equitable access to an affordable vaccine as early as possible. It also called for adapting the EU’s regulatory framework and taking advantage of regulatory flexibility to address the urgent need.

Let’s take a look at what the EU has said about its COVID-19 vaccine distribution plan and answer some frequently asked questions about its vaccine administration.

What vaccines are being used in the EU?

The European Commission says it wants to “build a diversified portfolio of vaccines based on different technologies, to increase the chances that one or more of the vaccine candidates are approved by EMA.”

The EU authorized the BioNTech-Pfizer COVID-19 vaccine on December 21, 2020, and the Moderna vaccine on January 6, 2021. It did this after the European Medicines Agency (EMA) assessed their safety, quality, and efficacy.

On January 8, the Commission reported that it had concluded contracts for 600 million doses of the BioNTech-Pfizer vaccine and 160 million doses of Moderna’s vaccine. It also reported securing contracts for millions of doses from AstraZeneca, Sanofi-GSK, Johnson and Johnson, and CureVac, and that it had concluded “exploratory talks” with Novavax and Valneva.

Then, on January 29, the Commission announced that AstraZeneca agreed to publish the redacted contract it signed on August 27, 2020, and that CureVac agreed to publish the Advance Purchase Agreement with the EU.

The Commission says it has secured more than 2.3 billion doses of COVID-19 vaccines, adding that if all the vaccine candidates are found to be safe and effective, EU Member States could donate part of their doses to lower- and middle-income countries.

Who will receive the vaccine and when?

As of January 8, the EU said that all Member States would have access to COVID-19 vaccines at the same time, based on the size of their population. On January 29, the Commission enacted a measure requiring Member States to authorize vaccine exports, stating this will “ensure timely access to COVID-19 vaccines for all EU citizens and … tackle the current lack of transparency of vaccine exports outside the EU.”

The Commission says the number of doses will be limited during the initial stages the immunization effort and before production can be ramped up. As in other countries, authorities have said that there will not be enough doses to vaccinate everybody right away; it will take time.

Most members have defined who will get the vaccine first and are further refining sub-groups to assign priority. Frontline healthcare professionals and people over 80 years old top the lists. For more insight about the rollout, see this December 2020 report from the European Centre for Disease Prevention and Control about preparedness in the EU, the European Economic Area, and the UK. The Centre also has a useful “Situation Update” page that tracks the pandemic in the EU.

Vaccine supplies will increase over time, the Commission says, and all adults should be able to get vaccinated during 2021. It predicts that at least 80 percent of people over the age of 80 and 80 percent of health and social care professionals should be vaccinated by March 2021. By this summer, the Commission says 70 percent of the EU’s adult population should be vaccinated. These projections, however, are probably optimistic, as the rollout has been slow and fewer doses than expected have been delivered.

Final thoughts

As we said in our blog post about COVID-19 vaccine distribution in the United States, the world is in an “all hands on deck” situation. We like to think we’ve been part of the effort since the pandemic began.

In April 2020, we joined the COVID-19 Healthcare Coalition, offering our Accurate Immunization Management (AIM) and rfxcel Integrated Monitoring (rIM) solutions. rIM is a real-time environmental monitoring solution that uses Internet of Things (IoT)-enabled devices to monitor products while they’re in transit; it’s a powerful, ideal solution for the pharma cold chain, which is vital to vaccine distribution.

AIM ensures that the right person gets the right vaccine at the right time. It can track COVID-19 vaccines — indeed, any vaccine — in any supply chain, monitor inventory, and facilitate safe, timely delivery to any location. We designed AIM to be fast, flexible, and compliant in any country. At a time when the world is depending on supply chains to function at peak performance, AIM is a tool to help get vaccines properly delivered and dispensed.

Furthermore, our signature rfxcel Traceability System has proven itself in the pharma supply chain, helping ensure products are safe and legitimate and that consumers know exactly what they’re getting. Contact us today to learn more our solutions and how we can help you secure your supply chain, no matter what industry you’re in or where you do business.

How the COVID-19 Vaccine Track and Trace Systems Work in the United States

On December 11, the Food and Drug Administration (FDA) issued an emergency use authorization for a COVID-19 vaccine in the United States. The Pfizer vaccine was the first vaccine made available to the public, followed by Moderna’s vaccine.

There are many challenges for U.S. track and trace systems monitoring COVID-19 vaccine shipments. There’s also the additional challenge of keeping tabs on who receives the vaccine and when, especially as the program is being conducted through both state and federal data networks.

Let’s take a look at how the United States is implementing its track and trace systems and address the unique challenges of vaccine distribution.

What track and trace systems are the United States using?

The United States is using federal immune registry systems and connecting them with a new project called the Immunization Gateway, or IZ Gateway. Put simply, the system enables providers, consumers, and other stakeholders to exchange immunization data. It’s sponsored by the Centers for Disease Control and Prevention’s Immunization Information Systems Support Branch and led by the U.S. Department of Health and Human Services (HHS) Office of the Chief Technology Officer.

IZ Gateway connects 64 Immunization Information Systems (IIS), which consolidate and “deduplicate” immunization information. IIS also have forecasting algorithms that can help people stay current on their vaccines. The IZ Gateway’s centralized technical infrastructure facilitates data exchange through an intelligent message router that connects the IIS to one another, connects large multi-jurisdictional provider organizations to the IIS, and connects the IIS to consumers.

The HHS says the IZ Gateway “aims to increase the availability and volume of complete and accurate immunization data stored within IIS and available to providers and consumers regardless of their jurisdictional boundaries.” Prisons and veteran’s affairs hospitals are also connected to the system.

The main challenge to the U.S. track and trace system

As we know, tracking and tracing the COVID-19 vaccine isn’t an easy task. There have been a variety of concerns, including securing pharma cold chain infrastructure and providing track and trace technology with real-time environmental monitoring, such as our rfxcel Integrated Monitoring solution.

However, two challenges have remained at the forefront of the conversation: the sheer scale of the immunization effort and the two-dose requirement. Although the IZ Gateway creates a nationwide network that can track if a person has received more than one dose, government, providers, and every other vested stakeholder should anticipate mistakes and inaccuracies and do everything within their power to optimize vaccine distribution and administration.

rfxcel’s Accurate Immunization Management (AIM) is one solution that can help. AIM is an automated, cloud-based solution that tracks the dispensing of vaccines in the supply chain. It seamlessly integrates with IIS, Electronic Health Records (EHRs), Allscripts, Nextgen, Urochart, Meridian, and iSalus, adding another layer of track and trace protection to vaccine distribution.

Final thoughts

COVID-19 vaccine distribution is an “all hands on deck” situation. Our signature rfxcel Traceability System has proven itself time and again in the pharma supply chain, helping ensure products are safe and legitimate and that consumers know exactly what they’re getting.

Now, AIM ensures that the right person gets the right vaccine at the right time. It can track COVID-19 vaccines — indeed, any vaccine — in any supply chain, monitor inventory, and facilitate safe, timely delivery to any location. We designed AIM to be fast, flexible, and compliant in any country. At a time when the world is depending on supply chains to function at peak performance, AIM is a tool to help get vaccines properly delivered and dispensed.

Contact us today to learn more about AIM, our rfxcel Traceability System and rfxcel Integrated Monitoring, and our other supply chain solutions.

Russia Pharma Serialization Update: “Notification Mode” Expedites Product Circulation

Russia pharma serialization has been underway for a little more than three years. The country’s National Track and Trace Digital System, which is known as Chestny ZNAK and covers a dozen industries, has been continually tweaked and refined since it was created a little more than three years ago.

Some important updates to Russia pharma serialization were made public toward the end of 2020. Here’s a quick rundown of what the government announced.

“Notification mode” will simplify Russia pharma serialization processes

As we noted last year, Russia’s Drug Circulation Monitoring System (MDLP) was compelled to develop new reporting requirements after technical problems created serious issues in the pharma supply chain.

In late October, the MDLP moved into so-called “notification mode” to help supply chain actors continue importing, distributing, and selling medicines in the event of errors or failures in Chestny ZNAK’s reporting system. This applied to over-the-counter and prescription medicines manufactured in Russia or imported into the country, including from the Eurasian Economic Union (EAEU).

Then, in early November, Decree 1779, “On Amendments to the Regulation on the Monitoring System for the Movement of Medicines for Medical Use,” consolidated measures to simplify and expedite reporting. This is why notification mode has also been referred to as “simplification mode” for Russia pharma serialization.

In essence, stakeholders can proceed with distribution or dispensing 15 minutes after they submit the required product information to the Government Information System for Marking (GIS MT), which catalogs all marked goods, even if they do not receive confirmation that the information has been accepted/approved in the system. (The “product information” pertains to Russia pharma serialization requirements, such as serial numbers and Global Trade Item Numbers.) The decree also simplifies importation, giving custom officials a 2-hour window to request product information.

For now, these Russia pharma serialization rules are to remain in effect until July 1, 2021. After that, notification mode will stop.

Final thoughts

As the leader in Russia pharma serialization, rfxcel knows the regulations are stringent and challenging. To help, we offer useful resources online, like this refresher course and white papers and webinars that explain the regulations in easy-to-understand language.

These are great places to start, but the best way to ensure you’re prepared to comply with Russia pharma serialization laws is to talk with us directly. Consider our credentials:

  • We’re an official integration, software, and tested solution partner with the CRPT.
  • We’ve demonstrated that our solutions, including our signature rfxcel Traceability System (rTS) and Compliance Management (rCM), can meet the stringent Russia pharma serialization requirements and ensure you stay compliant.
  • rTS works seamlessly with Chestny ZNAK, including a Russian-language user interface that makes integration and startup much quicker.
  • We’ve prepared for Russia pharma serialization and Chestny ZNAK since 2018.
  • We’re one of the few providers with active pharma implementations in Russia.
  • We’ve tripled our workforce in Russia over the last year. Our team in Moscow provides our clients, which include major global pharmaceutical and consumer goods companies, the quickest time to market while fully automating their compliance reporting.

Contact us today learn more about how we can help you with Russia pharma serialization and 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 you’ll be prepared and always be compliant with Russia’s complex regulations.

Russia Serialization Pilot to Combat Counterfeit Beer Set to Begin This Spring

Last October, Russia’s Ministry of Industry and Trade announced a supply chain pilot project to label beer and beer-based mixed drinks. Set to run from April 1, 2021, to February 28, 2022, its goal is to prevent counterfeit beer from entering the market and to protect consumers.

The pilot is part of Russia’s ongoing effort to serialize its entire supply chain. The country’s National Track and Trace Digital System, known as Chestny ZNAK and operated by the Center for Research in Perspective Technologies (CRPT), monitors the supply chains of more than a dozen industries, from pharmaceuticals and footwear to tires and tobacco. Pilots for other industries, including dairy and bicycles, have wrapped up and several are still underway, including wheelchairs and bottled drinking water.

Let’s take a look at the problem of counterfeit beer in Russia and globally, and what the pilot hopes to achieve.

The struggle with counterfeit beer and other alcohol

Counterfeit beer — and counterfeit wine, spirits, and other alcoholic drinks — is a global problem with a hefty monetary cost. For instance, it’s estimated that fake wine and spirts cost the global industry more than $3 billion a year in the EU alone. The illegal trade also decreases sales of legitimate products and has led to losses of industry jobs. For more insight into the problem, check out our two-part blog series about track and trace in the wine industry.

There’s also a human cost. Counterfeit alcohol can contain toxic “ingredients” such as jet fuel, embalming fluid, and methanol. The danger is great enough that governments and industry associations have issued guidance to help consumers spot fakes and stay safe. Last year, for example, the Wine & Spirts Wholesalers of America advised travelers to remember the “4 Ps” — place, product, price, and packaging — when purchasing any kind of alcohol.

Though the problem is global, it’s particularly acute in Russia. In 2014, Russia’s Federal Service for Alcohol Market Regulation said half of beer and beer-based beverages sold in the country were fake. (Beer wasn’t even classified as an alcoholic drink in Russia until 2011. Before then-President Dmitry Medvedev signed the bill making that distinction, anything containing less than 10 percent alcohol was considered a foodstuff.)

Today, the Ministry of Industry and Trade estimates that counterfeit beer accounts for 5–12 percent of the country’s $8.8 billion market, resulting in approximately $1 billion in lost tax revenue. The ministry also estimates that labeling beer and monitoring it via Chestny ZNAK will increase revenue for legal producers by as much as $4 billion. And, of course, mandatory labeling will help ensure counterfeit beer, including potentially harmful knock-offs, never reaches consumers.

Details of Russia’s beer labeling pilot

The Russian government is aware of its counterfeit beer problem. Talking about the pilot after it was announced last October, Minister of Trade and Industry Denis Manturov said, “We think it is important to start with labeling in the alcohol segment in order to protect consumers. This is important as this sector is particularly vulnerable to illegal goods and counterfeiting.”

The CRPT, industry representatives, regulators, retailers, and other stakeholders have been discussing parameters, technical features, and timing. As we noted above, the pilot will last 11 months (April 2021–February 2022). Progress reports are due to the government on October 29 of this year and February 14 next year, and a final decision about when mandatory labeling will begin will be made after a full review of the pilot.

Any company can volunteer to participate; however, it seems the organizers prefer companies that use several packaging form factors and have more than one product line. If you want to participate, you must send a letter of consent on company letterhead to the Beer and Beer Drinks Commodity Group. Visit the Chestny ZNAK website for details or, better yet, contact us directly. We’re an official partner of the CRPT, and our ever-growing team in Moscow is always ready to help.

What products will be labeled?

The pilot will test labeling for beer, beer drinks, and low-alcohol drinks that are not required to be labeled with federal special and excise stamps.

What do manufacturers have to do?

The CRPT will assign a dedicated project manager, technical manager, and business process specialist to every manufacturer in the pilot. These people will work at the manufacturer’s facilities and oversee pilot operations.

Manufacturers’ representatives are expected to attend working group meetings to discuss progress and make recommendations for the regulatory framework, which will be finalized after the pilot is over. Manufacturers are also expected to:

  • Understand the business processes required for digital labeling
  • Choose a technology partner to supply and install labeling and integration systems
  • Determine how to apply the marking codes
  • Determine what technical solution is most suitable for their production line(s)
  • Arrange delivery and perform commissioning/start-up of labeling equipment
  • Integrate the equipment with the Automated Control Systems of the Enterprise and Technological Process (ACSTP)
  • Adapt their inventory systems to work with labeled goods
  • Adapt their business processes to new requirements for digital marking
  • Train key personnel to work with digital marking
  • Ensure their suppliers are sufficiently prepared to work with digital marking

As with the other product categories regulated in Chestny ZNAK, manufacturers must follow a few core steps for labeling and track and trace processes. First, they must register an account with Chestny ZNAK. Next, they must describe their products in Russia’s catalog marked goods, which is managed by the Government Information System for Marking (GIS MT). Last, they have to order unique codes for each item (or, in some cases, for a group of goods), and put a Data Matrix code on each package, after which the goods may be to put into circulation and transferred for sale to wholesale or retail networks.

What do retailers have to do?

Retailers must scan the Data Matrix codes when they accept goods. This sends the product information to Chestny ZNAK and notifies the system that the products have arrived at the retail location.

When a consumer purchases a product, the cashier scans the code on the packaging using a scanner connected to a point-of-sale cash register. The data is synchronized with the information in the catalog  of marked goods and the item is officially removed from circulation. If the data doesn’t match, the product is counterfeit or otherwise illegitimate and cannot be sold.

Final thoughts

Russia wants to complete the transformation of its supply chain by 2024, a scant three years from now. What we’ve talked about today — fighting counterfeit beer and protecting consumers — follows the ultimate goal of Chestny ZNAK, which the government says is “to guarantee the authenticity and declared quality of goods being purchased by customers.”

rfxcel has been prepared for the Russian regulations since 2018, and we’ve established ourselves as the leader in Russian supply chain compliance. Chestny ZNAK compliance is embedded in our Compliance Management and Serialization Processing solutions, which are part of our award-winning rfxcel Traceability System.

We’re also an official software and integration partner of the CRPT, and one of only a few providers with in-country implementations. Our systems use Russian language, currency, and processes, and our customers include major global consumer goods and pharmaceutical companies.

And our qualifications go on and on. Connect with one of our supply chain experts today. If you’re looking to do business in Russia — or even if you’re already working with another provider — you should talk to us.

Russia Dairy Serialization Update: Mandatory Labeling for Cheese and Ice Cream

Some important updates to Russia dairy serialization were made public on January 13, 2021. The regulations pertain to cheese and ice cream products, as well as products with certain shelf lives.

Supply chain laws governing the country’s National Track and Trace Digital System, which is known as Chestny ZNAK and covers a dozen industries, have been continually tweaked and refined since it was created a little more than three years ago. Let’s take a look at what’s new for the dairy industry.

New rules for Russia dairy serialization

The Russia dairy serialization regulations were put forth in Decree No. 2099 of December 15, 2020; they will go into effect for different products at different times.

The first products to fall under mandatory labeling are cheeses and cottage cheese and ice cream and food ice. Companies can begin labeling these goods and transferring data to the Government Information System for Marking (GIS MT), which catalogs all marked goods, as early as January 20, 2021, but they must be registered with Chestny ZNAK to do so.

Mandatory labeling begins for these cheese and ice cream products on July 1, 2021. Only serialized products are allowed to be sold after this date. However, products produced or imported into Russia before July 1 may be sold until the product’s expiration date.

Deadlines for cheese and ice cream stakeholders

The Russia dairy serialization regulations for cheese and ice cream products apply to manufacturers, importers, wholesalers, and retailers. Here are the key dates:

  • June 1, 2021: Manufacturers and importers must begin labeling and transferring product data to GIS MIT.
  • December 1, 2021: All stakeholders must transmit information about the retail sale of goods to Chestny ZNAK. (This occurs via point-of-sale cash registers connected to the internet.)
  • September 1, 2022: Using Universal Transfer Documents (UTDs), stakeholders must transmit information on the turnover of goods (including wholesale sales) and the withdrawal of goods.
  • December 1, 2023: Unit-level serialization of products with a shelf life of more than 40 days begins. Each product’s unique identification code must be indicated in the UTD.

Labeling of other dairy products with a shelf life of more than/less than 40 days

Manufacturers, importers, wholesalers, and retailers must comply with the Russia dairy serialization regulations for these products, which include the following:

  1. Milk and cream
  2. Buttermilk, fermented milk products (e.g., curdled milk and cream, yogurt, kefir (a fermented milk drink)
  3. Butter and other fats and oils made from milk, milk pastes
  4. Milk whey and other dairy products not included in other groups
  5. Dairy products for baby food
  6. Drinks containing milk fats

Mandatory labeling of products with a shelf life of more than 40 days begins on September 1, 2021. Products with a shelf life of less than 40 days must be labeled beginning December 1, 2021. Only serialized products may be sold after these dates. However, products produced or imported into Russia before these dates may be sold until the product’s expiration date.

Furthermore, for both categories:

  • December 1, 2021: All stakeholders must transmit information about the retail sale of goods to Chestny ZNAK. (This occurs via point-of-sale cash registers connected to the internet.)
  • September 1, 2022: Using Universal Transfer Documents (UTDs), stakeholders must transmit information on the sale and withdrawal of goods.

And for products with a shelf life of more than 40 days:

  • December 1, 2023: Unit-level serialization Each product’s unique identification code must be indicated in the UTD.

Mandatory labeling will not apply to the following products:

  1. Baby food for children under 3 and specialized dietary therapeutic and preventive food
  2. Products packed in a non-industrial manner/method in retail organizations
  3. Products with a net weight of 30 grams or less
  4. Products produced or imported into Russia as advertising/marketing samples not intended for sale
  5. Products to be exported outside the EAEU
  6. Products for sale in duty-free shops
  7. Products being stored by manufacturers (i.e., not intended for distribution)
  8. Products acquired under a transaction, information about which constitutes a state secret

Final thoughts

As the leader in Russia dairy serialization solutions, rfxcel knows the regulations can be a challenge to decipher. To help, we offer useful resources online, like this refresher course and white papers and webinars that explain the requirements.

These are great places to start, but the best way to ensure you’re prepared to comply with Russia dairy serialization is to talk with us directly. Consider our credentials:

  • We’re an official integration, software, and tested solution partner with the CRPT.
  • We’ve demonstrated that our solutions, including our signature rfxcel Traceability System (rTS) and Compliance Management (rCM), can meet the stringent Russia dairy serialization requirements and ensure you stay compliant.
  • rTS works seamlessly with Chestny ZNAK, including a Russian-language user interface that makes integration and startup much quicker.
  • We’ve prepared for Russia dairy serialization and Chestny ZNAK since 2018.
  • We’re one of the few providers with active implementations in Russia.
  • We’ve tripled our workforce in Russia over the last year. Our team in Moscow provides our clients, which include major global consumer goods and pharmaceutical companies, the quickest time to market while fully automating their compliance reporting.

Contact us today learn more about how we can help you with Russia dairy serialization and 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 the complex regulations.

Food Traceability: What’s the Latest for 2021?

As we all know, the pandemic has revealed shortcomings in the supply chains of virtually every industry. And though the vaccine supply chain has dominated headlines over the last several months, food traceability has been top of mind for companies and governments alike since the earliest days of COVID-19.

Let’s take a look at the state of food traceability — what it is, how it works, and its future as we kick off 2021.

What is food traceability?

The U.S. Food and Drug Administration (FDA) defines food traceability as “the ability to follow the movement of a food product and its ingredients through all steps in the supply chain, both backward and forward.”

That’s a spot-on definition, but we’d like to add a few things. First, food traceability in 2021 means you can follow your products in real time. Yes, you can see where they’ve been and know where they’re going, but you can also see where they are right now. And with powerful tools like our rfxcel Integrated Monitoring (rIM) solution and Mobile Traceability app, you’ll have access to real-time information about environmental conditions (e.g., temperature, humidity, light, tilt, and shock) and location.

With this rich, actionable data, your food traceability capabilities expand exponentially. Not only can you take immediate action if there’s an environmental concern — a temperature excursion, for example — but you can course-correct if your vehicle is approaching a traffic jam or encountering other obstacles or delays. You can also tap data to combat theft and make recalls more efficient. (We wrote about modernizing food recall management late last year; check it out here.)

The other thing we’d like to add to the FDA’s definition is that, today, food traceability should be occurring in a digital supply chain. If you’re still pushing paper in 2021, it’s time for you to contact us and start thinking about upgrading to a digital supply chain powered by the rfxcel Traceability System (rTS). Our award-winning platform will transform your supply chain and how you use it. From ingredients to finished goods, rTS will bring state-of-the art food traceability to your operations.

Furthermore, rTS turns every one of your products into a “digital asset” that you can use to nurture and protect your brand and engage consumers. Complete food traceability, starting at the harvest and ending in your customers’ homes, builds an ironclad product provenance and a compelling story you can promote and share. Today’s consumers, especially with the health and safety of their families foremost in their minds, are demanding more from brands — more information, more transparency, more quality, more interaction. As we wrote last fall, food traceability is creating a new kind of “consumer kingdom,” and it’s a digital supply chain that’s making it possible.

Food traceability: An FDA priority

In “Modernizing Food Recall Management,” we talked about the FDA’s New Era of Smarter Food Safety. Announced in April 2019, it’s “a new approach to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system.”

Then, in July 2020 the Administration released the “New Era of Smarter Safety Blueprint,” which included a Food Traceability Proposed Rule designed to “help the FDA rapidly and effectively identify recipients of foods on its Food Traceability List to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.”

Next, to ring in 2021, the Administration on January 12 “made clarifying edits” to the Food Traceability List and published a FAQ for the Food Traceability Proposed Rule.

The Food Traceability List contains the foods that have additional traceability recordkeeping requirements per the Proposed Rule. The January 12 edits did not add or remove items from the list; instead, the FDA changed the descriptions of some commodities. For example, “fresh” was added to several fruits and vegetables “to clarify the scope of those commodities.” Revisions also clarified what cheeses fell under the category of “cheeses, other than hard cheeses.” See the FDA’s four-page memo for all the changes.

The FAQ for the Food Traceability Proposed Rule addresses questions the Administration has received about the Proposed Rule. Its primary goal is “to assist stakeholders who are considering providing feedback during the comment period, which has been extended until February 22, 2021.” If you want to submit a comment or review the comments that have been submitted, go to regulations.gov (Docket ID: FDA-2014-N-0053).

Final thoughts

Companies and governments around the world have been compelled to re-examine the security, efficiency, and resilience of their supply chains. Food traceability is vital to public health and safety, so it should rightfully remain a top priority.

rfxcel was founded on the principle of helping consumers know where products come from and being able to confirm that they’re safe and legitimate. With rfxcel’s Traceability System, Integrated Monitoring, Mobile Traceability app, and other solutions for food traceability, you’ll increase food quality and safety, modernize and improve recall management, optimize inventory tracking, and improve every aspect of customer service and interaction.

In other words, food traceability in a digital supply chain from rfxcel will ensure you’re doing everything possible to safeguard your customers, your brand, and your bottom line. No matter where you do business — the United States, Europe, Asia, South America, the Middle East — we can help make sure you’re ready for whatever 2021 (and beyond) has in store. Contact us today to arrange a demo.

Modernizing Food Recall Management

“Recall” is the one word food companies never want to hear. But recalls are a fact of life, so it’s the wise manufacturer, wholesaler, and retailer that prepares for the inevitable. What does it take to have fast, effective food recall management? The short answer is that you need to modernize your supply chain so you can act quickly based on high-quality data. Let’s take a look.

“Modernize” is today’s food and beverage buzzword

The Food Safety Modernization Act (FSMA) has been in effect for almost a decade, so modernizing the food and beverage supply chain isn’t a new idea. Designed to improve the security and safety of the U.S. food supply, FSMA focused on preventing food-borne pathogens across the food system. It also encouraged companies to be proactive instead of reactive when it comes to food safety — including how they deal with food recall management.

Now, the U.S. Food and Drug Administration (FDA) has ratcheted up its food safety efforts. On April 30, 2019, it announced the New Era of Smarter Food Safety, which it describes as “a new approach to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system.” To be rolled out over the next decade, it’s “also about simpler, more effective, and modern approaches and processes.”

In other words, more modernization that builds on FSMA. The “ultimate goal is to bend the curve of foodborne illness in this country by reducing the number of illnesses.”

Then, in July 2020, the Administration released the “New Era of Smarter Safety Blueprint” that

“ … outlines achievable goals to enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models, reduce contamination of food, and foster the development of stronger food safety cultures. It outlines a partnership between government, industry, and public health advocates based on a commitment to further modernize our approach to food safety.”

The Blueprint also includes a Food Traceability Proposed Rule (formal title: “Requirements for Additional Traceability Records for Certain Foods.”) It would implement Section 204(d) of FSMA, with requirements to “help the FDA rapidly and effectively identify recipients of foods on its Food Traceability List to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.” The list includes fruits and vegetables, fish, shellfish, cheeses, nut butters, eggs, herbs, and ready-to-eat salads.

What does modernization mean for food recall management?

It’s clear that FSMA and the New Era of Smarter Food Safety have recalls in mind when they mandate modernization or propose procedures to attain it. However, with or without the influence of regulations, rules, blueprints, and lists, modernization boils down to two things for food recall management: digitization and traceability.

A digital supply chain with end-to-end traceability delivers speed and high-quality data, the most crucial aspects of food recall management. Digitization — eliminating the physical paper trail in favor of a cloud-based management system — enables end-to-end traceability, and end-to-end traceability means you have rich, actionable data available in real time so you can find products quickly, make informed decisions, and act with authority and assuredness.

Digitization and traceability also expediate food recall management because they allow you to easily share information with your trading partners and regulators. If you’re a manufacturer or wholesaler, you’ll keep retailers up to date so they can take the recalled product off the shelves. Consumers benefit too, because they’ll get recall alerts and know to return the product or dispose of it as instructed.

Modernizing food recall management also helps mitigate the very things that can trigger a recall in the first place, such as poor visibility into the supply chain, lack of accountability, or an insufficient safety culture. Indeed, it’s up to companies to fix such shortcomings internally through training and establishing safety protocols, but digitization and traceability will carry and facilitate safety across the entire supply chain.

For instance, you can attach critical tracking events (CTEs) and key data elements (KDEs) to every product’s digital profile, creating an indelible provenance you can trace up and down the supply chain. You’ll see where a product has been, where it is (or is supposed to be), and where it’s going. During a recall, you can “reach into” your supply chain and extract the product quickly.

Final thoughts

As we move into 2021, F&B companies have absolutely no excuses to put off modernizing their supply chains and recall management systems. A poorly handled recall can result in catastrophic financial loss and cause irreparable damage to your reputation. And companies that don’t modernize will likely find themselves pursued by regulators, ostracized by trading partners, shunned by consumers, and, ultimately, out of business.

rfxcel can help. Our award-winning Traceability System (rTS) is the basis of a modernized, digital supply chain with fully customizable and scalable solutions that yield complete end-to-end traceability. It is the foundation of a digital supply chain and a successful food recall management system that operates with surgical precision.

For example, our Serialization Processing (rSP) solution assigns every product a unique digital ID that lets you locate affected products quickly, remove them from circulation, and record and verify that every recalled item was destroyed. Furthermore, rSP generates last-mile data that helps you identify the source of outbreaks and their scope for better consumer safety efforts.

Coupled with rSP, our Raw Materials Traceability (rRM) and Finished Goods Traceability (rFG) solutions build a digital supply chain that aids food recall management by maintaining a validated, traceable pedigree for every product. Track the transformation of raw materials into finished goods with total forward and backward traceability. Track lot to unit or unit to lot all the way to the consumer. Attach key data to every critical tracking event digitally. And if there’s a recall, see how exposed you are and respond rapidly by notifying affected customers and trading partners and changing the disposition of all units/lots to “RECALL” to prevent them from being included in any ship event. You can also use your data to aid investigations.

Contact us today to speak with one of our F&B supply chain experts. They’ll give you a short rTS demo that will show you how an rfxcel digital supply chain with end-to-end traceability will modernize your operations and optimize your food recall management.

Industry Reaction to Delayed Enforcement of DSCSA Saleable Returns

The Healthcare Distribution Alliance (HDA) sponsored a meeting on October 28 with more than 100 pharma industry stakeholders to discuss how the Food and Drug Administration’s (FDA) 3-year delay of enforcing the U.S. Drug Supply Chain Security Act (DSCSA) Saleable Returns Verification Requirement will affect its constituents.

This was the first formal meeting about the FDA announcement and marked the beginning of industry discussion that will no doubt continue well into the future. Below are some of the key points raised at the meeting:

Continue with the VRS. The prevailing sentiment is to continue the Verification Router Service (VRS) effort. The enforcement delay was not intended to stop progress, but to give the industry time to ensure readiness.

The industry needs a plan. As one meeting participant correctly called out, the intent to make progress is not good enough. “We need a plan,” they said. To jumpstart this effort, rfxcel and other VRS providers will draft a 2021 road map to work toward DSCSA readiness. The road map will focus on the VRS, but may also address authorized trading partners (ATPs) and other requirements.

VRS is still a “go.” Will the pharma industry really need the VRS in 2023, the year the DSCSA stipulates full serialization of the pharma supply chain? After a healthy discussion, the consensus was that, yes, the VRS will most likely be necessary. Some in the industry anticipated the “retirement” of VRS in 2023 because wholesale distributors would at that time be performing their own verification of serial numbers. However, not all wholesale distributors agreed with this assessment.

Final thoughts

For details about the FDA’s October 23 announcement, see our blog post. And visit our website regularly for more updates about the Saleable Returns Verification Requirement and the VRS.

rfxcel is the industry leader in DSCSA compliance and the VRS. If you have any questions about the delay and what you need to do to be ready for 2023, contact us today.

FDA Delays Enforcement of DSCSA Saleable Returns Requirement

Note: For the latest industry reaction to the FDA’s announcement, read our update here.

In a policy document published on October 23, the U.S. Food and Drug Administration (FDA) announced it was delaying enforcement of key aspects of the Drug Supply Chain Security Act (DSCSA) that will affect wholesale distributors and dispensers. The regulations were due to go into effect on November 27 of this year; now they won’t be enforced until November 27, 2023.

The delay, the second since 2019, pertains to the requirement to verify saleable returns under the DSCSA law. It also included guidance for wholesale distributors concerning transaction statements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Here are the details.

Wholesale distributors: product identifiers

The FDA announced that it did “not intend to take action against” wholesale distributors that did not verify product identifiers before further distributing returned products as required under the DSCSA.

It explained that wholesale distributors, other trading partners, and stakeholders had expressed concern about industry readiness to implement the Saleable Returns Verification Requirement since the delay in November 2019. Specifically:

  • Challenges developing interoperable, electronic systems to enable verification and achieve interoperability between networks
  • More time needed to test verification systems using real-time volumes of returned product with all trading partners
  • Significant delays testing verification systems due to the COVID-19 pandemic, especially because logistics and supply chain experts were reassigned from DSCSA preparation to responding to the pandemic

Wholesale distributors: transaction statements

The FDA also addressed transaction statements under the FD&C Act. This is a little complicated, so we’ll take it one step at a time.

Section 582 of the FD&C Act requires manufacturers, repackagers, wholesale distributors, and dispensers to exchange transaction information, transaction history, and a transaction statement — known collectively as “T3 information” — for transactions involving certain prescription drugs.

Section 581 of the FD&C Act requires transaction statements to include a statement that the entity transferring ownership — wholesale distributors in this case — had systems and processes in place to comply with verification requirements under Section 582.

Now, “prior to November 27, 2023, [the] FDA does not intend to take action against” wholesale distributors whose transaction statements do not include the statement required under Section 581. See pp. 7–8 of today’s announcement for full details about this change.

Distributors: product identifiers for suspect/illegitimate products

Distributors have also received a 3-year reprieve concerning requirements for product identifiers. The FDA said it did “not intend to take action against” dispensers that did not verify the statutorily designated portion of product identifiers of suspect or illegitimate product before November 27, 2023.” Section 582 of the FD&C Act stipulates how dispensers must investigate suspect and illegitimate products.

Final thoughts

If you’re a wholesale distributor or dispenser and have questions about these changes to the saleable returns verification requirement — or anything else about the DSCSA — we can help. rfxcel is the industry thought leader in DSCSA compliance, including the Verification Router Service (VRS), and we are ready to help you make the most of this extra time.

Contact us today and our supply chain experts will show you how our award-winning rfxcel Traceability System will fully prepare you for the DSCSA. We’ll answer your questions, address your concerns, and customize a solution that will ensure you’re compliant. The extra breathing room is nice, but the time to act is now.

DSCSA 2020: November Is Coming & It’s Time to Comply

Note: The FDA has delayed enforcement of the DSCSA for dispensers and wholesale distributors. Read the details here.

The next deadline for the U.S. Drug Supply Chain Security Act (DSCSA) is November 27. That means there’s only a little more than a month to comply. DSCSA 2020 means different things to different stakeholders. Here’s what you have to do if you’re a dispenser or a wholesale distributor.

DSCSA 2020 for dispensers (pharmacies, clinics, hospitals, healthcare systems, etc.)

If you’re a dispenser — an independent pharmacy or a pharmacy in a hospital, clinic, grocery store, or anywhere else — DSCSA 2020 means that you must be able to authenticate and verify all the medicines you buy before you can sell them to consumers.

You must meet two key requirements by November 27:

  1. You can buy and sell only products encoded with product identifiers (PIs). A PI contains a lot number, an expiration date, and the product’s standardized numerical identifier (SNI). The SNI includes the National Drug Code and a unique alphanumeric serial number.
  2. You must verify every product at the package level, including the SNI.

Because the clock is ticking and we want to help, our DSCSA Strategic Advisor Brian Files is hosting a special DSCSA 2020 Q&A session this Thursday, Oct. 15, at 12 p.m. PST/3 p.m. EST. Send your questions today, and Brian will answer them in this live Zoom event.

If you haven’t begun to prepare, Brain will tell you it’s critical to start now. Contact us. We have a proven a track record of success with DSCSA compliance. We have in-house DSCSA experts who will analyze your needs, explain what you need to do, and build a scalable solution tailored to your operations.

Also keep in mind that you must also be able to exchange “T3” information about every drug you buy and who handled it each time it changes ownership in the United States. T3 information” includes Transaction Information (TI) about a product (e.g., proprietary or established name or names and the strength and dosage form); Transaction History (TH), an electronic statement with the TI for every transaction going back to the manufacturer; and a Transaction Statement (TS), which is an electronic statement confirming the entity transferring ownership. We know all about T3 information. Read more about it here.

DSCSA 2020 for wholesale distributors

If you’re a wholesale distributor, DSCSA 2020 means must verify returned products before you can reintroduce them to the supply chain. You’ll do this through the Verification Router Service (VRS), an automated system that verifies if a PI is valid. You’ll initiate a verification request to a manufacturer to verify the PI of the returned product.

There are multiple VRS providers, and each is responsible for determining if a specific group of PIs is valid.  You can call any VRS provider to verify if a PI is valid, but if they do not manage the PI in question, they will automatically route your verification request to the provider that does. All of this happens in real time, and VRS ensures that information is accurate and up to date.

rfxcel is the thought leader in the DSCSA saleable returns verification requirement and the VRS. We implemented a VRS pilot for the Food and Drug Administration and extended industry testing of the VRS. Contact us today, and we’ll share our expertise in supply chain track and trace, serialization, and compliance solutions to make sure you’re ready for DSCSA 2020. We’ll also be happy to share our final report about the FDA pilot.

Final thoughts

The DSCSA was enacted to promote patient and consumer safety by facilitating product tracing in the pharma supply chain and ensuring the authenticity of products. DSCSA 2020 is the next step in verifying drugs.

November 27 will be here before you know it. If you’re a dispenser or a wholesale distributor, we can help. Reach out to us now and our supply chain experts will show you how our award-winning rfxcel Traceability System can ensure you comply with DSCSA 2020.