April 2020 - rfxcel.com
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Month: April 2020

What Do Pharma Dispensers Have to Do for the DSCSA?

Posted on by rfxadmin

If you’re a pharma dispenser, the Drug Supply Chain Security Act (DSCSA) is going to fundamentally change how you do business. What do pharma dispensers have to do for the DSCSA, you ask? There’s a big deadline coming up this November, but let’s take things in order. Here we go!

First things first: What is the DSCSA?

The DSCSA was created as Title II of the Drug Quality and Security Act (DQSA), passed by Congress in November 2013. It’s an initiative to prevent the introduction and distribution of counterfeit, stolen, contaminated, or otherwise harmful drugs in the United States. It outlines steps to build an interoperable electronic system to identify and trace prescription drugs as they are distributed throughout the country.

The DSCSA is being rolled out in two phases:

    • Phase I (2015–2023) addresses lot-level traceability. This means exchanging information about every package of medication so supply chain stakeholders can see exactly where it has been.
    • Phase II (2023) is complete unit-level serialization of the U.S. drug supply chain. This means stakeholders will have to electronically track products at the individual package level.

Are you considered a dispenser under the DSCSA?

According to the DSCSA, a dispenser is “a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor.”

If you dispense only products to be used in animals, you are not a dispenser under the DSCSA.

2016-present: What do pharma dispensers have to do for the DSCSA?

Here’s a no-frills answer to our question, What do pharma dispensers have to do for the DSCSA? This is everything you must be doing right now.

Exchange “T3” information. Dispensers must be able to exchange “T3” information about every drug they buy and who handled it each time it changes ownership in the United States. This “product tracing 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. TH is required until the final November 27, 2023, deadline.

Confirm trading partners are licensed or registered. If you can’t confirm your partners are licensed or registered, you can’t do business with them. There’s an FDA database to check the registration of manufacturers and repackagers and the licensing of wholesale distributors and third-party logistics providers. For dispenser-to-dispenser transactions, you must check licensing through state authorities.

Receive, store, and provide product tracing documentation. This is all about the T3 information. You must accept only prescription drugs with proper T3 information. You must store the T3 information for six years. And you must generate and provide all T3 information when you sell a prescription drug to a trading partner.

Investigate and properly handle suspect and illegitimate drugs. As you might imagine, this is a big part of the answer to our question, What do pharma dispensers have to do for the DSCSA? Suspect and illegitimate drugs include drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution.

As a pharma dispenser, you must quarantine and investigate these drugs to determine if they are fake. If they are determined to be fake, you should work with the manufacturer and take specific action to ensure they do not reach patients/consumers. You must also notify the FDA and trading partners (i.e., those they bought the drug from and those they sold it to) about the compromised drug.

November 2020 deadline: What do pharma dispensers have to do for the DSCSA?

The DSCSA deadline for pharma dispensers is November 27, and it’s about authenticating and verifying drugs. You’ll have to be able to authenticate and verify all the medicines you buy before selling them. This comes down to two key requirements:

    1. You may buy and sell only products encoded with product identifiers (PIs). A PI is a standardized graphic with three elements: the product’s standardized numerical identifier (SNI), which comprises the National Drug Code plus a unique alphanumeric serial number); a lot number; and an expiration date. PIs must be in human- and machine-readable formats.
    2. You must verify every product at the package level, including the SNI. The FDA defines a package as “the smallest unit placed into interstate commerce by the manufacturer or the repackager that is intended by that manufacturer or repackager, as applicable, for individual sale to the pharmacy or other dispenser of the drug product.”

Final Thoughts

Traceability and serialization technology is the cornerstone of the DSCSA — it is also the cornerstone of our business. rfxcel has been developing leading-edge track and trace and serialization solutions since 2003. Our supply chain experts have the DSCSA in their DNA. What do pharma dispensers have to do for the DSCSA? Let us go beyond the basics we’ve explained here and help you be compliant forever.

Contact us today to learn more about how we can help you with the DSCSA and your other supply chain needs. ANd be sure to download our “Dispensers and the DSCSA white paper.”

 

 

rfxcel Takes Big Step as Leader in Russian Aggregation, Serialization & Supply Chain Compliance

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If you follow our blog or have seen our articles in industry journals, you know rfxcel is the leader in Russian aggregation, serialization, and supply chain compliance. Now we’ve taken another big step to cement our status: We’ve been named an official integration, software, and tested solution partner with Russia’s Center for Research in Perspective Technologies (CRPT).

This is big news for us, so let’s summarize how we got here and what it means.

The CRPT and Russian aggregation, serialization, and supply chain compliance

The CRPT is a public-private partnership that manages Russia’s National Track and Trace Digital System, known as Chestny ZNAK. To achieve integration, software, and test partner status, we had to show the CRPT that our supply chain software could fully manage and execute all aspects of Chestny ZNAK’s notoriously stringent compliance reporting processes. For example, here are some the requirements for pharma:

    • A 2D barcode must be placed on all units; it must include a GTIN, serial number, a verification key, and a crypto code.
    • All medications must be serialized, including over-the-counter medications.
    • Different requirements for aggregations and batches.
    • Supply chain members must report every change to individual batches.
    • Foreign manufacturers may have to report up to 36 compliance events.

So, our Moscow-based team in Russia had a lot to prove when it met with a CRPT approval board in March. They presented a comprehensive demonstration of our signature full-stack solution, rfxcel Traceability System. They also answered technical questions and share examples of compliance reports.

After an internal evaluation, CRPT notified use that it had validated our solution and designated us as an official integration, software, and tested solution partner on its website. We look forward to working with companies in the pharma, food and beverage, consumer goods, and government industries to help the with Russian aggregation, serialization, and supply chain compliance.

Final thoughts

Our success with the CRPT was due to a lot of hard work and commitment to the Russian market. When Chestny ZNAK became law on December 29, 2017, we began honing our operations in Russia. In August 2019, we reported that we had doubled the size of our team in Russia; since then, we’ve tripled in size. As our CEO Glenn Abood said, “Today, we’re one of a very few supply chain solution providers with active implementations in the country, and we’re working with more and more companies as our reputation for ironclad compliance and supply chain management grows.”

Of course, we’re thrilled about our progress in Russia. It all boils down to the quality of our solutions and the knowledge and skill of our people, who have expertise in key areas of supply chain management and technology. They all speak the Russian, of course, and they know the regulations inside and out. They understand how to meet our customers’ needs while ensuring they’re fully compliant with Russian aggregation, serialization, and supply chain compliance requirements.

Contact us today learn more about how rfxcel can help you with Russian regulations. And be sure to ask about our other track and trace and compliance solutions. Sure, we’re the leader in Russian aggregation, serialization, and supply chain compliance solutions, but we can optimize any supply chain anywhere in the world. Ask us how!

rfxcel Becomes Official Partner with Russia’s CRPT

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Reno, Nevada, April 15, 2020. rfxcel, the global leader in digital supply chain traceability solutions, has been named an official integration, software, and tested solution partner with Russia’s Center for Research in Perspective Technologies (CRPT). The CRPT is a public-private partnership that manages Russia’s National Track and Trace Digital System, known as Chestny ZNAK.

Members of rfxcel’s Moscow-based team met with CRPT to demonstrate its signature full-stack solution, rfxcel Traceability System, answer technical questions, and share examples of compliance reports. After an internal evaluation, CRPT notified rfxcel that it had validated its solution and designated the company as an official integration, software, and tested solution partner on its website.

rfxcel CEO Glenn Abood said the success with the CRPT was the culmination of a lot of hard work in Russia. “We decided quite some time ago to commit ourselves to leading in Russia,” he said. “Today, we’re one of a very few supply chain solution providers with active implementations in the country, and we’re working with more and more companies as our reputation for ironclad compliance and supply chain management grows. We’ve tripled the size of our team there over the last year, and I can’t say enough about what they’ve accomplished.”

Enacted by Federal Law No. 425-FZ on December 29, 2017, Chestny ZNAK was designed to protect consumers by keeping fake and substandard products out of the market. As envisioned, by 2024 it will transform the Russian supply chain and affect virtually every industry, from pharmaceuticals, footwear, and photography equipment to tires and tobacco. The CRPT has managed Chestny ZNAK since November 2018.

“It all comes down to the quality of our solutions, the companywide support we’re getting, and the knowledge and skill of our people here,” said Victoria Kozlova, rfxcel’s general director of Russian operations. “We speak the language. We know the regulations inside and out. We understand how to meet customers’ requirements while ensuring they’re fully compliant with Russia’s strict regulations.”

CEO Abood concluded by putting the accomplishment into context. “Though this is an exciting time for us in Russia, it comes at a time when ‘business as usual’ has been turned on its head due to COVID-19. All our teams are working to keep supply chains moving where they need to go, including hospitals, clinics, supermarkets, and other critical locations. And we recently joined the COVID-19 Healthcare Coalition, donating our rfxcel Integrated Monitoring and Accurate Immunization Management solutions. We are working hard to be part of the solution.”

For more information on how rfxcel can help your company comply with Russian regulations or to learn more about rfxcel’s track and trace and compliance solutions generally, contact Vice President of Marketing Herb Wong or visit rfxcel.com. Mr. Wong can also answer questions about our response to the COVID-19 pandemic.

 

About rfxcel

Founded in 2003, rfxcel provides leading-edge software solutions to help companies manage every aspect of their supply chains, lower costs, and protect their products and brand reputations. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s signature Traceability System (rTS) to power end-to-end supply chain solutions in key areas such as traceability, environmental monitoring, regulatory compliance, serialization, and visibility. The company is headquartered in the United States and has offices in the EU, Britain, Latin America, Russia, the Middle East, India, Japan, and the Asia-Pacific region.

Why F&B Needs Real-Time Supply Chain Environmental Monitoring

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The F&B supply chain is becoming more complex. Routes that involve road, rail, sea, and air create many potential points of failure that, until recently, companies could not control or even detect. These “blind spots” include problems safeguarding food safety, deviations from required environmental conditions, theft, food fraud, and poor handling practices. This is why F&B needs real-time supply chain environmental monitoring.

Let’s take a closer look at some of these blind spots and how real-time supply chain environmental monitoring can minimize or eliminate them.

Common blind spots in the F&B supply chain

Food fraud. Food fraud costs the F&B industry at least $65 billion a year. All kinds of foods are counterfeited and incorrectly labeled, from luxury products such as Japanese Wagyu beef to more common items such as olive oil and seafood. Furthermore, buyers and consumers often have no way to trace the origins of what they’re purchasing.

Diversion and theft. Diversion and theft can happen at any supply chain blind spot. F&B cargo is valuable, easy to sell, and often perishable, and evidence of the theft does not last very long. The U.S. Federal Bureau of Investigation estimates that cargo theft costs U.S. businesses $30 billion each year, and food and beverages were among the top commodities targeted by thieves in North America last year, accounting for 34 percent of all cargo theft.

Ensuring quality and safety. It’s virtually impossible to ensure food quality and safety when cargo is poorly handled. Products can be exposed to and damaged by water, heat, and cold. Food is susceptible to contamination and spoilage if environmental conditions aren’t just so. Such damage can be particularly acute in the cold chain, where perishable products must be moved quickly under exacting parameters of temperature, humidity, and light.

Routing inefficiencies. Not monitoring traffic? Not using GPS location tracking? Not adhering to local, state, federal, or international transport regulations? No matter how basic or complicated, routing inefficiencies have the same consequences: delayed shipments, product spoilage, shortened shelf life, lost revenue. Plus, routing and environmental monitoring have become even more important as governments tighten oversight of the F&B supply chain. A perfect example is the Food Safety Modernization Act (FSMA), which the U.S. Food and Drug Administration designed to better protect consumers by strengthening food safety systems for foodborne illnesses.

Recalls. Though not a blind spot, per se, recalls can take companies by surprise and are a particularly important consideration. According to a study published in 2012 by the Food Marketing Institute and Grocery Manufacturers Association (GMA), the direct costs of a recall can reach $10 million. A separate GMA-sponsored survey reported that 5 percent of companies incurred more than $100 million in direct and indirect costs.

How does real-time supply chain environmental monitoring work for F&B?

Real-time environmental monitoring solutions give a vibrant and detailed picture of where products are and what is happening to them. Integrated monitoring in the F&B supply chain provides better continuity, visibility, security, and productivity. But how does it work, exactly?

Pallets, cases, or containers are equipped with Internet of Things (IoT)-enabled sensors that send data over communication networks at regular intervals. The sensors provide real-time information about how long an item has been in transit, if the vehicle transporting it adhered to the approved route, and, if the shipment stopped, where and for how long. This is crucial information, especially for highly perishable goods. For example, leafy greens can be ruined if a truck’s engine and cooling system are turned off for hours at a border crossing. With real-time environmental monitoring and tracking, companies can understand and act upon specific risks with detailed, unit-level data.

Data is made available via a software platform, through which users can set parameters (e.g., minimum and maximum temperature) to alert the system of irregularities or generate reports for analysis. This data is associated with the traceability data and becomes part of a product’s pedigree, making it a powerful tool for F&B supply chain visibility.

Environmental monitoring allows F&B companies to monitor their supply chains, protect consumers, protect their brands, and realize considerable return on investment. The technology can show companies how to maximize route efficiencies, change shippers, or detect theft or diversion in real time. The IoT-enabled sensors transmit alerts, empowering manufacturers and suppliers to use data to halt shipments that may have been adulterated, redirect shipments to extend shelf life, and manage food recalls — or avoid them altogether.

Final Thoughts

FSMA has shifted the responsibility for safety to F&B companies. Now, they must be proactive, not reactive. With real-time supply chain environmental monitoring, companies get actionable data that they can deploy to make decisions immediately, not after the fact when it’s too late. When necessary, they can divert or reroute shipments or take actions to remedy temperature excursions and other environmental concerns. Third-party logistics firms and contracted delivery companies can be held accountable for incidents and inefficiencies. This saves money and protects brand reputations.

Our rfxcel Integrated Monitoring (rIM) solution lets you see your products in real time and mine rich unit-level data about more than a dozen environmental conditions. It can integrate with multiple sensor devices or data loggers on land, sea, and air. With rIM, you get a truly complete view of your shipment — at a top-level (e.g., case, pallet, truck) and at an item level (e.g., packet, bottle). You’ll reduce costs and make proactive decisions based on variables such as temperature, tilt, humidity, light, and shock. By mitigating damage, delays, and diversion, your products will arrive safe and on time.

rIM also combats the key blind spots we talked about above: food fraud, diversion and theft, quality and safety concerns, routing inefficiencies, and recalls. Its real-time supply chain environmental monitoring will streamline your operations, prevent waste and financial losses, protect your investments and brand identity, and give you an advantage in the marketplace. If this sounds good, contact us today to talk about rIM with an rfxcel supply chain expert!

Compelling Arguments for Transparency in the Global Seafood Supply Chain

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This is the last installment of our global seafood supply chain Transparency Trilogy. Thanks for reading!

If you read our first and second blogs about transparency in the global seafood supply chain, you probably feel that the seafood sector needs to change its tune. Sure, industry thought leaders are re-evaluating how they do business and have taken some initial steps to make transparency the norm — that’s what leaders do — but widespread change has yet to come.

The seafood supply chain remains opaque and complex. There are countless opportunities for products to be compromised as they change hands over and over again on their global journey “from catch to plate.” Fish populations continue to be depleted. Trading partners don’t always trust each other, and they certainly don’t always like to share their data (if they have any data at all). And people continue to be exploited and abused on land and sea.

Let’s look at a few of the most pressing problems facing the industry and how transparency can help solve them.

The specter of slavery

Yes, slavery.

In a 2014 blog post, Human Trafficking Search, an international organization that seeks to raise awareness and help prevent and eliminate human trafficking worldwide, wrote, “It is not a new revelation that slavery plagues the global food system.”

So, six years ago, slavery was “not a new revelation.” Alas, more recent headlines confirm the global seafood supply chain has not dealt with this problem:

If ever there was an argument for change in the global seafood supply chain, this is it. Transparency will combat slavery by shining a light on who is doing the fishing, who is processing and transporting the seafood, etc. We’re all in.

Illegal, unreported, and unregulated (IUU) fishing

UII fishing includes fishing during off-season breeding periods, catching and selling unmanaged fish stocks, and selling fish caught by slaves. It threatens the stability of seafood ecosystems in every body of water where it occurs.

According to the Food and Agriculture Organization of the United Nations (FAO), IUU fishing “remains one of the greatest threats to marine ecosystems due to its potent ability to undermine national and regional efforts to manage fisheries sustainably as well as endeavors to conserve marine biodiversity.”

Furthermore, the FAO reports that IUU fishing accounts for as much as 26 million tons of seafood annually, valued between $10-23 billion. It capitalizes on corrupt governments and exploits weak management systems. In some countries, it has been linked to organized crime. It depletes resources, which can cause local fisheries to collapse. It threatens livelihoods, intensifies poverty, and increases food insecurity.

Transparency helps mitigate UII fishing because it enables buyers and wholesalers to guarantee the provenance of their product. It will help shrink markets for illegally sourced fish, as more trading partners — and consumers — will demand data that proves seafood is from a legal, regulated source and has been reported to the appropriate government agencies.

Food fraud

Food fraud is the illegal practice of substituting one food for another. It’s very dangerous, and it happens around the world, usually when the supply for a commodity fluctuates. To keep an in-demand product flowing to customers, fishermen and restaurateurs can feel pressure to commit seafood fraud, replacing one species for another.

Studies by Oceana, which works to protect and restore the Earth’s oceans, illustrate how pervasive food fraud is. For example, between March and August 2018:

    • Twenty-one percent of 449 fish Oceana researchers tested were mislabeled.
    • One-third of establishments sold mislabeled seafood.
    • Mislabeling was found at 26 percent of restaurants, 24 percent of small markets, and 12 percent of larger chain grocery stores.
    • Sea bass and snapper were mislabeled the most.

Transparency fights food fraud by holding all nodes of the seafood supply chain accountable for what they’re selling. Put simply, with transparency, there’s nowhere for unscrupulous actors to hide.

Consumer health and food safety

Without a transparent supply chain, it’s difficult to safeguard consumer health and food safety. Imagine what a widespread foodborne illness outbreak and consequent recalls would look like without supply chain transparency and traceability.

As with the problems we’ve discussed above, the seafood industry isn’t fully part of the solution for consumer health and food safety concerns. Food fraud (species substitution) continues to make people sick and cause death. Mishandled seafood continues to carry high histamine levels, posing health risks to millions of people.

People want to assume they are eating safe, authentic food. Transparency will not only give consumers peace of mind, it will go a long way to build — or rebuild — their sense of trust with the seafood industry. In every aspect, transparency is a win-win for everybody.

Final thoughts about transparency in the global seafood supply chain

To wrap up our transparency trilogy, we want the seafood industry to know that supply chain transparency is within reach and that it doesn’t have to be painful.

Forgive the pun, but the world is the industry’s oyster: Help is available all around you. Government and global initiatives such as the GDST want to work with you to become more sustainable, environmentally friendly, and ethical. Consumers are also ready to help; if you build transparency into your supply chain, they will come.

And rfxcel is with you too, here to answer your questions about achieving transparency in your supply chain. We want you to know you have three options that we call “Keep, Replace, Provide”:

    • Keep your current system, but integrate it with new solutions.
    • Replace outdated systems with less complicated solutions that, in the long run, do more for less money.
    • Look to rfxcel to provide a new supply chain system that closes all the gaps and brings you to full transparency.

Take a look at our signature rfxcel Traceability System (rTS), the most complete and flexible raw materials and finished goods traceability solution for the industry. Check out our rfxcel MobileTraceability app, which can track any batch, movement, and handler at any location, putting the power of a digital supply chain at your fingertips. And our rfxcel Integrated Monitoring (rIM) solution lets supply chain actors see their products in real time and mine rich unit-level data about more than a dozen environmental conditions.

Learn more about these and our other solutions for F&B here and contact us to start a conversation about transparency in your supply chain.

rfxcel Joins the COVID-19 Healthcare Coalition, Offers rIM and AIM Solutions

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rfxcel has joined the COVID-19 Healthcare Coalition, a collaborative private-industry response to novel coronavirus that brings together leading organizations in healthcare, technology, academia, the nonprofit sector, and government.

Members of the COVID-19 Healthcare Coalition include a “Who’s Who” of American healthcare and business, including the Mayo Clinic, Pfizer, athenahealth, and Amazon Web Services. (See the most recently updated list here.) Each will bring its unique assets to support industry stakeholders, front-line responders, and federal, state, and local government organizations in the COVID-19 pandemic.

rfxcel is happy to offer two of our cutting-edge supply chain solutions, rfxcel Integrated Monitoring (rIM) and Accurate Immunization Management (AIM), as part of its contribution to the coalition. More on this below.

More about the COVID-19 Healthcare Coalition: Goals, Principles

The goal of the COVID-19 Healthcare Coalition is to save lives through data analytics. Gathering real-time data is key to learning about COVID-19 and how to best deliver healthcare to protect public health.

The coalition operates according to five guiding principles. Quoted from its website, they are:

    • Everyone participates for the benefit of the country only — no preferential advantage to any one organization.
    • Everyone cooperates and openly shares their plans.
    • Nobody will get paid for coalition work – without exception. Everyone brings their own resources – no money is exchanged.
    • Verbal agreements will suffice to get us started.
    • Agree to these terms and conditions and you are in.

As of April 7, the coalition said it was organizing around five priorities as it “urgently [tries] to work at the speed of the pandemic”:

    • Connecting personal protective equipment (PPE) suppliers worldwide to healthcare organizations with immediate needs for N95 masks, ventilators, and protective gowns
    • Connecting government COVID-19 initiatives to startups to rapidly accelerate ventilator supplies
    • Connecting the best protocols for treating COVID-19 from across the nation and sharing them online for the public good
    • Connecting an ecosystem of private sector capabilities to accelerate telehealth, home care, and alternative options to reduce load at hospitals
    • Connecting the best sources of information from around the world to provide data, analytics, and insights to all

rfxcel’s contribution to the COVID-19 Healthcare Coalition

Our Washington, D.C.-based Worldwide Government Group is leading our efforts in the coalition’s fight against COVID-19. This team of government and supply chain experts focuses on mission readiness and develops tools to protect the supply chain against disruptions for the most vulnerable products. It will support the Supply Chain Working Group, facilitated by MITRE Corporation, to bring rIM and AIM to coalition members.

Here’s how our powerful solutions will contribute to the coalition’s goals:

    • rIM is award-winning solution that uses Internet of Things (IoT) technology to monitor the environmental condition of products in real time as they move through supply chains on land, sea, and air. It is widely used in pharmaceutical cold chains to monitor high-value medical supplies, including vaccines. rIM communicates with small IoT-enabled devices embedded with products and sends updates and alerts about more than a dozen environmental conditions, such as temperature, humidity, light, orientation (tilt), and shock. It also monitors location, so it can alert users about route diversions and ensure logistics providers remain in compliance with delivery agreements. It can monitor at both the top level (e.g., case, pallet, truck) and the item level (e.g., syringe, packet, bottle), yielding true supply chain traceability and transparency.

 

    • AIM is an automated, cloud-based solution that tracks the dispensing of vaccines — including potential vaccines for COVID-19 — in the supply chain and seamlessly integrates with critical healthcare applications such as Electronic Health Records (EHRs) and Immunization Information Systems (IIS). It empowers healthcare practitioners to view patients’ immunization records in real time, manage accurate administering, monitor inventory, and safely dispense the right vaccines to the right patient at the right time. AIM utilizes Centers for Disease Control and Prevention (CDC) rules and guidance for vaccine combinations, special populations, and required intervals between vaccines, and adheres to U.S. Food and Drug Administration (FDA) rules for dispensing. Because it is automated, users can be up and running with virtually no training, ensuring quick implementation in mission-critical locations.

Final thoughts

rfxcel is proud to be a member of the COVID-19 Healthcare Coalition. As Greg Moulthrop, vice president of our Worldwide Government Group, said, “We care about protecting the public … With rIM and AIM, rfxcel can do its part to safeguard people and, we hope, hasten both the end of COVID-19 and the recovery of our communities and economy.”

Our CEO, Glenn Abood, added, “We feel that our everyday work is helping by keeping supply chains moving in the pharma, food and beverage, and consumer goods industries, but we felt we could do more. When Greg told us about the coalition, we were all in.”

To learn more about rfxcel’s work with the COVID-19 Healthcare Coalition or what rfxcel offers the government, contact our Worldwide Government Group at publicservices@rfxcel.com or visit rfxgov.com. To learn more about all our supply chain solutions, contact Vice President of Marketing Herb Wong at hwong@rfxcel.com and take a look around our website.

How Transparency Benefits the Global Seafood Supply Chain

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This is Part 2 of our global seafood supply chain Transparency Trilogy. Check back on Friday for the last installment, as well as other food and beverage news!

In the first part of our trilogy, we talked about why the worldwide call for global seafood supply chain transparency has gotten louder and louder. Now we’re ready to talk about how transparency benefits the supply chain itself.

Spoiler alert: It just makes everything better!

Can a penny-pincher be proactive?

If asked, most seafood companies would probably say their intentions are good and they support a “do no harm” approach in their operations. They see themselves as guardians of a well-managed resource; indeed, they’d argue that it’s in their best interests to promote sustainability, legal fishing practices, environmental responsibility, and supply chain transparency. After all, if fish populations dwindle, they could be out of business.

Many companies have policies that require their buyers to verify (as much as possible) that the seafood they procure meets minimum standards for sustainability, safety, and quality. Such self-regulation is a good first step, but the reality is that enforcing these standards is tough. Very tough.

Lack of transparency in the supply chain is one reason for this. But given its overwhelming “pros,” why do seafood companies continue to view transparency as a cost rather than an investment? Sure, it takes money — sometimes a lot of money — to implement the systems, but there are compelling reasons for actors in the seafood industry to open their wallets and get on board with transparency in a digital supply chain.

The benefits of global seafood supply chain transparency: What stakeholders should know

From “catch to plate,” transparency benefits everybody in the seafood supply chain. Here’s how.

Suppliers. These are the processors and manufacturers. They benefit from transparency because it allows them to protect their business investments and comply with regulations. Suppliers can use transparency data to show their trading partners and consumers that they are doing things the right way, the responsible and sustainable way. Transparency also lets them control their supply chains more accurately and improves the quality of their product, also important selling points for partners and consumers.

Suppliers can also use transparency to build their brand reputations. For example, they can engage with consumers directly, using data to demonstrate that their products are sustainably sourced and legitimate, and that they are responsible corporate citizens. These are qualities that consumers will demand more, not less, as they have ever-expanding ways to verify what they’re buying and more options for where to spend their money.

Brands and distributors. Transparency lets brands and distributors know exactly what they’re purchasing, which will give them peace of mind about the origins, sustainability, and legitimacy of the products they offer. Furthermore, like suppliers, they can comply with regulations, such as the U.S. Seafood Import Monitoring Program (SIMP). Brands and distributors can also use transparency to build their reputations and solidify their relationships with customers. Being able to prove the who, what, when, where, how, and why of their products is a powerful tool for branding and communications.

Retailers, food service groups/providers, and consumers. High-quality products with traceable provenance give retailers and food service companies better control over their supply chains and more ways (i.e., data) to protect their brands. Like suppliers, brands, and distributors, they’ll be able to entice customers and secure their loyalty.

At the very end of the supply chain, it’s consumers who stand to gain the most from transparency. They’ll know where their seafood comes from. They’ll know it’s safe, and they’ll feel good about being responsible shoppers. And as transparency really becomes the norm, they’ll be inclined to purchase only products that can prove provenance, and only from companies that can prove they are “doing the right thing” when it comes to the global seafood supply chain.

Final thoughts about global seafood supply chain transparency

rfxcel is part of the transparency solution. If you read our last blog about transparency in the global seafood supply chain, you’ve seen that our solutions optimize traceability, transparency, efficiency, and quality so supply chain stakeholders and consumers alike can reap the benefits.

For seafood and all other F&B supply chains, the latest version of our signature rfxcel Traceability System (rTS) is the most complete and flexible raw materials and finished goods traceability solution for the industry. Our rfxcel MobileTraceability app can track any batch, movement, and handler at any location, putting the power of a digital supply chain at your fingertips. And with our rfxcel Integrated Monitoring (rIM) solution, supply chain actors can see their products in real time and mine rich unit-level data about more than a dozen environmental conditions.

Learn more about these and our other solutions for F&B here.

READ THE LAST INSTALLMENT OF OUR SEAFOOD TRANSPARENCY TRILOGY

Analyzing India’s Drug Export Restrictions and the iVEDA Portal

Posted on by rfxadmin

In recent weeks, India has made major changes to its exporting policies, launched its new iVEDA portal, and postponed pharmaceutical regulations. The timing — in the midst of the COVID-19 pandemic and a 21-day lockdown of the country’s 1.3 billion people — raised eyebrows in both industry and government circles. Let’s take a look at what’s been happening.

Restrictions on the export of active pharmaceutical ingredients (APIs) and medicines

India is the world’s primary source of generic drugs, so its announcement last month that it was restricting the export of 13 APIs and 13 associated medicines was unwelcome news in many quarters. Indian drug manufacturers must get government permission to ship any of these APIs or medicines overseas, including:

    • Paracetamol (a.k.a. acetaminophen), which is used in Tylenol
    • Acyclovir, an antiviral used to treat shingles
    • Antibiotics, including neomycin, clindamycin salts (i.e., hydrochloride), tinidazole, metronidazole, and chloramphenicol
    • Progesterone, a hormone supplement found in birth control pills
    • Vitamins, including B-12

India manufactures at least 20 percent of the world’s generic drugs; the restricted items account for about 10 percent of the country’s pharma exports. According to the FDA, in 2018, 24 percent of medicines and 31 percent of medicine ingredients imported into the United States came from India. The U.S. and Indian governments are currently holding discussions to ease the restrictions.

There has been pushback from India’s pharma sector. For example, it’s been reported that the Pharmaceuticals Export Promotion Council of India (Pharmexcil) wrote India’s Directorate General of Foreign Trade (DGFT) to protest that the restrictions will cause Indian drug companies to lose money and could harm their “credibility and reputation in the international market.”

Generic drug manufacturers in India had talked of shortages if COVID-19 continued in China, the source of many APIs for the Indian market. The Indian government has said the restrictions would be temporary. We will continue monitoring this supply chain story and provide updates when needed. Check back often.

The new national iVEDA portal for drug authentication and track and trace

On April 1, India officially replaced its Drugs Authentication and Verification Application (DAVA) with the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA). The iVEDA portal is a repository database that will be used for archiving serialized batch data; it’s key objective is not to track and trace India’s drug supply.

Manufacturers and exporters had complained of technical snafus with DAVA, including problems uploading data encoded on the 2D barcodes required on secondary and tertiary drug packaging and maintaining the parent-child relationship of these packaging levels. In response, the Department of Commerce convened a committee to consult with supply chain stakeholders, ultimately deciding to scrap DAVA and create an entirely portal for validation and authentication of drugs for export.

The iVEDA portal was developed by the Centre for Development of Advanced Computing (C-DAC), “the premier R&D organization of the Ministry of Electronics and Information Technology for carrying out R&D in IT, electronics, and associated areas.” Pharmexcil held testing workshops in Mumbai, Ahmedabad, Hyderabad, and Chandigarh on February 10, February 11, March 3, March 5, respectively, to give stakeholders an opportunity to use the portal and give feedback.

Big change to a regulatory deadline

Just before iVEDA launched, India’s Directorate General of Foreign Trade announced a deadline change for the implementation of the track and trace system for drug exports, particularly as it applies to the parent-child relationship of drug packaging.

On March 31, Public Notice No. 66/2015-2020 extended the date for compliance from April 1, 2020, to October 1, ,2020:

The date for implementation of track and trace system for export of drug formulations with respect to maintaining the parent-child relationship in packaging levels and its uploading on central portal has been extended up to October 1 this year.

The extension makes sense given the problems manufacturers and exporters had maintaining the parent-child relationship of secondary and tertiary drug packaging in DAVA and the newness of iVEDA.

The change applies to both small-scale industry (SSI) drugs and non-SSI drugs. Manufacturers and exporters must still print 2D barcodes for different packaging levels (i.e., primary, secondary, and tertiary) and upload the data to iVEDA, but they do not have to maintain the parent-child relationship between secondary and tertiary packaging until October 1. These stakeholders must also have a manufacturer code and product code allotted by GS1 India, though codes from C-DAC will apparently suffice. They are also responsible for the correctness and completeness of data and ensuring its timely upload to iVEDA, but according to some reports may shift this burden to an adjacent supply chain trading partner, such as a wholesaler, distributor, or retailer.

Final thoughts

rfxcel has worked in the Indian pharma market for many years. We understand its complexities, challenges, and benefits. Our signature rfxcel Traceability System (rTS) and rfxcel Compliance Management (rCM) solution have helped our customers keep up with India’s regulations and remain competitive. Contact us today to see how we can maximize your impact in India. And keep an eye on our blog for more information about how COVID-19 is affecting global supply chains. Stay safe!

rfxcel Joins the COVID-19 Healthcare Coalition

Posted on by rfxadmin

Washington, D.C., April 6, 2020. rfxcel, the global leader in digital supply chain traceability solutions, today announced that it has joined the COVID-19 Healthcare Coalition, a collaborative private-industry response to novel coronavirus that brings together leading organizations in healthcare, technology, academia, the nonprofit sector, and government.

The coalition’s goal is to save lives through data analytics. Gathering real-time data is key to learning about COVID-19 and how to best deliver healthcare to protect public health.

The coalition operates according to five guiding principles:

    • All members participate for the benefit of the country only. No organization will be given preferential advantage.
    • All members cooperate and openly share their plans.
    • Members will not be paid for working with the coalition. Each member brings its own resources; no money is exchanged.
    • Verbal agreements will suffice to get the coalition’s work started.
    • If an organization agrees to these terms and conditions, it can join the coalition.

rfxcel has been developing industry-leading track and trace software since 2003, longer than any company serving the life sciences and the business of government. Keeping with the coalition’s wish for members to bring their unique assets to support industry stakeholders, front-line responders, and federal, state, and local government organizations in the COVID-19 pandemic, the company is offering two of its cutting-edge supply chain solutions, rfxcel Integrated Monitoring (rIM) and Accurate Immunization Management (AIM), as part of its contribution to the COVID-19 Healthcare Coalition.

rfxcel Integrated Monitoring (rIM)

rIM uses Internet of Things (IoT) technology to monitor the environmental condition of products in real time as they move through supply chains on land, sea, and air. It is widely used in pharmaceutical cold chains to monitor high-value medical supplies, including vaccines. rIM communicates with small IoT-enabled devices embedded with products and sends updates and alerts about more than a dozen environmental conditions, such as temperature, humidity, light, orientation (tilt), and shock. It also monitors location, so it can alert users about route diversions and ensure logistics providers remain in compliance with delivery agreements. It can monitor at both the top level (e.g., case, pallet, truck) and the item level (e.g., syringe, packet, bottle), yielding true supply chain traceability and transparency.

Accurate Immunization Management (AIM)

AIM is an automated, cloud-based solution that tracks the dispensing of vaccines — including potential vaccines for COVID-19 — in the supply chain and seamlessly integrates with critical healthcare applications such as Electronic Health Records (EHRs) and Immunization Information Systems (IIS). It empowers healthcare practitioners to view patients’ immunization records in real time, manage accurate administering, monitor inventory, and safely dispense the right vaccines to the right patient at the right time. AIM utilizes Centers for Disease Control and Prevention (CDC) rules and guidance for vaccine combinations, special populations, and required intervals between vaccines, and adheres to U.S. Food and Drug Administration (FDA) rules for dispensing. Because it is automated, users can be up and running with virtually no training, ensuring quick implementation in mission-critical locations.

Greg Moulthrop, vice president of rfxcel’s Worldwide Government Group, and his Washington, D.C.-based team of government and supply chain experts are leading the company’s efforts to bring rIM and AIM to the coalition’s fight against COVID-19. rfxcel will support the Supply Chain Working Group, facilitated by MITRE Corporation, to bring its technology to coalition members. Working across government and in partnership with industry, MITRE and its public-private partnerships and federally funded R&D centers tackle challenges to the safety, stability, and well-being of the country.

“We are proud to be a member of the COVID-19 Healthcare Coalition and donate our time and resources to addressing this public health crisis,” Moulthrop said. “rfxcel’s Worldwide Government Group is focused on mission readiness and develops tools to protect the supply chain against disruptions for the most vulnerable products. We care about protecting the public; in this case, we must protect the health and well-being of people across the country — across the world — against COVID-19, which is revealing how much we rely on robust, secure supply chains. With rIM and AIM, rfxcel can do its part to safeguard people and, we hope, hasten both the end of COVID-19 and the recovery of our communities and economy.”

rfxcel CEO Glenn Abood said the company was honored to join the coalition and was eager to get to work. “We had been considering how we could do more to help defeat COVID-19,” he said. “We feel that our everyday work is helping by keeping supply chains moving in the pharma, food and beverage, and consumer goods industries, but we felt we could do more. When Greg told us about the coalition, we were all in.

“rIM is an award-winning environmental monitoring solution that’s proved itself over and over in the pharma industry,” Abood continued, “so it was a logical choice to share with the coalition. And AIM, which we released late last month, was a no-brainer. We had been working on it for a while and successfully tested it with some of our major customers. We were excited about releasing it, but we couldn’t have imagined the timing would coincide with COVID-19. We hope deploying it to the coalition will make a difference.”

To learn more about rfxcel’s work with the COVID-19 Healthcare Coalition or what rfxcel offers the government, contact Greg Moulthrop, vice president of rfxcel’s Worldwide Government Group, at publicservices@rfxcel.com or visit rfxgov.com.

To learn more about rfxcel and its supply chain solutions, contact Vice President of Marketing Herb Wong at 925-824-0300 or hwong@rfxcel.com and visit rfxcel.com.

About rfxcel

Founded in 2003, rfxcel provides leading-edge software solutions to help companies manage every aspect of their supply chains, lower costs, and protect their products and brand reputations. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s signature Traceability System (rTS) to power end-to-end supply chain solutions in key areas such as traceability, environmental monitoring, regulatory compliance, serialization, and visibility. The company is headquartered in the United States and has offices in the EU, Britain, Latin America, Russia, the Middle East, India, Japan, and the Asia-Pacific region.

FDA Asks for All Ranitidine Products (Zantac) to Be Removed from the Market

Posted on by rfxadmin

On April 1, the U.S. Food and Drug Administration (FDA) requested that manufacturers immediately withdraw from the market all prescription and over-the-counter (OTC) ranitidine drugs, commonly known by the brand name Zantac. As a result, ranitidine products will not be available for new or existing prescriptions or OTC use in the United States.

Ranitidine is widely used to treat and prevent heartburn. It can also treat gastroesophageal reflux disease (GERD), stomach ulcers, and conditions that cause too much stomach acid. As a generic drug, it’s sold primarily to decrease production of stomach acid.

As early as September 19, 2019, the FDA alerted patients and healthcare professionals that a contaminant known as N-Nitrosodimethylamine (NDMA), suspected to be a human carcinogen, had been found in samples of ranitidine. Since then, the agency has released more than 15 announcements about its investigation into the contamination, several of which called for limited voluntary recalls and culminated in the April 1 request that all ranitidine be removed from the market.

What the FDA testing revealed about Zantac/ranitidine

According to the FDA, the NDMA levels in some ranitidine products increases over time. Furthermore, when the products are stored at higher-than-room temperatures, it could “result in consumer exposure to unacceptable levels of the impurity.” Although the agency didn’t find unacceptable levels of NDMA in many of the samples that were tested, it decided to issue the request because it couldn’t verify under what conditions medications had been stored.

The FDA’s initial tests found low levels of NDMA in ranitidine. Low levels of NDMA can be found in foods and in water but are not expected to increase the risk of cancer; however, sustained higher levels of exposure may increase the risk. More recent testing confirmed the following:

    • NDMA levels increase in ranitidine even under normal storage conditions.
    • NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures products may be exposed to during distribution and handling by consumers.
    • The older a ranitidine product is, the greater the level of NDMA.
    • These conditions may increase the level of NDMA in ranitidine products above the acceptable daily intake limit.

What consumers should do if they’re taking Zantac/ranitidine and/or have it in their home

In addition requesting that manufacturers withdraw ranitidine products from the market, the FDA advises that consumers stop taking any OTC ranitidine tablets or liquid they have at home, dispose of them properly, and not buy more. People who want to continue treating their condition should use other approved OTC products. Patients taking prescription ranitidine should consult their doctors about other options before stopping the medicine.

There are several drugs approved for the same or similar uses as Zantac/ranitidine that do not have the same NDMA risk. To date, FDA testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

Because of the COVID-19 pandemic, the FDA asks that patients and consumers do not take their medicines to a drug take-back location; instead, they should follow disposal instructions included with their medication or follow the agency’s guidance for safe home disposal.

rfxcel’s Integrated Monitoring (rIM) solution monitors temperature and other environmental factors, safeguarding products in the supply chain

Our award-winning rIM solution uses Internet of Things (IoT) technology to monitor the environmental condition of products in real time as they move through supply chains on land, sea, and air. It is widely used in pharmaceutical cold chains to monitor medical supplies, including vaccines.

rIM communicates with small IoT-enabled devices embedded with products and sends updates and alerts about more than a dozen environmental conditions, including temperature, humidity, light, orientation (tilt), and shock. It also monitors location, so it can alert users about route diversions and ensure logistics providers remain in compliance with delivery agreements. It can monitor at both the top level (e.g., case, pallet, truck) and the item level (e.g., syringe, packet, bottle), yielding true supply chain traceability and transparency.

Our CEO, Glenn Abood, was compelled to start rfxcel 17 years ago when he realized that consumers didn’t have a way to check the authenticity of their prescription drugs. Click here to learn more about rIM and our other solutions for the life sciences, all of which safeguard the pharma supply chain and protect consumers from potentially harmful products.

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