Understanding the Two Parts of the Drug Quality and Security Act (DQSA)

Posted on November 24, 2021August 4, 2023 by rfxadmin

The Drug Quality and Security Act (DQSA) was enacted on November 27, 2013, to address gaps and oversights in the way compound medications — medications that are customized by combining, mixing, or altering two or more drugs to meet the needs of a specific patient — are prepared and distributed. It was a response to the inadvertent distribution of contaminated steroidal injections that killed 64 people and caused infections in 793 patients.

The DQSA comprises two pieces of legislation: The Compounding Quality Act and the Drug Supply Chain Security Act (DSCSA). Here’s a quick overview of each.

DQSA Part 1: The Compounding Quality Act

The goal of the Compounding Quality Act is to make compounded medicines safer for patients. It established a registration system for pharmaceutical industry stakeholders that create sterile drugs (e.g., manufacturers and pharmacies). It also reinstated Section 503A of the Food, Drug, and Cosmetic Act (FD&C Act), parts of which the Supreme Court in 2002 ruled unconstitutional.

Companies can register as an official outsourcing facility if they meet a specific set of criteria. Outsourcing facilities are usually larger companies that supply compounds to healthcare facilities such as pharmacies, hospitals, and clinics. The key requirements for outsourcing facilities under the Compounding Quality Act include the following:

They must report adverse events to the FDA twice a year.
They must submit reports about all compounded medications to the FDA twice a year
They must meet product labeling requirements.
They must agree to FDA inspections (according to a “risk-based schedule” and pay fees for any re-inspections.
They must pay a registration fee to the FDA.

Outsourcing facilities are also subject to increased quality standards and can be penalized for certain actions, including intentionally falsifying prescriptions for compounded medicines, failing to report adverse events or compounded medications to the FDA, making false claims about compounded medicines (i.e., false advertising), and selling medications with “not for resale” warnings.

All this said, it’s important to note that the FDA does not approve compounded drugs. The Agency does not verify their safety or effectiveness. Furthermore, compounded drugs do not have an FDA finding of manufacturing quality before they are marketed.

DQSA Part 2: The Drug Supply Chain Security Act (DSCSA)

The DSCSA is a wide-ranging piece of legislation designed to prevent counterfeit, stolen, contaminated, or otherwise harmful drugs from entering the U.S. pharmaceutical supply chain. It affects virtually every industry stakeholder, from manufacturers, distributors, and wholesalers to repackagers, logistics providers, and dispensers (i.e., pharmacies). It is

Enacted in November 2013 and culminating with the November 2023 deadline, the ultimate goal of the DSCSA is a fully serialized pharmaceutical supply chain with full electronic operability. There are four core requirements:

Product serialization
Product tracing
Verification (of product identifiers)
Authorized trading partners

If you follow our blog, you know we’ve been writing about the DSCSA for years. For a longer summary, check out “Countdown to DSCSA 2023 Serialization: The Deadline Is Two Years Away.” For an in-depth look at what’s in store for 2023, read “DSCSA 2023: The Future of Pharmaceutical Traceability in the USA.”

Final thoughts

rfxcel has been the leading provider of regulatory and compliance software for the pharmaceutical industry for almost 20 years. We’ve also been a thought leader on the DQSA and DSCSA compliance. Our goal is to keep all stakeholders informed and work with them to ensure they’re ready to meet all the requirements in 2023.

Below are a few of our most recent resources to help bring you up to speed. Take a look, and if you have any questions or want to see a short demo of our DQSA and DSCSA solutions, contact us today. Our supply chain experts know the legislation inside and out and will work with you to design a solution that’s right for you.

Brand Protection Strategies and Your Supply Chain

Posted on November 22, 2021August 4, 2023 by rfxadmin

Welcome to Part II of our brand protection series. In Part I, we talked about the top supply chain threats that brand protection strategies must address: counterfeits, diversion, theft, and insufficient traceability.

Today, we’re talking about the supply chain solutions that combat these threats — solutions that should be integral to your brand protection strategies.

A holistic supply chain approach to brand protection strategies

Your supply chain is the embodiment of your business. If it’s not healthy, your brand can’t be healthy. You need to be able to continuously scan it, diagnose it, and take immediate action should a threat arise.

Fine-tuned digital supply chain solutions are the answer. Working together from end to end, they create a “central nervous system” that monitors and senses every touch point in real time while collecting and sharing data to inform your next move.

Serialization, real-time monitoring, and end-to-end traceability are the key solutions that help mitigate supply chain threats and provide the intelligence for effective brand protection strategies. Let’s take a look.

Serialization

Serialization is the building block of a secure supply chain and effective brand protection strategies. By assigning a unique serial number to each product, you create what rfxcel calls a “digital asset” with a unique digital identity. Every product can be linked to virtually any information you want, such as its origin, when it was harvested or manufactured, its lot number, and its expiration date.

Serialization also enables you to track every individual unit through your entire supply chain, from production to retail distribution to the final consumer and beyond. It creates a barrier to fight counterfeits and fakes and contributes to end-to-end traceability that eliminates blind spots and locks down your supply chain.

Serialization also fuels brand protection strategies because you can leverage each digital asset for consumer engagement to build confidence and trust. As we said in Part I of our consumer engagement series, your customers are absolutely a part of brand protection, and serialization empowers them in three important ways.

First, it’s the basis of an indelible, demonstrable, shareable product provenance that proves that your product is what you say it is and gives consumers the information they demand.

Second, as we discussed in Part II of our consumer engagement series, your serialized product is a device for one-on-one communication with your customers. For example, with a quick smartphone scan of a 2D Data Matrix code, a person can access rich data about your product and exclusive content through which they’ll establish and build a relationship with your brand.

Third, serialization lets you “crowdsource” brand protection through your consumer engagement activities. For example, if a person scans a product and the scan doesn’t work or they’re taken to a suspect website or other suspicious content, you can incentivize them to contact you and report that something is wrong. This is actionable, granular data that will protect your brand.

Real-time monitoring

A blind spot in your supply chain creates opportunities for trouble. Common blind spots include deviations from prescribed routes and harmful environmental conditions. The solution is real-time monitoring.

rfxcel’s Integrated Monitoring solution paints a vibrant, detailed picture of where your products are and what is happening to them. It provides better data, continuity, visibility, and security to protect your products and consumers. With detailed, unit-level data coming in around the clock, you’ll understand and immediately act upon specific risks.

It works like this: Pallets, cases, or unit-level items 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 transport vehicle is sticking to its approved route, if the shipment stopped and for how long, and environmental conditions such as temperature, light, humidity, and shock. If something is not as it’s supposed to be, the sensors transmit an alert so you can halt shipments that may have been adulterated and redirect shipments to keep products safe. You’ll protect your customers and safeguard your brand.

Check out our short videos about our Integrated Monitoring solution for the pharmaceutical and food and beverage industries.

End-to-end traceability

End-to-end traceability in a digital supply chain means you can design end-to-end brand protection strategies.

With a suite of solutions acting in concert — like our Traceability System — you’ll create a full, traceable provenance for every product. You can add critical tracking events and key data elements at any point in your supply chain. For example, add a photo of a product as it leaves the factory or integrate a quality inspection to enrich the data associated with the product. Consumers can access this information and confirm that your product is what you say it is. This burnishes your reputation and builds trust with the people who buy your products or are thinking about buying your products.

And there are numerous other benefits of end-to-end traceability. If you can see every part of your supply chain from one end to the other, you’ll be able to manage operations more efficiently, including dealing with recalls and other crisis situations. You’ll make it harder for counterfeits and fakes to reach consumers. You’ll consolidate data to improve processes, outcomes, and product quality. And you’ll be empowered to make better decisions based on that data.

Mobile traceability: an on-the-go solution for brand protection strategies

A discussion of brand protection strategies isn’t complete without mentioning mobile traceability. Why? Because if you don’t have access to your supply chain data 24/7, no matter where you are, you’re not shedding light on blind spots and not building a solid perimeter around your brand.

rfxcel’s MobileTraceability solution brings our industry-leading track and trace capabilities to virtually any location, including places that traditionally may not have had absolute visibility in your supply chain, such as remote fields, distribution centers, and warehouses. With unparalleled convenience and speed, it gives you everything you need to keep you supply chain running at optimal efficiency. To learn more, read about what our Mobile Traceability solution can do for the pharmaceutical and food and beverage supply chains.

Final thoughts

A supply chain problem is a brand protection problem. By giving all your products a unique digital identity through serialization, then following and controlling them in real time with integrated monitoring and traceability solutions, you can demonstrate to the world that your brand is strong and reliable. You can build a reputation for integrity and transparency with partners and consumers. You can use data to innovate your brand protection strategies, consumer engagement activities, and every part of your operations.

With rfxcel, you can fortify your brand with data from a digital supply chain. You can combat the threats we’ve discussed no matter where you are and no matter where you supply chain goes. Contact us today to see how our solutions can work for better, stronger brand protection strategies.

Brand Protection Strategy and the Top Supply Chain Threats

Posted on November 17, 2021October 9, 2023 by rfxadmin

We just did two articles about why your supply chain is vital to an effective consumer engagement strategy. Now we want to jump into brand protection strategy and your supply chain.

First, let’s define our terms. Although consumer engagement is a usually a dedicated effort to boost brand recognition and loyalty, it must always be considered part of your brand protection strategy. As we’ll see, getting your customers involved in fighting counterfeits and identifying disreputable sellers and other bad actors is critical. Let’s continue breaking this down.

Why do you need a brand protection strategy?

Do you want to protect your business? Your employees, your bottom line, your reputation, your supply chain, your intellectual property?

Of course you do. Your brand protection strategy is your firewall. It’s how you shield your business from things that can harm it. And many — if not most — of the factors that can harm your brand are directly related to your supply chain. These include counterfeits (also called fakes), diversion, theft, and insufficient traceability.

Top supply chain threats

Let’s take a closer look at the top supply threats your brand protection strategy should address.

Counterfeits and fakes

The joke is that the best way to fight counterfeits is to make products nobody wants to buy.

We know that’s not how it works, though, which is why counterfeits and fakes are the No. 1 brand protection concern. In fact, counterfeits and pirated products accounted for up to 3.3 percent of world trade in 2016.

That statistic comes from a 2019 report by the Organisation for Economic Co-operation and Development (OECD) entitled “Trends in Trade in Counterfeit and Pirated Goods.” The OECD also found that trade in counterfeit and pirated goods was rising steadily despite stagnation in overall trade volumes. Based on 2016 customs seizure data, the value of imported fake goods worldwide was $509 billion, up from $461 billion in 2013.

But there’s a lot more to be concerned about. Counterfeits are of inferior quality and often contain harmful, even deadly, materials/ingredients. The people who make them, including children, often work for long hours in sweatshop conditions. Some may have been trafficked or coerced. Furthermore, it has been established that counterfeits are inextricably linked to organized crime.

The pandemic provided many examples counterfeits making their way into the global supply chain — fake vaccines, fake COVID-19 testing kits, fake masks, fake nitrile gloves. But counterfeiting affects every industry, from food and footwear to cosmetics and computers.

Diversion and theft

When your goods are in transit along your supply chain, you want them to reach their final destination as quickly and safely as possible. This is why diversion is another key consideration for a brand protection strategy.

Diversion is actually a two-pronged problem. Let’s use pharmaceuticals to illustrate. Many drugs must be kept within a certain temperature range or maintained under certain lighting or humidity conditions. Even the slightest delay could spell disaster — ruined products, which means patients might not get medicines on time.

Diversion can also indicate theft. If a truck goes off its prescribed route, bad actors might be hijacking it and your product could end up on unauthorized e-commerce sites (rogue websites) and other grey markets or black markets. If the diversion has compromised the integrity of your product — a drug, for example — people’s lives may be jeopardized.

Insufficient traceability

As we’ve discussed before, supply chain traceability brings tangible value to just about every part of your business, including your brand protection strategy. If you’re not taking traceability seriously, you’re not just opening the door to assaults on your brand; you’re risking problems with regulators, alienating (and losing) customers, and weakening your supply chain.

A recall is among the most damaging events that can happen to a brand, so let’s use it as case study. If you can trace a recalled item, you can better collaborate with trading partners and authorities and help to get the product out of the supply chain and out of stores. With traceability, you’re protecting consumers from a health hazard and safeguarding your brand from bad publicity. And with a transparent approach to engaging with customers about your products, you create a strong brand image that conveys trust, credibility, and reliability.

Traceability also helps fight counterfeits, diversion, and theft. The ability to trace and authenticate every product in your supply chain in real time, 24/7, is foundational to an effective brand protection strategy. We’ll get into those details in Part II of our brand protection series.

Final thoughts

At the end of August, the Office of the United States Trade Representative published a request for comments “that identify online and physical markets to be considered for inclusion in the 2021 Review of Notorious Markets for Counterfeiting and Piracy (Notorious Markets List).”

Counterfeits have also been making headlines in recent weeks:

In this environment, a comprehensive brand protection strategy driven by granular supply chain data is your best defense against bad actors. rfxcel understands this. We can help you leverage your supply chain to combat counterfeits and the other concerns we addressed today. Our brand protection solutions will fortify your brand with data from a digital supply chain. Contact us today to learn more — and read Part II of our brand protection series.

Top Reasons Your Supply Chain Is the Key to an Effective Consumer Engagement Strategy

Posted on November 15, 2021October 9, 2023 by rfxadmin

Welcome to Part II of our series about effective consumer engagement. In Part I, we talked about the benefits of consumer engagement. Today, we’re focusing on your supply chain — and how you can use it for a next-level consumer engagement strategy. Let’s jump right in.

It’s all about data from your supply chain

Your supply chain is a gold mine of information that you can leverage for a robust consumer engagement strategy. The basic building block is serialization, which turns each one of your products into what we call “digital assets.” Each digital asset has a unique digital identity that can be monitored from production all the way to the person who buys it.

With rich, traceable data about every item in your supply chain at your fingertips, you can establish and maintain connections with consumers before, during, and after the sale. (You can also do much, much more, but that’s beyond the scope of what we’re talking about today.)

Four ways supply chain data supercharges your consumer engagement strategy

1. You’ll share the product information that consumers demand.

Consumers demand information. Every product — every digital asset — in your supply chain can be “loaded” with data that consumers can access at the store, at home, at a restaurant, at a sporting event. Anywhere. For example, a quick scan of a 2D Data Matrix code or QR code with a smart phone will reveal every detail you want to share about your product: where and when it was grown or made, its ingredients, the route it took to get to the consumer. This demonstrable provenance using supply chain data builds consumer trust and confidence; it is foundational to consumer engagement.

2. You’ll create compelling customer experiences.

Consumers also want experiences. With data from your supply chain and other brand resources (e.g., an app) you can curate experiences such as contests, loyalty programs, games, and unique online content. You can encourage storytelling about your brand. If you’re a winemaker, connect people to a virtual tour of your vineyard. If you sell organic foods, share video recipes online or invite people to see your sustainable operations. If you make cosmetics, link to virtual try-ons. Importantly, you can hyper-personalize and hyper-target every engagement, and even “broadcast” specific information to specific locations or events.

3. You’ll communicate directly with consumers.

Your serialized product is a device for one-on-one communication with the person who bought it. When a customer accesses the information from your digital asset, you can connect them to your website, social media, an app, a survey, or other forums where they can start a conversation with your brand. They can ask questions and provide feedback — and you can give answers and reactions. Relationship-building is another cornerstone of an effective consumer engagement strategy, and the products people are literally holding in their hands are the first step of the conversation.

4. You’ll gain valuable insight into your customers.

An effective consumer engagement strategy creates a world for your customers. And as they navigate and participate in that world, they share information. Where are they buying your products? What do they like? What don’t they like? What inspires them? What engagement activities resonated the most? This business intelligence can inform every part of your business, from how your supply chain works to creating better consumer engagement strategies.

Final thoughts

The purchase used to be the last part of your supply chain; now it’s the beginning of a new realm of possibilities. Every digital asset is an opportunity to connect your customers to your brand and put your products front and center in their lives.

rfxcel’s Traceability System is an end-to-end supply chain solution that creates the digital assets. It gives you in-depth, real-time insights all the way from production to your final customers. The data you connect to your products will fuel compelling consumer engagement activities that can reach people everywhere you do business.

And now, as part of Antares Vision Group, we can offer even more ways to engage with consumers. Contact us today to find out more.

BONUS CONTENT!

Last year, we did a piece called “Supply-Chain Traceability Is Building a New Kind of Consumer Kingdom.” Here’s an excerpt that ties into what we’ve said about an effective consumer engagement strategy:

In fact, consumers are not only thinking deeply about where the things they buy come from and what goes into making them, they are actually becoming a pivotal part of the supply chain itself. What’s more, they’re participating willingly and with gusto, demanding detailed information about the goods they purchase and even expecting to interact with products far beyond the point of sale. Just how far will they go to get what they want? More than 70% of customers say they’re willing to share their data in exchange for a more personalized experience, according to one recent survey.

Read the full article here.

DSCSA Serialization Implementation and Compliance Guidelines

Posted on November 10, 2021January 16, 2024 by rfxadmin

Note: This article was originally published in November 2021. We’ve since updated some language after the FDA announced on August 25, 2023, that it was delaying by one year enforcement of key DSCSA requirements.

November 27, 2023 — the date the pharmaceutical industry has had its sights on since the U.S. Drug Supply Chain Security Act (DSCSA) was enacted eight years ago. With only two years until the deadline, we thought it was a good time to recap what’s in store for DSCSA serialization.

What is DSCSA serialization?

DSCSA serialization is not different from serialization any other industry: It means that certain drugs must traceable at the unit level. Specifically, manufacturers and repackagers must put a unique Product Identifier (PI), such as a bar code, on certain prescription drug packages. This must be able to be read electronically. Furthermore, manufacturers, wholesale distributors, repackagers, and many dispensers (primarily pharmacies) must provide certain information about drug and who handled it each time it’s sold:

Transaction information (TI) includes the product name; its strength and dosage form; its National Drug Code (NDC); container size and number of containers; lot number; transaction date; shipment date; and the name and address of the businesses from which and to which ownership is being transferred.
- The transaction statement (TS) is a paper or electronic attestation by the business transfer-ring ownership of the product that it has com-plied with the DSCSA.
- A third type of information, Transaction history (TH), is an electronic statement with the TI for every transaction going back to the manufacturer. It is not required after the law goes into effect on November 27, 2023; however, as we wrote about before, there is a “stabilization period” in effect until November 27, 2024, during which the FDA does not intend to take enforcement action. Read more about that here and below.

Meeting DSCSA serialization requirements is vital for all pharmaceutical supply chain members. Whether you are a manufacturer, wholesale distributor, or dispenser, DSCSA 2023 requirements apply to your business. The question is, are you ready?

The DSCSA 2023 deadline

As we just said, the DSCSA 2023 compliance deadline is still November 27. But the FDA postponed enforcement by one year to November 27, 2024. This change does not affect past deadlines on the DSCSA enforcement timeline, but does have implications for DSCSA requirements, including serialization.

This means that pharma stakeholders — manufacturers, wholesale distributors, repackagers, dispensers, and third-party logistics providers (3PLs) — now have an extra 12 months to get their systems in order. However, the FDA has made it clear that these entities should not regard the “stabilization period” as a delay of the 2023 requirements: It expects companies to have implemented the mandated systems and work to ensure they are operating correctly, smoothly, etc. The Agency’s Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies states:

This guidance is not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.

The DSCSA timeline

November 27, 2023, will be the 10th anniversary of the DSCSA. Per Section 582(g)(1) of the DSCSA (Title II of the Drug Quality and Security Act), “On the date that is 10 years after the date of enactment of the Drug Supply Chain Security Act … interoperable, electronic tracing of product at the package level requirements shall go into effect.” In other words, DSCSA 2023 serialization.

DSCSA serialization: recent developments

No more delays. On August 9, 2021, the FDA signaled that the DSCSA 2023 deadline for interoperability would not change. Leigh Verbois, the director of the FDA’s Office of Drug Security, Integrity, and Response, made the comments during a webinar hosted by the Healthcare Distribution Alliance (HDA).

Draft and final guidance on product identifiers (PIs) and more. On June 3, 2021, the FDA published “new guidance to further enhance the security of prescription drugs in the U.S. supply chain.” Guidance was released for PIs, suspect and illegitimate products, and enhanced drug distribution security.

Full serialization

For DSCSA serialization, certain drug packages must be labeled with a unique Product Identifier (PI). The PI comprises the National Drug Code, a serial number, a lot number, and an expiration date.

Furthermore, every time a product changes hands (i.e., between trading partners), supply chain actors must use the Electronic Product Code Information Services (EPCIS) to share Transaction Information (TI) and a Transaction Statement (TS) with their partners. A third requirement, Transaction History (TH), will not be required after the November 2023 deadline.

Even with the stabilization period until November 27, 2024, there’s no stopping the fact that significant changes are coming for pharmaceutical traceability under DSCSA. The primary focus? Serialization. Serialization involves assigning unique identifiers to each pharmaceutical product, enabling precise tracking and data reporting at every stage of its journey through the supply chain.

Authorized trading partners

Under the DSCSA, authorized trading partners (ATPs) may engage in transactions only with other ATPs. In other words, all manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers and their trading partners must be ATPs. If they’re not authorized, their access to the U.S. pharma supply chain will be severely restricted or denied altogether. Read our in-depth ATP blog series here.

Verification Router Service (VRS)

Under the DSCSA saleable returns verification requirement, wholesalers must verify saleable returns before they can be reintroduced to the supply chain. This is done by verifying the drug’s PI. A wholesaler must initiate a verification request (to a manufacturer) to verify the returned products, and the manufacturer must provide a verification response within 24 hours. The VRS enables the rapid, secure exchange of data between these parties. Get more details here.

Final thoughts: DSCSA Serialization

We have been talking about and reporting on the DSCSA Day 1. We’ve been active in industry initiatives, particularly the VRS and the Open Credentialing Initiative (OCI) to meet ATP requirements. We’re ensuring the Ohio Department of Veterans Affairs is DSCSA-compliant. And we’ll soon be announcing another exciting initiative in the move toward full serialization of the U.S. pharma supply chain. Keep an eye out for that.

This year, we hosted a “Plan for DSCSA Readiness” webinar in March and a DSCSA 2023 webinar series in June that covered ATPs, EPCIS, and the VRS. We also published a “Dispensers and DSCSA 2023” white paper in May.

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

Take another look at our DSCSA timeline. A lot has happened since 2013 — and the pace will only intensify over the next two years. Contact us today if you need to know more. Our supply chain and DSCSA experts are here to help and make sure you’re ready for 2023

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

Posted on October 26, 2021August 4, 2023 by rfxadmin

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

Key Brazil ANVISA requirements for April 28, 2022

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

There are three key requirements for April 2022:

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

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

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

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

Final thoughts

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

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

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

The Top 3 Benefits of Supply Chain Traceability for Your Business

Posted on August 9, 2021August 10, 2023 by rfxadmin

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

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

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

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

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

1. Supply chain traceability for brand protection and customer satisfaction

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

Response to complaints and recalls

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

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

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

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

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

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

Transparency about sourcing

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

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

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

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

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

2. Supply chain traceability is key to compliance

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

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

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

Serialization makes supply chain track and trace easier

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

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

Prove your product claims

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

Regulations evolve over time

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

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

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

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

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

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

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

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

Final thoughts

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

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

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

DSCSA Authorized Trading Partners: Questions and Answers

Posted on July 22, 2021November 7, 2023 by rfxadmin

Navigating complicated pharmaceutical regulations like the Drug Supply Chain Security Act (DSCSA) can be daunting. However, the DSCSA is crucial for ensuring the safety of the drugs that patients depend on — and compliance isn’t an option.

Introduced to prevent counterfeit, stolen, or contaminated prescription drugs from entering the supply chain, the DSCSA is enforced by the Food and Drug Administration (FDA) and provides regulations for manufacturers, wholesale distributors, dispensers, repackagers, and third-party logistics providers (3PLs).

In addition to product labeling and traceability standards, the DSCSA created a framework for credentialing and identifying authorized trading partners (ATPs). This allows supply chain actors to ensure that they are working only with verified and compliant companies. Here is everything you need to know about DSCSA ATPs.

Who Are Authorized Trading Partners Under DSCSA?

DSCSA authorized trading partners (ATPs) include manufacturers, wholesale distributors, dispensers, repackagers, and 3PLs. To be an ATP, companies must meet DSCSA compliance requirements and obtain a valid license to participate in the pharmaceutical supply chain.

Every member of the supply chain has a responsibility to maintain drug traceability records, thereby promoting public health interests under the DSCSA. These entities are charged with working together to identify illegitimate/suspect products, gather and store product tracing information, and adhere to FDA reporting requirements.

What Are the DSCSA Requirements for Authorized Trading Partners?

The foundational idea of the DSCSA is electronic interoperability among trading partners. Broadly, interoperability means that manufacturers, wholesale distributors, dispensers, repackagers, 3PLs, and other supply chain members can exchange mandated Transaction Information (TI) and Transaction Statements (TS) every time a drug changes hands. And they must do so in a secure, electronic, and interoperable manner. For DSCSA, this means using Electronic Product Code Information Services (EPCIS), a global GS1 Standard for creating and sharing visibility event data.

Required product data includes Product Identifiers (PIs) serial numbers, expiration dates, and lot and batch codes.

For more information regarding DSCSA requirements for ATPs, explore our DSCSA Compliance Library.

How Does DSCSA Define “Trading Partner”?

Pharmaceutical supply chain members are considered to be trading partners if they are involved in the exchange, purchase, or sale of drug products and biologics. It’s essential to distinguish between being a “trading partner” and an authorized trading partner.

The latter has met DSCSA requirements by obtaining proper licensure. If necessary, they have also registered with the appropriate state board of pharmacy.

What Are the Benefits of Being an Authorized Trading Partner?

Becoming an authorized trading partner isn’t just about ticking regulatory boxes. There are also tangible benefits for your business, your trading partners (who must also be ATPs, of course), and your patients and customers. These benefits include:

Better patient safety: Ensuring that only genuine drugs reach patients promotes safety and benefits public health
Improved product integrity: The DSCSA traceability requirements promote drug distribution security and supply chain integrity
A competitive advantage: Complying with DSCSA regulations means you’ll have full access to the U.S. pharma supply chain and can even help your brand reputation

Additionally, complying with DSCSA requirements means you’ll avoid penalties, including fines. In turn, this will lead to enhanced trust with consumers and trading partners.

How Can Companies Verify Their Partner’s ATP Status?

Before engaging with any partner, always verify their ATP status. This isn’t an option; it’s a requirement.. To verify a trading partner, simply:

Verify their licensing status with their respective state board
Ensure they have the appropriate permits
Retain copies of their licenses and permits for your records

Retaining copies of a trading partner’s license and permits proves that they were properly authorized at the time of your transaction.

The Role of ATPs in Pharmaceutical Traceability

Authorized trading partners play a pivotal role in pharmaceutical traceability. At every node of the supply chain, products could be damaged, tainted, or otherwise altered. However, when each entity does its part, you can ensure that the drug’s journey, from manufacturer to the patient, is transparent and verifiable.

Final Thoughts: DSCSA Authorized Trading Partners (ATPs)

In August 2023, the FDA postponed the enforcement of key DSCSA requirements to November 27, 2024. While this “stabilization period” gives DSCSA trading partners some breathing room, all pharmaceutical supply chain members must still be ATPs. Therefore, DSCSA ATPs should not view the extra time as a grace period to proceed with business as usual. Instead, they should continue getting their houses in order. As the FDA said, it “strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.”

So what should you be doing? First, ensure that your current trading partners are also continuing their work for DSCSA compliance, including achieving ATP status. Additionally, you should explore technology upgrades that will help you comply with forthcoming DSCSA requirements.

To learn more about how you can prepare, connect with rfxcel. Our No. 1 priority is to help you understand the DSCSA regulations and be prepared to fully comply with the law.

DSCSA 2023: Top EPCIS Questions, Answered

Posted on July 21, 2021July 25, 2023 by rfxadmin

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

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

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

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

When will companies start sending EPCIS?

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

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

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

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

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

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

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

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

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

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

More DSCSA 2023 resources from rfxcel

DSCSA VRS: Addressing Your Top Questions with rfxcel

Posted on July 20, 2021July 25, 2023 by rfxadmin

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

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

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

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

When do I need to implement the DSCSA VRS?

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

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

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

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

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

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

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

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

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

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

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

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

More DSCSA 2023 resources from rfxcel