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FDA DSCSA Guidance Update: EPICS, ATPs, and the Countdown to 2023

If androids dream of electric sheep, do pharma stakeholders dream of GS1’s Electronic Product Code Information Services (EPCIS) standard? Considering recent FDA DSCSA guidance and the industry reaction, the answer could very well be “yes.”

On July 5, the FDA published two draft guidance documents about the Drug Supply Chain Security Act (DSCSA). One deals with using electronic standards for tracing pharmaceutical products in the U.S. supply chain and one addresses authorized trading partners (ATPs):

Let’s take a closer look at the FDA DSCSA guidance and where the pharma industry stands as we count down to November 27, 2023. That’s when manufacturers, wholesalers, distributors, and dispensers will be required to exchange serialized product information and verify their ATP status.

Quick history of FDA DSCSA guidance

The FDA has released DSCSA guidance and policy documents since 2014, most of which are all available on the Agency’s “Drug Supply Chain Security Act Law and Policies” page. This year, in addition to the July draft guidance, the Agency published the following:

What did the July FDA DSCSA guidance say?

The FDA said the July documents updated guidance from November 2014 and August 2017 that was never finalized.

Electronic traceability standards/EPCIS

The new FDA DSCSA guidance for electronic traceability standards confirms that paper-based product tracing “will no longer be permitted and verification of product at the package level will be required, unless a waiver, exception, or exemption applies.” Furthermore, it recommends that stakeholders use EPCIS to exchange information.

It’s worth quoting the guidance at length, as the Agency clearly states its position on EPCIS, including that it will “help secure” DSCSA compliance:

FDA recommends that trading partners use the Electronic Product Code Information Services (EPCIS) standard to provide and maintain the data associated with transaction information and transaction statements. EPCIS is a global GS1 standard that allows trading partners to capture and share information about products as they are transacted through the supply chain. Use of EPCIS can support and enable electronic and interoperable interfaces used by trading partners to help ensure compliance with the DSCSA requirements and is compatible with a range of different technological approaches. FDA believes that EPCIS is an appropriate globally recognized standard, and FDA understands there is considerable agreement among stakeholders that EPCIS is a suitable standard to adopt for the enhanced drug distribution security requirements.

The comment period for this guidance ends September 6.

Identifying trading partners

The FDA said it issued this guidance “to assist industry and state and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the” DSCSA. It also does the following:

      • Explains how to determine when certain statutory requirements will apply to entities that are considered trading partners.
      • Discusses the activities of private-label distributors, salvagers, and returns processors and reverse logistics providers.
      • Discusses the distribution of drugs for emergency medical reasons, office use, non-human research purposes, and research purposes in humans under an investigational new drug application.

The comment period for this guidance also ends September 6.  As for licensure for trading partners, the FDA put a reminder on its DSCSA page that wholesalers and third-party logistics providers (3PLs) are required “to report licensure and other information to FDA annually under sections 503(e)(2) and 584 Federal Food, Drug, and Cosmetic Act.” The intro on this page references the July 5 draft guidance.

Industry reaction to the FDA DSCSA guidance

The Regulatory Affairs Professionals Society (RAPS) earlier this month published an excellent article about industry reaction. Here are some of the key takeaways:

      • Trading partners need to begin testing and piloting data exchanges now to identify and remedy any glitches.
      • Manufacturers in particular need to focus on data accuracy to ensure legitimate products aren’t rejected.
      • The FDA must clarify if web portals will be allowed for data exchanges. Web portals are a good solution for smaller companies (e.g., dispensers) that might not have the means to build compliant tracing systems from scratch.
      • The FDA should finalize its proposed rule on licensing standards for 3PLs.

Final thoughts

The July FDA DSCSA guidance was another important marker along the 10-year rollout of the law. We’ll be writing more about this next week, when we sit down with Herb Wong, rfxcel’s senior vice president of product and strategy.

If you don’t know Herb, he’s a DSCSA guru who’s been deeply involved in outreach, education, and initiatives to help the industry prepare for November 2023. For example, he was integral to the formation of the EPCIS Center of Excellence and led our FDA-approved pilot to extend testing of the Verification Router Service (VRS). He was also recently name-checked by the Open Credentialing Initiative (OCI), which focuses on meeting ATP requirements, for his “collaborative spirit and dedication to improving the U.S. pharmaceutical supply chain.”

So check back next week for our conversation with Herb. In the meantime, if you have questions or feel you’re not on track to comply by November 2023, contact us today to build a solution tailored to your exact needs. Also visit our DSCSA Compliance Library to access our extensive collection of articles, webinars, white papers, and news.

Why FDA Food Traceability Regulations Are a Business Opportunity

It’s going to be a busy couple of years for the food industry as the Food and Drug Administration (FDA) formalizes key parts of its plan to modernize and further secure the U.S. food supply chain. The next milestone for FDA food traceability regulations is just four months away, so let’s take a look at the requirements — and why food companies should embrace them as an opportunity to improve their businesses.

But first, if you’re intrigued by the idea that opportunities are “hiding” in the FDA food traceability regulations, join us for our “Safety, Regulatory Compliance & Beyond: Leveraging Traceability to Optimize the Food & Beverage Supply Chain” webinar on Wednesday, August 10, at 1 p.m. EST. Our experts will break down the “whys” and “hows” of traceability, discuss the real-world applications and value-adds, and take your questions.

Recap of FDA food traceability regulations & upcoming deadlines

Here’s a quick rundown of what’s on the table and upcoming deadlines.

Food Safety Modernization Act (FSMA)

      • Signed into law on Jan. 4, 2011
      • Aims to ensure the food supply is safe by shifting the focus to preventing contamination rather than responding to it
      • Applies to human food as well as to food for animals, including pets

Proposed Rule (FSMA 204)

      • Establishes additional traceability recordkeeping requirements for people who manufacture, process, pack, or hold foods on the Food Traceability List
      • Food Traceability List contains foods with additional traceability recordkeeping requirements (see table below)
      • Stakeholders to establish and maintain records with key data elements (KDEs) associated with different critical tracking events (CTEs)

Key dates

      • Nov. 7, 2022: FDA to finalize and submit the Food Safety Modernization Act (FSMA) Proposed Rule to the Federal Register
      • January 2023: Proposed Rule goes into effect
      • Jan. 6, 2025: Deadline for full compliance

The FDA has also launched the New Era of Smarter Food Safety and an accompanying New Era of Smarter Food Safety Blueprint, which envision a modern approach to ensuring food safety through digital, tech-enabled traceability. Get more details in our blog here.

FDA food traceability regulations: What to know now and how to seize opportunities

This is really just a preview of our August 10 webinar about leveraging traceability. We’ll touch on a few key points below; sign up for the webinar to take a deep dive.

Just the facts

The FSMA 204 deadlines are set. You’ll have to be fully compliant in about two years, so the time to prepare is now.

The Food Traceability List is a living document. More and more food items are sure to be added over time.

The FDA is committed to modernizing and securing the U.S. food supply chain. Expect the Agency to continue promoting (and regulating) traceability in a digital supply chain. This includes improving recall management.

Where’s the opportunity?

End-to-end traceability makes everything better. With the right solution, you’ll not only be compliant — you’ll make your supply chain faster, leaner, and more cost-effective.

“1-up, 1-down” is useful, but antiquated. Today, 1-up, 1-down traceability is merely a facet of end-to-end traceability (and visibility and transparency) in a digital supply chain. The right solutions transform your supply chain into an ecosystem that optimizes operations and creates opportunity and value beyond the point of sale.

Serialization is the building block of compliance — and added value. Serialization turns every product into a “digital asset” that can be traced in real time from virtually any location, yielding practical benefits to your operations. But these digital assets can accomplish much, much more, including brand protection and consumer engagement.

Traceability enables precise, targeted recall management — which means better outcomes for your brand. We’ve all heard the statistic that the average food recall costs $10 million. With traceability, you can locate specific items quickly, identify where they came from (e.g., grower, warehouse), take clear, decisive action to remove only those items from circulation, and protect consumers and your reputation.

Traceability in a digital supply chain means less clutter — literally. Do you have nightmares about back rooms full of boxes stuffed with paperwork? Traceability turns your nightmare into an operational dream. Get rid of all the paper and gain the power to quickly dial up any document, any time, from any location, including from mobile devices.

Traceability and added value

Traceability is the key to keeping consumers happy and inspired. Consumers are thinking deeply about the things they buy — where they come from and what goes into making them. They also expect to interact with the brands they trust. We wrote way back in October 2020 that supply chain traceability was building a new kind of consumer kingdom; it was true then, it’s true today, and it will be true tomorrow.

The era of digital assets and smart products is here. Products are no longer just products. With serialization and traceability, products are gateways to experiences. They’re beacons to broadcast information. They are conduits for hyper-targeted and hyper-personalized consumer engagement.

Final thoughts

FDA food traceability regulations are center stage in FSMA, the Food Traceability Proposed Rule (FSMA 204), the Food Traceability List, and the New Era of Smarter Food Safety. The deadlines are coming and you should be preparing.

But now you know that savvy companies will see traceability as more than a compliance mandate from the government — they’ll see it as a technology that creates a universe of opportunities for their businesses and brands.

Companies that are thinking only about the mechanics of complying with FDA food traceability regulations will miss these opportunities to be proactive about ensuring food safety and quality, reducing  risks, protecting and building their brands, and leveraging every single product to connect with individual consumers in exciting, meaningful ways.

We don’t want you to miss these opportunities. To get started, sign up for our food traceability webinar to see how traceability works and how it delivers value.

Next, contact us to schedule a short demo of our food and beverage solutions, including our award-winning Traceability System and Mobile Traceability App. In about 15 minutes, our supply chain experts will show you how we create end-to-end traceability in a fully interoperable digital supply chain that’s visible anytime, anywhere.

Last, take a look at our other food traceability materials, some FDA links, and our shortened version of the Food Traceability List.

Our FSMA & Food Traceability Resources

Other FDA Resources

Food Traceability List (see full FDA document here)

FDA Food Traceability List

Antares Vision Group Will Be at GS1 Connect 2022 in San Diego Next Month!

We’re getting excited for GS1 Connect, June 7-9 at the Marriott Marquis San Diego Marina! Not only are we a Premier Sponsor — we’ll be speaking about supply chain traceability and smart hospital systems.

We’ll also be at Booth 115 with our award-winning Traceability System, demonstrating solutions for the food and beverage, pharmaceuticals, and cosmetics industries.

So take 20 seconds (really) to sign up to meet us. We have a limited number of discount codes for 10 percent off your registration fee. And while you’re at Booth 115, take our short survey and you could win a $500 DoorDash gift card.

More about GS1 Connect and our speakers

The theme of this year’s conference is “Adapt.” The focus is on how businesses have used GS1 Standards to overcome challenges to thrive in uncertain times. There will be 40+ live sessions (including ours!), 50+ exhibitors (including us!), trading partner roundtables, and other events centered on user stories and leadership insights for supply chain optimization.

As GS1 says, the event is a place to “network with the greatest supply chain minds and learn how to leverage GS1 Standards to optimize your business.” Indeed.

In “Supply Chain Traceability: Can Your Business Survive Without It?” Herb Wong, our vice president of product and strategy, will discuss why traceability is foundational to business success in a rapidly evolving landscape of digitalization, ever-changing consumer expectations and power dynamics, tougher regulations, and supply chain uncertainty. He’ll be speaking on Thursday, June 9, at 1:45 p.m.

In on-demand session 509, “Smarter and Safer Hospitals: When Innovative Technologies Meet Patient Safety, our Digital Healthcare Department Director Adriano Fusco and Dr. Alberto Sanna, director of the Research Center for Advanced Technologies for Health and Well-Being of the IRCCS San Raffaele Hospital in Milan, Italy, will discuss how traceability and GS1 Standards enable end-to-end visibility of medications from arrival at the hospital to dispensation and optimized resources to focus on patient safety.

Final thoughts

We’ve always valued GS1 Standards, and we’ve always ensured our customers can adhere to them and take full advantage of them to maximize efficiency and create value across their operations everywhere they do business.

And who took the time to note the 50th anniversary of the venerable Global Trade Item Number (GTIN)? We did, with a blog post devoted to GS1 barcodes.

As we said in that article, “Where would we be without standards?” We’d love to see you at GS1 Connect and talk about those standards and how they fuel traceability. We hope you’ll take those few seconds to sign up to meet us at Booth 115, get 10 percent off your registration, and enter to win a nice prize when you take our survey.

In the meantime, drop us a line if you have any questions or want to know more about our traceability solutions for pharma, food and beverage, cosmetics, and other industries. We never pass on an opportunity to talk about what makes us your best partner for end-to-end supply chain solutions, from L1 all the way to L5!

See you in San Diego June 7-9!

DSCSA EPCIS Update: 3 Questions for rfxcel Vice President of Strategy and Innovation Herb Wong

Herb Wong’s a busy guy. As vice president of strategy and innovation at rfxcel, he’s always on the go, advising and conferring with customers, talking and brainstorming with industry leaders, dashing off to speak at conferences, and thinking of new ways to improve … everything. So we were happy that he found time to talk with us about what’s happening with DSCSA EPCIS.

Our chat comes as Herb is fresh off an appearance at the Healthcare Distribution Alliance (HDA) Distribution Management Conference in Austin, Texas, where he participated in the “EPCIS Standards and Implementation Process” panel discussion. HDA also recently published a DSCSA EPCIS Implementation Benchmarking Survey about the progress of adoption and trading partner plans for sending data.

Here’s the scoop:

Herb, what has the EPCIS Center of Excellence learned about industry readiness for the DSCSA EPCIS requirements?

Well, the EPCIS COE, which we introduced at the HDA Quarterly Update in September last year, has discovered a number of things through our studies and meetings. Here are takeaways in the key areas of education, consistency, and standards.

As we get closer to the November 2023 deadline, new participants are less knowledgeable about EPCIS and DSCSA. Their integrations take more time and they have more questions and need more education. This was a recurring theme we started hearing during our EPCIS COE interviews. Because of this, the HDA and GS1 are looking to see how they can offer/repackage training to get the industry up to speed.

In terms of consistency, we are looking into developing a common, consistent process for all solution providers to begin an EPCIS exchange. This can improve the efficiency across all supply chain partners.

And for standards, we have been discussing a process or tool to have all participants verify that their EPCIS data is formatted correctly before they begin exchanging it with others. GS1 developed an offering for this and everyone agrees that it’s a good idea; but determining who pays for this testing has been challenging.

How has the industry reacted to the EPCIS COE’s efforts?

Overall, everyone has been receptive. But this is a huge undertaking. It reminds me of the question, “How do you eat an elephant?” Answer: “One spoonful at a time.” Accelerating EPCIS data exchange is like that. It’s so big that people don’t know exactly where to start.

The answer is to just start somewhere and then learn and improve. The hardest part is getting started. Once we decide on a few areas where we can make an impact, momentum will keep us moving forward. We are in the process of agreeing on what we can do, so stay tuned!

What are your thoughts about industry readiness?

A number of supply chain partners asked me this question at the HDA Distribution Management Conference in Austin earlier this month. The industry is becoming more focused on the deadline. Everyone is realizing that the time for open-ended discussion is coming to a close and decisions must be made. We have 19 months to be ready for DSCSA 2023 and a lot of different efforts must be aligned.

Final thoughts

Herb Wong, everyone!

We hope Herb’s answers were helpful and shed light on the industry’s efforts to be ready for the DSCSA EPCIS requirements. As he said, it’s an elephant-sized undertaking with a lot of moving parts that need coordination and consensus. The EPCIS COE is “the spoon” that’s helping the pharmaceutical industry digest the requirements, address the challenges, and get everyone compliant by November 27, 2023.

If you still have questions, your first step should be to contact us. One of our supply chain experts can explain the requirements and how our solutions will get your house in order. If you like, we can probably arrange a meeting with Herb. So reach out today and let’s talk.

We also encourage you to browse our DSCSA Compliance Library. It’s a clearinghouse of information with links to our blog posts, white papers, webinars — everything — about the law, including EPCIS requirements.

Last, we want to let you know that in June Herb will head to San Diego to speak at the GS1 Connect 2022 conference. On Thursday, June 9, he’ll present “Supply Chain Traceability: Can Your Business Survive Without It?” Herb will discuss why traceability is foundational to business success and how companies in any industry can leverage traceability in a digital supply chain to ensure they comply with regulations and much more. Check back for updates as we get closer to June!

rfxcel DSCSA Compliance Library: Our DSCSA Resources in One Place

Welcome to the rfxcel DSCSA Compliance Library. It’s a collection of our DSCSA resources (as of January 2022). As we move toward the November 2023 deadline, we thought it would be a good idea to make this information available in one convenient location.

We will, of course, continue writing about the DSCSA and providing the best supply chain solutions to ensure manufacturers, wholesalers, dispensers, repackagers, third-party logistics providers — all pharmaceutical stakeholders — meet the requirements and remain compliant forever.

So bookmark this page and our blog. You can also subscribe to our newsletter to make sure you don’t miss anything about the DSCSA and other important developments in the pharma industry. Just fill out the short form at the bottom of any page on our website.

And of course, contact us today with your questions about the DSCSA or anything else about the pharma supply chain. Our experts are here to help.

A note about the rfxcel DSCSA Compliance Library

Please note that that we haven’t included everything we’ve written or presented about the DSCSA. Deadlines and requirements have changed since the law was enacted in November 2013, so some of our earlier pieces are, logically, outdated. Rest assured that the contents of the rfxcel DSCSA Compliance Library are up to date.

If you want to see how we’ve followed the evolution of the DSCSA in our blog or track down other news we shared over the years, look around our “Resources” page. You’ll probably find some other things that interest you too.

­­Our top DSCSA webinars
The DSCSA in our blog
DSCSA compliance white papers + global compliance resources
Our top DSCSA news items
The DSCSA timeline

DSCSA 2023 Serialization Timeline

Who Investigates Counterfeit Cosmetics Products?

In our last blog post, we talked about the global problem of counterfeit cosmetics. Today, we’re talking about who investigates counterfeit cosmetics products, starting with how cosmetics are regulated in the United States and the EU.

Regulation of cosmetics products varies greatly from country to country, so our discussion today should not be taken as an overview of what to expect everywhere cosmetics are sold. Enforcement of laws and the actions authorities take to target counterfeits also vary.

What is universal, however, is that the cosmetics industry faces unique challenges with consumer safety, increased consumer demand for transparency, and being targeted by counterfeiters. It’s good to know who investigates counterfeit cosmetics products and what measures you can take to be part of the solution.

Who investigates counterfeit cosmetics products: USA and EU

Counterfeit cosmetics are dangerous because the criminals who make them don’t follow regulations or standards for production. Fakes are often contaminated with “stuff” you really don’t want to think about, let alone put on your face, such as bacteria, animal and human feces, arsenic, and mercury. So, regulators keep an eye on cosmetics.

United States

In the United States, the Food and Drug Administration (FDA) is the governing body for cosmetic regulations. Cosmetics products do not require FDA approval — but they are regulated. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA) explain the FDA’s requirements, restrictions, and disciplinary actions regarding cosmetics.

The FDA focuses on preventing adulteration and misbranding, mislabeling, and harmful ingredients or drugs. Adulteration refers to products or product ingredients that are not in line with FDA regulations or that have been contaminated. A misbranded product is “improperly labelled or deceptively packaged,” which could include counterfeit cosmetics products. The FDA prohibits 11 chemicals from being used in cosmetics products.

Additionally, the FDA reserves the authority to request recalls and work with the Department of Justice, Federal Bureau of Investigation (FBI), and Border Customs if any violations are found. It maintains a “Cosmetics Recalls & Alerts” page and has a searchable “Enforcement Report” database of recalled products.

The European Union

Cosmetics products manufactured in and imported to Europe are regulated under the EU Cosmetic Regulation. Like the FDA, the EU regulates ingredients and labeling; generally, however, the regulations are broader and more precisely defined.

For example, more than 1,300 substances (e.g., chemicals, colorants, and preservatives) are banned from cosmetic use, and hundreds more are permitted only under certain conditions. The regulations also mandate Good Manufacturing Practices (GMP), whereas the FDA only suggests GMP as “guidelines for effective self-inspection.”

Furthermore, the EU requires significant product documentation. Every cosmetics company must have a “responsible person” for every product they make. This person is responsible for ensuring products are safe and comply with regulations, and must submit a cosmetics product notification through an online portal before a product can be sold.

The responsible person must also create a product information file that includes the name, description, and nature of the product; description of the manufacturing methods; statement of compliance with regulations and GMP; a product safety report; and data about animal testing, if any. They must also assemble a product safety report that contains product safety information and a product safety assessment.

Do consumers have a role?

Yes, and it begins with vigilance with prices, packaging, and product quality:

      • Prices: If the price is too good to be true or just noticeably cheaper than the last time you bought it, there’s a good chance it’s a fake.
      • Packaging: The printing might look shoddy or the colors might seem off. There might not be a barcode. There might not be packaging at all, and the products might be offered in bulk.
      • Product: If the consistency or texture seem different, it’s likely a fake

In the United States, consumers can “report suspicions concerning the manufacture or sale of counterfeit or pirated goods” to the FBI. For suspected counterfeit cosmetics products seen online, consumers can contact the FBI Internet Fraud Complaint Center. The FBI has also partnered with the National Intellectual Property Rights Coordination Center to create a tip line where consumers can report products they suspect to be fake.

In the EU, consumers are encouraged to contact their local authorities about counterfeit cosmetics products. Depending on the nature of the situation, the authorities might investigate themselves or contact the appropriate investigative body, which could include Europol. The United Kingdom has Action Fraud, an online reporting tool for fraud and cybercrime.

Consumers should also be aware of what brands are doing to combat counterfeits and consumer engagement programs that encourage people to report suspicious products.

Final thoughts

If you really want to drill down into the U.S. and EU regulations, download our “Global Cosmetics Market” white paper today. It also has a section about regulations in Singapore, plus more information about counterfeit cosmetics products.

In “Top Supply Chain Trends of 2021,” we posed some important questions companies should ask themselves as we move toward what is likely to be another challenging year for supply chains. Many of those questions, listed below, fit perfectly with what we talked about today — regulations, counterfeits, brand protection, consumer engagement.

Your supply chain is where all of these concerns converge. Which is why you should schedule a short demo of our solutions. In about 15 minutes, we can show you the basics of our Traceability System and how it transforms your supply chain into a strategic asset that will improve and protect every facet of your business.

 

  • Are you keeping up with supply chain trends?
  • Are there gaps and blind spots in your supply chain?
  • Are counterfeits a problem in your industry?
  • Are you doing everything you can to protect your brand?
  • Are you actively reaching out to your customers to bring them closer to your brand?
  • Are there compliance deadlines on the horizon?
  • Are you certain your current supply chain solutions are truly optimal?
  • Are you using your supply chain as a strategic asset?

Why We Should Worry About Counterfeit Cosmetics

Counterfeit cosmetics have boomed during the pandemic. Not that they’ve ever not been in fashion among the criminal set. But recent research shows a renaissance, a proliferation of often dangerous fakes readily available to more people and through newer channels.

We just published a white paper about the global cosmetics market. It has a section about counterfeit cosmetics, and now we want to keep the conversation going with more information about this global problem. Here we go.

The statistics reveal “a worrying threat”

In “Global Trade in Fakes: A Worrying Threat” (June 2021), the Organisation for Economic Co-operation and Development (OECD) reported that the global value of counterfeits and pirated goods amounted to as much as $464 billion in 2019, or 2.5 percent of world trade.

Worldwide, there were “consistently” more than 130,000 customs seizures of counterfeit and pirated goods annually in 2017, 2018, and 2019. “Overall,” the report continues, “the unified database on customs seizures of IP-infringing goods includes almost half [a] million observations.”

In 2017 and 2018, counterfeit cosmetics and perfumery products accounted for about 4 percent of all customs seizures. That rose to just under 10 percent in 2019 — a considerable jump in a very short time. Furthermore, cosmetics and perfumery products were among the Top 5 products “targeted by counterfeiters” every year from 2011 to 2019. (The others were articles of leather, clothing, footwear, and watches.)

What toll do counterfeit cosmetics take on the industry’s fiscal health? One report shows that annual sales losses from counterfeiting in cosmetics and personal care products sector amounted to 4.7 billion euros, or about $5.3 billion.

Our brand protection series talks more about counterfeits. It’s a real problem that every industry, some more than others, must contend with.

Counterfeit cosmetics in a huge global market

According to a Fortune Business Insights report published in September, the cosmetics market was worth $277.67 billion in 2020. Despite an overall decline in sales during the pandemic, the market is projected to grow to $415.29 billion by 2028.

The market has responded to consumer demand for a wider variety of products, and online shopping has added an ease of access. Online shopping will drive the market and, according to industry watchers, could account for nearly 30 percent of global beauty sales by 2026.

However, the dramatic shift from in-person to online purchasing during the pandemic has emboldened criminals to churn out more and more counterfeit cosmetic products. As OECD put in its “Global Trade in Fakes” report, “Under confinement, consumers turn to online markets to [fulfill] their needs, driving significant growth in the online supply of a wide range of counterfeits.”

Research from the U.S. Department of Homeland Security supports this finding. Its “Combating Trafficking in Counterfeit and Pirated Goods” report (January 2020) noted that “Selling counterfeit and pirated goods through e-commerce platforms and related online third-party marketplaces is a highly profitable venture.”

The threat to businesses and consumers

Counterfeit cosmetic products are a real threat to manufacturers and consumers. The bogus goods mimic the original, undercutting company sales. They bypass quality control processes and regulatory oversight, which means they can contain harmful “ingredients.”

For example, in 2018 authorities in the United Kingdom recovered counterfeit cosmetics that were found to contain mercury and high levels of hydroquinone, a skin-whitening agent. UK Police have also warned consumers about fake products containing “rat droppings, human urine, and arsenic.” Police in Los Angeles found counterfeits with bacteria and animal waste.

With the surge in online orders, shipping has become important to the counterfeit industry. The OECD reported that between 2017 and 2019, 64 percent of global seizures were postal shipments and 13 percent involved express couriers. In the same period, 77 percent of all counterfeits seized by authorities were discovered during the shipping period.

Final thoughts

Counterfeit cosmetics — counterfeit anything — threaten consumer safety and brand reputations.

Your supply chain is your first line of defense. With the right solution for end-to-end traceability, like our rfxcel Traceability System, you can leverage data and lock down your supply chain guard to against counterfeits and help mitigate other risks.

You’ll also be able to meet consumer demand for transparency. You can tell them with certainty that your products are what you say they are. You’ll ensure product safety and protect your brand.

If you have questions, we can help. Take a look at our solutions for brand protection and download our white paper about the global cosmetics market. And contact us today to arrange a short demo of our Traceability System. In about 15 minutes, our supply chain experts can show how our solutions will turn your supply chain into your most valuable strategic asset.

Antares Vision Group, Through rfxcel, Announces EPCIS Center of Excellence to Enable DSCSA Serialization Requirements by 2023

The Center of Excellence is a dedicated group of solution providers that will work with the industry to accelerate the rollout of serialized data in advance of the November 27, 2023, DSCSA deadline.

Reno, Nevada, Dec. 7, 2021 (EINPRESSWIRE). Antares Vision Group, through rfxcel, today announced an EPCIS Center of Excellence (COE) to help pharmaceutical stakeholders prepare for upcoming serialization requirements in the U.S. Drug Supply Chain Security Act (DSCSA). rfxcel first introduced the COE at a Healthcare Distribution Alliance (HDA) Quarterly Update on September 27.

Antares Vision Group is a global leader in creating end-to-end data connection ecosystems with solutions for quality, traceability, and data management for supply chains and digital factories. rfxcel is a global leader in digital supply chain traceability solutions and regulatory compliance.

DSCSA regulations will take effect on November 27, 2023, that require every supply chain partner to share unit-level product data electronically in a secure, interoperable manner. This data will include detailed transaction information and product identifiers, which include a unique serial number. At present, EPCIS — Electronic Product Code Information Services — is the most widely recognized international standard that will allow stakeholders to meet these requirements for transaction data connections.

rfxcel will coordinate with other recognized solution providers to develop processes to accelerate the rollout of EPCIS and ensure that serialized data is exchanged properly. rfxcel CEO Glenn Abood underlined that the COE is a group effort focused on the benefit all pharmaceutical supply chain participants.

“The EPCIS COE is an industry-wide undertaking that relies on the knowledge and expertise of every member,” Abood said. “The serialization deadline is just two years away, and rfxcel is excited to announce the COE and to be working with our peers to ensure the success of the DSCSA by meeting the requirements for accurate, high-quality data.”

rfxcel will provide regular updates about the COE’s activities and progress on its website. For more information, contact Vice President of Marketing and Strategic Initiatives Herb Wong at 925-791-3235 or hwong@rfxcel.com.

About Antares Vision Group

Antares Vision Group protects products, people, profits, and our planet with inspection systems featuring 6,500 quality controls, track and trace software solutions for end-to-end transparency and visibility in digital supply chains, and smart data management tools for maximum operational efficiency, from raw materials to final consumers. It provides solutions to five primary industries: pharmaceuticals and life sciences (medical devices and hospitals), food and beverage, cosmetics, and consumer packaged goods. Active in more than 60 countries, Antares Vision Group has seven production facilities and three Innovation and Research Centers in Italy, 22 foreign subsidiaries, and a global network of more than 40 partners. Today, 10 of the world’s 20 leading pharmaceutical companies use its solutions to secure their production and supply chain operations; worldwide, it has deployed more than 25,000 inspection systems and more than 3,500 serialization modules. Antares Vision Group has been listed on the Italian Stock Exchange’s AIM Italia market since April 2019 and in the STAR Segment of the Mercato Telematico Azionario (MTA) since May 2021. In March 2021, Antares Vision acquired 100 percent of rfxcel Corporation, which specializes in software solutions for digitalization and supply chain transparency.

About rfxcel

Part of Antares Vision Group, rfxcel has a long history of providing leading-edge software solutions to help companies build and manage their digital supply chain, lower costs, protect their products and brand reputations, and engage consumers. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s Traceability System to power end-to-end supply chain solutions in track and trace, environmental monitoring, regulatory compliance, serialization, and visibility. Founded in 2003, the company is headquartered in the United States.

What is the Drug Supply Chain Security Act?

Today’s question: What is the Drug Supply Chain Security Act?

We’ve written extensively about the legislation, which was passed on November 27, 2013. But with the deadline for full compliance quickly approaching, we thought a quick overview was in order. So let’s answer the question, What is the Drug Supply Chain Security Act?

What Is the Drug Supply Chain Security Act?

If you’re a pharmaceutical company — a manufacturer, wholesaler, dispenser, repackager, or third-party logistics provider — you must comply with the Drug Supply Chain Security Act (DSCSA) if you want to do business in the United States.

The U.S. Food and Drug Administration (FDA) says the goal of the DSCSA is “to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.” The Act “will enhance [the] FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful” and “improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.”

The law has been rolled out in phases since it was passed nearly 10 years ago. Implementation culminates on November, 27, 2023, at which time the U.S. pharmaceutical supply chain will be fully serialized.

Key requirements of the Drug Supply Chain Security Act

The FDA puts DSCSA requirements into the following categories:

1. Product identification/serialization

A unique product identifier (PI), such as a bar code, must be placed on certain prescription drug packages.

2. Product tracing

Stakeholders must provide information about a drug and who handled it each time it’s sold. This includes transaction information (TI), a transaction statement (TS), and a transaction history (TH), collectively known as “T3” information. Read our “Dispensers and DSCSA 2023” white paper for more about T3 information.

3. Product verification

Stakeholders must establish systems and processes to verify PIs for certain prescription drugs packages. The Verification Router Service (VRS) enables a rapid, secure exchange of data to do this. See more about VRS below.

4. Detection and response + notification

Stakeholders must quarantine and promptly investigate suspect or illegitimate drugs. They must also notify the FDA and other interested parties when they find such drugs.

5. Licensing

Wholesalers must report their licensing status and contact information to the FDA. Third-party logistics providers must obtain a state or federal license.

Looking forward

The FDA has delayed the rollout of the DSCSA two times, giving the industry extra time to prepare. However, an FDA official recently said there will be no more delays. November 27, 2023, is a done deal.

In terms of what’s next, take a look at our “DSCSA 2023: The Future of Pharmaceutical Traceability in the United States” blog post. This gets into the granular details of the transformation that’s going to happen in 2023, but here are the basics of what to expect:

Serialization

Serialization relies on product identifiers (the “PIs” we mentioned above), which include serial numbers and expiration dates. For 2023, all transaction information (the “TI” we mentioned above) must include the PI. TI includes the following:

  • The product name
  • The product’s strength and dosage form
  • The product’s National Drug Code
  • The container size and number of containers
  • The lot number
  • The transaction date
  • The shipment date
  • The name and address of the businesses from which and to which ownership is being transferred
Authorized trading partners

Put simply, the DSCSA says that if you’re not an authorized trading partner (ATP), your access to the U.S. pharma supply chain will be severely restricted or denied altogether. All manufacturers, wholesale distributors, repackagers, third-party logistics providers, and dispensers and their trading partners must be ATPs. We did a deep dive on ATPs earlier this year; read our two-part series here.

Verifying drugs

The DSCSA’s saleable returns verification requirement stipulates that wholesalers must verify all returned drugs before they can be reintroduced to the supply chain. This is done by verifying a drug’s PI. A wholesaler must initiate a verification request to the drug’s manufacturer, then the manufacturer must provide a verification response within 24 hours. The Verification Router Service — the VRS — is what enables the rapid, secure exchange of data between these parties. Like everything else in the DSCSA, we’ve written extensively about the VRS. Our “DSCSA Saleable Returns Verification Requirement: Just the Facts” article is a good place to start.

Final thoughts

What is the Drug Supply Chain Security Act? The DSCSA makes pharma stakeholders responsible for securing the U.S. supply chain. It doesn’t matter if you’re a manufacturer, wholesaler, repackager, third-party logistics provider, or a dispenser — the law affects how you conduct business. Your compliance depends on making sure you can meet your responsibilities.

That’s where rfxcel comes in.

A fully serialized pharma supply chain is just two years away. It’s important to use this time to get your systems in place. We have almost 20 years of experience providing the pharmaceutical industry with leading regulatory and compliance software. So if you aren’t sure if you’re going to be ready for DSCSA 2023 and want to see a short demo of our solutions — or just want to know more about your responsibilities — contact us today. Our DSCSA experts will work directly with you to design a solution that meets your specific needs, no matter your role in the supply chain.

In the meantime, you can hear directly from our experts in our “Plan for DSCSA Readiness” webinar and our DSCSA 2023 webinar series. These are great resources to help you better understand the law.

Drug Supply Chain Security Act Pharmacy Responsibilities

Drug Supply Chain Security Act pharmacy responsibilities are complex. They can be confusing. But the clock is ticking to be ready for the November 27, 2023, deadline. Let’s do a quick recap for pharmacies.

What is the U.S. Drug Supply Chain Security Act?

The U.S. Drug Supply Chain Security Act, enacted on November 27, 2013, establishes a system to track and trace prescription drugs in a fully serialized supply chain. It calls for end-to-end traceability and electronic interoperability to prevent counterfeit, stolen, contaminated, or otherwise harmful drugs from entering the U.S. supply chain.

So far, the DSCSA has mostly focused on lot-level traceability — exchanging information about every package of medication so stakeholders can see exactly where it has been. Enactment culminates in November 2023, with 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.

Drug Supply Chain Security Act pharmacy responsibilities: definitions

Pharmacies are referred to as “dispensers” in the DSCSA. The legislation defines a dispenser as “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.

How to comply with the DSCSA

As we said above, the Drug Supply Chain Security Act pharmacy responsibilities are complex. Let’s break them down into easy-to-understand pieces.

You must exchange information about every drug you buy and who handled it each time it changes ownership in the United States.

The DSCSA calls this “product tracing information,” and it has three components, collectively referred to as “T3 information”:

  1. Transaction Information (TI) about a product (e.g., proprietary or established name or names and the strength and dosage form)
  2. Transaction Statement (TS), which is an electronic statement confirming the entity transferring ownership.
  3. Transaction history (TH), an electronic statement with the TI for every transaction going back to the manufacturer. TH is required until the November 27, 2023, deadline.
You must receive, store, and provide product tracing documentation

You can accept prescription drugs only if they have proper tracing information, and you must store the information for six years. You must also generate and provide all information when you sell a prescription drug to a trading partner.

You can only do business with authorized trading partners (ATPs)

And speaking of trading partners, if you can’t confirm your they’re licensed or registered, you can’t do business with them. 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 for all the details.

You must investigate and properly handle suspect and illegitimate drugs

Suspect and illegitimate drugs include drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution — the problem the DSCSA was designed to eliminate. Pharmacies must quarantine and investigate these drugs to determine if they are fake. If you make this determination, the next step is to work with the manufacturer and take specific action to ensure the bad drug does not reach patients/consumers. You must also notify the FDA and your trading partners about the drug.

You must authenticate and verify drugs

This is what’s coming in 2023. You’ll have to be able to authenticate and verify all the medicines you buy before you can sell them. The fundamental requirement is that TI (transaction information) must include a product identifier (PI), which includes serial numbers and expiration dates. The Electronic Product Code Information Services (EPCIS) is likely to be the standard the industry will use to enable this exchange.

Final Thoughts

We’re writing this on November 24, 2021. Yes, it’s the day before Thanksgiving. (Happy Thanksgiving!) It’s also almost exactly two years from the DSCSA implementation deadline. That may seem like a long time, but …

It is definitely not a long time. There’s a lot to do to ensure you’ll comply with your Drug Supply Chain Security Act pharmacy responsibilities. If you aren’t sure you’ll be ready, contact us to schedule a short demo of our DSCSA solutions. Our team of supply chain experts will design a solution to ensure you meet all DSCSA requirements and remain compliant forever.

And if you’re looking for something to read over the Thanksgiving holiday, download our “Dispensers and DSCSA 2023” white paper. It drills down into what we talked about today and is a great reference tool to have on hand as you prepare for the full serialization of the U.S. pharma supply chain.

Happy Thanksgiving!