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

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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 SVP of Product and Strategy Herb Wong

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Herb Wong’s a busy guy. As senior vice president of product and strategy 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!

DSCSA Compliance Library: Comprehensive DSCSA Information in One Location

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Welcome to the rfxcel DSCSA Compliance Library. It’s a collection of our key DSCSA resources (as of September 2023) and is a convenient place to get information as the industry navigates the “extended stabilization period” until FDA enforcement begins on November 27, 2024.

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.

The DSCSA in our blog

DSCSA compliance white papers

Our top DSCSA news items

­­Our top DSCSA webinars

The DSCSA timeline

A timeline showing key dates of the U.S. Drug Supply Chain Security Act (DSCSA) from 2013 to 2024

Who Investigates Counterfeit Cosmetics Products?

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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?

Addressing the Concern: The Threat of Counterfeit Cosmetics

Posted on by rfxadmin

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

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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 (DSCSA)?

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

The Drug Supply Chain Security Act (DSCSA) was passed on November 27, 2013. Envisioning a 10-year journey leading to the complete serialization of the U.S. pharma supply chain and electronic, interoperable exchange of product information, the law is scheduled to take effect on November 27, 2023.

We’ve written extensively about the legislation, but with the deadline for full compliance quickly approaching, we thought an overview was in order.

So let’s take a look at the DSCSA from top to bottom — milestones, requirements, highlights, expectations, and challenges — and answer the question, What is the Drug Supply Chain Security Act?

The Most Recent DSCSA Developments

As the timeline below shows, the FDA has adjusted DSCSA compliance deadlines during the rollout. The most recent — and arguably most significant — happened in August 2023, when the Agency announced that it was delaying by one year enforcement of key DSCSA requirements. This “extended stabilization period” moves the enforcement date to November 27, 2024.

However, it’s vital that all supply chain actors understand that the original compliance deadline of November 27, 2023, still stands. The Agency has made it clear that the stabilization period is not 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.

In Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies, the FDA 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.

So what’s the key takeaway: Don’t stop preparing for the DSCSA. If you have questions about the DSCSA stabilization period or are concerned that your current provider isn’t doing everything it can to set you up for success, we encourage you to contact us today to speak with one of our DSCSA experts. We are 100 percent committed to ensuring all of our customers meet DSCSA compliance.

DSCSA Timeline

A timeline showing key dates of the U.S. Drug Supply Chain Security Act (DSCSA) from 2013 to 2024

DSCSA at a Glance

Created as Title II of the Drug Quality and Security Act (DQSA), passed by Congress in November 2013, the DSCSA is an initiative to prevent the introduction and distribution of counterfeit, stolen, contaminated, or otherwise harmful drugs in the United States. It outlines steps to build an interoperable electronic system to identify and trace prescription drugs as they are distributed throughout the country. By providing comprehensive FDA guidance, the act facilitates the accurate tracing of products from the point of production to distribution to dispensation and beyond.

Understanding 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.”

As we said above, the law has been rolled out in phases since it was passed nearly 10 years ago. Even though enforcement was delayed until November 2024, the FDA expects all supply chain stakeholders to keep preparing.

Key Requirements of the Drug Supply Chain Security Act

The DSCSA requirements can be divided into several categories that apply to manufacturers, repackagers, wholesale distributors, dispensers, and 3PLs. Each is important, but four are particularly vital to being ready for November 2023 because they require these stakeholders to have specific systems in place to be fully compliant. These are the “four cornerstones” of DSCSA compliance:

Product identification (serialization)

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.

Product tracing

Manufacturers, wholesale distributors, repackagers, and many dispensers (primarily pharmacies) must provide certain information about the 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 transferring ownership of the product that it has complied 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 required before the November 27, 2023, deadline; it is not required after that date.

Verification

Manufacturers, wholesale distributors, repackagers, and dispensers must establish systems and processes to verify PIs for certain prescription drug packages. For saleable returns, manufacturers and wholesale distributors must use the Verification Router Service (VRS). 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.

Authorized trading partners (ATPs)

All manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers must be ATPs and be able to electronically verify that their trading partners are ATPs.

In broad terms, to be an ATP you must meet certain registration, licensing, and licensure reporting requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and comply with state licensing requirements. The definitions of ATP also include language about accepting or transferring direct ownership or possession of products.

There are “four cornerstones” of DSCSA compliance requirements:

Other DSCSA Requirements to Consider

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.

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

Final thoughts

What is the Drug Supply Chain Security Act? The DSCSA requires pharma stakeholders to work together to secure 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.

We have 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 2023–2024 or you’re wondering if your current solution provider is doing everything it can to prepare you for compliance, contact us today.

Our DSCSA experts can show you a short demo of our solutions, clarify what your responsibilities are, and answer questions about your needs and how to meet them, no matter your role in the supply chain.

In the meantime, check out some of our other DSCSA resources, including our DSCSA: Preparing for the Full Serialization of the U.S. Pharmaceutical Supply Chain white paper and our DSCSA 2023 webinar series. These are great resources to help you better understand the law. You can click on those links or jump right to our DSCSA Compliance Library, a clearinghouse of all our information about the law.

Drug Supply Chain Security Act (DSCSA) Pharmacy Responsibilities

Posted on by rfxadmin

Drug Supply Chain Security Act pharmacy responsibilities are complex. They can be confusing. But the clock continues to count down to the final compliance deadline.

On August 25, 2023, the U.S. Food and Drug Administration (FDA) announced that it was delaying by one year enforcement of key DSCSA requirements. This “extended stabilization period” moves the enforcement date to November 27, 2024. Read our blog post here for all the details.

If you want to ensure that your business processes comply with DSCSA pharmacy regulations, the first step is to familiarize yourself with the nuances of the law. With that in mind, 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 will culminate next year 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.

As the final link in the pharmaceutical supply chain, pharmacies are the last safeguard between suspect products and patients. They are responsible for gathering transaction information and reviewing supply chain data to verify the legitimacy of products (more on that below).

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. The DSCSA pharmacy requirements apply only to dispensers that provide medication to patients or end-users. If your pharmacy is providing medications to another dispenser or another member of the pharmaceutical supply chain, it is acting as a distributor, which means other DSCSA requirements would apply.

How to comply with the DSCSA

Compliance is mandatory if you are a dispenser under DSCSA pharmacy requirements. Failure to comply will raise flags with the FDA and open your organization to penalties, including fines.

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 only until the November 27, 2024, deadline.

Under DSCSA pharmacy requirements, you have to obtain and exchange this data for every transaction. The purpose of these traceability requirements is to promote drug distribution security and to identify potential discrepancies in the supply chain records. If a product cannot be traced back to a legitimate source, it is considered “suspect.”

Adhering to these transaction requirements will help pharmacies protect their consumers from illegitimate drug products. Traceability standards also help the FDA ensure that suspect prescription drugs do not enter the supply chain in the first place.

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.

If the FDA conducts a DSCSA pharmacy audit, it can examine records dating back six years. If information is missing, you will be found in violation of the DSCSA and could face substantial penalties.

Providing product traceability information is another important part of DSCSA pharmacy requirements, as pharmacies frequently send inventory to other companies within their healthcare networks. When you engage in these activities, you are acting as a distributor and must adhere to all relevant standards regarding the creation of lot numbers and product-level tracing.

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.

For now, we will provide a brief recap of what constitutes an ATP under the DSCSA guidelines. The FDA states that an authorized partner is:

  • A manufacturer or repackager that has a valid registration with the FDA
  • A wholesale distributor that has a valid license under state law
  • A third-party logistics provider (3PL) that has a valid license in accordance with state law
  • A dispenser that has a valid license in accordance with state law

The FDA defines a trading partner as:

  • An entity (i.e., manufacturer, distributor, repackager, or dispenser) that accepts director ownership of a product from a manufacturer
  • An entity that transfers direct ownership of a product
  • A 3PL that accepts or transfers products to another entity in the supply chain

In other words, an ATP is an entity that is appropriately licensed and accepts or transfers direct ownership of a regulated pharmaceutical product. Before a pharmacy does business with a repackager, wholesaler, or distributor, it must verify the organization’s ATP status.

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.

Identifying illegitimate products is one of the most important roles of pharmacists under DSCSA requirements. It is also one of the most challenging tasks, as each pharmacist and pharmacy technician must be trained on how to identify illegitimate or suspect products. All pharmacies should train their employees about the DSCSA requirements (e.g., abnormalities in transaction information) and other methods to identify suspect products.

You must authenticate and verify drugs

This is what’s coming in 2024. 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.

EPCIS is a standard from GS1, an international organization responsible for creating and maintaining operational standards for key industries, including healthcare. EPCIS is a means to electronically share the “what, when, where, why, and how” information about pharmaceutical products, promoting end-to-end traceability and interoperability among supply chain actors.

Final thoughts

Navigating complex compliance requirements and adapting to new standards can present challenges. Fortunately, you have options — like partnering with rfxcel to help you meet DSCSA pharmacy requirements.

Even though the enforcement deadline has been extended until November 2024, the time to act is now. If you aren’t sure you’ll be ready, contact us to schedule a short demo of our DSCSA pharmacy compliance solutions, which include robust traceability tools, data management solutions, and more. As an rfxcel partner, you’ll tap into the expertise of our DSCSA pharmacy compliance experts, who will collaborate with you to design a solution to ensure you meet all DSCSA requirements and remain compliant forever.

We also invite you to download our DSCSA compliance 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. Also bookmark our DSCSA compliance library, which has all our resources about the law.

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

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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:

  1. Product serialization
  2. Product tracing
  3. Verification (of product identifiers)
  4. 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 Strategy and the Top Supply Chain Threats

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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.

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