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Join Antares Vision Group at the HDA 2022 Traceability Seminar in October

Antares Vision Group will be at the HDA 2022 Traceability Seminar October 12-14 at the Marriott Marquis in Washington, D.C. We’re an official sponsor, and our team will be there with our latest technologies and solutions. Stop by to meet us!

The HDA 2022 Traceability Seminar brings together healthcare supply chain leaders to learn more about implementation milestones of the DSCSA as distributors, manufacturers, and dispensers implement serialization and traceability technologies.

Attendees also discuss innovative approaches and lessons learned from the first 9 years of the DSCSA rollout and what to expect during the “last mile” of implementation until the November 2023 deadline.

Get the latest DSCSA intel from our experts at the HDA 2022 Traceability Seminar

If you’re reading this, chances are you know that we’ve been leading on the DSCSA since Day 1 and have collaborated with the pharma industry to test key systems, work out kinks, and help all stakeholders prepare. Here are just a few examples:

And it should come as no surprise that Herb Wong, our SVP of product and strategy, will be at the Seminar. He’ll be at our booth, of course, but he’s also doing the “EPCIS Onboarding Across the Supply Chain” panel discussion on Thursday, Oct. 13, from 1:30 to 2:30 p.m.

Herb will also host a Friday morning roundtable about DSCSA readiness. Antares Vision Group is sponsoring the day’s Roundtable Discussions (9:35-10:50 a.m.), where you can discuss operational issues associated with traceability implementation. Choose a topic that interests you and rotate through the tables with your peers. Highlights from the discussions will be shared at the end of the session.

With this experience and knowledge, our team wants to answer your questions and show you our solutions while you’re at the Seminar. No matter how far along you are in your DSCSA preparations, time with our team will be time well spent — informative, interesting, and maybe even game-changing.

Final thoughts

We’re just a year away from the final DSCSA deadline and the full serialization of the U.S. pharmaceutical supply chain. The HDA 2022 Traceability Seminar is really the place to be when it comes to the “right now” of the DSCSA for product identification, product tracing, product verification, and requirements for authorized trading partners.

So bring your DSCSA questions for our team and let us know how things are going. Visit our booth. Sit in on Herb’s Thursday EPCIS panel discussion and his Friday roundtable. If you have 3 minutes, take our DSCSA Readiness Survey. You can also check out our DSCSA Compliance Library for all of our resources about the law.

We hope to see you in October!

FDA National Drug Code: Proposed Format Changes & Industry Impact

If you follow our blog (and we know you do), you know that pharma stakeholders will have to verify all products at the individual package level when the Drug Supply Chain Security Act (DSCSA) goes into full effect about 1 year from now. The FDA National Drug Code, or NDC, is integral to this requirement.

At some point, however, the FDA realized that it was “running out of” National Drug Codes. One reason was the pandemic, which the Agency said “significantly increased the rate at which NDC codes were issued.” In response, on July 22 it published a proposed rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements.”

What does this mean? How will a new FDA National Drug Code format affect the pharma industry? Let’s take a look.

What is the FDA National Drug Code?

The FDA National Drug Code is the Agency’s “standard for uniquely identifying drugs marketed in the United States.” The codes are usually found on product labeling and might be part of the universal product code (UPC). Today, National Drug Codes comprise 10 digits in three segments:

      1. Labeler code (4 or 5 digits), which identifies the labeler. The FDA defines a labeler as “any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug.” The FDA assigns labeler codes.
      2. Product code (3 or 4 digits), which identifies strength, dosage form, and formulation for a particular firm. Firms assign product codes.
      3. Packaging code (1 or 2 digits), which identifies the package size and type. Firms assign packaging codes.

National Drug Code formats are commonly referred to as “5-4-1,” “5-4-2” (HIPAA standard), “5-3-2,” or “4-4-2” depending on how many digits each segment has. The illustration below is adapted from an FDA graphic depicting the current format.

Current FDA National Drug Code NDC Format

The Proposed Changes to the FDA National Drug Code

The proposed FDA National Drug Code would have a “uniform” 12-digit, “6-4-2” format, as illustrated below. The Agency says this “would facilitate the adoption of a single NDC format by all stakeholders [and] eliminate the need to convert NDCs from one of FDA’s prescribed formats to a different standardized format used by other sectors of the healthcare industry (e.g., healthcare providers and payors).”

Proposed Changes to FDA National Drug Code NDC

When and how will the change be rolled out?

The FDA proposes an effective date 5 years after the final rule is published “to allow stakeholders time to develop and implement changes to their systems.” Pharma stakeholders that use FDA-assigned codes will need to have systems in place to handle the new format by the effective date.

The Agency would begin assigning new 12-digit National Drug Codes in the 6-4-2 format on the effective date. Drug listing files submitted on or after the effective date would also have to use the new 6-4-2 format.

However, “to reduce the burden on registrants,” the FDA says it won’t require companies to resubmit all of their existing drug listing files; instead, the Agency itself would convert the existing codes “by adding leading zeros to the appropriate segments.” For example:

All FDA National Drug Code NDC

And though the Agency’s proposing a 3-year labeling transition period from the effective date, it’s encouraging manufacturers and distributors to start using the new National Drug Codes as early as possible. Still, during this 3-year period the FDA “does not intend to object to the continued use of 10-digit NDCs on the labeling of products that were assigned a 10-digit NDC prior to the effective date.”

Impact on product labeling

Product labeling will have to be updated with the uniform 12-digit FDA National Drug Code. To make this easier for stakeholders, the Agency proposes revising requirements to allow linear or nonlinear barcodes — as long as they meet mandated standards.

The FDA says it’s also looking into revising 21 CFR 201.25(c), “Bar code label requirements,” to “accommodate potential advances in technologies and standards development by allowing the use of unspecified automatic identification and data capture (AIDC) formats other than linear or non-linear barcodes … without the need to revise the regulation again.”

Industry reaction

These proposed changes to the FDA National Drug Code would affect manufacturers of human and animal drugs, insurers/payors, wholesale distributors, drug databanks, pharmacies, hospitals, small clinics and healthcare practitioners, dentist offices, prisons, nursing care facilities, importers, federal agencies using the National Drug Code, state and local governments, and other supply chain stakeholders that use FDA National Drug Codes.

The pharma industry has known for at least 4 years that the FDA was concerned about running out of codes and was thinking about proposing changes. The Agency held a public hearing on Nov. 5, 2018, “to receive input from stakeholders on how to maximize the benefit and minimize this impact well in advance of any forthcoming change.” Four options were presented at this hearing:

      • Option A: Use 5-digit labeler codes until they run out, then adopt a 6-digit labeler code
      • Option B: Start using 6-digit labeler codes on a designated date
      • Option C: Change to an 11-digit format, then a 12-digit format, when the 5 -digit label codes are gone
      • Option D: Adopt the 12-digit format before the 5-digit labeler codes are gone.

Most comments from industry supported Option D. “Comments were in favor of FDA’s adoption of a single standardized format that could be used by all stakeholders,” the Agency reported. “The majority of the commenters were in favor of FDA establishing a certain date when stakeholders would be required to have systems capable of handling the new format.”

However, industry leaders raised concerns in their public comments. The Healthcare Distribution Alliance (HDA) noted its “agreement with those speaking at the public meeting that … Options, A, B and C, are infeasible. Some of them, for example, would negatively impact bar code technology and interoperability, and others would perpetuate, or even exacerbate the confusion created by the current multiple formats, by adding even more formats. These three Options could also result in creating duplicate NDCs.”

GS1, with input from its New NDC Format Workgroup, advocated for Option D, including implementing “a standards-based format for NDC” (i.e., using a Global Trade Item Number, or GTIN; see below). It also noted concerns, saying this option had “cons,” including its impact on standardized numerical identifiers (SNIs). Let’s examine this a bit further.

FDA National Drug Codes will play a significant role when the DSCSA goes into full effect on Nov. 27, 2023. At that time, drug package labels must include a product identifier. A product identifier is a standardized graphic that contains the product’s SNI, a lot number, and an expiration date. The SNI comprises two data points: the National Drug Code and a unique alphanumeric serial number.

With this in mind, GS1 commented that the “SNI Guidance will need modification in advance of and as preparation for Option D implementation. The SNI guidance defined SNI as NDC + serial number. However … this does not support unique identification at every level of the packaging hierarchy, and therefore is not sufficient to support traceability. GS1 members had been able to overcome this challenge by embedding the NDC in a GTIN. However, with Option D, members will no longer have this technical mechanism.”

Final thoughts

That’s a lot to think about. The comment period for the FDA National Drug Code proposed rule ends Nov. 22, 2022, and industry stakeholders are sure to once again share their opinions in the docket. Some of the issues that could be raised include the following:

      • Companies’ serialization systems and ancillary systems could be affected because they contain and use FDA National Drug Codes.
      • Systems will have to accept and store both the current and new formats.
      • Stakeholders will have to know which format to send and when.
      • Systems may have to carry both formats simultaneously for current medicines.

The biggest takeaway, though, is that companies should be thinking about the change and preparing now. This is a DSCSA mantra, right? Prepare for the Verification Router Service (VRS). Prepare for ATPs. Prepare for  product identification, serialization, and EPCIS.

If you have questions, contact us today to speak to one of our  DSCSA and supply chain experts. We’re participating on the GS1 New NDC Format Workgroup and have been actively involved in discussions about how the changes will affect pharma companies. With only a little more than a year to go before rollout of the DCSCA is complete, now is the time to connect with us and make sure you’re going to be ready for the full serialization of the U.S. pharma supply chain.

 

DSCSA Summary: A Look at the Law as We Count Down to 2023

As the clock continues to tick toward the November 27, 2023, U.S. Drug Supply Chain Security Act (DSCSA) deadline, we thought it was a good time for a recap. Our DSCSA summary will hit the major milestones, changes from the FDA, and compliance requirements.

We’ll also include an updated timeline graphic that first appeared during our three-part DSCSA webinar series last summer, which dealt with authorized trading partners (ATPs), EPCIS, and the Verification Router Service (VRS). We wrote about those topics twice just last week: Check out our FDA DSCSA Guidance Update: EPICS, ATPs, and the Countdown to 2023 and the Q&A with our SVP of Product and Strategy Herb Wong.

Now, on to the DSCSA summary: everything you need to know in 5 minutes.

What is the DSCSA?

The DSCSA is a 10-year plan to transform the U.S. pharmaceutical supply chain. It became law in November 2013, as Title II of the Drug Quality and Security Act (DQSA), and has been rolled out since 2015. Implementation culminates on November 27, 2023, at which time the U.S. pharmaceutical supply chain will be fully serialized.

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.”

Furthermore, the DSCSA “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.”

Who has to comply?

Manufacturers, wholesalers, dispensers, repackagers, and third-party logistics providers (3PLs) must comply with DSCSA if they want to do business in the United States.

Key requirements

The FDA puts DSCSA requirements into four categories. This is what Herb Wong calls “the four cornerstones” of the law.

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 the following:

        • 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. Note: We’ll be writing more about NDCs soon.
        • 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.
        • Transaction history (TH) is an electronic statement with the TI for every transaction going back to the manufacturer. Note: TH will not be required after the November 2023 deadline.

For the record, the FDA defines “transaction” as the “transfer of product between persons in which a change of ownership occurs.”

3. Verification (VRS). 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

4. Authorized trading partners (ATPs). The DSCSA also says that if you’re not an ATP, your access to the U.S. pharma supply chain will be severely restricted or denied altogether. All manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers and their trading partners must be ATPs

If you want to know more, read our in-depth explanations of the VRS and ATPs. Or just contact us today to talk to one of our DSCSA experts!

Other requirements

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.

DSCSA Summary: Timeline

The FDA has delayed the rollout of the DSCSA two times (September 2019 and October 2020). However, an FDA official said in August 2021 that there would be no more delays. November 27, 2023, is a done deal.

DSCSA Timeline 2013-2023

 

Final thoughts

If you have any questions about this DSCSA summary, contact us today. There might be one or two things that surprised you — like the sunsetting of the transaction history (TH) requirement — and we want to make sure you’re sure about what’s happening.

Our extensive writing about the law is a valuable resource, but nothing beats spending 15 minutes with one of our supply chain experts. So schedule a short demo of our DSCSA compliance solution. Our No. 1 priority is to help you understand the regulations and be prepared for the full serialization of the U.S. pharma supply chain next November.

And if you happen to be going to this year’s HDA Traceability Seminar in Washington, D.C., drop us a line here to arrange a meeting and be sure to catch Herb Wong in the “EPCIS Onboarding Across the Supply Chain” panel discussion and his roundtable about industry readiness for November 2023.

 

 

 

 

 

 

DSCSA Compliance Update with Herb Wong: What’s Happening Right Now?

Herb Wong’s a busy guy. We said that the last time we did a DSCSA compliance update with him, and it’s still true today Just last week, for instance, he participated in two Healthcare Distribution Alliance (HDA) webinars, “DSCSA 2023: How a Service Provider Can Help You Prepare” and “All About the VRS.” These were part of the HDA’s 2022 Traceability Webinar Series, which Antares Vision Group is sponsoring.

That’s why it was such a treat to get some one-on-one time with Herb for a real-time DSCSA compliance update — what’s happening right now with industry readiness.

We asked Herb to talk about what he calls “the four cornerstones” of DSCSA compliance: product identification (EPCIS and serialization), product tracing, authorized trading partners (ATPs), and verification (the Verification Router Service, or VRS). Here’s what he had to say.

DSCSA compliance update #1: product identification (EPCIS and serialization)

All solution providers’ systems are ready to send and receive serialization data in the EPCIS format, but we still need to help the industry get data flowing. To use an analogy, even though the pipes have been laid and connected, we’re just not getting enough water through to test for “leaks” in the system — errors in send/receive processing. Just as important, we need time to “flush the pipes” to ensure that we have “clean water.” By that I mean ensuring that the data is correct.

We’re trying to do everything we can. We’ve actually developed a standard process for onboarding customers and getting data exchanged with other solution partners. We’re going to be piloting this so we can refine the onboarding process. [Herb’s talking about the EPCIS Onboarding Guide Workgroup and its draft “Guide for Accelerated EPCIS Onboarding.”]

What’s the key takeaway, Herb?

The key takeaway is, “Let’s connect, let’s get the serialized data out.” Time is running out. That’s the biggest message. People who think they have time to wait until next year, you really don’t. Because what’s going to happen is similar to what happened when the lot-based laws went live: The people who waited couldn’t find help. All the solution providers were busy; everyone was busy. And everyone who waited was trying to get through the same door to meet the deadline.

So, if you’re a manufacturer, you have to start sending data early. If you’re serializing and not sending data downstream, start now. Don’t wait till the November 2023 deadline. You have to “turn on the switch.” Send your data downstream now.

At this point, we decided to ask Herb about aggregation.

DSCSA doesn’t say anything about aggregation. But wholesalers are asking for aggregation to support their business processes. When you send electronic data, wholesalers need to know what serial numbers are in the cases they just received.

Aggregation is a business requirement for operational efficiency. For example, if you get 10 cases with a hundred items in each case, you don’t want to open the cases and scan every item to see what you received and will ultimately ship. Aggregation makes things faster and more efficient. It’s similar to how VRS had both a legal and a business requirement: The legal requirement mandated a response within 24 hours for saleable returns verification. But given the potential volume of saleable returns, 24 hours was too slow for wholesalers; it would cause the receiving docs to fill up with products pending verification. For this reason, wholesalers mandated a business requirement of sub-second response times.

DSCSA compliance update #2: product tracing

A centralized solution or standard has not been defined for product tracing. A lot of different approaches have been discussed, but there’ve been no specs, no firm requirements, that solution providers can implement at this time.

Right now, we’re supporting the industry’s manual process for product tracing. The HDA, NABP, and PDG have done a really good job of outlining what’s required for tracing. [That’s the Healthcare Distribution Alliance, the National Association of Boards of Pharmacy, and the Partnership for DSCSA Governance.]

They’ve walked through a series of scenarios that can be executed manually and have helped the industry to better understand the complexity and nuances of tracing a product through the system. In parallel to this effort, the PDG is working on a data format to communicate traceability requests and responses. PDG is putting that information into a JSON format to communicate the need. [JSON is the JavaScript Object Notation data interchange format. Its advantages are that it uses human-readable text and is a more compact means of communicating data.]

What’s the key takeaway, Herb?

Pay attention to the traceability scenarios that are coming out of the HDA, NABP, and PDG. They’re doing a really good job of trying to show how tracing workflows will happen. They’ll be publishing more results and helping the industry understand. Watch for these, because it will enlighten you about what’s coming in 2023.

DSCSA compliance update #3 and #4: ATPs and VRS

From a solution provider standpoint, the ATP and VRS initiatives have become one and the same. Right now, ATPs have only been applied against the VRS, so the timing for us to get that done has become one implementation effort.

When you make a VRS request, you have to prove you’re an ATP. ATP is there to confirm two things: you are who you say you are and you are authorized to transact business. Proof that you are an ATP is especially important in the VRS network since trading partners may not have direct relationships with other VRS participants.

For VRS, there’s a new version 1.3 that will be deployed before the DSCSA 2023 deadline. The current version we have is based on the 1.2 standards interface. The 1.3 version “opens up” VRS beyond what it was intended to do, which is the verification of saleable returns.

What people should know is that VRS 1.3 is not backwards-compatible. This means VRS providers have to upgrade at once. To ensure that the upgrade occurs on time, solution providers have agreed to “decouple” the 1.3 interface from the 1.3 functionality.

What this means is that everyone on the VRS network will remain connected since we will all support the new 1.3 connections. However, solution providers (or customers) who are not ready to upgrade to the new 1.3 functionality can continue to use VRS as needed. That’s going to be important because it allows us to change the interface so we can at least keep talking to each other. We can be interoperable. But not everyone has to support the features of 1.3 at the same time.

As for timing of the update, we’re talking about doing the testing of the interoperability of 1.3 in Q1 [of 2023]. So we’ll have to push this into a production environment after Q1, but we haven’t agreed on a production date.

What’s the key takeaway, Herb?

There is going to be an upgrade required soon and the industry and solution providers are working to make sure it’s easy to implement. We realize that is not as simple as a software upgrade but we need to carefully consider the revalidation requirements of our customers.

Final thoughts

And there you have it: A DSCSA compliance update about what’s happening right now with industry readiness for product identification (EPCIS and serialization), product tracing, and ATPs and VRS. Thanks, Herb!

Contact us if you have questions about what Herb talked about or the DSCSA in general. We can explain the requirements and how our solutions will help ensure you’re ready for November 2023 and the full serialization of the U.S. pharmaceutical supply chain.

If you like, we can probably arrange a meeting with Herb. But remember, he’s busy. In the coming weeks, he’ll travel to the Antares Vision Group global HQ in Italy, visit the Group’s brand-new North America HQ in New Jersey, and join a panel discussion at the HDA Traceability Seminar in Washington, D.C. (Antares Vision Group is also a sponsor of that annual event.) So reach out today and let’s see what we can work out.

Also take a look at our DSCSA Compliance Library. It’s a clearinghouse of information with links to our blog posts, white papers, webinars — everything — about the law, including the “four cornerstones” Herb talked about in today’s DSCSA compliance update.

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.

Antares Vision Group Selected to Speak on Supply Chain Traceability and Smart Hospital Systems at GS1 Connect 2022

AV Group members will present “Supply Chain Traceability: Can Your Business Survive Without It” and “Smarter and Safer Hospitals: When Innovative Technologies Meet Patient Safety”

Travagliato (Brescia), June 1, 2022 Antares Vision Group (AV Group), a technological partner of excellence in digitalization and integrated data management, the global leader in track and trace hardware and software solutions, and one of the main players in inspection systems for quality control and integrated data management, has been chosen to provide thought leadership presentations at the GS1 Connect Conference, June7-9 in San Diego.

In “Supply Chain Traceability: Can Your Business Survive Without It?” Herb Wong, vice president of strategy and innovation at rfxcel, which is part of AV Group, 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. The session will be held Thursday, June 9, at 1:45 p.m.

In on-demand session 509, “Smarter and Safer Hospitals: When Innovative Technologies Meet Patient Safety,” Antares Vision 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, will discuss how traceability and GS1 standards enabled end-to-end visibility of medications – from their arrival at the hospital to dispensing – through the use of optimized resources that focus on patient safety.

AV Group Chairman and Co-CEO Emidio Zorzella said he was excited that GS1 Connect attendees would have the opportunity to hear Mr. Wong, Mr. Fusco, and Dr. Sanna talk about the Group’s technology. “The ultimate goals of traceability and GS1 standards are to protect people and optimize business processes,” he said. “These are also AV Group’s goals. I think people will have a strong reaction when they see how our technology is improving people’s lives, making businesses more efficient and effective and, we hope, making the world a better place.”

GS1 Connect is an annual event hosted by GS1 US. It brings together trading partners to network and learn about the value of using standards-based business processes and best practices for optimum efficiencies in managing the supply and demand sides of their value chains. The theme of this year’s conference is “Adapt,” focusing on how businesses have used GS1 Standards to overcome challenges to thrive in uncertain times. It will feature more than 40 live sessions, more than 50 exhibitors, trading partner roundtables, and other events centered on user stories and leadership insights for supply chain optimization.

For more information, contact AV Group Public Relations Specialist Davide Antonioli at davide.antonioli@antaresvision.com or +39 339-812-4446.

 

ABOUT ANTARES VISION GROUP

Antares Vision Group is an outstanding technology partner in digitalization and innovation for enterprises and institutions, guaranteeing the safety of products and people, business competitiveness, and environmental protection.

AV Group provides a unique and comprehensive ecosystem of technologies — including software and hardware — to guarantee product quality (inspection systems and equipment) and end-to-end traceability (from raw materials to production, from distribution to the consumer), through integrated data management, applying artificial intelligence and blockchain too.

AV Group is active in the life sciences (pharmaceuticals, biomedical devices, and hospitals), beverage, food, and cosmetics industries, and is expanding into other sectors. The world leader in track and trace systems for pharmaceutical products, it provides major global manufacturers, including more than 50 percent of the Top 20 multinationals, and numerous government authorities with solutions to monitor their supply chains and validate product authenticity.

Listed since April 2019 on the Italian Stock Exchange in the Alternative Investment Market (AIM) segment and from May 2021 in the STAR segment of the Mercato Telematico Azionario (MTA) (electronic equity market), AV Group operates in 60 countries, employs approximately 1,000 people, and has a consolidated network of more than 40 international partners. antaresvisiongroup.com

rfxcel, part of AV Group, has deep expertise in providing leading-edge software solutions to help companies build and manage digital supply chains, lower costs, protect products and brand reputations, and engage consumers. rfxcel.com

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!

Uzbekistan ASL BELGISI Update: Deadline for Pharma Serialization Extended

On February 7, 2022 — just 10 days after we posted our Uzbekistan ASL BELGISI update — the country’s State Tax Committee announced that it was “extending the timeframe for the phased introduction of mandatory digital markings” of pharmaceutical products.

The requirements were originally scheduled to take effect on February 1.

The extension was announced in a letter signed by Mubin Mirzaev, the first deputy chairman of the State Tax Committee. A new deadline was not stipulated, so the country’s serialization scheme for pharmaceuticals is effectively on hold until further notice. The letter did not mention 2022 deadlines for other regulated product categories (e.g., tobacco products; alcohol, including wine and wine products; beer and brewing products; appliances; and water and soft drinks).

Delay or not, we expect the serialization and labeling requirements, which are based on Russia’s Chestny ZNAK system, to remain the same. Read our Uzbekistan ASL BELGISI update for more details about the regulations.

More provisions for Uzbekistan ASL BELGISI from the State Tax Committee

Deputy Chairman Mirzaev’s letter outlined two provisions:

      • A provision to instruct the State Tax Committee and CRPT Turon, which operates Uzbekistan ASL BELGISI, to submit proposals to the country’s Cabinet of Ministers for a system to recognize marking codes from other countries, “primarily markings applied [in] the territory of the Russian Federation.”
      • A provision to “implement a mechanism for electronic registration of non-resident foreign manufacturers of pharmaceutical products with the tax authorities.” Manufacturers would be assigned a non-resident taxpayer identification number (TIN) and would have to obtain a non-resident electronic digital signature (EDS).

The letter also said that the “norms for amending the Technical Regulations for the production of pharmaceutical products were transferred from the project for labeling ‘household appliances’ to the project for mandatory digital labeling of pharmaceutical products.”

As we wrote in our Uzbekistan ASL BELGISI update, a pilot for appliances began on July 1, 2021, and mandatory labeling is being introduced in phases. Vacuum cleaners, refrigerators, freezers, washing machines, TVs, and monitors were required to be labeled beginning December 1, 2021.

Final thoughts

The Uzbekistan ASL BELGISI delay illustrates a truth about supply chain regulations: Deadlines change. All the time. Announcements like the one we talked about today should never come as a surprise or catch you off guard.

The good news is that deadline changes are not the end of the world. What’s important is for you to have a supply chain solution that meets established standards, such as the world-leading GS1 standard. If your solution is fast, flexible, scalable, and automated — like our Traceability System — you will be ready to comply and keep your supply chain moving. All the time.

We’ll continue to monitor Uzbekistan ASL BELGISI as we do with other supply chain regulations. In just the last two weeks or so, we’ve written about the Africa supply chain (first of a two-part series), Egypt’s pharmaceutical regulations, Russia Chestny ZNAK requirements for beer and dietary supplements, the United Arab Emirates’ “Tatmeen” platform, and the U.S. Drug Supply Chain Security Act (DSCSA). Count on us to keep you informed about regulations around the world.

And contact us if you have any questions or want to see our solutions in action. Our digital supply chain experts are always here to listen to you, help you evaluate your needs, and work directly with you to design a solution customized for your business.

UAE Pharmaceutical Products Traceability Requirements for 2022: “Tatmeen” Platform

The global push for pharmaceutical traceability and serialization continues at a furious pace. Today, we’re looking at the United Arab Emirates (UAE), whose Ministry of Health and Prevention (MOHAP) in June 2021 announced the “Tatmeen” platform for UAE pharmaceutical products traceability. There are key deadlines this year, so let’s take a look.

UAE Pharmaceutical Products Traceability and the Tatmeen System

MOHAP established Tatmeen, which means “assurance” in Arabic, in Ministerial Decree No. 73 on June 14, 2021. Described as a “central command center,” it’s a GS1-based platform for UAE pharmaceutical products traceability. MOHAP’s partners include the Dubai Health Authority (DHA), Department of Health (Abu Dhabi), and EVOTEQ, a “digital transformation catalyst” based in the UAE, and GS1 UAE.

Tatmeen’s goals should sound familiar:

    • Fight counterfeits and illegal and substandard medications
    • Eliminate unauthorized imports
    • Improve recall management
    • Ensure expired and about-to-expire drugs don’t reach consumers
    • Forecast demand and avoid shortages
    • Move drugs where they’re needed quickly and safely
    • Protect pharma companies, including their intellectual property rights

These other aspects should also sound familiar:

    • Products are scanned at every node of the supply chain
    • Product information is reported into to a central repository (in this case GS1’s BrandSync platform)
    • Scanning captures and verifies data in real time and reports information into a central database
    • Hospitals and pharmacies scan when drugs arrive at their facility and when they’re dispensed
    • Patients and consumers can scan with mobile devices to validate products, report expired products, fakes, and suspected gray market activity

Tatmeen will integrate with the DHA’s electronic medical record system, Salama (incorrectly identified as “Salam” in some industry sources). It will also utilize DHA’s Tarmeez, a paperless drug and medical supplies management system that gives authorized users access to a centralized electronic catalog of all available inventory.

Tatmeen labeling and reporting requirements

All conventional medicines sold, distributed, or stored in the UAE are regulated and must be serialized. These products are exempt:

    • Free samples
    • Products imported for personal use only
    • Medical devices and supplies
    • General sales list (GSL) products

And —surprise, surprise — UAE pharmaceutical products traceability requirements should sound familiar. Secondary packaging must contain four data points in a GS1 DataMatrix code and in human-readable form:

    1. Global Trade Item Number (GTIN)
    2. Randomized serial number (up to 20 characters)
    3. Expiry date (in YYMMDD format)
    4. Batch or lot number

This example is adapted from the MOHAP’s serialization guide:

UAE DataMatrix Code

Aggregation requirements should also ring a bell: All logistic units must be aggregated and labeled with a GS1-128 barcode encoded with a serial shipping container code (SSCC). Manufacturers are responsible for aggregation.

If a brand owner regards an item as a trade item, “it may additionally be identified with a GTIN.” Distributors, wholesalers, and health facilities that unpack and re-pack products to deliver to points of dispensing are required to aggregate the logistic units using their own SSCC codes.

Marketing authorization holders (MAHs), brand owners, manufacturers, or their subsidiaries must register and upload the mandated product master data into the BrandSync platform.

Domestic and foreign manufacturers, third-party logistics providers, batch releasers, contract manufacturing organizations, distributors, licensing agents, and MAHs are responsible for collecting serialized product item traceability records and reporting them to Tatmeen.

UAE pharmaceutical products traceability rollout and 2022 deadline

There was a 6-month “status adjustment” period after Tatmeen was announced for manufacturers and marketing authorization holders to register with the BrandSync platform and begin using 2D DataMatrix codes. This deadline passed on December 13, 2021.

The next major deadline is December 13, 2022. By that date, all supply chain actors in the UAE must obtain a Global Location Number (GLN) from GS1 UAE to identify their organization, where it’s located, and other required information. Relevant stakeholders must also begin reporting serial numbers to Tatmeen and begin aggregation with GS1-128 barcodes and SSCCs.

Final thoughts

We noted a few times that parts of the Tatmeen regulations should sound familiar. If you follow our blog and read our articles about pharmaceutical regulations in other countries — DSCSA in the United States, Chestny ZNAK in Russia, ANVISA in Brazil, ASL BELGISI in Uzbekistan, and so on — everything about UAE pharmaceutical products traceability should ring a bell.

As we said right at the start today, the global push for pharmaceutical traceability and serialization continues at a furious pace. Requirements may vary from country to country, but their essence is the same (e.g., protecting consumers, serialization, traceability, electronic reporting, central repositories, GS1 standards). Tatmeen is just one more example in a very large regulatory ocean.

It’s easy to feel swept up in this current. And, truth be told, if you’re not complying now or preparing to comply by published deadlines, you’re putting your business in jeopardy. If you have questions about Tatmeen or complying with pharmaceutical serialization and traceability regulations in any country, contact us today. In just a few minutes, our supply chain specialists can demonstrate how our award-winning Traceability System ensures you’re compliant in any country, today, tomorrow — always.

For even more information, check out our Global Compliance Page, download our Worldwide Pharmaceutical Compliance Requirements white paper, and catch up on other pharma news in our blog: