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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.

What Is the Healthcare Value Chain and Why Is It Important?

In the healthcare sector, delayed, lost, and damaged products can cause grave danger, as patients might not receive the medicines they need on time and many items are susceptible to fluctuations in environmental conditions. That’s why it’s crucial to have a reliable and robust healthcare value chain.

Let’s examine the critical role that the healthcare value chain plays. Our technologies and solutions help pharmaceutical companies, hospitals, and other healthcare stakeholders streamline and manage their entire supply chain, from procurement to distribution.

Understanding the healthcare value chain

Most may believe that the value chain and supply chain are synonymous. However, they are two different terms describing different aspects of supply logistics. The supply chain refers to the movement of goods from suppliers to customers; the value chain encompasses all activities involved in creating and delivering a product or service.

In other words, the supply chain is more about the physical movement of goods and the value chain adds value to a product, including production, marketing, and customer support after the sale. So, the healthcare value chain allows medical institutions to provide patients with the best possible care by ensuring they have the supplies and treatments they need when they need them.

What happens in a healthcare value chain?

Understanding the activities involved in the healthcare value chain is the first step in managing and streamlining its processes. We’re talking about logistics, operations, marketing and sales, and service.

Inbound logistics. The value chain is not a product-driven process, so explaining inbound logistics can be challenging. Generally, inbound logistics in a value chain refers to the quality of inventory and the management of that inventory. Value-driven inbound logistics ensures that all inventory is accounted for and is of the highest quality. This includes checking that items are not expired or damaged and meet all necessary requirements (e.g., internal quality control, standard operating procedures).

Operations. The operations stage of the healthcare value chain is where the actual product or service is produced. In this value-driven scenario, product operations and/or manufacturing aim to reduce waste and create efficiencies. This might involve automating processes, changing production methods, and improving the quality of raw materials. In healthcare, the goal of operations might be to streamline the manufacturing of drugs or medical devices.

Outbound logistics. Like inbound logistics, outbound logistics in a value chain should strive to ensure that a product or service reaches the customer in the best possible condition and in a timely manner. In healthcare, this means making sure that patients receive their supplies and treatments when they need them, as well as ensuring products are safe and legitimate.

It’s also important to note that outbound logistics isn’t just about the distribution of supplies outside a warehouse. It also concerns how medical institutions distribute supplies internally. This is important to consider when managing a hospital or other medical facility.

Marketing and sales. Marketing and sales in the healthcare value chain focus on creating demand for a product or service. Traditionally, this includes advertising, promotions, and other marketing initiatives. In a value-driven context, marketing and sales are strategically designed to go beyond a one-time sale to create long-term relationships with customers. There are numerous ways to do this, ranging from creating educational materials for patients and promoting online services to partnering with insurance providers.

Service. The service stage of the healthcare value chain is where post-sales activities occur, such as continuing customer support, repairs, and maintenance. Value-driven service helps maintain customer satisfaction with the product or service and helps ensure their needs are being met. Customer loyalty programs, follow-up communications, and offering extended warranties are common examples.

The healthcare value chain in numbers

Now that we’ve summarized the different stages of the healthcare value chain, let’s look at some numbers that help illustrate why these processes are so vital to the healthcare industry.

One 2019 report found that clinicians devote about 17 percent of their time to logistics and storage management activities. This affects their productivity and the quality of care they can provide.

The report also found that more than 4,500 different medical devices and products are recalled every year — and 10 percent of these have the potential to cause harm or death. One study published by the well-known consulting outfit McKinsey & Company reported that the “costs of a single non-routine quality event, like a major recall, have been as high as $600 [million] in medical device companies.”

The long-term business benefits of an effective healthcare value chain

An effective healthcare value chain creates benefits beyond improving quality of care and securing patient safety and satisfaction. It creates business benefits, including:

Improved profitability. An effective healthcare value chain can boost a bottom line by improving supply systems, reducing waste, and creating efficiencies across healthcare systems.

Promoting innovation. Less waste and more efficient systems mean savvy companies can devote more resources to R&D that can lead to innovation in all realms, including the development of new treatments or therapies and better manufacturing and distribution schemes.

Helping meet business goals. An effective healthcare value chain contributes to business success by reducing waste, increasing efficiencies, and promoting innovation. It also helps businesses connect with customers and build brand loyalty.

Final thoughts

What’s the main takeaway from this overview of the healthcare value chain? Establishing an agile and robust value chain is essential to success in the healthcare industry — in every industry.

We’ve specialized in creating software solutions for the healthcare value chain (and the healthcare supply chain) for almost 20 years. Our No. 1 priority is to help businesses optimize their operations and improve the quality of the products they manufacture and deliver to consumers.

For the healthcare and pharmaceutical industries, this means providing a digital traceability platform that helps ensure your devices and medications are safe, are transported following proper protocols (e.g., routes and environmental parameters), are delivered on time, and meet all regulatory requirements. It means real-time data and visibility into every aspect of your operations from virtually any location in the world.

rfxcel and Antares Vision Group understand the healthcare value chain, its complexities, and how to optimize it for patient security, customer satisfaction, and business success. Contact us today to schedule a short demo of our solutions. Our experts will answer your questions and show you why major global healthcare and pharmaceutical companies rely on our technology to secure and improve their operations.

 

 

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.

Everything You Need to Know About Kazakhstan Pharma Serialization

Welcome to Part 2 of our series about Kazakhstan serialization and traceability requirements. Part 1 detailed the country context, including government efforts to achieve pharma independence. October 1, 2022, is the next deadline in the rollout of Kazakhstan pharma serialization, so today we’ll get into the specifics of the regulations, as well as regulations for other key industries. Let’s get started.

Kazakhstan pharma serialization: pilot, goals, operator, timeline, marking requirements

The transformation of Kazakhstan’s pharmaceutical supply chain began almost seven years ago, when the government in September 2015 issued guidelines on labeling, marking, and requirements for accessing and uploading data to a central portal. In November of the same year, the Ministry of Health tapped GS1 Kazakhstan to conduct a pilot for the traceability system, which is called the Special Information System for Marking and Traceability of Goods (IS MPT).

Pilot

The pilot ran from Sept. 9, 2019, to July 31, 2021. It was led by Kazakhstan’s state-run distributor, SK Pharmacy, which labeled 100,000 packages of 30 different drugs and traced them all the way through the supply chain to hospitals and pharmacies. Four domestic manufacturers, 1 importer, 2 distributors, 5 pharmacies, and 8 medical institutions also participated.

Goals

The goals of Kazakhstan pharma serialization — and labeling of other product categories — are essentially the same as regulatory goals in other countries:

      • Communicating product information to consumers
      • Combating counterfeit and falsified products
      • Eliminating gray markets (“Shadow market” seems to be the preferred term in Kazakhstan.)
      • Protecting consumers
      • Protecting legal businesses
      • Identifying entities that violate tax laws

The Kazakh government has also said that digital labeling will help businesses increase productivity, improve logistics, increase market share, ultimately leading to increased revenue.

IS MPT Operator

Kazakhtelecom JSC, the country’s largest telecommunications company, operates the IS MPT. Sometimes referred to as “the Single Operator,” it’s the equivalent of Russia’s Center for Research in Perspective Technologies (CRPT) and Uzbekistan’s CRPT Turon. Its main offices are in Nur-Sultan (formally Astana) and Almaty.

As operator, Kazakhtelecom JSC is responsible for the following:

      • Generating marking codes
      • Providing traceability to the state
      • Interacting with the integrated system of the Eurasian Economic Commission (EEC) and operators in other Eurasian Economic Union (EAEU) states
      • Providing a digital passport of goods for market participants
      • Developing a free mobile application (NAQTY SAUDA) ​​to accept and withdraw marked goods from circulation (primarily for participants who are unable to purchase scanners)
      • Developing a free mobile application (NAQTY ÓNIM) for the public to participate in the system
      • Creating a 24/7 IS MPT contact center

In official government reporting dated Nov. 17, 2020, Kazakhtelecom JSC’s Chair of the Board Kuanyshbek Yessekeyev talked about the benefits of the IS MT. “Among its main advantages,” he said, “one can single out a decrease in the shadow market by 50 percent until 2025, which will lead to additional budget revenues by 2025 in the amount of 58.4 billion tenge [$122.5 million], according to our calculations.”

Yessekeyev also concluded that additional legal business revenues would reach 336.5 billion tenge [$706.5 million] by 2025.

Timeline

Here are the key dates for Kazakhstan pharma serialization:

Planning and pilot

      • September 2015: The government issues guidelines on labeling, marking, and requirements for accessing and uploading data to a central portal.
      • November 2015: The Ministry of Health taps GS1 Kazakhstan to conduct a pilot for IS MT.
      • 2018–2019: GS1 Kazakhstan conducts testing for the pilot.
      • Sept. 9, 2019: The pilot begins.
      • July 31, 2021: The pilot ends and the government issues serialization guidelines.
      • August 8, 2021: The Ministry of Health identifies 93 products — about 1% of all drugs in the country — for the first phase of serialization.

Rollout (note upcoming deadlines in October and early 2023)

      • June 5, 2022: The Ministry of Health delays the first phase of serialization from May 2022 until August 1, 2022.
      • August 2022: Mandatory serialization for the 93 products begins. This list includes drugs produced by four Kazakh manufacturers and 12 foreign manufacturers.
      • October 1, 2022: Mandatory serialization for 20% of drugs scheduled to begin.
      • January 1, 2023: Mandatory serialization for 60% of drugs and mandatory data reporting for 20% of drugs scheduled to begin.
      • April 1, 2023: Mandatory serialization of at least 80% of drugs scheduled to begin.
      • July 1, 2023: Mandatory serialization of 100% of drugs scheduled to begin

Note: At present, Kazakhstan pharma serialization regulations do not require aggregation.

Marking requirements

As in other EAEU and Commonwealth of Independent States (CIS) countries (e.g., Russia and Uzbekistan, respectively), products must be labeled with a DataMatrix code with four data points:

      1. A 14-digit product code (i.e., Global Trade Item Number, or GTIN) (GS1 Application Identifier 01)
      2. A 13-character randomized serial number (21)
      3. A four-character verification key (91)
      4. A 44-character verification code (92)

The maximum cost of one code will be 2.68 tenge ($0.0056) without VAT. Every code goes through the same five steps during its “lifetime”:

      1. The manufacturer applies a code to every package and sends them to a distributor.
      2. The distributor receives and scans the products, then sends them to the retailer (e.g., a store or supermarket).
      3. The retailer receives the new (legal) batch of goods, scans the codes, and sells the products.
      4. At checkout, the cashier scans each code (either with a scanner or using the NAQTY SAUDA app) and it’s withdrawn from circulation.
      5. Consumers can use the NAQTY ÓNIM app to learn more about the product.

Here are some images of the apps:

Kazakhstan pharma serialization Naqty Sauda

 

Other regulated products/industries

In 2019, Kazakhstan ratified an agreement for labeling of goods within the territory of the EAEU. In doing so, it agreed to the EEC’s decisions concerning labeling of fur products, shoes, perfumes, tires, and other products. Here is the latest information from IS MPT:

      • Tobacco products: Mandatory labeling of cigarettes began Oct. 1, 2020; April 1, 2021, for cigars, cigarillos, and other categories.
      • Fur products: Mandatory labeling began March 1, 2019.
      • Footwear: Production and import of unmarked shoes have been prohibited since Nov. 1, 2021; sale of unmarked shoes has been prohibited since April 1, 2022.
      • Alcohol: Mandatory labeling began April 1, 2021.
      • Light industry (primarily clothing and linens): A pilot ran from Dec. 15, 2020, to Dec. 31, 2021.
      • Dairy products: A pilot began on Oct. 1, 2020, and was extended in November 2021.
      • Soft drinks: A pilot ran from July 1, 2020, to Jan. 31, 2022
      • Jewelry: A pilot began in March 2022 and is scheduled to end on Oct. 31, 2022.

Final thoughts

That’s a lot to think about. We’ve provided the granular details of Kazakhstan pharma serialization requirements, but let’s boil them down to what you have to be ready for in just a few weeks: Mandatory serialization for 20 percent of drugs starts on October 1.

If this affects you, are you ready? The good news is that complying with Kazakhstan pharma serialization requirements doesn’t have to be difficult. The fastest way to ensure you’re ready for the October deadline — and all the 2023 deadlines — is to contact us and walk through our solutions with one of our supply chain experts.

We offer a holistic, fully validated, preconfigured, automated platform for compliance and L1-L5 connectivity. With rfxcel and Antares Vision Group, you’ll be prepared for regulations in the EAEU and everywhere else your supply chain goes.

 

Kazakhstan Serialization and Traceability Requirements, Part 1

We posted an Uzbekistan pharma serialization update the other day. This got us thinking about Kazakhstan serialization and traceability requirements, as Uzbekistan’s neighbor to the north is working to localize production, digitalize its infrastructure, and incentivize continued growth in key sectors, including pharmaceuticals.

So, welcome to the first of our two-part series about Kazakhstan serialization and traceability requirements. As we did in our series about the Africa supply chain, we’re going to start with context — information about the efforts mentioned above and a snapshot of what’s happening with the pharma industry. Part 2 will get into the specifics of Kazakhstan serialization and traceability requirements in pharma and other sectors.

Kazakhstan serialization and traceability requirements in context

To understand Kazakhstan serialization and traceability requirements, we must first understand what the country is doing to foster economic growth, including modernizing its infrastructure,  developing its business enabling environment, and improving the lives of its citizens. Here’s a rundown of what’s been happening.

The Economy of Simple Things

Launched in March 2019, the Economy of Simple Things program is designed to increase domestic production of mostly low-tech, everyday consumer goods and services. The government also hopes to simultaneously boost demand for these goods, decrease reliance on imports, and increase “Made in Kazakhstan” exports.

The program was funded with 1 trillion tenge (almost $2.4 billion in 2019), of which 400 billion tenge (approximately $953 million) was earmarked for manufacturing and services. It was originally slated to end in July 2022 but was extended until the end of 2023.

When Prime Minister Alikhan Smailov announced the continuation, he said the Economy of Simple Things had subsidized more than 1,100 projects valued at almost $2.1 billion, had helped increase production output and payment of taxes by 33 percent and 80 percent, respectively, and had retained and created 67 jobs.

Digital Kazakhstan

Digital Kazakhstan aims to utilize digital technologies to “allow the economy, business, and citizens to enter a fundamentally new development trajectory.” It began in 2018; barring an extension, it will end this year.

The “new development trajectory” means Kazakhstan will work to transition to a digital economy that will improve people’s quality of life. The initiative focuses on five areas, each with publicly stated goals for “What will change/be changed by 2022”:

      1. Digitization of the economy: reorganization of the economy using technology to increase productivity and growth; focused on businesses of all sizes. Example of “what will change by 2022”: Labor productivity will increase to the level of “TOP-30 world countries.”
      1. Transition to the digital state: transformation of infrastructure to provide services for and anticipate the demands of people and business; calls for “open, transparent, and convenient opportunities” that can be accessed online 24/7. Example of “what will be changed by 2022”: Government services available in electronic format will increase by 80 percent.
      1. Implementation of the digital Silk Way: development of a high-speed, secure infrastructure for data transfer, storage, and processing (i.e., internet access and high-quality mobile communications coverage). Example of “what will change by 2022”: ICT development will reach the level of “TOP-30 countries.”
      1. Evolution of the human capital assets: transformational changes to enable a creative society and the “transition to the new realities”; calls for a knowledge-based economy and digital literacy through innovations in education. Example of “what will be changed by 2022”: Digital literacy will increase to 83 percent.
      1. Innovative ecosystem formation: foster a supportive environment for technological entrepreneurship and industry innovation characterized by stable relations between business, academic institutions, and government. Example of “what will be changed by 2022”: The Astana Hub will become an “international park of IT start-ups.”

Promoting pharma independence

According to the United Nations Comtrade database, a repository of official international trade statistics and relevant analytical tables, Kazakhstan’s pharma imports were valued at $1.56 billion in 2020.

The country’s efforts to attain pharma independence date to at least the mid-2010s. In 2014, for example, the now-discontinued State Program of Accelerated Industrial-Innovative Development (SPAIID) aimed to increase the share of domestically produced medicines to 40-50 percent of the overall market.

How far have they come toward that goal? In October 2020, The Asana Times reported that “the share of domestic manufacturers in the procurement of medicines and medical devices has grown to 30 percent and continues to grow steadily.” It also reported the following:

      • In the first eight months of 2020, production volume increased 34.1 percent, reaching 81.5 billion tenge ($190.28 million).
      • Investments into the industry reached 5.2 percent and 4.1 billion tenge ($9.57 million).

For a little more context, consider these stats from an analysis published in early 2021:

      • In 2018, Kazakh pharma manufacturers produced products valued at 42 billion tenge (about $88 million at current exchange rates).
      • In the first 9 months of 2019, the market for finished pharmaceutical products had grown to 460 billion tenge (about $966 million today), a 22-percent year-on-year increase.

To fuel growth, the government in September 2020 adopted the “Comprehensive Plan for the Development of the Pharmaceutical Industry” through 2025. As reported in the Asana Times, the plan includes the following benchmarks:

      • Thirty new large pharmaceutical operations valued at 77.8 billion tenge ($163.4 million in 2020 dollars)
      • Double medicine production to 230 billion tenge ($537.55 million)
      • Triple exports to 75 billion tenge ($175.10 million)
      • Train more than 2,000 specialists and create permanent jobs for them
      • Increase domestic pharmaceutical production to 50 percent in physical terms

Furthermore, then-Prime Minister Askar Mamin directed the government to scale up support for the domestic pharma industry, especially by stimulating clinical and preclinical trials. He also tasked the Ministries of Industry and Infrastructure Development, Healthcare, and Foreign Affairs to incentivize blue-chip pharma companies to set up shop in Kazakhstan.

One last note for further context: Striving for pharma self-sufficiency isn’t a new idea. For example, earlier this year we wrote about Egypt’s Gypto Pharma City. The Egyptian government envisions this “medicine city” as a regional hub for the international pharmaceutical and vaccine industries, calling it “one of the most important national projects … with the aim of possessing the modern technological and industrial capacity in this vital field.”

Final thoughts

On August 8, the Kazakh Trade and Integration Ministry reported that the country boosted its exports to $34.2 billion between January and May 2022, a 37.2 percent increase over the same period last year.

It seems, then, that the Economy of Simple Things, Digital Kazakhstan, and the Comprehensive Plan for the Development of the Pharmaceutical Industry are reaping dividends. They’re promoting the economic vitality that will help propel the implementation of Kazakhstan serialization and traceability requirements across diverse industries, from pharmaceuticals to footwear.

We’ll talk about those requirements next week in in Part 2. In the meantime, take a look at our solutions for Kazakhstan and the other countries in the Eurasian Economic Union (EAEU). You can also contact us to schedule a short demo of our technologies — rfxcel and Antares Vision Group are committed to ensuring you’re compliant everywhere you do business.

Uzbekistan Pharma Serialization Update: September 1 Deadline & More

We’ve been following the Uzbekistan pharma serialization rollout as part of our ongoing survey of global pharmaceutical regulations and compliance.

As we wrote in mid-February 2022, the country’s State Tax Committee “extend[ed] the timeframe for the phased introduction of mandatory digital markings” of pharmaceutical products. That announcement, however, didn’t stipulate a new deadline.

So, what’s the latest with Uzbekistan pharma serialization? Let’s take a look.

Uzbekistan pharma serialization and Resolution No. 149

On April 2 of this year, Uzbekistan’s Cabinet of Ministers adopted Resolution No. 149, “On the introduction of a system of mandatory digital labeling of medicines and medical devices.” This established the following labeling deadlines for medicinal products and medical devices:

      • September 1, 2022: products produced with secondary (external) packaging (except for orphan drugs)
      • November 1, 2022: products produced with primary (internal) packaging (provided there is no secondary packaging) and medical agricultural products (except for orphan drugs)
      • March 1, 2023: products and medical products to treat orphan diseases as designated by the Ministry of Health
      • March 1, 2023: drugs included in the register of drugs with foreign registrations, the results of which are recognized in Uzbekistan
      • February 1, 2025: medical products on a list approved by tax authorities and the Ministry of Health

Additionally, there seems to be a grace period for the mandatory labeling in two circumstances:

      • Products that were produced domestically within 90 days of these deadlines do not have to be labeled and may be circulated.
      • Products that were imported within 180 days of these deadlines do not have to be labeled and may be circulated.

More about the labeling requirements

The Uzbekistan traceability system is called ASL BELGISI. It’s managed by CRPT Turon, the equivalent of Russia’s Center for Research in Perspective Technologies (CRPT), which manages Russia’s National Track and Trace Digital System (Chestny ZNAK).

The regulations currently apply to five product categories other than medicines and medical devices: tobacco; alcohol, including wine and wine products; beer and brewing products; appliances; and water and soft drinks.

Products in every regulated industry must be labeled with DataMatrix codes that include four data points:

      • A 14-digit product code (i.e., Global Trade Item Number, or GTIN)
      • A 13-character randomized serial number generated by CRPT Turon or a supply chain participant
      • A four-character verification key generated by CRPT Turon
      • A 44-character verification code (i.e., crypto code) generated by CRPT Turon

To learn more about Uzbekistan pharma serialization, how ASL BELGISI works, and labeling requirements, read our “Uzbekistan Traceability Update” from earlier this year. Keep in mind that we wrote this before the first deadline delay and adoption of Resolution No. 149.

Final thoughts

The Uzbekistan pharma serialization deadlines are upon us — about three weeks away. Since its inception, ASL BELGISI has been a hot topic in the industry, especially in key pharma-producing countries.

India, for example, has taken a keen interest in the requirements. One recent article reported that Indian pharma companies are “looking for more clarity over regulations and technical standards … and looking for a transition period to migrate to digital labeling.” The same article noted several other interesting points:

      • India’s pharma exports to Uzbekistan more than doubled in fiscal year 2020-21.
      • India’s export of pharma products to Uzbekistan totaled $137 million in 2021.
      • Uzbekistan’s pharma market is valued at $1.5 billion.
      • There are opportunities for investment and exports in Uzbekistan’s oncology and dermatology sectors.

The good news is that we can help you navigate Uzbekistan pharma serialization requirements no matter where you’re based — India, Asia, the EU, the UK, Latin America, the United States. We have experts in all of these markets, and rfxcel and Antares Vision Group are committed to ensuring you’re compliant everywhere you do business. Contact us today and schedule a short demo of our award-winning Traceability System and our Compliance Management solution.

 

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!