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FSMA 204 Data Carrier Requirements: FDA Guidance & GS1 Standards

Posted on by rfxadmin

We’ve recently talked about Food Safety Modernization Act (FSMA) traceability requirements and GS1 standards and the FSMA traceability lot code. Today, we’re covering FSMA 204 data carrier requirements: FDA guidance and — once again — GS1 standards, including incorporating the mandated traceability lot code into compliant barcodes.

Like our previous post, we’re basing much of this discussion on GS1’s March 1, 2023, industry guidance document, “Application of GS1 System of Standards to Support FSMA 204.” For an in-depth description of GS1 data carriers, check out our “Understanding GS1 Barcodes in the Global Supply Chain” article.

Data carriers: a quick definition for context

A building block for traceability in any supply chain, data carriers enable product information to be quickly and accurately captured, stored, shared, and leveraged for business needs. Companies can mark their entire product hierarchy — from individual items and inner packs to cases/boxes and pallets — with data carriers, which include barcodes (e.g., linear, 2D DataMatrix codes, and QR codes).

Do GS1 barcodes meet FSMA 204 data carrier requirements?

The short answer is “yes.”

However, FSMA does not mandate the use data carriers to provide product information and the FDA does not say what data must be present to meet the FSMA traceability requirements. This is stated clearly in Federal Register Response 524, in which the FDA says that “firms may use product labels to provide the information required [our emphasis] to their supply chain partners if that suits their business practices.”

In the context of this question, suggestions for “product labels” included twist ties, bags, food-grade stickers, and traditional-type labels on produce or customer order forms. For GS1, product labels mean data carriers, primarily barcodes.

What does GS1 say about FSMA 204 data carriers?

In its guidance document, GS1 says this about the FSMA 204 data carrier requirements (or lack thereof):

“Data carriers are not required to meet the requirements of the Final Rule. For this reason, there is no clear prescription of what data must be present in a data carrier to fulfill traceability for the Final Rule. Instead, companies must evaluate what data will enable rapid access to the necessary information in the event the FDA requests their records.”

GS1 explains three types of data carriers that might have applications for the FSMA 204:

      1. GS1 Element String (1D and 2D), which can contain the primary identifier (e.g., Global Trade Item Number, or GTIN) and attribute data (e.g., lot/batch number, expiration date, sell-by date, net weight)
      2. GS1 Digital Link URI (2D), a web-compatible format that can contain the primary identifier and attribute data
      3. Electronic Product Code Uniform Resource Identifier (EPC URI), which can contain the primary identifier with a serial number plus attribute data for use in RFID tags, primarily UHF passive tags (also called RAIN RFID).

Using GS1 barcodes as a FSMA 204 data carrier

Below are some examples of how GS1 barcodes might look when used as FSMA 204 data carriers. (We’re not going to get into RAIN RFID today.)

Specifically, we want to illustrate how these barcodes could meet the FSMA traceability lot code requirement, which GS1 says a GTIN + batch/lot numbers would satisfy. (Read our article here for more about the traceability lot code.) In the illustrative images below, we’ve highlighted the GS1 Application Identifiers (AIs) for GTIN (01), lot/batch number (10), and expiration date (17). AIs tell systems what information is being interacted with and enable them to process that information accordingly.

GS1-128. GS1-128 is a 1D barcode that can be up to 6.5 inches long and have up to 48 data characters. In terms of FSMA 204 data carriers, GS1 includes an “important” note that “1D barcodes cannot be removed until all stakeholders expected to scan the barcode are fully capable of interacting with 2D barcodes. This means that both a 1D and 2D barcode would be required during any transition period.”

GS1 DataMatrix. GS1 DataMatrix codes are omnidirectional and support attributes and all GS1 identification keys. They can hold 3,116 numeric or 2,335 alphanumeric characters.

GS1 DataMatrix + GS1 Digital Link URI. The GS1 Digital Link URI essentially turns data carriers into web links. GS1 says that “scanning capabilities are not widely available for GS1 Digital Link URI in general distribution,” so companies would  have to update their systems in order to process these barcodes and the data they contain.

GS1 QR Code + GS1 Digital Link URI. Like GS1 DataMatrix codes, GS1 QR codes are omnidirectional and support attributes and all GS1 ID keys; however, they can hold 7,089 numbers or 4,296 alphanumeric characters. Some mobile device cameras cannot process DataMatrix codes, so GS1 says QR Codes are “the current preference for engagement through mobile devices.”

GS1 Barcodes FSMA 204 data carrier

Final thoughts

Let’s repeat what we said in our post about GS1 and FSMA traceability requirements:

One takeaway from today’s article is that the FDA might be telling food companies what the FSMA traceability requirements are, but it’s not telling them how to comply. This is why it’s important to understand GS1’s “take” on the situation and the rationale behind its suggestions.

Food companies are already using GS1 barcodes; adapting them as FSMA 204 data carriers or “product labels” makes good sense. GTINs, batch/lot numbers, Serialized Shipping Container Code (SSCC) data, and other information can be encoded into GS1-128, GS1 DataMatrix, GS1 QR code barcode configurations, as well as Electronic Product Code-enabled RAIN RFID tags and labels.

Contact us today if you’d like to learn more about using a barcode as a FSMA 204 data carrier, how to integrate data capture technology into you FSMA 204 compliance strategy, and everything else you need to have in place by the January 2026 deadline. A short talk with one of our supply chain experts will get you going in the right direction or help you course-correct if you feel like you’ve been treading water with your FSMA initiatives.

And if you’re interested in learning how we’ve put more than 1.5 billion of barcodes on as many products to help a major berry producer control product safety and quality, click here.

FSMA Traceability Requirements: FDA Guidance & GS1 Standards

Posted on by rfxadmin

People have been asking us about the Food Safety Modernization Act (FSMA), so we’ve recently written about the Final Rule, the Food Traceability List, and the FSMA traceability lot code. Now we’re going to cover what GS1 is saying about the FSMA traceability requirements.

It’s a timely — and important — topic for the food industry. About two weeks ago, GS1 published an industry guidance document about applying its standards to support FSMA 204. Among other things, the 62-page paper “defines the recommendations for product and location identification, structured product descriptions, and recording common industry defined events to support the additional traceability records required in the Final Rule.”

Today, we’re looking at three things:

      1. What the FDA says about complying with FSMA traceability requirements
      2. GS1 standards for identification
      3. GS1 standards and the FSMA traceability lot code

Caveats and context

GS1 says its guidance document, which was developed by its US FSMA 204 Workgroup, “does not provide any guidance or advice regarding regulatory compliance.”

It also states that the “guideline reflects current industry understanding of the Additional Traceability Records for Certain Foods. Those requirements, and the statutes and regulations affecting them, are subject to change and may evolve in a manner this guideline cannot anticipate.”

Keep these statements in mind as you’re reading. Also know that the purpose of this blog post is to summarize what GS1 is saying about its standards and FSMA traceability requirements, not to advise on or advocate for the use of GS1 standards for FSMA compliance.

Of course, if you do want to get into specifics of ensuring you’re FSMA-compliant, contact us today and start that conversation with one of our supply chain experts.

Last, we’re going to be getting into technical aspects of GS1 standards, including Application Identifiers, identification keys, and barcodes. We’ll explain everything, but read our “Understanding GS1 Barcodes in the Global Supply Chain“ article for more detailed information.

What does the FDA say about complying with FSMA traceability requirements ?

The answer is pretty simple: The FDA does not provide concrete guidance about how to meet FSMA traceability requirements; instead, it speaks in general terms. For example:

      • In Federal Register Final Rule Response 507 to a question about “requiring the use of globally unique product identifiers” — including GS1 identifiers — the Agency says, “we are not making this a requirement under the final rule.”
      • In Federal Register Final Rule Response 516 to a question about GS1 Serial Shipping Container Codes (SSCCs), the Agency says, “we encourage the use of any tools that will improve a firm’s procedures for traceability and support the maintenance and sharing of the required traceability records under the final rule.”
      • Though it does mention the GS1 Global Trade Item Number (GTIN) in a response about the traceability lot code, it says “firms are not required to use GTIN or any other particular coding system or technology.”

In this regulatory context, let’s see what GS1 says about using its standards for the FSMA traceability requirements.

GS1 standards for identification

GS1 says food companies can use GTINs, SSCCs, and Global Location Numbers (GLNs) for the FSMA traceability requirements.

      • GTINs identify individual products. They can be linked to key data elements (KDEs) in a database; food companies wouldn’t need to maintain required information in a separate location. (See our simple explanation of KDEs here.)
      • SSCCs identify single logistics units (e.g., pallets). They can be paired with the mandated FSMA traceability lot codes to improve traceability.
      • GLNs identify the “who” and “where” of a product/company. They would provide required company and location identification.

GS1 standards and the FSMA traceability lot code

Though the FDA does not commit to a standard for the traceability lot code, it does indicate some options. For example:

      • In Final Rule Response 324, the Agency says there are “industry-supported traceability initiatives [to use] a combination of a globally unique product identifier, firm-assigned internal lot code, and standard date code [that] could be used as a traceability lot code.”
      • In Response 361, it says “a traceability lot code may include a product identifier such as a GTIN and/or an internal lot code (provided the definition of ‘traceability lot code’ in § 1.1310 is met).”

GS1 says a GTIN plus batch/lot numbers would meet the FSMA traceability lot code requirements. Here’s a step-by-step explanation of why it would work:

      • GS1 uses Application Identifiers (AI) to indicate identification keys, attribute information, and secondary information.
      • There are 12 identification keys, including GTINs, SSCCs, and GLNs. Every identification key also has an AI. (Read our article about GS1 barcodes for a more thorough explanation of identification keys.)
      • The GTIN AI is 01 and “uniquely identifies [a] trade item.” It can be 8, 12, 13, or 14 digits long.
      • The batch/lot number is AI 10 and “identifies a group of the same product, all of which were manufactured under identical conditions to support traceability and other use cases.” It can be up to 20 characters (letters, numerals, and a defined subset of special characters).
      • The batch/lot number must be expressed in conjunction with a GTIN (AI 01) because it is a product attribute.

Final thoughts

One takeaway from today’s article is that the FDA might be telling food companies what the FSMA traceability requirements are, but it’s not telling them how to comply. This is why it’s important to understand GS1’s “take” on the situation and the rationale behind its suggestions.

It also reinforces a point we’ve been making for quite some time: Companies that see regulations as a chance to lead in their industry and create business value will win the day, and companies that think only about the mechanics of compliance will likely miss these opportunities.

So, like we said above, if you want to talk turkey about ensuring you’re FSMA-compliant, contact us today to start the conversation. In about 15 minutes, one of our supply chain experts can show you Antares Vision Group’s solutions for the food industry and how rfxcel technology drives them.

Also check back next week. We’ll continue this discussion with a piece about data carriers — 1D and 2D barcodes, QR Codes, RFID tags — and what the FDA and GS1 is saying about their role in FSMA traceability requirements. Last but not least, click here to learn how we barcoded more than 1.5 billion products help a major berry producer control product safety and quality.

What is the FSMA Traceability Lot Code and Who Must Comply?

Posted on by rfxadmin

If you read our blog (and we know you do), you’re up to speed on the fundamentals of Food Safety Modernization Act (FSMA) Section 204, including the Food Traceability List (FTL) and the food traceability “Final Rule.” Today, we’re looking at an important part of the regulations — the FSMA traceability lot code — and who must comply.

What is the FSMA traceability lot code?

The FDA defines the FSMA traceability lot code as “a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the firm that assigned the traceability lot code.”

Certain types of companies must assign, record, and share with their trading partners the traceability lot codes for foods on the FTL. These companies must also link the codes to information that identifies FTL foods as they move through the supply chain. (More on this below.)

A traceability lot code must be assigned when any of the following occur:

      • Initial packing of a raw agricultural commodity (RAC*), other than a food obtained from a fishing vessel
      • Performing the first land-based receiving of a food obtained from a fishing vessel
      • Transformation of a food

Section 201(r) of the Federal Food, Drug, and Cosmetic Act defines a RAC as “any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.”

The FSMA traceability lot code in action: CTEs and KDEs

To fully understand the FSMA traceability lot code, we have to talk about the cornerstones of FSMA traceability: critical tracking events (CTEs) and key data elements (KDEs), which are required for foods on the FTL.

In broad terms:

      • CTEs include events that happen during growing and processing, such as harvesting, cooling, initial packing, and distribution.
      • KDEs provide the granular details for food traceability, including time, location, unit measurements, and information about the businesses handling the food.
      • Different companies are responsible for different types of KDEs (e.g., for receiving, shipping, transformation).

A FSMA traceability lot code is typically assigned during the “initial packing” CTE, which the law describes as “packing a RAC, other than a food obtained from a fishing vessel, for the first time.” This means that a code is not assigned at previous supply chain nodes, such on a farm, during harvest, or at a cooling facility.

Once a traceability lot code has been assigned, the records required at each CTE must include that code. Furthermore, companies shouldn’t change the traceability lot code they receive from their partners (e.g., a shipper shouldn’t change the code it receives from an initial packager).

Do you have to comply? Are you exempt?

The Final Rule does have exceptions to the requirements we’ve discussed above.

Overall, the law stipulates that “persons who manufacture, process, pack, or hold foods on the FTL [must] maintain records containing KDEs associated with CTEs” and “provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.”

Therefore, speaking generally, initial packagers, shippers, and receivers have to assign, record, and/or share include a FSMA traceability lot code. Companies that transform FTL foods into other products must include the traceability lot code for each ingredient received and a new traceability lot code for the product you’ve created.

However, companies that receive an FTL food from a partner that is exempt from the regulations must assign a traceability lot code if one has not already been assigned — unless the receiving company is a retail food establishment or a restaurant.

Again, we’re speaking generally. The FDA has an online tool to determine if you’re exempt from the Final Rule.

Final thoughts

This is a lot to digest. Online tools are fine, but the better option is to contact us and nail down your FSMA traceability lot code obligations — and to make sure you’re ready to comply with every FSMA requirement.

As we wrote in our last FSMA update about two weeks ago, the deadline to comply is January 20, 2026. That seems like a long way off, but it’s really not when you factor in the complexity of the Final Rule, the FTL, and the other mandates.

Antares Vision Group can help. We’ll answer your questions. We’ll demonstrate how our traceability and compliance solutions meet your exact needs. And we’ll show you how technology from rfxcel brings added value for brand protection, risk mitigation, customer engagement. Drop us a line today and let’s get started.

Antares Vision Group, Through rfxcel, Begins Partnership with Renown Health Network for DSCSA-Compliant Pharmaceutical Tracking

Posted on by rfxadmin

rfxcel, part of Antares Vision Group, will implement DSCSA compliance solutions to help ensure pharmacies across the northern Nevada healthcare network comply with the regulations.

Reno, Nevada, March 8, 2023 — Antares Vision Group (EXM, AV:IM), a leading provider of track and trace and quality control systems, today announced that rfxcel, which is part of the Group, has begun a partnership with Renown Health Foundation to implement compliance software so the network can track and trace pharmaceuticals in compliance with the Drug Supply Chain Security Act (DSCSA).

With rfxcel’s DSCSA compliance solutions, Renown Health’s medical groups and pharmacies will achieve real-time electronic tracing of drug products at the package level to identify and trace prescription drugs as they are distributed throughout the health system. This will enhance Renown’s ability to help protect patients from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

“Reno has been our home since 2018 and many of our employees live and work in the northern Nevada region,” said rfxcel CEO Glenn Abood. “Renown is one of the leading not-for-profit healthcare organizations here and is the perfect partner to team with to give back to our community. We are excited about the opportunity to work with them and to help improve the health and well-being of our friends and neighbors.”

“Ensuring our patient’s medications are safe and legitimate is of the upmost importance to us,” said Renown’s Vice President of Pharmacy Services Adam Porath. “When members of our community get involved in our work, it brings us all closer together. We are thankful that Antares Vision Group and rfxcel are partnering with us on our healing mission. They are making it possible for us to keep our patients safe, comply with the demanding DSCSA requirements, and respond quickly to changing supply chain requirements.”

For further information, write us at news@rfxcel.com.

 

ABOUT ANTARES VISION GROUP

Antares Vision Group is an outstanding technology partner in digitalization and innovation for companies and institutions, guaranteeing the safety of products and people, business competitiveness, and environmental protection. The Group provides a unique and comprehensive ecosystem of technologies to guarantee product quality (inspection systems and equipment) and end-to-end product traceability (from raw materials to production, from distribution to the consumer) through integrated data management, applying artificial intelligence and blockchain technology. Antares Vision Group is active in life science (pharmaceutical, biomedical devices and hospitals) and Fast-Moving Consumer Goods (FMCG), including food, beverage, cosmetics, and glass and metal containers. As a world leader in track and trace solutions for pharmaceutical products, the Group provides major global manufacturers (over 50% of the top 20 multinationals) and numerous government authorities with solutions, monitoring their supply chains and validating product authenticity. Listed since April 2019 on the Italian Stock Exchange in the Alternative Investment Market (AIM) segment and from 14 May 2021 in the STAR segment of the Mercato Telematico Azionario (MTA), Antares Vision Group recorded a turnover of €179 million in 2021, operates in 60 countries, employs more than 1,000 people, and has a consolidated network of over 40 international partners. To learn more, please visit www.antaresvision.com and www.antaresvisiongroup.com.

ABOUT RENOWN HEALTH

Renown Health is Nevada’s largest, not-for-profit integrated healthcare network serving Nevada, Lake Tahoe, and northeast California. With a diverse workforce of more than 9,000 employees, Renown has fostered a longstanding culture of excellence, determination, and innovation. The organization comprises a trauma center, two acute care hospitals, a children’s hospital, a rehabilitation hospital, a medical group and urgent care network, and the locally owned not-for-profit insurance company, Hometown Health. Renown is currently enrolling participants in a community-based genetic population health study, the Healthy Nevada Project®.

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

Posted on by rfxadmin

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

Posted on by rfxadmin

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

Posted on by rfxadmin

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.

 

 

 

 

 

 

Why Cosmetics Supply Chain Sustainability Is the Industry’s Hottest Topic

Posted on by rfxadmin

The health and beauty industry is under increasing pressure from regulatory bodies and consumers to maintain and demonstrate due diligence in their supply chains. Forward-thinking companies are responding by making cosmetics supply chain sustainability an integral part of their mission statements and consumer engagement activities.

For example, “The Big 3” are prioritizing cosmetics supply chain sustainability. L’Oréal puts environmental and social performance at the heart of its business to drive value.  Estée Lauder’s mission is “to bring the best to everyone we touch and to support the environment in which we live.” And Unilever reports thoroughly on environmental and ethical statistics, including water, energy, greenhouse gases, waste and plastic packaging, sustainable sourcing, and community investment.

So let’s take a look at  sustainability in the cosmetics supply chain. The industry faces a slew of challenges with sustainability, such as environmental and human rights issues, counterfeiting, an evolving regulatory landscape, changes in consumer behavior, and utilizing new technologies, and all affect their decisions and processes.

What is “sustainability”?

Before we get into cosmetics supply chain sustainability, let’s take a step back for a moment and talk about sustainability generally.

Sustainability might seem to be a relatively new concept, but it has been around since the 19th century, when some industries sought to improve working environments and create less pollution. In the 1960s, new laws and organizational bodies were introduced to address pollution in the United States and Europe.

The U.S. Food and Drug Administration (FDA) “is required under the National Environmental Policy Act of 1969 (NEPA) to evaluate all major agency actions to determine if they will have a significant impact on the human environment.” Federal agencies implement NEPA and evaluate the possibility for environmental impacts by condcuting categorical exclusions, environmental assessments, and environmental impact statements.

The European Commission says it “aims to ensure coherence between industrial, environmental, climate and energy policy to create an optimal business environment for sustainable growth, job creation and innovation.”

In 2015, the Association of Southeast Asian Nations (ASEAN) adopted the ASEAN Socio-Cultural Community Blueprint 2025, which “promotes and ensures balanced social development and sustainable environment that meet the needs of the peoples at all times.”

If you read our Global Cosmetics Market white paper, you’ll know why we used the United States, Europe, and Asia as examples: They’re the world’s top cosmetics markets — and their regulators are concerned about sustainability.

What is cosmetics supply chain sustainability?

Cosmetics supply chain sustainability addresses the environmental and human impact of products, from the sourcing and production of raw materials, through to manufacturing, packaging, distribution to the final customer, and post-consumer activities.

Increasingly, there are calls for cosmetics supply chain sustainability standards to be made mandatory. The European Parliament in March passed a resolution to tackle environmental and human rights in EU supply chains. This new Supply Chain Act will require organizations to integrate sustainability into corporate governance and management systems, and frame business decisions in terms of human rights, climate, and environmental impact.

The United States is yet to follow suit, but consumer groups are letting the government know they want tighter standards for the raw materials used in cosmetics.

Even without government mandates, organizations that want to burnish their environmental credentials would do well start with their supply chains. In a January 2021 report called Net Zero Challenge: The Supply Chain Opportunity, the World Economic Forum states that companies wanting to improve their environmental and social performance can look to their supply chains to make cost-effective improvements.

Environmentally responsible production: the rise of “Clean Beauty”

Much of the drive toward sustainability is coming from consumers, who want to know that ingredients are pure (or at the very least safe) and have been ethically sourced. For example, 62 percent of Generation Z consumers (born in the late 1990s) prefer to buy from sustainable brands, and 73 percent will pay more for sustainable products.

In the United States, where the Food and Drug Administration (FDA) from being used in cosmetics, there is mounting pressure for stricter regulations. For example, environmental and consumer advocate groups such as the Environmental Working Group (EWG) believe more chemicals should banned, like in the EU, where 1,300+ substances are prohibited from being used in cosmetics.

This is part of larger “Clean Beauty” movement that advocates for safe, clean ingredients and transparency in product labeling. According to a

Clean Beauty is also concerned with ethical sourcing of ingredients. Consumers want reassurance that their cosmetics are not linked to issues such as deforestation, pollution, and animal or child cruelty. The primary problem here is that a wide variety of cosmetic products use a few “core” ingredients, many of which pose unique challenges for achieving sustainability in the cosmetics supply chain. They are difficult to obtain sustainably and ethically, and child labor, poor working conditions, and illegal mining are common.

For example, a 2016 report from the Amsterdam-based nonprofit Centre for Research on Multinational Corporations (SOMO) found that more than 20,000 children are forced to work in mica mines while their families live in severe poverty. Similarly, palm oil, the global market for which is expected to reach $57.2 billion by 2026, has a history of human rights problems. Palm oil is used for moisturizing or texture effects.

As more companies stake their reputations on being sustainable and consumers become more aware and demanding, it’s certain that the call for cosmetics supply chain sustainability will only get stronger.

How can we achieve cosmetics supply chain sustainability?

As we’ve seen, cosmetics companies operate in a challenging environment where many groups — including consumers, perhaps their most important audience — are calling for them to achieve sustainability in their supply chains.

To be successful, they must be able to adapt to changes in the market as technology, product development, and consumer sentiment shape the industry. Whether it’s faster production methods, demand for new products, or desire for ethical and sustainable options, companies must be able to change with the market if they want to survive and succeed.

The key takeaway is that cosmetics supply chain sustainability is not a pipe dream. Technology and solutions exist right now to help companies evaluate their operations and identify strengths, weaknesses, and pain points and take corrective action. These include supply chain digitalization, cloud-based data systems, and real-time monitoring. For instance, a 2021 report by Gartner said that digitalization is a key enabler of agility because it supports a more transparent, automated, intelligent, and orchestrated end-to-end supply chain.

Final thoughts

Sustainability. Consumers want it. More and more regulators are demanding it. It’s good for the planet. It’s good for people. It’s a business best practice.

Is it difficult to attain sustainability? Yes and no. It is a process. It has a lot of moving parts that may require tough decisions. But if a company has the will to be sustainable, it can develop strategies, chart a course, and get to work … and reap the benefits.

Technology is essential for sustainability. rfxcel and Antares Vision Group are committed to helping companies meet their sustainability goals and empowering them to protect product, profit, people, and planet.

Our Traceability System enables you to see and follow everything in your supply chain in real time from virtually anywhere in the world. It makes every product a “digital asset” with a certified, sharable provenance that proves to consumers and regulators that your sustainability initiatives are real and working as intended. Its intuitive, scalable solutions can be used individually or as a complete platform to shepherd sustainability initiatives to completion and create end-to-end traceability, transparency, and visibility.

Contact us today to see how it works. And be sure to check out our other resources about the cosmetics industry, sustainability, and traceability:

Cosmetics Supply Chain Transparency for Business Value and Opportunity

Posted on by rfxadmin

Today, we’re looking at what cosmetics supply chain transparency means, why it matters, and how cosmetic companies can achieve it through the use of technology and gain much more than just a healthier bottom line.

Cosmetics supply chain transparency vs. traceability

Cosmetics supply chain transparency means the whole supply chain is visible, from raw materials, production, and packaging to delivery to retailers and, ultimately, consumers. A lack of transparency in complex supply chains that move billions of products can cause significant risks to both consumer and product owner.

Transparency results from creating a full, shareable, fact-based profile of every aspect of the supply chain. It is a means for companies to support its claims (e.g., product provenance, sustainability, ethical sourcing) and tell the world, “We are what we say we are.” In this way, transparency is a strategic concept — one more and more cosmetic companies are adopting because of its significant benefits for operational efficiency, consumer engagement, brand protection, and profitability.

Traceability most often concerns individual products and aggregations (e.g., boxes, cartons, pallets) and observing/monitoring them as they make their way through the supply chain. It is a means to identify, follow, and verify what’s in your supply chain, as well as comply with regulations that mandate traceability through serialization and digitalization.

Cosmetics supply chain transparency for business value

It’s the global cosmetics market will grow from $287.94 billion in 2021 to $415.29 billion in 2028. Indeed, there are signs the market is booming. For example, L’Oréal, the world’s largest beauty brand, reported record profits last year, with CEO Nicolas Hieronimus, recently commenting, “2021 was a historic year for L’Oréal … Over two years, the Group achieved growth of +11.3 percent like-for-like, spectacularly outperforming a market that had returned almost to 2019 levels.”

The other leading cosmetics brands also did well in 2021. Unilever reported just over $24 billion in beauty and personal care sales, and Estée Lauder had $16.2 billion in sales, an increase of 13 percent over last year.

The “Big 3” of the cosmetics industry have something in common other than strong market performance: Each is committed to transparency and puts it front and center in their business strategy and mission. For example, L’Oréal held a virtual “Transparency Summit” last year, Unilever equates transparency with “integrity,” and Estée Lauder has a dedicated supply chain transparency page on its website.

Transparency and risk management

Despite the opportunity for growth, however, global supply chain challenges can threaten a company’s ability to satisfy growing consumer demand. We all know about the supply chain weaknesses revealed during the pandemic, including overreliance on manufacturing hubs and shipping bottlenecks, not to mention changes in consumer expectations and the way they want to buy and interact with cosmetics.

In a rapidly evolving landscape of tougher regulations, ongoing supply chain uncertainty, increased consumer expectations, and brand risk, transparency has become foundational for success.

Regulatory compliance. Cosmetics regulations vary around the world. For instance, laws in the EU are much broader than in the United States. Generally, however, companies are responsible for making sure their cosmetics are safe, properly labeled, and comply with the regulations that apply to them.

Furthermore, more and more regulatory bodies are calling for modernization via the adoption of digital technologies to ensure products are safe and that companies are able to remain compliant as regulations evolve. Cosmetics supply chain transparency (and traceability) is crucial to compliance. Read our “Global Cosmetics Market” white paper to learn more about regulations in key markets and how technology is driving the industry.

Counterfeits and fakes. And as we’ve written before, counterfeiting is a big problem for the cosmetics industry. Fake products endanger consumers’ health. They can contain toxic substances such bacteria, animal waste, and carcinogenic substances (e.g., lead).

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

Brand reputations are also jeopardized by counterfeits. One bad (or very bad) experience can send customers to your competitors and tarnish your image, especially as consumers broadcast their opinions online. Our brand protection series talks more about counterfeits. It’s a real problem that every industry must contend with.

Diversion, theft, and gray markets. The complexity of global supply chains makes it possible for products to end up in markets where they shouldn’t be. Unauthorized or unofficial distribution channels shepherd expired, damaged, or otherwise compromised goods to unauthorized third-party sellers that consumers may think are legitimate. A product bound for Asia winds up in the United Kingdom.

Transparency is not a singular solution for these problems, but it is an indispensable facet of a coordinated, integrated supply chain management strategy to mitigate risk and create real business value.

Mainstreaming sustainability and ESG reporting

As we’ve noted, consumers are demanding more information about the products they purchase; they want to know that ingredients have been ethically sourced and are safe. They want a trust-based relationship with their brands — and if they don’t get it, they’ll happily take their business elsewhere.

This means cosmetics companies must be vigilant and forthcoming about everything in their operations, from their labor standards and how they source raw materials to packaging and other fundamentals of their supply chains. In response, environmental, social, and governance (ESG) reporting has become more prevalent.

ESG reporting measures a company’s social and environmental performance through its supply chain and operations. Cosmetics companies are under pressure, not least from consumers, to reduce their environmental and social impact, set up monitoring systems, use sustainable materials, and publish their social credentials. In this way, ESG reporting is part of cosmetics supply chain transparency.

Or, more accurately, cosmetics supply chain transparency enables effective, accurate ESG reporting.

Leading cosmetics companies are now using ESG reporting, or some form of it, as a strategic tool to monitor their success in sustainability. For example, in 2021, L’Oréal implemented “L’Oréal for the Future,” its sustainability program for 2030. Without mincing words, it prioritizes transparency in product manufacturing, transport, the sourcing and quality of ingredients, sustainability, and more:

“Our commitments towards 2030 mark the beginning of a more radical transformation and embody our view as to what a company’s vision, purpose and responsibilities should be to meet the challenges facing the world.”

Ironically, ESG has enabled some bad players to essentially fake their declarations of transparency and sustainability. It’s called “greenwashing,” when “a company purports to be environmentally conscious for marketing purposes but actually isn’t making any notable sustainability efforts.” Greenwashing is the antithesis of transparency. It’s unethical, and companies that engage in it never intend to meet or quantify their stated transparency, sustainability, and ESG claims.

We’ll be talking more about cosmetics supply chain sustainability tomorrow. Be sure to visit our blog for that.

Final thoughts

Cosmetics supply chain transparency benefits consumers and brand owners alike. For consumers, it means products are safe and legitimate, comply with regulations, and demonstrably rise to the company’s sustainability and ESG goals. For brand owners, transparency offers greater operational efficiencies, mitigates common supply chain risks, and creates opportunities to burnish their reputations, engage with consumers, and tell them with certainty that your products and processes are what you say they are.

Is it difficult to attain transparency? No. Our Traceability System enables companies to follow everything in their supply chains in real time from virtually anywhere in the world. It makes every product a “digital asset” with a certified, provable, and sharable provenance. Its intuitive, scalable solutions can be used individually or as a complete platform to create transparency and end-to-end supply chain traceability and visibility. rfxcel and Antares Vision Group are committed to bringing transparency to all supply chains. We can show you how we do it in about 15 minutes, so contact us to schedule a demo.

And if you’re interested in a transparency case study of sorts, read our global seafood “Transparency Trilogy.” What’s true for seafood is true for cosmetics: Its supply chain reaches into remote areas and involves vulnerable populations and threatened resources.

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

Posted on by rfxadmin

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.

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