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FSMA 204 Data Carrier Requirements: FDA Guidance & GS1 Standards

Posted on March 23, 2023March 27, 2023 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. 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.”

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 March 16, 2023March 27, 2023 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. 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 March 14, 2023March 14, 2023 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 March 8, 2023March 7, 2023 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®.

India Track and Trace Regulations: March 31 Deadline for Exports & More

Posted on March 2, 2023 by rfxadmin

This year will be a busy one for pharmaceutical compliance as governments around the world continue to roll out their serialization and traceability plans. India track and trace regulations are no exception: There was a deadline in January, there’s one at the end of this month, and another is coming in August.

Let’s take a look at the India track and trace regulations and what the pharma industry has to do to be ready.

January 1: Labeling APIs

As of January 1, 2023, all imported and domestically manufactured active pharmaceutical ingredients (APIs) must be labeled with QR codes “at each level packaging that store data or information.” This is the culmination of a process that began in June 2019, when the Drugs Technical Advisory Board (DTAB) approved a proposal mandating QR codes on APIs. At that time, DTAB estimated that the regulation would affect approximately 2,500 APIs.

The QR codes must contain 11 data points, including a unique product identification code, the name of the API, and the manufacturing and expiry dates. The QR codes must link to a national database with pricing data from the National Pharmaceutical Pricing Authority.

March 31: Full track and trace and reporting to the iVEDA Portal for exported drugs

For all exported drugs, March 31 is the deadline for full track and trace and reporting to the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA) portal. The rules apply to both small-scale industry (SSI)- and non-SSI-manufactured drugs. The iVEDA portal is used for only registering and reporting exported drugs.

August 1: Barcoding for the Top 300 domestic pharma brands

These rules were originally scheduled to come into force on May 1, but that was pushed back to August 1. The rules stipulate that eight data points must be incorporated into a “Bar Code or Quick Response Code” to be printed on or affixed to the primary packaging, including a unique product identification code (e.g., GTIN), the brand name, and manufacturing and expiry dates.

Final thoughts about the India track and trace regulations

We talked about these regulations in more detail last year. See that article here. As we said then, our team has worked in the India pharma market for many years and understands its complexities, challenges, and benefits. We have offices and experienced staff in the country. Contact us today to learn more about the India track and trace regulations and to arrange a demo. In about 15 minutes, one of our supply chain experts can show you how we can help ensure you comply while maximizing your impact in this huge market.

Brazil ANVISA Update: SNCM Status, Medical Device Regulations & More

Posted on February 28, 2023March 2, 2023 by rfxadmin

We thought it was time for a Brazil ANVISA update. News has been sporadic since last September, when the Brazilian Health Regulatory Agency — ANVISA — permanently suspended its contract with DataPrev to develop and manage the country’s National Medicine Control System (SNCM).

Let’s catch up with what’s been happening.

Brazil ANVISA update, Part 1: What happened in 2022?

We’ve been following Brazil’s pharma regulations regularly since the SNCM was established in 2016. There were several delays in the rollout, but as we wrote early last year, the industry was anticipating an April 28, 2022, deadline to comply with the SNCM’s serialization, reporting, and traceability requirements.

However, just before that date, the SNCM was put on hold. Events start to cascade from there:

- - May 12: Law No. 14,338/2022 was enacted. This mandated that manufacturers had to provide digital versions of the printed inserts included in drug packaging. The inserts had to have a QR code linked to a digital version maintained in a database authorized by ANVISA. The law also confirmed that ANVISA intended to have a drug traceability system, but did not stipulate a timeline for implementing it.
  - May 23: ANVISA suspended its contract with SNCM developer DataPrev for 120 days.
  - September 12: ANVISA dissolves its contract with DataPrev, and test and production environments were not accessible. The SNCM is effectively suspended.

In case you need a refresher, the SNCM was going to require every pharma supply chain actor to capture, store, and exchange data electronically. All products were to be labeled with a GS1 2D Data Matrix barcode with five data points:

1. 1. Global Trade Item Number (GTIN)
  2. A 13-digit ANVISA Medicine Registry Number
  3. A unique 13-digit serial number
  4. An expiration date (in the MM/YY format for human-readable form)
  5. A lot/batch number (up to 20 alphanumeric characters)

For the April 28, 2022, deadline specifically, all prescription medicines had to be serialized; all manufacturers and importers had to have a “serialization plan” in the SNCM portal; and all supply chain stakeholders had to submit product event reports to the SNCM.

Brazil ANVISA update, Part 2: Will the SNCM resume in 2023?

On February 14, 2023, a Brazilian publication called JOTA, which monitors Brazil’s government and whose stated mission “is to make Brazilian institutions more predictable,” published an interview with ANVISA Director-President Antonio Barra Torres.

Torres said “the merits of traceability are still alive,” adding the time was right to resume the discussion about the SNCM. Other key takeaways from the interview included the following:

- - Torres said ANVISA was ready, technologically, to support the SNCM; resumption should be able to occur quickly.
  - He believes big manufacturers and most smaller ones are ready to comply.
  - He expects the World Health Organization (WHO) will inspect the SNCM in 2024; the Pan American Health Organization (PAHO) has also offered to inspect the system.
  - He said traceability data wouldn’t solve drug shortages, but could contribute to mitigation strategies.
  - ANVISA is currently short-staffed and needs to fill about 1,110 positions.

Brazil ANVISA update, Part 3: Medical device regulations

New medical device regulations were supposed to go into effect this month but were put on hold. Here’s the context:

Law RDC 751/2022 was passed September 21, 2022. It included rules for medical device classification and regulatory regimes and replaced two previous laws, RDC 185/2001 and RDC 40/2015. Here are some of the requirements in simple terms:

- - Risk classification of medical devices is consolidated into four levels (low, medium, high, maximum). The classifications rules and medical device definitions generally follow the European Medical Device Regulation (MDR).
  - There are specific classification rules for new technologies, including software as a medical device (SaMD) and nanomaterials.
  - Manufacturers must upload medical device instructions for use to an ANVISA portal.
  - Instructions for use, labels, and ANVISA documentation must be in Portuguese; other documents can be in English.
  - The law includes requirements for Brazilian Good Manufacturing Practices.
  - The law does not apply to vitro diagnostic devices, refurbished devices, and personal medical devices.

At the time we’re writing this, it seems the proposed timeline to comply with the new classification rules will begin next year and end in 2028.

Final thoughts

We’ll continue monitoring what’s happening with ANVISA and the SNCM — the entire global regulatory landscape — so bookmark our blog and check back often.

If you have questions about the regulations, contact us today. Our team in Brazil can walk you through what to expect for 2023 and beyond and demonstrate how our pre-configured and pre-validated solutions take the guesswork out of SNCM compliance. We’ve been ready to go since 2016 and we’re ready to go today.

Uzbekistan Serialization Requirements: March 1 Deadline and More

Posted on February 27, 2023February 28, 2023 by rfxadmin

The rollout of Uzbekistan serialization requirements will continue on schedule as spring 2023 approaches. Let’s take a look at the requirements, what happened last year, and what to expect for the March 1 deadline.

What are the Uzbekistan serialization requirements?

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

Today, the Uzbekistan serialization requirements apply to seven product categories: medicines; medical devices; tobacco; alcohol, including wine and wine products; beer and brewing products; appliances; and water and soft drinks. Regulated products 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

Product packaging must also have the following human-readable information:

- - GTIN
  - Serial number
  - Expiration date in YY/MM/DD format
  - Batch number or lot number

Key dates in 2022

It’s been a little more than a year since Uzbekistan’s State Tax Committee extended the schedule for the “phased introduction of mandatory digital markings” of pharmaceutical products.

We’re also approaching the 1-year anniversary (April 2) of Resolution No. 149, which established the labeling deadlines for four groups of medicinal products and medical devices. There were two deadlines in 2022:

- - September 1: Products produced with secondary (external) packaging (except for orphan drugs)
  - November 1: Products produced with primary (internal) packaging (provided there is no secondary packaging) and medical agricultural products (except for orphan drugs)

March 1 Uzbekistan serialization requirements

Resolution No. 149 stipulates two labeling deadlines for March 1:

- - Products and medical products to treat orphan diseases as designated by the Ministry of Health
  - Drugs included in the register of drugs with foreign registrations, the results of which are recognized in Uzbekistan

As with the 2022 deadlines, it seems that Resolution No. 149 established a grace period for 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.

Final thoughts

The Uzbekistan serialization requirements mean that pharma companies that want to do business in the country have a long list of items to check off their compliance to-do list, including generating and managing serial numbers, obtaining crypto codes from CRPT Turon, and monitoring packing lines to ensure compliance with the requirements.

The good news is that we can help you navigate the requirements. Contact us today and schedule a short demo of our compliance management solution, which takes the guesswork out of compliance by automatically sending reports to regulators, adapting to changes in laws, and updating your partners. Our digital supply chain experts will help you evaluate your needs and work directly with you to design a solution customized for your business.

And sure to bookmark our blog and check back for more updates about Uzbekistan serialization requirements and requirements in other Commonwealth of Independent States nations and members of the Eurasian Economic Union.

Published Feb. 27, 2023

FSMA Traceability: What the Food Industry Needs to Know Today

Posted on February 24, 2023March 27, 2023 by rfxadmin

U.S. regulators want a more robust, technology-driven approach to traceability and safety in the food supply chain. Their strategy has several components, but the FSMA traceability requirements published in November 2022 should be top-of-mind for the food industry in the United States and elsewhere.

Let’s take a look at the Food Safety Modernization Act (FSMA) and FSMA traceability requirements. Even though the compliance deadline is about three years away, now is the time to start planning your strategy.

FSMA implementation and goals

The Food and Drug Administration (FDA) is the primary implementing regulatory agency of FSMA, a law that seeks to transform the United States’ food safety system “by shifting the focus from responding to foodborne illness to preventing it.” It focuses on five areas:

1. Preventive controls
2. Inspection and compliance
3. Imported food safety
4. Response (i.e., recalls)
5. Enhanced partnerships

In terms of FSMA traceability, the regulations address the “need for rapid and effective tracking and tracing of foods.”

FSMA Section 204 and the three pillars of FSMA traceability

Section 204 of FSMA is entitled “Enhancing Tracking and Tracing of Food and Recordkeeping.” It has three traceability requirements and instructs the FDA to develop additional recordkeeping requirements for certain foods. Quoting verbatim from the Agency’s website, the FDA must:

1. Establish pilot projects in coordination with the food industry to explore and evaluate methods and appropriate technologies for rapid and effective tracking and tracing of foods.
2. Designate foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health.
3. Publish a notice of proposed rulemaking to establish such additional recordkeeping requirements for the designated foods, to help in tracing such foods.

Today, we’re going to focus on Nos. 2 and 3, which concern the FDA’s Food Traceability List and the Final Rule on Requirements for Additional Traceability Records for Certain Foods (“Final Rule”).

The Food Traceability List and the Final Rule

The Food Traceability List (FTL) was developed with input from a 2014 Request for Comments and for Scientific Data and Information in the Federal Register, members of the FDA and the Centers for Disease Control and Prevention, and external subject matter experts. It includes “high-risk foods” such as leafy greens, shell eggs, crustaceans (e.g., shrimp, crab, lobster), and finfish (e.g., cod, tuna, salmon).

In September 2020, the FDA published “Requirements for Additional Traceability Records for Certain Foods.” Known as the “Food Traceability Proposed Rule” or “Proposed Rule,” it defined additional recordkeeping requirements for businesses that manufacture, process, pack, or hold foods on the FTL.

After making modifications and holding a period for public comments, The FDA in November 2022 announced the Final Rule on Requirements for Additional Traceability Records for Certain Foods.

The gist of the Final Rule and FSMA traceability is that businesses are responsible for establishing and maintaining records of critical tracking events (CTEs) and associated key data elements (KDEs).

CTEs are typically events that occur during growing and processing (e.g., harvesting, initial packing, and shipping). KDEs provide the granular details for FSMA traceability, such as time, location, unit measurements, and a company’s contact information.

The information companies must keep and share with their partners depends on the type of supply chain activities they perform with respect to food(s) on the FTL. The activities encompass the entire food supply chain, from harvesting or production, to processing, distribution, and receipt at a retail location or other point of service.

The FDA says this “framework forms the foundation for effective and efficient tracing and clearly communicates the information that FDA needs to perform such tracing.”

Final thoughts

The deadline to comply with FSMA traceability requirements is January 20, 2026. (That’s a Tuesday, if you’re wondering.) The FDA is giving the food industry the extra time because it wants all regulated businesses to come into compliance by the same date — and because it acknowledges that trading partners have to get their systems in place.

The worldwide food industry should monitor events in the United States as FSMA traceability requirements evolve. It’s not just about compliance and being able to sell products in America; it’s about being able to anticipate regulatory trends, keeping your supply chain moving at peak performance, and leading in the industry through adaptation and innovation. It’s also about leveraging the FSMA regulations to create business opportunities.

This is where Antares Vision Group can help. We offer a full-stack solution for the food industry. A “soup to nuts” solution, if you will. We can answer your questions, show you in concrete detail how we create end-to-end traceability in supply chains, and discuss how to use traceability to safeguard your brand and protect your bottom line. Contact us today to talk with us and schedule a demo.

And read this if you’re interested in learning about how rfxcel technology helped a major berry producer control the safety and quality of more than 1.5 billion products.

For a Leading Berry Producer, Antares Vision Group Digitalizes Billions of Products for Tight Supply Chain Oversight and Direct Consumer Connections

Posted on January 20, 2023January 20, 2023 by rfxadmin

The Group’s Supply Chain Transparency solution serializes packages in the field, enabling the use of unit-level data to help ensure customers are satisfied with product quality.

Travagliato (Brescia), January 17, 2023 – Antares Vision Group (EXM, AV:IM), an Italian multinational and a leading provider of track and trace and quality control systems that ensures the transparency of products and supply chains through integrated data management, has successfully piloted a Supply Chain Transparency solution for a prominent berry company. The project entails the digitalization of over 1.5 billion products, empowering the berry producer to protect, support, and communicate with its customers.

Powered by technology from rfxcel, which is part of Antares Vision Group, the Supply Chain Transparency solution package enables data concerning harvested berries to be collected and integrated into a platform that fully controls product safety and quality.

Using Antares Vision Group’s advanced serialization and mobile traceability technologies, the producer scans each individual clamshell to associate berry type, farm, and growing conditions, giving each package a unique digital identity with detailed product information. Consumers can scan an on-package QR Code to take a survey, giving the producer valuable insight into its customers’ impressions of specific berries grown at specific locations. This allows the company to focus on the types of berries consumers like best, and to ensure product quality is maintained at high standards from field to end user.

Glenn Abood, CEO of rfxcel, said the project showcases the technology’s impact and scalability. “We’re really expanding boundaries with this project,” he said. “Our coordination with the berry producer has been greatly rewarding; together, we’ve designed a system that reliably manages billions of products in the first and last mile of the supply chain. It performs these tasks day in and day out, with sub-second scanning times and exacting accuracy.”

Abood added that Antares Vision Group and the producer had discussed other applications for the wide-scale serialization of products, such as using digitalized unit-level data for consumer engagement activities and risk-mitigation strategies.

Abood continued: “Our serialization technologies are opening up entirely new avenues for brand value and benefits, connecting safety, quality, efficiency, and trust. The brand owners have actionable and granular information about consumer preferences, opening new dialogue channels and highly targeted customer interactions. Recall management is another benefit: It’s not necessary to recall every package, only a single clamshell. These advantages are available only with serialized products, which unlock opportunities with the power of unit-level data.”

For further information

Herb Wong, Senior Vice President, Product and Strategy: +1 925 791 3235 / hwong@rfxcel.com

Alessandro Baj Badino, Head of Investor Relations: +39 030 72 83 500 / investors@antaresvision.com

Davide Antonioli, Investor Relator: +39 030 7283500 / investors@antaresvision.com

Federica Menichino, Axelcomm (Press Contact): +39 3496976982 / federica.menichino@axel-comm.it

ABOUT ANTARES VISION GROUP

India Track and Trace Requirements Update: APIs, iVEDA, and Barcoding

Posted on September 27, 2022March 17, 2023 by rfxadmin

It’s been a busy year with India track and trace requirements. The Ministry of Health has extended a deadline, announced a new deadline, and released new draft rules concerning key areas of the country’s pharmaceutical regulations.

There are deadlines coming up in the next 6 months, so let’s take a look at what’s happening with these India track and trace requirements..

India track and trace requirements for 2023

The upcoming India track and trace requirements affect three areas of manufacturing: labeling active pharmaceutical ingredients (APIs), reporting, and product labeling for the Top 300 brands. We’ll go in chronological order:

Labeling APIs: January 2023 deadline

Starting January 1, 2023, all imported and domestically manufactured APIs must be labeled with QR codes “at each level packaging that store data or information.” The government says this will help combat falsified drugs.

This is the culmination of a process that began in June 2019, when the Drugs Technical Advisory Board (DTAB) approved a proposal mandating QR codes on APIs. At that time, DTAB estimated that the regulation would affect approximately 2,500 APIs.

The QR codes must contain 11 data points:

1. 1. Unique product identification code
  2. Name of the API
  3. Brand name (if any)
  4. Name and address of the manufacturer
  5. Batch number
  6. Batch size
  7. Date of manufacturing
  8. Date of expiry or retesting
  9. Serial shipping container code
  10. Manufacturing license number or import license number
  11. Special storage conditions required (if any)

QR codes will also link to a national database with pricing data from the National Pharmaceutical Pricing Authority.

Companies are required to get a GS1 Company Prefix, a unique number that identifies a company as the owner a barcode and the product to which it’s affixed, and a GS1 Global Location Number. GS1 Global Trade Item Numbers will serve as the “unique identification code.”

Reporting to the iVEDA Portal: March 2023 deadline

On April 4, 2022, the Directorate General of Foreign Trade (DGFT) released a public notice that extended to March 31, 2023, the deadline for export reporting to the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA) portal. The change applies to both small-scale industry (SSI)- and non-SSI-manufactured drugs.

The deadline for this requirement has been postponed at least four times, starting in 2018, when India track and trace requirements centered around another reporting portal, the Drugs Authentication and Verification Application (DAVA). As we reported when iVEDA was launched, the deadline was changed from April 1, 2020, to October 1, 2020. It was changed again in April 2021 and, as we’re discussing now, in April 2022.

Draft regulations for barcoding pharma products: May 2023 deadline

On September 5, the Ministry of Health and Family Welfare published draft guidelines for barcoding the Top 300 brands in the country, all of which are named in “Schedule H2” of the announcement. The rules will come into force on May 1, 2023.

The goal of these India track and trace requirements — like so many other regulations around the world — is to combat counterfeiting, diversion, and unauthorized sales. The rules stipulate that eight data points must be incorporated into a “Bar Code or Quick Response Code” to be printed on or affixed to the primary packaging:

- - Unique product identification code (e.g., GTIN)
  - Proper and generic drug name
  - Brand name
  - Batch number
  - Expire date
  - Manufacturer name and address
  - Manufacture date
  - Manufacturing license number

If there is “inadequate space in primary package label,” the codes must be placed on the secondary packaging.

Industry observers have noted concerns with the guidelines, including:

- - QR codes may not be practical for data-dense pharmaceutical labeling.
  - The guidelines may not actually help fight counterfeits, diversion, and unauthorized sales.
  - In order for the eight mandated data points to be readable, labels would have to be unrealistically large — too big to fit on most packages.
  - It’s not clear if 2D DataMatrix codes would meet the requirements for a “Bar Code” in the guidelines.
  - GS1 standards are not required; in fact, they’re not mentioned at all.

To this last point, the initial response seems to point toward a call for GS1 standards: DataMatrix for barcoding, GTINs to identify products, use of two-digit Authentication Identifiers.

Final thoughts

India track and trace requirements are obviously evolving. Expect more changes as the deadlines for APIs, iVEDA reporting, and barcoding get nearer.

But one thing won’t change: India will continue to cultivate its position in the global pharmaceutical industry. Consider these statistics from its Department of Pharmaceuticals 2020-21 Annual Report:

- - The Indian pharmaceutical industry is the world’s third largest by volume and 14th largest in terms of value.
  - It has the second-most FDA-approved plants for generic drug manufacturing outside the United States.
  - It accounts for 60% of global vaccine production.
  - It is the world’s third-largest API market (8% share of global API industry, 500+ APIs manufactured in India, and it contributes 57% of APIs on the World Health Organization’s Prequalified List of APIs).

Our team has worked in the India pharma market for many years and understand its complexities, challenges, and benefits. We have offices and experienced staff in the country. And our signature Traceability System and Compliance Management solution have helped our customers keep up with India track and trace requirements and remain competitive.

Contact us today to lean more about the India track and trace requirements and to arrange a demo. In about 15 minutes, one of our supply chain experts can show you how we can maximize your impact in India.