August 2023 - rfxcel.com

Antares Vision Group, Through rfxcel Technology, Becomes the First DSCSA Solution Provider to Join NABP’s Pulse Interoperable Partner Program

A pharmacist in a white lab coat scanning a box of prescription medicine

AV Group, which has a long history of working with the National Association of Boards of Pharmacy, extends its commitment to DSCSA compliance by joining the Partner Program.

Travagliato (Brescia), August 29, 2023. Antares Vision Group, an Italian multinational and a leading provider of track and trace and quality control systems, today announced that it has partnered with the National Association of Boards of Pharmacy® (NABP®) through the Pulse Interoperable Partner program. This new initiative aims to accelerate interoperability in the drug supply chain by providing a framework for solution providers to integrate directly with Pulse by NABP™, an inclusive, accessible, and secure digital platform that simplifies the process of achieving Drug Supply Chain Security Act (DSCSA) compliance.

Nearly 10 years ago, the DSCSA was enacted to ensure the safety of the U.S. pharmaceutical supply chain. The law, which has a deadline of November 2023, requires cooperation and interoperability among a wide range of industry stakeholders and solution providers. As the deadline approaches, these actors must continue to work together to ensure they will meet the complex requirements of the DSCSA.

NABP has been and will continue to be a key stakeholder in the DSCSA effort, representing the needs and interests of state regulators. This includes Pulse by NABP, which facilitates DSCSA compliance across the supply chain by providing additional functionality and data required to ensure seamless interoperability among participants. Antares Vision Group, through rfxcel technology, recognizes the importance of NABP’s contributions and is proud to be the first solution provider to sign up for this partner program.

“We have been working with the NABP for years and have watched their continued commitment to the DSCSA effort,” said rfxcel Senior Vice President of Product and Strategy Herb Wong. “Their involvement offers critical insight into the needs of the state boards of pharmacy and the small dispenser community and reflects the feedback that we’ve been hearing from our customers. We are excited to participate in the Pulse Interoperable Partner Program to ensure safe pharmaceuticals for patients and consumers.”

”Antares Vision Group became the first solution provider to be a Pulse Interoperable Partner, signing on within hours of the program being announced at  NABP’s recent Interoperability Summit,” said NABP Executive Director/Secretary Lemrey “Al” Carter, PharmD, MS, RPh. “They have been an ardent supporter of Pulse and we’re delighted to continue the collaboration to secure the prescription drug supply chain and protect public health.”

For more information, contact Herb Wong, senior vice president of product and strategy, at hwong@rfxcel.com.

About Antares Vision Group

Antares Vision Group is driving digitalization of products and supply chains by leading traceability, inspection, and integrated data management. AV Group helps companies and institutions to achieve safety, quality, efficiency, and sustainability, enabling Trustparency®.

DIAMIND, AV Group’s integrated ecosystem of solutions, simplifies the technology environment and supports businesses’ growth by enabling a data-driven and tailored journey to digital innovation. Connecting physical products with digital identities, DIAMIND runs at the line, factory, warehouse, enterprise, and supply chain levels, and helps guarantee product quality (inspection systems and equipment) and end-to-end traceability (from raw materials to production, from distribution to the consumer and back) through integrated data management.

AV Group operates in the life science (pharmaceuticals, medical devices, and hospitals), beverage, food, cosmetics, chemicals, and packaging industries and potentially many others.

AV Group has been listed in STAR segment of Euronext since May 2021 and has been included in the Euronext Tech Leaders index, dedicated to leading tech companies with high growth potential, since July 2022.

In 2022, Antares Vision Group recorded a turnover of €223 million. The Group operates in 60 countries, employs more than 1,300 people, and has a consolidated network of over 40 international partners. To learn more, please visit antaresvisiongroup.com and rfxcel.com.

FDA Postpones Enforcement of Key DSCSA Requirements to November 27, 2024

In a guidance document published on Friday, August 25, the U.S. Food and Drug Administration (FDA) announced that it was delaying by one year enforcement of key requirements under the Drug Supply Chain Security Act (DSCSA). This “extended stabilization period” moves the enforcement date to November 27, 2024.

The guidance is primarily for manufacturers, wholesale distributors, dispensers, and repackagers; delayed enforcement pertains to product identifiers at the package level; saleable returns; interoperable, electronic product tracing; and investigating suspect and illegitimate products. We provide the specifics below.

The key takeaway: Don’t stop preparing for the DSCSA requirements. If you have questions about the DSCSA delay or are concerned that your current provider may not have the tools you need to comply, we encourage you to contact us today to speak with one of our DSCSA experts. We are committed to meeting DSCSA compliance for all our customers in a timely manner.

And if you’re going to the Healthcare Distribution Alliance (HDA) 2023 Traceability Seminar in Washington, D.C., stop by Table-Top 21 to meet our team and talk about the developments in person. Click here to learn more.

Overall FDA rationale for the DSCSA delay

The FDA said extending enforcement will give supply chain stakeholders — particularly manufacturers, wholesale distributors, dispensers, and repackagers — the extra time that may be necessary “to continue to develop and refine appropriate systems and processes to conduct interoperable, electronic tracing at the package level, to achieve robust supply chain security under the DSCSA while helping ensure continued patient access to prescription drugs.”

Furthermore, the Agency said, “additional time beyond November 27, 2023, may be needed for systems to stabilize and be fully interoperable for accurate, secure, and timely electronic data exchange.”

What DSCSA requirements are affected?

Product identifiers

The requirement. Trading partners must include the product identifier at the package level for each package in a transaction into the transaction information. Furthermore, a product’s manufacturer or repackager must incorporate the PI at the package level for each package “introduced in a transaction into commerce.” These requirements are included in section 582(g)(1)(B) of the Food, Drug, and Cosmetics Act (FD&C Act).

Reasoning for DSCSA delay. The FDA said the delay will “accommodate the additional time (beyond November 27, 2023) that may be needed by trading partners to achieve compliance and to help ensure continued access to prescription drugs as trading partners continue to refine processes” to include the PI at the package level. Furthermore, the FDA said “this policy will facilitate the use and exhaustion of product supply already in the supply chain prior to November 27, 2024.”

What is a PI? The PI is a standardized graphic that contains, in both human-readable form and on a machine-readable data carrier, four data elements:

      1. National Drug Code (NDC)
      2. Serial number
      3. Lot number
      4. Expiration date

Saleable returns

The requirement. Each person accepting a saleable return must have systems and processes in place to allow acceptance of the product. Furthermore, they may accept saleable returns only if they can associate the product with its transaction information — including the PI — and transaction statement. These requirements are included in section 582(g)(1)(F) of the FD&C Act.

Reasoning for DSCSA delay. FDA said delaying enforcement of this requirement until November 27, 2024, will “facilitate the continued use of methods currently being used by wholesale distributors for associating a saleable return product with its applicable transaction information and transaction statement while accommodating the additional time that may be needed for all trading partners to mature the new systems and processes required for acceptance of saleable returns.”

Interoperable, electronic product tracing at the package level

The requirement. Transaction information and transaction statements must be exchanged in a secure, interoperable, electronic manner. This requirement is included in section 582(g)(1)(C) of the FD&C Act; the standards for exchange are established under section 582(h) of the DSCSA.

Furthermore, systems and processes for verifying products at the package level, including the standardized numerical identifier, must meet the standards established in DSCSA section 582(a)(2) and the guidance in DSCSA section 582(h).

Reasoning for DSCSA delay. The FDA these policies will allow trading partners to continue to provide, capture, and maintain data for the data exchange for product tracing and verification while providing additional time that may be needed to “continue to develop and refine systems and processes for electronic data exchange.”

Investigating suspect and illegitimate products

The requirement. In the even of a recall or to help investigate a suspect or illegitimate product, stakeholders must be able to promptly provide product transaction information and transaction statement when requested by the FDA secretary or other appropriate federal or state official. This requirement is included in section 582(g)(1)(D) of the FD&C Act.

Furthermore, Section 582(g)(1)(E) of the FD&C Act requires stakeholders to “produce the transaction information for each transaction going back to the manufacturer” in certain situations, including a recall or investigating a suspect product or an illegitimate product.

Reasoning for DSCSA delay. FDA believes these compliance policies will facilitate the continued use of methods currently being used by trading partners to respond to the type of requests for information described above while accommodating the additional time that may be needed for trading partners to mature the new systems and processes required for such activities under section 582(g)(1)(D) and (E) of the FD&C Act.

Antares Vision Group, Through rfxcel Technology, Joins the Gateway Certified™ Program to Lead Verification Router Service (VRS) Standardized Testing Initiative

 

Serialized boxes of medicine on a manufacturing line in a pharmaceutical production facility

AV Group, which led an FDA-approved pilot to extend testing of the VRS, continues its industry leadership by helping to test industry readiness ahead of this year’s DSCSA deadline.

Travagliato (Brescia), August 22, 2023. Antares Vision Group, an Italian multinational and a leading provider of track and trace and quality control systems, today announced that it has joined the Gateway Certified™ program for Verification Router Service (VRS) verification to help pharmaceutical stakeholders prepare for upcoming serialization and drug product verification requirements in the U.S. Drug Supply Chain Security Act (DSCSA).

The industry established the VRS specifications to help verify the authenticity of products for salable returns. Many providers have developed solutions based on the VRS specification and have voluntarily collaborated in testing to ensure compliance and interoperability.

The Gateway Certified™ program for VRS Verify was established in response to industry concerns that manual methods and self-testing among more than a dozen solution providers was time-consuming, was not scalable, and lacked independent oversight.

Recognizing the importance of connectivity and interoperability, Antares Vision Group, through rfxcel technology, is committed to independent and objective VRS verification testing. “We recognize that solution providers need a more scalable, repeatable, and open testing approach,” said rfxcel CEO Glenn Abood. “We see the limitations of the current approach and see the potential impact on robust, reliable systems as well as adaptation to emerging requirements.”

“We appreciate Antares Vision Group’s leadership and ongoing commitment to facilitate information interoperability and product verification in the pharmaceutical supply chain,” said Gary Lerner, President of Gateway Checker Corporation. “We encourage all solution providers interested in establishing demonstrable VRS conformance to join the Gateway Certified™ program.”

The Gateway Certified™ program provides independent, objective, automated use-case testing to assure that pharmaceutical drug product verification requests and responses consistently meet industry and FDA regulatory requirements. It examines a system’s conformance to requirements and provides objective evidence that it consistently meets industry and regulatory needs.

Herb Wong, rfxcel senior vice president of product and strategy, will be facilitating a Roundtable Discussion about the VRS at the Healthcare Distribution Alliance (HDA) 2023 Traceability Seminar in Washington, D.C. To learn more, click the image below and visit Antares Vision Group at Table-Top 21 at the seminar.

About Antares Vision Group

Antares Vision Group is driving digitalization of products and supply chains by leading traceability, inspection, and integrated data management. AV Group helps companies and institutions to achieve safety, quality, efficiency, and sustainability, enabling Trustparency®.

DIAMIND, AV Group’s integrated ecosystem of solutions, simplifies the technology environment and supports businesses’ growth by enabling a data-driven and tailored journey to digital innovation. Connecting physical products with digital identities, DIAMIND runs at the line, factory, warehouse, enterprise, and supply chain levels, and helps guarantee product quality (inspection systems and equipment) and end-to-end traceability (from raw materials to production, from distribution to the consumer and back) through integrated data management.

AV Group operates in the life science (pharmaceuticals, medical devices, and hospitals), beverage, food, cosmetics, chemicals, and packaging industries and potentially many others.

AV Group has been listed in STAR segment of Euronext since May 2021 and has been included in the Euronext Tech Leaders index, dedicated to leading tech companies with high growth potential, since July 2022.

In 2022, Antares Vision Group recorded a turnover of €223 million. The Group operates in 60 countries, employs more than 1,300 people, and has a consolidated network of over 40 international partners. To learn more, please visit antaresvisiongroup.com and rfxcel.com.

For further information, contact Herb Wong, senior vice president of product and strategy, at hwong@rfxcel.com.

About Gateway Checker Corporation

Gateway Checker™ provides a software as a service platform to facilitate product traceability, DSCSA compliance, and unambiguously verify the interoperability readiness of serialized pharmaceutical transaction records. Drug manufacturers, repackagers, wholesalers, and distributors can quickly and continuously test, validate, and certify adherence to GS1 US Rx EPCIS and VRS product verification application standards.

Gateway Checker is the GS1 US Rx Certified Conformance Testing Service, and is owned and operated by the Gateway Checker Corporation, a wholly owned subsidiary of BrandSure, LLC.

For more information about the Gateway Certified™ program, including VRS System Validation, contact Eran Strod at certified@gatewaychecker.com.

FSMA Rules: A Guide to FDA Food Safety Modernization Act Regulations

The Food Safety Modernization Act (FSMA) is transforming the food supply chain in the United States. Learn about FSMA requirements and how they affect the food industry.

Understanding the FDA Food Safety Modernization Act (FSMA)

The Food Safety Modernization Act (FSMA), signed into law in 2011, aims to reduce foodborne illness, protect the U.S. food supply, and ensure public health. The law gives the U.S. Food and Drug Administration (FDA) authority to regulate the production, processing, packing, and transport of food throughout the country.

The FDA has finalized nine major rules through FSMA that address different aspects of the food supply chain. FSMA covers both human and animal food, and the rules are designed to address issues such as traceability, sanitation, produce safety, and supplier verification.

7 FSMA rules and requirements

Through FSMA, the FDA has issued rules that govern food production and distribution. The food traceability final rule established additional traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). Additionally, there are seven main roles that the FDA implemented in the final FSMA rules.

      1. Preventive Controls for Human and Animal Food: Require food facilities to meet Current Good Manufacturing Practice (CGMP) requirements, conduct hazard analyses, and establish risk-based preventive controls.
      2. Produce Safety Rule: Established science-based standards for the production, packing, and storage of fruits and vegetables on farms in the U.S. and other countries.
      3. Foreign Supplier Verification Program (FSVP): Requires foreign suppliers to show that they are meeting food safety standards required in the U.S.
      4. Sanitary Transportation Rule: Established regulations for the sanitary transportation of human and animal food.
      5. Accredited Third-Party Certification Rule: Created a program to accredit specific third-party certification bodies to conduct food safety system audits of foreign facilities.
      6. Protection Against Intentional Adulteration: Aims to address the probability of an outbreak due to potential food safety risks of intentional adulteration.
      7. Voluntary Qualified Importer Program (VQIP): fee-based program provided by the FDA FSMA to foreign food facilities that intend to import their products into the country.

Other rules concern protection against intentional adulteration of food and guidelines for the use of agricultural water.

Compliance strategies for FSMA

Navigating FSMA can be complicated, especially as rules are proposed, reviewed, and finalized. To implement effective compliance strategies, organizations should:

      • Review: Start by conducting a thorough review of FSMA requirements to understand which rules apply to your business.
      • Develop: Create a robust FSMA food safety plan that’s tailored to your operations, including hazard analysis and critical control points (HACCP).
      • Implement: Establish preventive controls and monitoring systems across the organization and have a plan in place for food recalls.
      • Verify: Use audits and validation procedures to ensure compliance.

Implementing FSMA’s Preventive Controls and Hazard Analysis

FSMA’s Preventive Controls for Human Food, finalized in 2015, was created to minimize and prevent hazards at food facilities. Key components of this rule include:

      • Current Good Manufacturing Practice (CGMP) revisions: FSMA updated FDA’s existing CGMP requirements to create binding requirements for employee education and training.
      • Food safety plans: The rule created new requirements for risk-based preventive controls and hazard analysis at food facilities, including sanitation practices and allergen controls.

Businesses covered under the Preventive Controls rule must perform a hazard analysis of their facilities and products, implement food safety practices, and provide ongoing monitoring and verification of all preventive controls.

Ensuring FSMA compliance in supply chain management

Even if you’re confident about your organization’s food safety practices, you need to know that your supply chain partners are holding themselves to the same standards. Establishing clear supplier approval and verification processes can help you thoroughly vet the growers, suppliers, processors, or distributors you work with.

By implementing traceability and documentation requirements, you’ll be able to track specific products and lots in real-time. As with your internal processes, conduct regular assessments to ensure suppliers and co-manufacturers are maintaining FSMA compliance.

Final thoughts: FSMA rules and regulations

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.

We understand the importance of complying with FSMA and other regulations for the food and beverage industry. We have extensive experience delivering tailored traceability, visibility, and transparency solutions that not only help ensure compliance, but also create added value for operational efficiency, brand protection, and customer loyalty. Contact us today and one of our traceability experts will show you how it works.

And be sure to download our “Traceability in the Food Supply Chain” white paper, which explains the FSMA Food Traceability List and the Food Traceability Final Rule in detail.

The Importance of Food Traceability: Impacts on Safety and Business

As food traceability regulations continue to evolve, it can be difficult to navigate requirements and ensure you remain compliant everywhere you do business. Find out more about the traceability of food products in this guide from Antares Vision Group and rfxcel.

Understanding food traceability

In broad terms, traceability is the process of utilizing data to know the history of everything in your supply chain — every input and ingredient, every finished product. Traceability empowers you to know where something came from, where it has been, and where it is right now. It’s the ability to find granular details about the past and present of an item.

No matter your role in the supply chain, food traceability can play a vital role in securing and improving your business, from ensuring you comply with regulations to helping manage risks (e.g., making recalls faster and more accurate) and connecting with consumers.

Benefits of food traceability

The advantages of a strong food traceability system for you, your partners, and your customers include:

      • Food safety: Traceability reduces the risk of foodborne illnesses and helps ensure your products are safe for consumption.
      • Risk mitigation: If a food safety issue does arise, traceability facilitates prompt, informed responses. For example, traceability speeds food recalls and targeted product withdrawals to minimize the impact on public health and lessen interruptions to your operations.
      • Operational efficiency: Food traceability solutions act across your supply chain to improve operations and make it easier to manage your inventory.
      • Trust: Food traceability can help build consumer trust and confidence through transparent processes and demonstrating that you are a reliable brand whose products are exactly what you say they are.

Key elements of food traceability

The primary components of a good food traceability system include:

      • Identification: Companies must be able to trace individual products and raw materials back to specific locations, batches, lots, etc.
      • Product tracing: Each product must be traceable from farm to fork, with granular documentation that captures its journey at every stage of the supply chain.
      • Data capture and management: A strong, centralized system is needed for collecting, analyzing, sharing, and storing traceability records.
      • Authentication: Verification tools ensure the accuracy and integrity of food traceability data and can help resolve errors before they affect other parts of the supply chain.

Implementing food traceability systems

Here are some things to consider if you want to implement a new food traceability solution or improve your existing systems:

      • Evaluate: Start by assessing traceability requirements and regulatory obligations. Examine what industry leaders are doing to identify best practices and opportunities.
      • Select tools: Choose the appropriate traceability technologies and systems for the type of products you grow, pack, process, distribute, etc. (Working with a reliable, experienced solution provider is essential.)
      • Implement processes: Establish your traceability protocols and standard operating procedures, training relevant staff. (Again, make sure you’re working with a solution provider that will work with you and your team to ensure implementation is quick and efficient.)
      • Collaborate: Work with partners and stakeholders to implement traceability measures across the supply chain.

Food traceability in action: U.S. FDA Food Safety Modernization Act

Passed in 2011, the Food Safety Modernization Act (FSMA) made sweeping reforms to food safety regulations in the United States. The legislation empowered the U.S. Food and Drug Administration (FDA) to create and enforce rules on how food is harvested, processed, stored, and distributed throughout the United States.

FSMA’s No. 1 goal is to reduce the rates of illness from foodborne pathogens; food traceability is an important component of the FDA’s strategy to achieve that goal. The Agency’s primary guidance for traceability is the Food Traceability Final Rule, which went into effect in November 2022. It establishes additional traceability recordkeeping requirements for businesses that manufacture, process, pack, or hold foods on the Food Traceability List (FTL).

These food supply chain stakeholders are responsible for establishing and maintaining critical tracking events (CTEs) and associated key data elements (KDEs) for events such as harvesting, cooling, packing, and receiving. CTEs and KDEs are the building blocks of food traceability under FSMA. Read our food traceability white paper to learn how they work.

What food products are required to be traced under FSMA?

FSMA’s Food Traceability Final Rule sets the recordkeeping requirements for any business that manufactures, processes, packs, or holds foods on the Food Traceability List, which includes almost 20 types of food, such as:

  • Fresh fruits and vegetables
  • Leafy greens
  • Melons
  • Nut butters
  • Finfish
  • Crustaceans
  • Soft cheeses
  • Ready-to-eat deli salads

Final thoughts: food traceability

Traceability is essential to ensure the safety, transparency, and quality of the global food supply chain. Our goal is to equip businesses with modern food traceability solutions that improve operational efficiencies, comply with regulations, foster consumer confidence, and help create a more secure and transparent food industry. Offering end-to-end traceability, visibility, and transparency, our solutions for the food and beverage industry make it easy to track and trace products across every step of the supply chain. Contact us today to speak with one of our traceability experts and see a short demo of how our solutions work.