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DSCSA Serialization Implementation and Compliance Guidelines

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Note: This article was originally published in November 2021. We’ve since updated some language after the FDA announced on August 25, 2023, that it was delaying by one year enforcement of key DSCSA requirements.

November 27, 2023 — the date the pharmaceutical industry has had its sights on since the U.S. Drug Supply Chain Security Act (DSCSA) was enacted eight years ago. With only two years until the deadline, we thought it was a good time to recap what’s in store for DSCSA serialization.

What is DSCSA serialization?

DSCSA serialization is not different from serialization any other industry: It means that certain drugs must traceable at the unit level. Specifically, manufacturers and repackagers must put a unique Product Identifier (PI), such as a bar code, on certain prescription drug packages. This must be able to be read electronically. Furthermore, manufacturers, wholesale distributors, repackagers, and many dispensers (primarily pharmacies) must provide certain information about drug and who handled it each time it’s sold:

  • 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.
    • The transaction statement (TS) is a paper or electronic attestation by the business transfer-ring ownership of the product that it has com-plied with the DSCSA.
    • A third type of information, Transaction history (TH), is an electronic statement with the TI for every transaction going back to the manufacturer. It is not required after the law goes into effect on November 27, 2023; however, as we wrote about before, there is a “stabilization period” in effect until November 27, 2024, during which the FDA does not intend to take enforcement action. Read more about that here and below.

Meeting DSCSA serialization requirements is vital for all pharmaceutical supply chain members. Whether you are a manufacturer, wholesale distributor, or dispenser, DSCSA 2023 requirements apply to your business. The question is, are you ready?

The DSCSA 2023 deadline

As we just said, the DSCSA 2023 compliance deadline is still November 27. But the FDA postponed enforcement by one year to November 27, 2024. This change does not affect past deadlines on the DSCSA enforcement timeline, but does have implications for DSCSA requirements, including serialization.

This means that pharma stakeholders — manufacturers, wholesale distributors, repackagers, dispensers, and third-party logistics providers (3PLs) — now have an extra 12 months to get their systems in order. However, the FDA has made it clear that these entities should not regard the “stabilization period” as a delay of the 2023 requirements: It expects companies to have implemented the mandated systems and work to ensure they are operating correctly, smoothly, etc. The Agency’s Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies states:

This guidance is not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements. 

The DSCSA timeline

November 27, 2023, will be the 10th anniversary of the DSCSA. Per Section 582(g)(1) of the DSCSA (Title II of the Drug Quality and Security Act), “On the date that is 10 years after the date of enactment of the Drug Supply Chain Security Act … interoperable, electronic tracing of product at the package level requirements shall go into effect.” In other words, DSCSA 2023 serialization.

DSCSA 2023 Serialization Timeline

DSCSA serialization: recent developments

No more delays. On August 9, 2021, the FDA signaled that the DSCSA 2023 deadline for interoperability would not change. Leigh Verbois, the director of the FDA’s Office of Drug Security, Integrity, and Response, made the comments during a webinar hosted by the Healthcare Distribution Alliance (HDA).

Draft and final guidance on product identifiers (PIs) and more. On June 3, 2021, the FDA published “new guidance to further enhance the security of prescription drugs in the U.S. supply chain.” Guidance was released for PIs, suspect and illegitimate products, and enhanced drug distribution security.

Full serialization

For DSCSA serialization, certain drug packages must be labeled with a unique Product Identifier (PI). The PI comprises the National Drug Code, a serial number, a lot number, and an expiration date.

Furthermore, every time a product changes hands (i.e., between trading partners), supply chain actors must use the Electronic Product Code Information Services (EPCIS) to share Transaction Information (TI) and a Transaction Statement (TS) with their partners. A third requirement, Transaction History (TH), will not be required after the November 2023 deadline.

Even with the stabilization period until November 27, 2024, there’s no stopping the fact that significant changes are coming for pharmaceutical traceability under DSCSA. The primary focus? Serialization. Serialization involves assigning unique identifiers to each pharmaceutical product, enabling precise tracking and data reporting at every stage of its journey through the supply chain.

Authorized trading partners

Under the DSCSA, authorized trading partners (ATPs) may engage in transactions only with other ATPs. In other words, all manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers and their trading partners must be ATPs. If they’re not authorized, their access to the U.S. pharma supply chain will be severely restricted or denied altogether. Read our in-depth ATP blog series here.

Verification Router Service (VRS)

Under the DSCSA saleable returns verification requirement, wholesalers must verify saleable returns before they can be reintroduced to the supply chain. This is done by verifying the drug’s PI. A wholesaler must initiate a verification request (to a manufacturer) to verify the returned products, and the manufacturer must provide a verification response within 24 hours. The VRS enables the rapid, secure exchange of data between these parties. Get more details here.

Final thoughts: DSCSA Serialization

We have been talking about and reporting on the DSCSA Day 1. We’ve been active in industry initiatives, particularly the VRS and the Open Credentialing Initiative (OCI) to meet ATP requirements. We’re ensuring the Ohio Department of Veterans Affairs is DSCSA-compliant. And we’ll soon be announcing another exciting initiative in the move toward full serialization of the U.S. pharma supply chain. Keep an eye out for that.

This year, we hosted a “Plan for DSCSA Readiness” webinar in March and a DSCSA 2023 webinar series in June that covered ATPs, EPCIS, and the VRS. We also published a “Dispensers and DSCSA 2023” white paper in May.

We’ve also been helping pharma companies and public-sector organizations comply with the DSCSA and other pharma regulations around the world. From our Serialization Processing and Compliance Management solutions to the full-scale power of our Traceability System, we ensure compliance no matter your role in the supply chain.

Take another look at our DSCSA timeline. A lot has happened since 2013 — and the pace will only intensify over the next two years. Contact us today if you need to know more. Our supply chain and DSCSA experts are here to help and make sure you’re ready for 2023

 

Traceability in the Food Supply Chain

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This white paper describes how traceability transforms food products into powerful “digital assets,” helps prevent common supply chain and business problems, and brings an array of benefits to all actors in the food supply chain. It examines the regulatory landscape in the United States, where the Food and Drug Administration has made food traceability one of its top priorities. We examine the Food Safety Modernization Act (FSMA), the Food Traceability List, and the Final Rule on Requirements for Additional Traceability Records for Certain Foods. We feel food companies and their trading partners everywhere can benefit from understanding these requirements and should see them as indicative of where the industry is headed in terms of regulations, technology, and consumer expectations.

 

Food Traceability Data: Not Just for Compliance Anymore

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As the Food and Drug Administration (FDA) continues to evolve its traceability and modernization initiatives across the U.S. food supply chain, the need for more accurate food traceability data is more important than ever.

Foundationally, the FDA’s initiatives require companies to have digital traceability systems in place that facilitate greater food safety. But food traceability data means more than ensuring you’re complying with regulations: It offers significant business value. Let’s take a look.

FDA’s food traceability initiatives: a refresher

In 2011, Congress enacted the Food Safety Modernization Act (FSMA) to regulate the way foods are grown, harvested, and processed in the United States. The law transforms the nation’s food safety system from an after-the-fact response to foodborne illness to a proactive posture aimed at prevention.

To address the rapid and effective tracking and tracing outlined in FSMA, the FDA in April 2019 launched the New Era of Smarter Food Safety, a tech-enabled approach to food traceability to ensure food safety, and the New Era of Smarter Safety Blueprint (July 2020), which outlined the Agency’s vision for how to get there and included the Food Traceability Proposed Rule, which defines specific traceability recordkeeping requirements for foods on its Food Traceability List.

Food traceability data delivers benefits beyond mere compliance

Although food traceability data serves as the cornerstone of effective recall management and outbreak prevention as required by the FDA, it means much more than compliance. Here are three ways food traceability data can drive business value to support sustainable growth.

Create operational efficiencies

Food traceability data yields complete, real-time visibility into operations across every node in the supply chain. This empowers food companies to take immediate action, solve problems, coordinate with partners and regulators, and keep things moving.

For example, by tracking a product’s ingredients from harvest through production through the last mile to delivery, you can quickly trace raw materials backward and forward, pinpoint supply chain weaknesses or trouble spots, and strengthen your recall program and minimize the impact of recalls. And with a traceability system that allows you to monitor products anywhere in transit, you can collect data on environmental conditions, track the location of all your deliveries, and set precise parameters for alerts.

This food traceability data allows you to proactively protect your shipments, safeguard their environmental integrity, track their position on land, sea, and air, and intervene immediately should something seem awry, such as a spike in temperature or a route diversion. Add critical tracking events (CTEs) and other information (e.g., quality inspections) to the process and you’ve got an indelible product provenance from farm to table.

Build consumer engagement and trust

These days, consumers are more attuned than ever to family health and finances. They want to know more about what they’re eating, such as ingredients, how food is raised or grown, and the safety and environmental practices used to produce it. They want to feel good about what they eat and where they are spending their money. By supplying information that meets this demand, you build trust and loyalty and build a community of customers who will advocate for your products.

The simple truth is that food traceability data creates tremendous opportunities to communicate with consumers and nurture more committed relationships. You can back your claims and prove your product is what you say it is.

Protect your brand

This dovetails with consumer engagement and trust. With modernized, secure, and compliant food traceability protocols, you can better collaborate with partners and authorities if there’s a recall. In this scenario, you’re not only protecting consumers from a health hazard — you’re safeguarding your brand from bad publicity. And with a transparent approach to engaging with customers about the foods they consume, you create a strong brand image that conveys trust, credibility, and reliability. You can even use your food traceability data as a core differentiator in your value proposition messaging.

Final thoughts

Food traceability data has always been important, but the FDA has clearly put it center stage with FSMA, the New Era of Smarter Food Safety, the Food Traceability Proposed Rule, and the Food Traceability List.

Do not expect this to change.

rfxcel believes industry leaders will see traceability as an investment in their businesses and brands, not a compliance mandate from the government. If fact, savvy companies will know the FDA’s initiatives are an opportunity to be involved in shaping the future of the U.S. food supply chain. Keep an eye out this summer for more from rfxcel about how you can tap into the FDA’s initiatives to help lead the transformation of the U.S. food supply chain. As we said above, this is a moment of opportunity for the food industry. Don’t miss the boat.

In the meantime, take a look at our solutions for food and beverage:

Contact us today for more information and to schedule a short demo of our food traceability solutions. Get started now and take advantage of all the opportunities food traceability data can create for you.

Food Traceability Regulations in the United States: A Timeline

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The U.S. Food and Drug Administration (FDA) is orchestrating the construction of a more robust, technology-driven approach to food traceability and safety. And it’s happening as the food industry is undergoing major change, including scores of new foods being introduced to the market, rising consumer demand for more information about the food they buy, the development of more sophisticated production and delivery methods, and a growing push for digitization of the supply chain.

As regulations in the United States continue to evolve, manufacturers, wholesalers, distributors, and retailers need to keep a finger on the pulse of the latest developments. Today, we’ll help with a quick rundown of what’s happened with food traceability over the last year.

Food traceability regulations in the United States: 2020-present

On September 23, 2020, the FDA published “Requirements for Additional Traceability Records for Certain Foods” on its Food Traceability List. Referred to as the “Food Traceability Proposed Rule,” it’s part of the FDA’s New Era of Smarter Food Safety Blueprint and aims to standardize the data elements and information required to rapidly and accurately identify foods that may be causing illness. It defines additional recordkeeping requirements for businesses that manufacture, process, pack, or hold foods on the FDA’s Food Traceability List, which must establish and maintain records containing key data elements (KDEs) associated with specific critical tracking events (CTEs).

In January 2021, the FDA made clarifying modifications to the Food Traceability List and published a detailed FAQ that answered commonly asked questions that emerged following the announcement of the Proposed Rule. In February 2021, the comments period for the modifications closed. The FDA has until November 2022 to finalize it.

More about the New Era of Smarter Food Safety Blueprint

These initiatives are part of the FDA’s New Era of Smarter Food Safety. Announced in April 2019, it envisions a modern approach to ensuring food safety through digital, tech-enabled traceability.

The New Era of Smarter Food Safety Blueprint, announced in July 2020, outlines the FDA’s methodology for achieving its traceability and safety goals. It’s based on the following four pillars, which leverage a range of technologies, analytics, business models, modernization, and values as its building blocks:

1. Tech-enabled food traceability

A supply chain that includes paper-based recordkeeping and yields insufficient data makes it difficult to track and trace foods rapidly. Fast, accurate food traceability is essential to safeguarding consumers’ health — and your brand reputation and bottom line.

For example, modernized food traceability that leverages the latest technologies and integrates expanding data streams empowers supply chain stakeholders to identify an outbreak and trace a contaminated food product’s origin within minutes — or even seconds — and be proactive about getting the product off of shelves.

2. Smarter tools and approaches for prevention and outbreak response

In addition to better food traceability, the FDA wants to ensure the root cause of an outbreak or contamination can be easily identified to support a prevention-based approach. To do this, stakeholders need to incorporate new knowledge while continuously assessing how they can make processes and communications more effective and efficient. As more data becomes available, the use of predictive analytics tools becomes increasingly important to predict when a significant food event may occur. With this information, manufacturers can prevent a contaminated food products from entering the supply chain or target efforts to remove a potentially contaminated product from the market.

3. New business models and retail modernization

As the industry continues to find new ways to produce and distribute food, the FDA is seeking to explore new approaches in ensuring food traceability and safety. This includes:

  • Educating supply chain actors on the importance of food safety issues
  • Adapting FDA oversight to ensure the safety of novel ingredients, new foods, and new food production methods
  • Advancing the safety of foods sold in traditional retail establishments
4. Food safety culture

The FDA wants to encourage an environment of support for a stronger food safety culture on farms, in food facilities, and in homes. If the food industry does not commit to embracing food traceability and safety, real improvements will be difficult to achieve.

Final thoughts

We can be certain of two things when it comes to food traceability regulations in the United States: they’re going to keep evolving and they’re not going away. The good news is advancements in technology are making it profoundly easier — and even more affordable — to ensure food traceability across the entire supply chain. Yes, the FDA’s proposed requirements technically apply only to items on the Food Traceability List, but the Agency is encouraging voluntary adoption of these practices industry-wide. Savvy food companies will see this as an opportunity to get involved early and be part of the process, helping to set the industry’s regulatory course while going a long way to secure their own business.

rfxcel can help you comply with U.S. food traceability regulations today, tomorrow — always. From raw ingredients to finished goods, our rfxcel Traceability System (rTS) offers end-to-end food supply chain traceability and visibility. Our rfxcel Integrated Monitoring (rIM) is a real-time traceability and supply chain visibility solution that helps you remotely monitor products in transit And our MobileTraceability app brings the power of rTS to every node of your operations, including places that have traditionally been “blind spots.” Contact us today to arrange a demo.

DSCSA 2023: Unlocking the Future of Pharmaceutical Traceability in the USA

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Welcome to the third and final installment of our DSCSA 2023 series. The first two parts talked about DSCSA authorized trading partners — manufacturers, wholesale distributors, repackagers, third-party logistics providers, and dispensers. If you’re not a DSCSA authorized trading partner, it will be difficult to do business in the United States, so be sure to read Part 1 and Part 2.

Today, we’re focusing on the day we’ve all been preparing for: November 27, 2023, the 10th anniversary of the DSCSA. Per Section 582(g)(1) of the DSCSA (Title II of the Drug Quality and Security Act):

“On the date that is 10 years after the date of enactment of the Drug Supply Chain Security Act … interoperable, electronic tracing of product at the package level requirements shall go into effect.”

So, in a little more than 2 years and 8 months from now, the U.S. pharmaceutical supply chain will be fully serialized. Let’s take a closer look at what this means for the pharma industry and its authorized trading partners.

A quick clarification

This blog post looks at “the letter of the law” — the language in Section 582(g)(1) that lays out six requirements for DSCSA 2023.

For its part, the pharma industry has tended to see the DSCSA as having four pillars, as illustrated below. These pillars encompass the six requirements we’re talking about today.

DSCSA 2023 Four Pillars

Our own Herb Wong, VP of marketing and strategic initiatives, recently hosted a webinar about DSCSA 2023 readiness that included an overview of the four pillars. It’s a great follow-up to what you’ll read below and a valuable resource for every pharma supply chain stakeholder. If you missed it or want to watch it again, Herb’s webinar is here.

DSCSA 2023: six key requirements

To date, the DSCSA has focused on lot-level traceability, or exchanging information about every package of medication so supply chain stakeholders can see exactly where each has been. DSCSA 2023 is all about complete unit-level serialization through the use of product identifiers, meaning stakeholders will have to electronically track products at the individual package level. Here are the six requirements for DSCSA 2023 laid out in Section 582(g)(1):

  1. Authorized trading partners must exchange transaction information (TI) and a transaction statement (TS) in a secure, interoperable, electronic manner.

TI includes the product name; its strength and dosage form; its National Drug Code; 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. The TS is an attestation by the business transferring ownership of the product that it has complied with the DSCSA.

Trading partners must maintain all transaction data for 6 years.

The law requires the standards for interoperable exchange of TI to “comply with a form and format developed by a widely recognized international standards development organization.” Right now, EPCIS 4 (Electronic Product Code Information Services) is the only standard that meets this requirement; however, the industry is investigating alternatives.

  1. TI must include the product identifier (PI) at the package level for each package included in the transaction.

The upshot of this requirement is unit-level traceability (i.e., serialization). A PI is a standardized graphic that contains the product’s standardized numerical identifier (SNI), a lot number, and an expiration date. The SNI comprises two data points: the National Drug Code and a unique alphanumeric serial number. PIs must be human- and machine-readable.

  1. Authorized trading partners must have systems and processes to verify products at the package level, including the SNI.

According to the definition in Section 581 of the DSCSA, “verification” or “verify” means determining if the PI “affixed to, or imprinted upon, a package or homogeneous case corresponds to the SNI or lot number and expiration assigned to the product by the manufacturer or the repackager.”

  1. Authorized trading partners must have the systems and processes to promptly respond with the TI and TS for a product upon a request by the Secretary (or other appropriate federal or state official) in the event of a recall or for the purposes of investigating a suspect or illegitimate product.

The “Secretary” here is the commissioner of the U.S. Food and Drug Administration (FDA). Suspect and illegitimate products include drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution.

This requirement dovetails with the FDA’s push for modernization of the U.S. food supply chain, including recall processes.

  1. Authorized trading partners must have the systems and processes necessary to promptly facilitate gathering the information necessary to produce the TI for each transaction going back to the manufacturer.

This requirement is similar to No. 4 in that authorized trading partners must provide this information to the FDA commissioner or other federal or state officials; however, goes a step further by adding trading partners. The law says these systems and processes

“shall be required in the event of a request by an authorized trading partner, in a secure manner that ensures the protection of confidential commercial information and trade secrets, for purposes of investigating a suspect product or assisting the Secretary (or other appropriate Federal or State official) with a request described in clause.”

  1. Each person accepting a saleable return must have systems and processes in place to allow acceptance the product(s). Furthermore, they may accept saleable returns only if they can associate the returned product(s) with its TI and TS.

This has to do with the DSCSA saleable returns verification requirement and the Verification Router Service (VRS). Supply chain stakeholders must verify saleable returns before they can be reintroduced to the supply chain; they do this by verifying the drug’s PI. The VRS is the system they use to rapidly verify PIs.

rfxcel is the industry leader in the VRS. We led an FDA-approved pilot to extend testing of the VRS and continue to focus on making it ready for DSCSA 2023. Here a few of our resources to answer any questions you may have:

Final thoughts

As we said in Part 1, we’ve been covering the DSCSA for a long, long time. We’ve done webinars, written white papers, and been active in industry initiatives, particularly the VRS and the Open Credentialing Initiative (OCI) to meet the requirements for DSCSA authorized trading partners.

We’ve also been helping pharma companies comply with the DSCSA and other pharma regulations around the world. From our rfxcel Serialization Processing and Compliance Management solutions to the full-scale power of our rfxcel Traceability System, we ensure compliance no matter your role in the supply chain.

So contact us with your questions about DSCSA 2023 or the DSCSA in general. Our supply chain experts can give you a short demonstration of our solutions, share their insights and knowledge, and work with you to ensure you’re compliant today, tomorrow — always.

 

 

 

 

 

 

Exploring Meat Traceability in the Food Supply Chain: Getting to Know Your Protein

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Today’s consumers demand transparency, particularly when it comes to the meat they consume. They want more information about how and where the livestock was raised and processed — not just from a nutritional standpoint, but also with regard to food safety practices, animal care practices, environmental impact, and worker safety. Put simply, they want meat traceability.

Consumers are making an emotional connection to the foods they buy and consume; they want to feel good about where their money is going and what they are putting into their bodies. While this trend has been growing over the past several years, it has gained significant traction recently. Add the pandemic into the mix, and you’ve got an even greater demand for transparency amid an environment driven by heightened health and financial concerns.

The supply chain saw significant disruption during the pandemic, as high infection rates in processing plants led to a marked curtail in operations in pork, beef, and poultry plants—and in some cases, plant closures. In fact, roughly 65 percent of meat processing plants experienced outbreaks and 20 percent were forced to temporarily suspend operations, which, in a consolidated meat industry, had a ripple effect across the country. As the outbreaks played out publicly, consumers grew even warier of the origins of their meats.

Adding more complexity to the issue, bad weather over the past year meant smaller corn and soybean harvests, making it harder and more expensive for cattle, hog, and poultry farmers to feed their herds. The last time the industry saw such high grain prices was during the 2012 U.S. drought.

As meat supplies diminished, consumer demand grew, with more people stuck inside and forced to cook and eat at home. The result: price inflation at the grocery stores, making it more expensive for consumers to feed their families. As they pay more for the foods that nourish their families and read headlines about the pandemic’s effects on the food supply chain, their demand for transparency has only become greater.

Meat traceability is more essential than ever

As we usher in a new era in food safety, meat traceability is no longer a “nice-to-have” — it’s essential. With increasing consumer demand for more information about where their protein is coming from, clear documentation from the farm to the end product is a must.

The Global Food Traceability Center defines traceability as the “ability to access any or all information relating to a food under consideration, throughout its entire life cycle, by means of recorded identifications.” This goes beyond the information itself; it’s about linking the information throughout the supply chain and ensuring coordinated processes and end-to-end meat traceability.

The good news is that tech-enabled meat traceability doesn’t have to be complicated, and its benefits are vast and powerful. From increased meat quality, improved food safety, and fewer product recalls to better inventory tracking and superior customer service, traceability delivers a range of benefits that go far beyond simply responding to consumers’ demand for information. With visibility across the entire supply chain, manufacturers can document and link the production, processing, and distribution chain of their protein products, which results in greater organizational efficiencies, reduced market and operational risks, a stronger competitive advantage, and a better brand image.

Final thoughts

While challenges continue to emerge amid a rapidly evolving global landscape, brands have an opportunity to tell a story that evokes a positive emotion and inspires a purchase. Consumers want to know that their meats were produced ethically and safely, and, of course, pose no risk to themselves or their families. As more and more people scan labels and packages for information about where their food came from and how it was made, transparency will play an increasingly crucial role in a meat producer’s brand image. It really comes down to trust: If consumers don’t trust your brand, they’ll be more than happy to buy another company’s product. Meat traceability satiates a consumer’s need for information, which builds trust with your brand.

From farm to table, rfxcel’s food supply chain solutions have you covered. Our award-winning Traceability System (rTS) is the basis of a modernized, digital supply chain with fully customizable and scalable solutions that yield complete end-to-end meat traceability. It is the foundation of a digital supply chain and a successful food recall management system that operates with surgical precision.

Offering the most complete and flexible raw materials and meat traceability solution for food and beverage, we’ll help you to optimize your supply chain operations while catering to the consumers’ increasing demand for information about the meats they consume.

Food Traceability: What’s the Latest for 2021?

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As we all know, the pandemic has revealed shortcomings in the supply chains of virtually every industry. And though the vaccine supply chain has dominated headlines over the last several months, food traceability has been top of mind for companies and governments alike since the earliest days of COVID-19.

Let’s take a look at the state of food traceability — what it is, how it works, and its future as we kick off 2021.

What is food traceability?

The U.S. Food and Drug Administration (FDA) defines food traceability as “the ability to follow the movement of a food product and its ingredients through all steps in the supply chain, both backward and forward.”

That’s a spot-on definition, but we’d like to add a few things. First, food traceability in 2021 means you can follow your products in real time. Yes, you can see where they’ve been and know where they’re going, but you can also see where they are right now. And with powerful tools like our rfxcel Integrated Monitoring (rIM) solution and Mobile Traceability app, you’ll have access to real-time information about environmental conditions (e.g., temperature, humidity, light, tilt, and shock) and location.

With this rich, actionable data, your food traceability capabilities expand exponentially. Not only can you take immediate action if there’s an environmental concern — a temperature excursion, for example — but you can course-correct if your vehicle is approaching a traffic jam or encountering other obstacles or delays. You can also tap data to combat theft and make recalls more efficient. (We wrote about modernizing food recall management late last year; check it out here.)

The other thing we’d like to add to the FDA’s definition is that, today, food traceability should be occurring in a digital supply chain. If you’re still pushing paper in 2021, it’s time for you to contact us and start thinking about upgrading to a digital supply chain powered by the rfxcel Traceability System (rTS). Our award-winning platform will transform your supply chain and how you use it. From ingredients to finished goods, rTS will bring state-of-the art food traceability to your operations.

Furthermore, rTS turns every one of your products into a “digital asset” that you can use to nurture and protect your brand and engage consumers. Complete food traceability, starting at the harvest and ending in your customers’ homes, builds an ironclad product provenance and a compelling story you can promote and share. Today’s consumers, especially with the health and safety of their families foremost in their minds, are demanding more from brands — more information, more transparency, more quality, more interaction. As we wrote last fall, food traceability is creating a new kind of “consumer kingdom,” and it’s a digital supply chain that’s making it possible.

Food traceability: An FDA priority

In “Modernizing Food Recall Management,” we talked about the FDA’s New Era of Smarter Food Safety. Announced in April 2019, it’s “a new approach to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system.”

Then, in July 2020 the Administration released the “New Era of Smarter Safety Blueprint,” which included a Food Traceability Proposed Rule designed to “help the FDA rapidly and effectively identify recipients of foods on its Food Traceability List to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.”

Next, to ring in 2021, the Administration on January 12 “made clarifying edits” to the Food Traceability List and published a FAQ for the Food Traceability Proposed Rule.

The Food Traceability List contains the foods that have additional traceability recordkeeping requirements per the Proposed Rule. The January 12 edits did not add or remove items from the list; instead, the FDA changed the descriptions of some commodities. For example, “fresh” was added to several fruits and vegetables “to clarify the scope of those commodities.” Revisions also clarified what cheeses fell under the category of “cheeses, other than hard cheeses.” See the FDA’s four-page memo for all the changes.

The FAQ for the Food Traceability Proposed Rule addresses questions the Administration has received about the Proposed Rule. Its primary goal is “to assist stakeholders who are considering providing feedback during the comment period, which has been extended until February 22, 2021.” If you want to submit a comment or review the comments that have been submitted, go to regulations.gov (Docket ID: FDA-2014-N-0053).

Final thoughts

Companies and governments around the world have been compelled to re-examine the security, efficiency, and resilience of their supply chains. Food traceability is vital to public health and safety, so it should rightfully remain a top priority.

rfxcel was founded on the principle of helping consumers know where products come from and being able to confirm that they’re safe and legitimate. With rfxcel’s Traceability System, Integrated Monitoring, Mobile Traceability app, and other solutions for food traceability, you’ll increase food quality and safety, modernize and improve recall management, optimize inventory tracking, and improve every aspect of customer service and interaction.

In other words, food traceability in a digital supply chain from rfxcel will ensure you’re doing everything possible to safeguard your customers, your brand, and your bottom line. No matter where you do business — the United States, Europe, Asia, South America, the Middle East — we can help make sure you’re ready for whatever 2021 (and beyond) has in store. Contact us today to arrange a demo.

Industry Reaction to Delayed Enforcement of DSCSA Saleable Returns

Posted on by rfxadmin

The Healthcare Distribution Alliance (HDA) sponsored a meeting on October 28 with more than 100 pharma industry stakeholders to discuss how the Food and Drug Administration’s (FDA) 3-year delay of enforcing the U.S. Drug Supply Chain Security Act (DSCSA) Saleable Returns Verification Requirement will affect its constituents.

This was the first formal meeting about the FDA announcement and marked the beginning of industry discussion that will no doubt continue well into the future. Below are some of the key points raised at the meeting:

Continue with the VRS. The prevailing sentiment is to continue the Verification Router Service (VRS) effort. The enforcement delay was not intended to stop progress, but to give the industry time to ensure readiness.

The industry needs a plan. As one meeting participant correctly called out, the intent to make progress is not good enough. “We need a plan,” they said. To jumpstart this effort, rfxcel and other VRS providers will draft a 2021 road map to work toward DSCSA readiness. The road map will focus on the VRS, but may also address authorized trading partners (ATPs) and other requirements.

VRS is still a “go.” Will the pharma industry really need the VRS in 2023, the year the DSCSA stipulates full serialization of the pharma supply chain? After a healthy discussion, the consensus was that, yes, the VRS will most likely be necessary. Some in the industry anticipated the “retirement” of VRS in 2023 because wholesale distributors would at that time be performing their own verification of serial numbers. However, not all wholesale distributors agreed with this assessment.

Final thoughts

For details about the FDA’s October 23 announcement, see our blog post. And visit our website regularly for more updates about the Saleable Returns Verification Requirement and the VRS.

rfxcel is the industry leader in DSCSA compliance and the VRS. If you have any questions about the delay and what you need to do to be ready for 2023, contact us today.

DSCSA 2020: November Is Coming & It’s Time to Comply

Posted on by rfxadmin

Note: The FDA has delayed enforcement of the DSCSA for dispensers and wholesale distributors. Read the details here.

The next deadline for the U.S. Drug Supply Chain Security Act (DSCSA) is November 27. That means there’s only a little more than a month to comply. DSCSA 2020 means different things to different stakeholders. Here’s what you have to do if you’re a dispenser or a wholesale distributor.

DSCSA 2020 for dispensers (pharmacies, clinics, hospitals, healthcare systems, etc.)

If you’re a dispenser — an independent pharmacy or a pharmacy in a hospital, clinic, grocery store, or anywhere else — DSCSA 2020 means that you must be able to authenticate and verify all the medicines you buy before you can sell them to consumers.

You must meet two key requirements by November 27:

  1. You can buy and sell only products encoded with product identifiers (PIs). A PI contains a lot number, an expiration date, and the product’s standardized numerical identifier (SNI). The SNI includes the National Drug Code and a unique alphanumeric serial number.
  2. You must verify every product at the package level, including the SNI.

Because the clock is ticking and we want to help, our DSCSA Strategic Advisor Brian Files is hosting a special DSCSA 2020 Q&A session this Thursday, Oct. 15, at 12 p.m. PST/3 p.m. EST. Send your questions today, and Brian will answer them in this live Zoom event.

If you haven’t begun to prepare, Brain will tell you it’s critical to start now. Contact us. We have a proven a track record of success with DSCSA compliance. We have in-house DSCSA experts who will analyze your needs, explain what you need to do, and build a scalable solution tailored to your operations.

Also keep in mind that you must also be able to exchange “T3” information about every drug you buy and who handled it each time it changes ownership in the United States. T3 information” includes Transaction Information (TI) about a product (e.g., proprietary or established name or names and the strength and dosage form); Transaction History (TH), an electronic statement with the TI for every transaction going back to the manufacturer; and a Transaction Statement (TS), which is an electronic statement confirming the entity transferring ownership. We know all about T3 information. Read more about it here.

DSCSA 2020 for wholesale distributors

If you’re a wholesale distributor, DSCSA 2020 means must verify returned products before you can reintroduce them to the supply chain. You’ll do this through the Verification Router Service (VRS), an automated system that verifies if a PI is valid. You’ll initiate a verification request to a manufacturer to verify the PI of the returned product.

There are multiple VRS providers, and each is responsible for determining if a specific group of PIs is valid.  You can call any VRS provider to verify if a PI is valid, but if they do not manage the PI in question, they will automatically route your verification request to the provider that does. All of this happens in real time, and VRS ensures that information is accurate and up to date.

rfxcel is the thought leader in the DSCSA saleable returns verification requirement and the VRS. We implemented a VRS pilot for the Food and Drug Administration and extended industry testing of the VRS. Contact us today, and we’ll share our expertise in supply chain track and trace, serialization, and compliance solutions to make sure you’re ready for DSCSA 2020. We’ll also be happy to share our final report about the FDA pilot.

Final thoughts

The DSCSA was enacted to promote patient and consumer safety by facilitating product tracing in the pharma supply chain and ensuring the authenticity of products. DSCSA 2020 is the next step in verifying drugs.

November 27 will be here before you know it. If you’re a dispenser or a wholesale distributor, we can help. Reach out to us now and our supply chain experts will show you how our award-winning rfxcel Traceability System can ensure you comply with DSCSA 2020.

DSCSA Saleable Returns: Enhancing Efficiency in Pharmaceutical Product Returns

Posted on by rfxadmin

Note about DSCSA saleable returns: On October 23, 2020, the FDA delayed enforcement of the DSCSA for dispensers and wholesale distributors. Read the details here.

The Drug Supply Chain Security Act (DSCSA) is transforming every aspect of the U.S. pharmaceutical supply chain. The law has many parts, but today we’re focusing on the DSCSA saleable returns verification requirement, one of its key mandates. Let’s jump right in.

First, what is the DSCSA?

The DSCSA went into effect on November 27, 2013. It is actually Title II of the Drug Quality and Security Act (DQSA) and calls for product tracing, product identifiers (PIs), authorized trading partners, and verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers (pharmacies).

The goal of the DSCSA is to facilitate product tracing in the pharmaceutical supply chain and, ultimately, promote patient and consumer safety and ensure the authenticity of products. Non-compliance is “prohibited … and subject to enforcement action under the [Federal Food, Drug, and Cosmetic Act].” In a nutshell, if you’re out of compliance, you’re out of business.

What is the DSCSA saleable returns verification requirement?

Millions of pharmaceutical products are returned for resale every year in the United States. These are known as “saleable returns.” Under the DSCSA saleable returns verification requirement, wholesalers must verify saleable returns before they can be reintroduced to the supply chain. In other words, every returned drug has to be vetted — declared as safe and legitimate — before it can be sold again. This is accomplished by verifying the drug’s PI, which has four components: a Global Trade Item Number (GTIN), a unique serial number, a lot ID, and an expiration date.

The DSCSA saleable returns verification requirement for distributors was originally scheduled to take effect on November 27, 2019; however, as we discussed in a previous blog post, the FDA in late September 2019 announced that it did “not intend to take action against” wholesalers that did not meet the requirement before November 27, 2020. This 1-year postponement gave pharma supply chain stakeholders more time to prepare to comply.

Of course, November 27, 2020, is only a few months away. Are you going to be ready? More on that below.

How does the DSCSA saleable returns requirement work?

The easiest way to understand the DSCSA saleable returns requirement is to think of the U.S. pharma supply chain as having only two members: wholesalers and manufacturers. And the law requires them to talk with one another about returned drugs. Here’s what we mean.

To meet the DSCSA saleable returns verification requirement, a wholesaler must initiate a verification request (to a manufacturer) to verify the returned products before it can resell them. The manufacturer that receives that request must provide a verification response within 24 hours. This is why wholesalers are called requestors and manufacturers are called responders.

The 24-hour deadline, however, doesn’t meet business realities. Why? Because, as we mentioned above, millions and millions of drugs are returned every year. The volume is just too great. Therefore, wholesalers need manufacturers to provide verification responses almost instantaneously — at the sub-second level, not in a few minutes, let alone an entire day.

Enter the Verification Router Service (VRS).

The VRS and the DSCSA saleable returns verification requirement

VRS is a huge topic, and to get into the details is outside the scope of what we’re talking about today. Put simply, the VRS enables the rapid, secure exchange of data between requestors and responders to meet the DSCSA saleable returns verification requirement.

The Healthcare Distribution Alliance (HDA) is the driving force behind the VRS, which facilitates the “talk” between wholesalers (requestors) and manufacturers (responders) to verify every drug. Here, a third member joins the DSCSA saleable returns “family”: A solution provider that enables the verification requests to be routed between wholesalers and manufacturers.

The VRS is an automated service that verifies if a PI is valid. There are multiple VRS providers, and each is responsible for determining if a specific group of PIs is valid. A wholesaler can call any VRS provider to verify if a PI is valid. If a provider does not manage that particular PI, it will automatically route the verification request to the appropriate provider. All of this happens in real time, and the VRS ensures that information is accurate and up to date.

Final thoughts

rfxcel is the industry thought leader in the DSCSA saleable returns verification requirement and the VRS. Not only did we extend testing of VRS, we implemented a VRS pilot program for the Food and Drug Administration. We’re applying our expertise in supply chain track and trace, serialization, and compliance solutions to help the pharma industry prepare for November.

And we can help you too. Contact us today to talk with one of our supply chain experts and see how our award-winning rfxcel Traceability System can ensure you comply with the DSCSA saleable returns verification requirement — and meet all your other supply chain needs.

CONTACT US TO SEE THE VRS SOLUTION AND FDA TEST RESULTS:


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