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rfxcel, Part of Antares Vision Group, and MVC Sign Agreement with Lebanese Republic to Deploy End-to-End Pharmaceutical Traceability Hub

The agreement continues the partners’ success in the Middle East, where they recently launched the first GS1-compliant Traceability Hub in the Kingdom of Bahrain.

Reno, Nevada, Sept. 22, 2021 (EINPRESSWIRE). rfxcel, part of Antares Vision Group and a global leader in digital supply chain traceability solutions, today announced that it signed a five-year cooperative agreement with the Lebanese Republic’s Ministry of Public Health to provide a GS1-compliant Traceability Hub to secure the country’s entire pharmaceutical supply chain. The company will implement the system with its partner Medical Value Chain (MVC), the Bahrain subsidiary of U.S.-based AVC Global.

The announcement comes only a few months after rfxcel and MVC were selected by Bahrain’s National Health Regulatory Authority and Supreme Council of Health to provide the first GS1-compliant system to track the Kingdom’s entire pharmaceutical supply chain on a blockchain platform.

The Lebanon Traceability Hub will deliver end-to-end visibility into every aspect of the country’s pharmaceutical supply chain, from the manufacturer of origin, importers, wholesalers, and distributors to pharmacies, clinics, and hospitals — all the way to individual patients. It will integrate with the Ministry of Public Health’s MediTrack system for domestic manufacturers.

The Hub is designed to achieve the following:

  • Lower the cost of pharmaceuticals
  • Provide patients with only authentic, safe medications
  • Combat drug counterfeiting and smuggling
  • Ensure access to pharmaceuticals subsidized by the Banque du Liban, the central bank of Lebanon
  • Prevent hoarding of medicines

“The Hub is all about leveraging leading-edge technology to secure Lebanon’s pharmaceutical supply chain and safeguard patients and consumers,” rfxcel CEO Glenn Abood said. “Security and safety — these are the very reasons I founded rfxcel almost 20 years ago. We’re eager to begin our work with MVC in Lebanon, and we’ll continue to focus on bringing Traceability Hubs to other countries in the Middle East and beyond.”

MVC Co-Founder and President Leo Giacometto said, “The MVC technology platform with blockchain revolutionizes the delivery and integrity of pharmaceutical supply chains in Lebanon. We are excited and honored to deploy our platform in partnership with the Ministry of Public Health in the Republic of Lebanon.”

Emidio Zorzella, Antares Vision Group CEO, said, “We’re all eager to start working with the Ministry of Public Health and gratified that everything has come together so well. When we unveiled the Bahrain Traceability Hub in June, I said we’d be announcing national hubs in other countries. Here we are today, continuing our vision of protecting products and people, and making supply chains safer and more efficient.”

About rfxcel

Part of Antares Vision Group, rfxcel provides leading-edge software solutions to help companies build and manage their digital supply chain, lower costs, protect their products and brand reputations, and engage consumers. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s Traceability System to power end-to-end supply chain solutions in track and trace, environmental monitoring, regulatory compliance, serialization, and visibility. Founded in 2003, the company is headquartered in the United States and has offices in the United Kingdom, the EU, Latin America, Russia, India, Japan, the Middle East, and the Asia-Pacific region.

About Antares Vision Group

Antares Vision Group protects products, people, and brands with inspection systems featuring 6,500 quality controls, track and trace software solutions for end-to-end transparency and visibility in digital supply chains, and smart data management tools for maximum operational efficiency, from raw materials to final consumers. It provides solutions to five primary industries: pharmaceuticals and life sciences (medical devices and hospitals), food and beverage, cosmetics, and consumer packaged goods. Active in more than 60 countries, Antares Vision Group has seven production facilities and three Innovation and Research Centers in Italy, 22 foreign subsidiaries, and a global network of more than 40 partners. Today, 10 of the world’s 20 leading pharmaceutical companies use its solutions to secure their production and supply chain operations; worldwide, it has deployed more than 25,000 inspection systems and more than 3,500 serialization modules. Antares Vision Group has been listed on the Italian Stock Exchange’s AIM Italia market since April 2019 and in the STAR Segment of the Mercato Telematico Azionario (MTA) since May 2021.

For further information

Antares Vision S.P.A.

Via Del Ferro, N. 16

25039 – Travagliato (BS)

Alessandro Baj Badino, Investor Relator

Tel.: +39 030 72 83 500

E-mail: Investors@antaresvision.com

Herb Wong, rfxcel Vice President of Marketing and Strategic Initiatives

Tel.: +1 925-791-3235

E-mail: hwong@rfxcel.com

FDA Official Says DSCSA 2023 Interoperability Deadline Will Not Change

The Food and Drug Administration (FDA) appears to be digging in its heels and insisting pharma stakeholders be ready to comply with interoperability requirements by November 27, 2023, the deadline mandated in the U.S. Drug Supply Chain Security Act (DSCSA).

Leigh Verbois, director of FDA’s Office of Drug Security, Integrity, and Response, indicated there would be no delays during a Healthcare Distribution Alliance (HDA) webinar on August 9.

As reported by Regulatory Focus, Verbois said, “It is FDA’s goal that we not extend the November deadline for interoperability … We have been working at a full tilt to make sure that we can make our goal of an interoperable system by 2023.”

Verbois also said that the FDA was continuing to develop a framework for interoperability, adding that the Agency knew there were “a number of important issues” to address and that regulators had been “working to understand the interplay between the elements that are necessary to build a system.”

Director Verbois’ comments at the HDA webinar come just two months after the FDA published draft and final guidance on key aspects of the DSCSA: product identifiers, suspect and illegitimate products, and enhanced drug distribution security.

  1. Product Identifiers under the Drug Supply Chain Security Act: Questions and Answers (final guidance)
  2. Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry (final guidance)
  3. Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry (revised draft guidance)
  4. Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (new draft guidance)

What are the DSCSA interoperability requirements?

The DSCSA requires pharma supply chain trading partners to exchange transaction information (TI) “in a secure, interoperable, electronic manner in accordance with the standards established [through FDA guidance].”

Trading partners must provide TI and a transaction statement (TS) to the subsequent owner of a product “prior to, or at the time of, each transaction.” TI must “include the product identifier at the package level for each package included in the transaction.”

What’s changing in 2023?

Right now, TI and TS are being electronically exchanged at the lot-level, which is usually done with an advance ship notice (ASN).

In 2023, however, TI must include the product identifier, which includes serial numbers and expiration dates. This means the U.S. pharmaceutical supply chain will be fully serialized, and the Electronic Product Code Information Services (EPCIS) appears to be the standard the industry will use to enable this exchange.

The transition from ASN to EPCIS is one of the “four pillars” of the regulations that we talked about in our three-part DSCSA 2023 webinar series in June, which you can view and download here. We also hosted a “Plan for DSCSA Readiness” webinar in March that you can view here.

DSCSA 2023 Four Pillars

Final thoughts

As we reported in our blog, the FDA has twice delayed enforcement of the DSCSA Saleable Returns Requirement. Now, the table seems to be set for November 2023: No more delays, no more extensions.

The pace will only intensify. In just about two years, you’ll have to be up and running in a fully serialized U.S. pharmaceutical supply chain. Now, the question we’ve been asking for so long is even more critical: Will you be ready?

In terms of interoperability, ask yourself these questions:

  • Can you send and receive serialized data?
  • Can you send and receive aggregated data?
  • Do you have procedures and training in place to support serialized data exchange?

Contact us today if you need to know more. Our supply chain and DSCSA experts are here to help.

 

 

 

3 Benefits of Supply Chain Traceability for Your Business

Imagine for a minute that you get the phone call all companies dread. It’s the “I am dissatisfied with my product” call, direct from a customer. You take the call, help the customer, and move on, right? You’re feel good about solving the problem — and are definitely not thinking about supply chain traceability.

A few days go by, then you’re flooded with more complaints, none of which seem to be related. You scramble to identify the root cause of all your problems, but you don’t know where to look. What should you do?

This is when you should be thinking about supply chain traceability. It is the key to having total insight into how your products get made, where they’ve been, and where they’re going. By employing supply chain traceability, you can:

  • Assure your brand and customers are protected
  • Maintain regulatory compliance
  • Pinpoint common problems, such as counterfeits and diversion

Let’s take a deeper look into each of these benefits.

1. Supply chain traceability for brand protection and customer satisfaction

Customers grade a brand on both the quality of its products and how it responds when an issue arises. Brands build loyalty with their customers by being transparent and demonstrating consistent product and service quality. Brands lose customers by failing to respond to complaints and recalls.

Response to complaints and recalls

Supply chain traceability is helpful when investigating a customer complaint. It is also essential when assessing a potential recall or managing an actual recall.

All the products you make and sell must have identification that traces back their source. Manufacturers and retailers can follow a problematic unit backward through its life cycle. Information collected through traceability includes:

  • Date and time of manufacturing
  • Equipment used for manufacturing and packaging
  • Personnel involved in manufacturing and packaging
  • Raw materials and components
  • Physical locations of inventory throughout its life

In a best-case scenario, the complaint is an isolated incident that’s easy to fix. But if the complaint means there’s been a breakdown somewhere or a product has been compromised, a recall may be triggered.

Recalls happen for any number of reasons. For example, you might discover a material that is out of specification. Once identified, it is necessary to trace all usage of that material. Another example is contamination, especially in the food supply chain.

A recall of any size can have a significant impact on your business. Having a supply chain traceability system will speed recalls, improve cooperation with regulators and other authorities, enable better information-sharing with your customers, and reduce damage to your brand reputation. Faster batch recalls are possible only when there is a robust supply chain traceability system.

Transparency about sourcing

A study conducted by the Consumer Goods Forum found that “70 percent of consumers are most interested in transparency about products.” Customers want to know where the materials used in their products came from and how they were sourced.

Some companies are publishing reports to make their supply chains and operations more transparent — and to make their brand more appealing to consumers. In addition to how they source materials, they’re sharing information about things such as:

  • Origins and purposes of raw ingredients
  • Manufacturing processes
  • Safe handling practices along the supply chain
  • The brand’s mission and values

This type of “transparency marketing” is effective in the food and consumer packaged goods industries, as it entices consumers to make a purchase because they’re getting the product information they demand.

A 2016 study by Label Insight indicated that 94 percent of consumers are not only likely to be loyal to a brand that offers complete transparency but are willing to pay more for products that meet such standards. This has powerful implications for brands; it shows that transparency made possible with supply chain traceability inspires product and brand loyalty.

2. Supply chain traceability is key to compliance

Being able to track material movement and consumption is critical for regulatory compliance.

The ISO 9000 Standards Series is the basis for most industries’ standards and provides expectations to help companies structure their quality management systems. Within these standards, traceability is defined as “The ability to trace the history, application, use and location of an item or its characteristics through recorded identification data.”

To meet this standard, it’s critical to be able to identify individual product units. Also, you must collect information about subcomponents. This information will allow for the tracing of parts of products throughout your supply chain.

Serialization makes supply chain track and trace easier

Serialization is the process of assigning unique identifiers to outbound and inbound materials. This makes the parts of products easier to track and trace throughout your processes. Utilizing software such as our Serialization Processing solution will save you time and effort in managing your supply chain.

Collecting supply chain data on your materials and finished products can also help to identify problems before they become an issue. This empowers you to be proactive and assess what works well (or what does not work well) throughout your entire supply chain process, which allows you to standardize your work processes and cut out waste.

Prove your product claims

Marketing claims must be substantiated, not only to consumers but also to regulatory agencies. Claims about sustainable sourcing, organic certifications, and other attributes can be demonstrated with supply chain traceability. Safe and compliant handling of products is also best demonstrated with traceability. Many retailers and manufacturers have routine audits to assure that they have processes to trace a product’s life cycle. In some industries, the results of these audits are available as public information.

Regulations evolve over time

Regulatory requirements for the documentation of traceability are constantly evolving. For example, the U.S. Food and Drug Administration (FDA) published the “Proposed Rule for Food Traceability,” which called for additional traceability records for certain foods. The FDA is encouraging the voluntary adoption of these new practices for all food products. These new requirements will affect all who manufacture, process, pack, or hold foods.

We’ve written extensively about the FDA’s push for traceability in modern food supply chain. For example, check out “Food Traceability Regulations in the United States: A Timeline.”

rfxcel is prepared to help you comply with all current and future requirements in any industry, including food and beverage, life sciences/pharmaceuticals, government, and consumer goods. We track industry regulations and guidance documents for upcoming and proposed legislation. We have software solutions that take the guesswork out of compliance no matter where you do business.

3. Combat counterfeits and diversion/theft by identifying supply chain weak spots

One of the worst things that can happen to any business is having their products counterfeited or stolen.

Counterfeits not only result in a direct loss of sales, but your customers might lose faith in your brand. If a person winds up with an inferior counterfeit product with your name and logo on it, there’s a good chance they will be dissatisfied with your brand and take their business somewhere else. And if your products are diverted or stolen, then you’re losing money and might have a much larger supply chain problem on your hands.

Supply chain traceability is like a forensic tool to help fight counterfeits and diversion — and host of other problems. Here’s how it works:

  • You know the origin of your ingredients. You can verify that all ingredients or components are legitimate. You can see the history of any ingredient, including its origin and when it was combined with other ingredients to make a finished product.
  • You can trace a product’s every move. Traceability means you can see everywhere a product has been before, during, and after it was harvested or manufactured. You can see every case or box, every pallet, every delivery vehicle, every stop along the supply chain (e.g., a warehouse, a retail store, a pharmacy or hospital). Even after a product has been unloaded from the delivery vehicle and taken out of cases or boxes, you see where individual units have been right up to the time the consumer takes possession (check-out at the cash register, dispensation at a clinic, etc.).
  • You can pinpoint where a product might have been harmed or compromised. Traceability data will show if a shipment strayed from its prescribed route, which could indicate theft or other mischief that could harm your bottom line and brand. Serialization, compliance, real-time monitoring, and other supply chain traceability solutions create a provenance that can demonstrate the legitimacy and purity of every product.

Final thoughts

We hope you have a better idea of how supply chain traceability can help your brand and business. Traceability is a crucial aspect of managing your business operations.

Are you ready to get started? Setting up your own supply chain traceability system might seem daunting, but rfxcel is here to help. We have easy-to-use, scalable solutions for all of your track and trace needs, no matter what industry you’re in.

Contact us today if you would like to see a short demo of how we can help you to build an effective traceability system. Together, we can protect your brand, ensure regulatory compliance, and fight counterfeits and theft.

DSCSA ATPs: Top Authorized Trading Partner Questions, Answered

What’s being discussed to ensure interoperability of different credentialing solutions for authorized trading partners (ATPs)? Is GS1 going to set standards for ATP credentialing solutions? If a solution provider supports DSCSA compliance and customers will aggregate serial numbers, why do users need to do anything else? 

These were the Top 3questions from “Authorized Trading Partners: The OCI Solution,the third and final presentation in the “DSCSA 2023” webinar series we hosted last month. rfxcel Global Executive Advisor Brian Files was hosting that day, and we share his answers below.

We also shared our answers to the top questions from the two other webinars, The Verification Router Service: Aligning to the Standardand ASN to EPCIS: Industry Change, Your Challenge.” There’s a lot of good information there, so be sure to check them out!

Our “DSCSA 2023” webinars were part of our ongoing efforts to keep the pharma industry updated about the DSCSA and help all stakeholders be ready for the full serialization of the U.S. pharma supply chain in November 2023. If you have other questions or want more details about DSCSA 2023, contact us today. You can also watch the webinars and download the presentation slides here.

What’s being discussed to ensure interoperability of different ATP credentialing solutions?

The same industry stakeholders are involved in developing the different solutions, whether it’s the Open Credentialing Initiative (OCI), .MED, or XATP. It’s important to have systems that connect and exchange information. The HDA has been hosting meetings with the three ATP providers to determine how/if interoperability can be achieved. Great progress has been made in a short time but there are still many open issues to be resolved as of mid-July 2021.

Is GS1 going to set standards for ATP credentialing solutions?

GS1 is not setting the standards; however, as part of the HDA effort to ensure interoperability, the teams are keeping GS1 updated on their efforts to ensure any GS1 specifications are updated/clarified as needed. For example, ATP will leverage the VRS messaging standards, which may need to be updated/clarified to include ATP.

If a solution provider supports DSCSA compliance and customers will aggregate serial numbers, why do users need to do anything else? 

For DSCSA 2023, the onus is on companies to ensure they’re getting their data in the proper format. Just having a DSCSA solution will not make you compliant. You have to go through your operational protocols and procedures and design your internal systems so they’ll be DSCSA-compliant.

Some companies have been working with solution providers since the early days of the DSCSA rollout, but have yet to optimize how their compliance software works with their internal systems, how they work with their provider, and, critically, how they communicate with their trading partners. Companies need to optimize internally to get the most out of their solutions — and to ensure compliance.

More DSCSA 2023 resources from rfxcel

DSCSA 2023: The Future of Pharmaceutical Traceability in the United States

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.

 

 

 

 

 

 

DSCSA 2023: Understanding DSCSA Authorized Trading Partners, Part 2

Welcome to Part 2 of our discussion about DSCSA authorized trading partners. The 10-year rollout of the U.S. Drug Supply Chain Security Act — the DSCSA — is scheduled to conclude on November 27, 2023, so now’s a good time to take stock of where we are and what to expect over the coming months.

As we said in Part 1, everybody’s talking about DSCSA authorized trading partners — manufacturers, wholesale distributors, repackagers, third-party logistics providers (3PLs), and dispensers. From now until November 2023, it’s really all about ensuring these supply chain actors are ready to comply with the regulations.

Remember, under the DSCSA, authorized trading partners may engage in transactions only with other authorized trading partners. In other words, if you’re not a DSCSA authorized trading partner, your access to the U.S. pharma supply chain will be severely restricted or denied altogether.

Below, we finish our discussion of DSCSA authorized trading partners by defining who qualifies as a repackager, a 3PL, and a dispenser.

Repackagers

Repackagers own or operate an establishment that repacks and relabels a product or package for further sale or distribution without a further transaction.

Generally, dispensers (specifically pharmacies) are not considered repackagers. By this definition, a dispenser/pharmacy only packs and labels a product for dispensation to a person who has a valid prescription for that product; they do not do “bulk” repackaging.

Repackagers are considered trading partners if they accept or transfer direct ownership of a product from or to a manufacturer, another repackager, a wholesale distributor, or a dispenser. To be a DSCSA authorized trading partner, repackagers, like manufacturers, must be registered with the U.S. Food and Drug Administration (FDA) in accordance with Section 510 of the Food, Drug, and Cosmetics Act (FD&C Act), “§360. Registration of producers of drugs or devices.”

3PLs

The DSCSA defines a 3PL as an “entity that provides or coordinates warehousing or other logistics services with regard to a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.”

3PLs are considered trading partners if they accept or transfer direct possession of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser. Returns processors and reverse logistics providers are considered 3PLs. There are two reasons for this:

  1. They provide other logistics services for other trading partners in a facility they own, rent, or lease.
  2. They do not take ownership of the product and do not direct the sale or disposition of the product.

Generally, brokers, solution providers, common carriers, and logistics or administrative services contractors are not considered 3PLs because they don’t provide or coordinate warehousing and don’t accept or transfer direct possession of the product. These stakeholders do not have to be licensed.

To be a DSCSA authorized trading partner, 3PLs must have a valid license under state law or FD&C Act Section 584(a)(1), “National Standards for Third-Party Logistics Providers,” in accordance with Section 582(a)(7), “Requirements, Third-party logistics provider licenses”, as amended by the DSCSA and in compliance with reporting requirements under Section 584(b).

Dispensers

To be considered a dispenser, you must meet one of three criteria:

  1. You’re a retail pharmacy, a hospital pharmacy, or a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor.
  2. You’re a person legally authorized to dispense or administer prescription drugs.
  3. You’re an affiliated warehouse or distribution center of a dispenser under common ownership and control that does not act as a wholesale distributor.

A dispenser is considered a trading partner if they accept or transfer direct possession of a product from or to a manufacturer, repackager, wholesale distributor, or another dispenser. To be a DSCSA authorized trading partner, a dispenser must have a valid state license.

Generally, veterinarians are not considered dispensers, per FD&C Act Section 512(a)(5).

Final thoughts

The table below summarizes everything we’ve laid out above and in Part 1 of our DSCSA authorized trading partners series. It’s adapted from an August 2017 FDA publication.

As you’re reading, remember that all of our stakeholders are considered to be trading partners if they accept or transfer direct ownership of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser. To be an DSCSA authorized trading partner, however, they must meet the criteria explained in the table.

There’s one last installment of our “DSCSA 2023” series coming soon. In it, we’ll talk about the key requirements for 2023 and the future of traceability in the pharma supply chain. While you’re waiting for that, take a moment to check out our webinars, white papers, pharmaceutical compliance solutions, and other resources about the DSCSA. If you feel inspired, contact us to schedule a demo to see our solutions in action.

DSCSA Authorized Trading Partners

DSCSA Authorized Trading Partners

What Does the EU COVID-19 Vaccine Distribution Plan Look Like?

The EU announced its COVID-19 vaccine strategy on June 17, 2020. Among other things, it called for ensuring the quality, safety, and efficacy of vaccines, securing quick access to vaccines, and ensuring equitable access to an affordable vaccine as early as possible. It also called for adapting the EU’s regulatory framework and taking advantage of regulatory flexibility to address the urgent need.

Let’s take a look at what the EU has said about its COVID-19 vaccine distribution plan and answer some frequently asked questions about its vaccine administration.

What vaccines are being used in the EU?

The European Commission says it wants to “build a diversified portfolio of vaccines based on different technologies, to increase the chances that one or more of the vaccine candidates are approved by EMA.”

The EU authorized the BioNTech-Pfizer COVID-19 vaccine on December 21, 2020, and the Moderna vaccine on January 6, 2021. It did this after the European Medicines Agency (EMA) assessed their safety, quality, and efficacy.

On January 8, the Commission reported that it had concluded contracts for 600 million doses of the BioNTech-Pfizer vaccine and 160 million doses of Moderna’s vaccine. It also reported securing contracts for millions of doses from AstraZeneca, Sanofi-GSK, Johnson and Johnson, and CureVac, and that it had concluded “exploratory talks” with Novavax and Valneva.

Then, on January 29, the Commission announced that AstraZeneca agreed to publish the redacted contract it signed on August 27, 2020, and that CureVac agreed to publish the Advance Purchase Agreement with the EU.

The Commission says it has secured more than 2.3 billion doses of COVID-19 vaccines, adding that if all the vaccine candidates are found to be safe and effective, EU Member States could donate part of their doses to lower- and middle-income countries.

Who will receive the vaccine and when?

As of January 8, the EU said that all Member States would have access to COVID-19 vaccines at the same time, based on the size of their population. On January 29, the Commission enacted a measure requiring Member States to authorize vaccine exports, stating this will “ensure timely access to COVID-19 vaccines for all EU citizens and … tackle the current lack of transparency of vaccine exports outside the EU.”

The Commission says the number of doses will be limited during the initial stages the immunization effort and before production can be ramped up. As in other countries, authorities have said that there will not be enough doses to vaccinate everybody right away; it will take time.

Most members have defined who will get the vaccine first and are further refining sub-groups to assign priority. Frontline healthcare professionals and people over 80 years old top the lists. For more insight about the rollout, see this December 2020 report from the European Centre for Disease Prevention and Control about preparedness in the EU, the European Economic Area, and the UK. The Centre also has a useful “Situation Update” page that tracks the pandemic in the EU.

Vaccine supplies will increase over time, the Commission says, and all adults should be able to get vaccinated during 2021. It predicts that at least 80 percent of people over the age of 80 and 80 percent of health and social care professionals should be vaccinated by March 2021. By this summer, the Commission says 70 percent of the EU’s adult population should be vaccinated. These projections, however, are probably optimistic, as the rollout has been slow and fewer doses than expected have been delivered.

Final thoughts

As we said in our blog post about COVID-19 vaccine distribution in the United States, the world is in an “all hands on deck” situation. We like to think we’ve been part of the effort since the pandemic began.

In April 2020, we joined the COVID-19 Healthcare Coalition, offering our Accurate Immunization Management (AIM) and rfxcel Integrated Monitoring (rIM) solutions. rIM is a real-time environmental monitoring solution that uses Internet of Things (IoT)-enabled devices to monitor products while they’re in transit; it’s a powerful, ideal solution for the pharma cold chain, which is vital to vaccine distribution.

AIM ensures that the right person gets the right vaccine at the right time. It can track COVID-19 vaccines — indeed, any vaccine — in any supply chain, monitor inventory, and facilitate safe, timely delivery to any location. We designed AIM to be fast, flexible, and compliant in any country. At a time when the world is depending on supply chains to function at peak performance, AIM is a tool to help get vaccines properly delivered and dispensed.

Furthermore, our signature rfxcel Traceability System has proven itself in the pharma supply chain, helping ensure products are safe and legitimate and that consumers know exactly what they’re getting. Contact us today to learn more our solutions and how we can help you secure your supply chain, no matter what industry you’re in or where you do business.

How the COVID-19 Vaccine Track and Trace Systems Work in the United States

On December 11, the Food and Drug Administration (FDA) issued an emergency use authorization for a COVID-19 vaccine in the United States. The Pfizer vaccine was the first vaccine made available to the public, followed by Moderna’s vaccine.

There are many challenges for U.S. track and trace systems monitoring COVID-19 vaccine shipments. There’s also the additional challenge of keeping tabs on who receives the vaccine and when, especially as the program is being conducted through both state and federal data networks.

Let’s take a look at how the United States is implementing its track and trace systems and address the unique challenges of vaccine distribution.

What track and trace systems are the United States using?

The United States is using federal immune registry systems and connecting them with a new project called the Immunization Gateway, or IZ Gateway. Put simply, the system enables providers, consumers, and other stakeholders to exchange immunization data. It’s sponsored by the Centers for Disease Control and Prevention’s Immunization Information Systems Support Branch and led by the U.S. Department of Health and Human Services (HHS) Office of the Chief Technology Officer.

IZ Gateway connects 64 Immunization Information Systems (IIS), which consolidate and “deduplicate” immunization information. IIS also have forecasting algorithms that can help people stay current on their vaccines. The IZ Gateway’s centralized technical infrastructure facilitates data exchange through an intelligent message router that connects the IIS to one another, connects large multi-jurisdictional provider organizations to the IIS, and connects the IIS to consumers.

The HHS says the IZ Gateway “aims to increase the availability and volume of complete and accurate immunization data stored within IIS and available to providers and consumers regardless of their jurisdictional boundaries.” Prisons and veteran’s affairs hospitals are also connected to the system.

The main challenge to the U.S. track and trace system

As we know, tracking and tracing the COVID-19 vaccine isn’t an easy task. There have been a variety of concerns, including securing pharma cold chain infrastructure and providing track and trace technology with real-time environmental monitoring, such as our rfxcel Integrated Monitoring solution.

However, two challenges have remained at the forefront of the conversation: the sheer scale of the immunization effort and the two-dose requirement. Although the IZ Gateway creates a nationwide network that can track if a person has received more than one dose, government, providers, and every other vested stakeholder should anticipate mistakes and inaccuracies and do everything within their power to optimize vaccine distribution and administration.

rfxcel’s Accurate Immunization Management (AIM) is one solution that can help. AIM is an automated, cloud-based solution that tracks the dispensing of vaccines in the supply chain. It seamlessly integrates with IIS, Electronic Health Records (EHRs), Allscripts, Nextgen, Urochart, Meridian, and iSalus, adding another layer of track and trace protection to vaccine distribution.

Final thoughts

COVID-19 vaccine distribution is an “all hands on deck” situation. Our signature rfxcel Traceability System has proven itself time and again in the pharma supply chain, helping ensure products are safe and legitimate and that consumers know exactly what they’re getting.

Now, AIM ensures that the right person gets the right vaccine at the right time. It can track COVID-19 vaccines — indeed, any vaccine — in any supply chain, monitor inventory, and facilitate safe, timely delivery to any location. We designed AIM to be fast, flexible, and compliant in any country. At a time when the world is depending on supply chains to function at peak performance, AIM is a tool to help get vaccines properly delivered and dispensed.

Contact us today to learn more about AIM, our rfxcel Traceability System and rfxcel Integrated Monitoring, and our other supply chain solutions.

Russia Pharma Serialization Update: “Notification Mode” Expedites Product Circulation

Russia pharma serialization has been underway for a little more than three years. The country’s National Track and Trace Digital System, which is known as Chestny ZNAK and covers a dozen industries, has been continually tweaked and refined since it was created a little more than three years ago.

Some important updates to Russia pharma serialization were made public toward the end of 2020. Here’s a quick rundown of what the government announced.

“Notification mode” will simplify Russia pharma serialization processes

As we noted last year, Russia’s Drug Circulation Monitoring System (MDLP) was compelled to develop new reporting requirements after technical problems created serious issues in the pharma supply chain.

In late October, the MDLP moved into so-called “notification mode” to help supply chain actors continue importing, distributing, and selling medicines in the event of errors or failures in Chestny ZNAK’s reporting system. This applied to over-the-counter and prescription medicines manufactured in Russia or imported into the country, including from the Eurasian Economic Union (EAEU).

Then, in early November, Decree 1779, “On Amendments to the Regulation on the Monitoring System for the Movement of Medicines for Medical Use,” consolidated measures to simplify and expedite reporting. This is why notification mode has also been referred to as “simplification mode” for Russia pharma serialization.

In essence, stakeholders can proceed with distribution or dispensing 15 minutes after they submit the required product information to the Government Information System for Marking (GIS MT), which catalogs all marked goods, even if they do not receive confirmation that the information has been accepted/approved in the system. (The “product information” pertains to Russia pharma serialization requirements, such as serial numbers and Global Trade Item Numbers.) The decree also simplifies importation, giving custom officials a 2-hour window to request product information.

For now, these Russia pharma serialization rules are to remain in effect until July 1, 2021. After that, notification mode will stop.

Final thoughts

As the leader in Russia pharma serialization, rfxcel knows the regulations are stringent and challenging. To help, we offer useful resources online, like this refresher course and white papers and webinars that explain the regulations in easy-to-understand language.

These are great places to start, but the best way to ensure you’re prepared to comply with Russia pharma serialization laws is to talk with us directly. Consider our credentials:

  • We’re an official integration, software, and tested solution partner with the CRPT.
  • We’ve demonstrated that our solutions, including our signature rfxcel Traceability System (rTS) and Compliance Management (rCM), can meet the stringent Russia pharma serialization requirements and ensure you stay compliant.
  • rTS works seamlessly with Chestny ZNAK, including a Russian-language user interface that makes integration and startup much quicker.
  • We’ve prepared for Russia pharma serialization and Chestny ZNAK since 2018.
  • We’re one of the few providers with active pharma implementations in Russia.
  • We’ve tripled our workforce in Russia over the last year. Our team in Moscow provides our clients, which include major global pharmaceutical and consumer goods companies, the quickest time to market while fully automating their compliance reporting.

Contact us today learn more about how we can help you with Russia pharma serialization and Chestny ZNAK compliance. No matter how far along you are in your preparations to comply, you should talk to us — even if you’re already working with another provider. Our powerful software ensures you’ll be prepared and always be compliant with Russia’s complex regulations.

rfxcel Responds to Unprecedented Cold Chain Requirements and Logistics Challenges as COVID-19 Vaccine Distribution Nears

Reno, Nevada, Dec. 2, 2020. rfxcel, the global leader in digital supply chain traceability solutions, continues to address cold chain and logistical challenges it anticipates will arise from the first widespread distribution of COVID-19 vaccines. The company has been preparing for a “vaccine surge” since the pandemic began to ensure it can respond to customer and industry needs when distribution begins to exert pressure on supply chains.

“The pandemic has revealed shortcomings in every supply chain, and we’ve seen increased competition for resources,” said rfxcel CEO and Co-Founder Glenn Abood. “We’ve worked with our global customers in pharma/life sciences, food and beverage, consumer goods, and government to keep their operations responsive and nimble. Now, we’re prepared to address additional stresses distribution of COVID-19 vaccines could create as the call for ‘all hands on deck’ commences and already scarce resources are redirected for the effort.”

rfxcel has provided traceability solutions since 2003. Its rfxcel Traceability System comprises discrete solutions that work in concert to harmonize, optimize, automate, and monitor supply chain operations, including serialization, compliance, environmental monitoring, raw materials traceability, and data analytics.

The company’s Integrated Monitoring (rIM) solution uses Internet of Things (IoT) technology to monitor the environmental condition of products in real time as they move through supply chains on land, sea, and air. rIM communicates with small IoT-enabled devices embedded with products and sends updates and alerts about more than a dozen environmental conditions, such as temperature, location, humidity, light, and shock. It can alert users about route diversions and ensure logistics providers remain in compliance with delivery agreements.

rfxcel has also developed Accurate Immunization Management (AIM), an automated, cloud-based solution that tracks the dispensing of vaccines. It seamlessly integrates with critical healthcare applications such as Electronic Health Records (EHRs) and Immunization Information Systems (IIS). It empowers healthcare practitioners to view patients’ immunization records in real time, manage accurate administering, monitor inventory, and safely dispense the right vaccines to the right patient at the right time. Because it is automated, users can be up and running with virtually no training, ensuring quick implementation in mission-critical locations.

“We want to provide foolproof traceability,” Abood said. “Today, it’s more important than ever to be able to question, examine, and control every part of the supply chain, which is what our rfxcel Traceability System platform provides with solutions such as rIM and AIM.”

For more information about rfxcel’s Traceability System, rIM, AIM, and other solutions, contact Herb Wong, vice president of marketing and strategic initiatives, at hwong@rfxcel.com or 925-824-0300.

About rfxcel

Founded in 2003, rfxcel provides leading-edge software solutions to help companies build and manage their digital supply chain, lower costs, and protect their products and brand reputations. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s signature Traceability System (rTS) to power end-to-end supply chain solutions in key areas such as track and trace, environmental monitoring, regulatory compliance, serialization, and visibility. The company is headquartered in the United States and has offices in the United Kingdom, the EU, Latin America, Russia, India, Japan, the Middle East, and the Asia-Pacific region.