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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

DSCSA 2023: Understanding DSCSA Authorized Trading Partners, Part 1

The Drug Supply Chain Security Act (DSCSA), enacted in 2013, was envisioned as a 10-year plan to secure the U.S. pharmaceutical supply chain through enhanced track and trace systems and processes. Milestones have come and gone, 2023 isn’t that far off, and now everybody is talking about DSCSA authorized trading partners.

Why are DSCSA authorized trading partners on everyone’s mind? It’s because these supply chain stakeholders — manufacturers, wholesale distributors, repackagers, third-party logistics providers (3PLs), and dispensers — are pivotal to the regulatory rollout, which is scheduled to conclude on November 27, 2023. From here on out, the focus will be getting DSCSA authorized trading partners ready to comply with the regulations.

The U.S. Food and Drug Administration (FDA) has clarified the definitions of and guidance for DSCSA authorized trading partners, but we want to distill that further into an easy-to-understand explanation. In Part 1 of our “DSCSA 2023” series, we’ll take a look at manufacturers and wholesalers; Part 2 will talk about repackagers, 3PLs, and dispensers. In Part 3, we’ll break down the specific requirements for 2023.

DSCSA authorized trading partners: an overview

Under the DSCSA, authorized trading partners may engage in transactions only with other authorized trading partners. In other words, manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers and their trading partners must all be authorized trading partners. If you are not a DSCSA authorized trading partner, your access to the U.S. pharma supply chain will be severely restricted or denied altogether.

Below, we explain how the DSCSA defines manufacturers and wholesale distributors.

Manufacturers

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

  1. You manufactured the product.
  2. You’re an approved application holder or a co-licensed partner of the approved application holder; if the latter, you must have obtained the product directly from the application holder or entity that manufactured the product.
  3. You’re an affiliate of the manufacturer and obtained the product directly from the application holder or entity that manufactured the product.

A manufacturer is considered a trading partner if it accepts or transfers direct ownership of a product from or to another manufacturer, a repackager, a wholesale distributor, or a dispenser. As defined in 1-3 above, a manufacturer is a DSCSA authorized trading partner if it:

  1. Is registered with the FDA in accordance with Section 510 of the Food, Drug, and Cosmetics Act, Ҥ360. Registration of producers of drugs or devices
  2. Is compliant with Section 510 of the FD&C Act
  3. Is compliant with Section 510 of the FD&C Act

Wholesale distributors

To be considered a wholesale distributor, you must distribute a drug to a person other than a consumer or patient.

A wholesale distributor is considered a trading partner if it accepts or transfers direct ownership of a product from or to another wholesale distributor, a manufacturer, a repackager, or a dispenser. To be a DSCSA authorized trading partner, a wholesale distributor must have a valid license under state law or FD&C Act Section 583, “National Standards for Prescription Drug Wholesale Distributors,” in accordance with Section 582(a)(6), “Wholesale distributor licenses,” as amended by the DSCSA and in compliance with reporting requirements under Section 503(e), “Licensing and reporting requirements for wholesale distributors.”

Of note: manufacturers that distribute their own drugs are not required to meet licensure requirements for wholesale distributors. In fact, the FDA excluded several other entities from the definition:

  • A manufacturer’s co-licensed partner
  • A 3PL
  • A repackager
  • Entities excluded from “wholesale distribution” pursuant to Section 503(e)(4) — a dispenser, a dispenser-affiliated warehouse or distribution center, or a dispenser who transfers product to another dispenser for a specific patient need

However, “jobbers” are considered wholesale distributors. The FDA defines jobbers as those who do wholesale distribution on a small scale or sell products only to retailers and institutions. Dispensers that transfer product to another dispenser without a specific patient need are also jobbers — which means they’re also considered wholesale distributors.

Final thoughts

If you follow our blog, you know we’ve been covering the DSCSA for a long, long time. We’ve hosted webinars, including the recent “Plan for DSCSA Readiness,” written white papers , and been active in industry initiatives, particularly the Verification Router Service (VRS), for which we led an FDA-approved pilot to extend testing of the system, and the Open Credentialing Initiative (OCI) to meet the requirements for DSCSA authorized trading partners.

So check back soon for Part 2 of our “DSCSA 2023” series, which will discuss repackagers, 3PLs, and dispensers. In the meantime, contact us if you have questions about the DSCSA. Our supply chain experts will be happy to speak with you and demonstrate how our solutions have made us the leader in pharmaceutical compliance.

Requirements for Russia’s Textile and Apparel Supply Chain

There’s always something interesting going on with Chestny ZNAK, Russia’s National Track and Trace Digital System. (Well, we think it’s interesting, and chances are you do too if you’re reading this.). Adjustments, pilots beginning and ending, mandatory product labeling going into effect … it’s a treasure trove of track and trace. Such is the case with today’s topic: Russia’s textile and apparel supply chain.

Technically, Chestny ZNAK refers to some facets of the textile and apparel supply chain as “clothing items and light industry goods.” The category includes coats, shirts, blouses, and linens.

Globally, footwear and some items made with fur are certainly part of the textile and apparel supply chain. Chestny ZNAK, however, treats these as separate categories, so we’re not including them in today’s discussion. We’ve written about footwear before — mandatory serialization and other requirements went into effect on July 1, 2020 — and you can learn more about requirements for fur (and all regulated product categories) by downloading our “Overview of Chestny ZNAK Compliance for Key Industries” white paper. It’s fully updated for 2021 and available in both English and Russian.

Okay, let’s get into clothing items and light industry goods in Russia’s textile and apparel supply chain.

Serialization in Russia’s textile and apparel supply chain

A pilot for clothing/light industry products was conducted during the second half of 2019, and mandatory labeling began on January 1, 2021. To date, Chestny ZNAK reports that more than 130,000 textile and apparel supply chain stakeholders have been issued more than 1.4 billion marking codes.

All products must be labeled with a DataMatrix code containing four data points:

  • A 14-digit Global Trade Item Number (GTIN)
  • A 13-digit serial number
  • A 4-digit verification key
  • A 44-digit verification code (i.e., crypto code)

The Center for Research in Perspective Technologies (CRPT), which manages Chestny ZNAK, issues verification keys, crypto codes, and serial numbers. Manufacturers, importers, wholesalers, and retailers, referred to as “economic agents,” can also generate serial numbers.

Before economic agents are issued codes, they must create a “product card” for Russia’s catalogue of marked goods. These must note four product attributes

  • The product name
  • The 4-character EAEU Combined Nomenclature of Foreign Economic Activity (TN VED) code
  • The corresponding GTIN
  • The trademark (if any)

New goods produced in Russia must be marked before leaving the factory. For importation from other Eurasian Economic Union (EAEU) countries (Armenia, Belarus, Kazakhstan, and Kyrgyzstan), codes must be applied before the goods enter Russia’s textile and apparel supply chain. For imports from all other countries, codes must be applied before customs processes begin.

Economic agents must have an encrypted digital signature and equipment to handle codes, including scanners, printers, and point-of-sale cash registers connected to the internet (for retail sales).

These are the broad strokes of compliance for the textile and apparel supply chain. For full details, be sure to download our white paper.

Final thoughts

Russia’s textile and apparel supply chain is large and lucrative. But to participate and succeed, you need to be able to navigate Chestny ZNAK’s strict requirements. To do this, you need the right partner, one that knows the regulations, has a local team, and actually has active in-country implementations.

Right off the bat, we can say that we’re the only official CRPT software or integration partner for clothing items and light industry goods. In fact, we’re the only official CRPT partner for several other industries; we’ve proven that our signature rfxcel Traceability System integrates seamlessly with Chestny ZNAK and meets regulatory requirements for key industries. We were also recently accredited as an IT company by the Ministry of Digital Development, Communications, and Mass Media.

To learn more about our leadership in Russian supply chain compliance, check out these recent blog posts:

If you have questions about the textile and apparel supply chain in Russia — or any other market where you’re doing business or want to do business — contact us today to schedule a demo. See how our powerful software can ensure you’ll remain compliant with textile and apparel supply chain regulations around the world.

 

Mandatory Dairy Product Labeling in Russia to Begin in Two Months

It’s going to be a busy year for dairy product labeling in Russia. In fact, it’s going to be a busy year for product labeling in Russia generally. A quick look at our blog reveals that the National Track and Trace Digital System, or Chestny ZNAK, is not relenting on its goal of transforming Russia’s supply chain by 2024:

But let’s stay focused on dairy product labeling, which is scheduled to commence on June 1 for two product categories, then will be phased in for two other categories later in the year.

Dairy product labeling in Russia: background

The Chestny ZNAK pilot for dairy product labeling from July 15, 2019, to December 31, 2020. The dairy supply chain has a unique configuration because Chestny ZNAK will share track and trace duties with the “Mercury” electronic veterinary certification system, which tracks animal products in Russia.

Dairy product labeling requires a DataMatrix code containing four data points: a 14-digit Global Trade Item Number (GTIN), a 13-digit serial number, a 4-digit verification key, and an expiration date.

Other dairy product labeling requirements include the following:

  • Product packaging must have a blank field up to 15×15 mm to accommodate the DataMatrix code.
  • Caps on PET bottles must be able to accommodate either printing or labeling with a laser.
  • Manufacturers can have unusually shaped cartons or bottles tested to determine if the form factor affects dairy product labeling and scanning accuracy/reliability.
  • Aggregation is required; the parent-child relationship must be maintained between the aggregation and the individual units within it.

If you want to learn more about Russian dairy product labeling, download our “Russia Chestny ZNAK and the Dairy Industry” white paper. It’s fully updated for 2021 and really drills down into the details.

While we’re at it, if you want to learn about product labeling and serialization for all of the industries regulated in Russia, download our “Overview of Chestny ZNAK Compliance for Key Industries.” This is also fully updated for 2021 and is our most comprehensive publication about Russian supply chain compliance.

The June 1 dairy labeling requirements

Mandatory dairy product labeling begins June 1 for cheeses and ice cream and other edible ice with or without cocoa. Only serialized products can be sold after this date. However, products produced or imported into Russia before June 1 may be sold until the product’s expiration date.

Companies were permitted to begin labeling these cheese and ice cream products as early as January 20, 2021. They were also allowed to transfer dairy product labeling data to the Government Information System for Marking (GIS MT), which catalogs all labeled goods in Russia’s supply chain. To transfer data to GIS MT, you must be registered with Chestny ZNAK.

The table below shows Russia’s product classification codes (OKPD2) and the corresponding Eurasian Economic Union (EAEU) Combined Nomenclature of Foreign Economic Activity (TN VED) codes for labeling these products. This information comes from Chestny ZNAK.

Russia Dairy Product Labeling

 

Final thoughts

rfxcel is the leader in Chestny ZNAK compliance. Not just for dairy product labeling — for labeling requirements in all regulated industries. We know these regulations can be tough to decipher. To help, we have useful resources, like the stories we linked above, our Chestny ZNAK refresher course, our white papers, and our webinars.

These are great places to start, but the best way to ensure you’re prepared to comply with Russia dairy product labeling requirements is to talk with us directly. When we say we’re the leader in Russian compliance, consider our credentials:

  • We’re an official integration, software, and tested solution partner with the Center for Research in Perspective Technologies (CRPT), which operates Chestny ZNAK.
  • We were recently accredited as an IT company by the Ministry of Digital Development, Communications, and Mass Media.
  • We’re one of the few providers with active implementations in Russia.
  • We’ve tripled our workforce in Russia over the last year.
  • Our Moscow-based team provides our clients, which include major global consumer goods and pharmaceutical companies, the quickest time to market while fully automating their compliance reporting.

We’ve also demonstrated that our solutions, including our signature rfxcel Traceability System (rTS), Compliance Management (rCM), and Serialization Processing (rSP), can meet the stringent Russia dairy serialization requirements and ensure you stay compliant. In fact, we had to prove this to the CRPT to be named an official partner. rTS works seamlessly with Chestny ZNAK, including a Russian-language user interface that makes integration and startup much quicker.

So contact us today learn more about how we can help you with dairy product labeling and other 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 companies in any industry remain compliant with Russia’s complex regulations.

 

 

 

 

Russia Chestny ZNAK Bottled Drinking Water Pilot Ending Soon

A year ago today — April 1, 2020 — Russia started its Chestny ZNAK bottled drinking water pilot. Chestny ZNAK is Russia’s National Track and Trace Digital System, which is transforming how the country runs and regulates the supply chain for everything from pharmaceuticals to fur. It’s managed by the Center for Research in Perspective Technologies (CRPT).

If all goes as planned, the Chestny ZNAK bottled drinking water pilot will wrap up on June 1. Let’s take a quick look at the pilot and what we can expect going forward.

The Chestny ZNAK bottled drinking water pilot

As we said, the pilot (or “experiment,” as these projects are called in Russia) began on April 1, 2020, and is scheduled to end just two months from now, on June 1. The bottled drinking water category includes mineral and carbonated waters, waters without sweeteners or other flavoring, and non-carbonated water. The table below shows the Eurasian Economic Union Combined Nomenclature of Foreign Economic Activity (TN VED) code for the products that must be labeled, as provided by Chestny ZNAK.

 

BOTTLED DRINKING WATER

Pilot: April 1, 2020–June 1, 2021

TN VED CodeDescription
2201Beverages and spirits and vinegar: waters, including natural or artificial mineral waters and aerated (i.e., carbonated) waters, not containing added sugar or other sweetening matter nor flavored; ice and snow

 

Like pilots for other industries, the Chestny ZNAK bottled drinking water pilot tests end-to-end tracking and tracing of marked goods from manufacturing sites or import/customs locations to final sale to consumers. It’s also designed to determine the best approaches for marking and tracing products, including testing methods of applying codes to different types of packaging, such as PET bottles and bottles with irregular shapes.

Chestny ZNAK, which is now in its fourth year of operation, generally requires products to be labeled with a 2D DataMatrix code containing four data points: a Global Trade Item Number (GTIN), a serial number, a verification key, and a verification code (i.e., crypto code).

The DataMatrix codes being used in the Chestny ZNAK bottled drinking water pilot must contain three data points: a 14-digit GTIN, a 13-character serial number, and a 4-character verification code. An optional fourth data point can include information such as the minimum retail price and expiration date. Product packaging is required to have a blank field up to 15×15mm to accommodate the code.

The pilot’s goals include the following:

  • Supply chain actors order DataMatrix codes and apply them to products.
  • All labeling information is transferred electronically to Chestny ZNAK.
  • Products in shipping packages are aggregated; codes for each unit in the aggregation are also aggregated.
  • Marked products enter circulation.
  • Products are tracked and traced in the supply chain, and stakeholders exchange Universal Transfer Documents (UTDs) to record transfer of codes.
  • Consumers purchase goods, which are withdrawn from circulation at checkout via point-of-sale cash registers and scanning devices.

Final thoughts

The CRPT has not announced when mandatory marking of bottled water products will begin. If the pilot ends on schedule, there will likely be a final report and review period, so it could be late 2021 or even early 2022 before you’ll have to comply.

Regardless, the time to think about compliance is now. If you want more details about the Chestny ZNAK bottled drinking water pilot — or any of the regulated industries — start by downloading our white papers. We’ve updated all of our Russia white papers for 2021 and included even more details about what you need to know and do to be compliant.

You should also contact us. We’ve been prepared for Russia’s regulations since 2018. Here a just a few of the reasons why we’re the leader in Chestny ZNAK compliance:

  • We are an official software and integration partner of the CRPT.
  • We’re accredited as an IT company by the Ministry of Digital Development, Communications, and Mass Media.
  • We are one of only a few providers with in-country implementations; clients include global consumer goods and pharma companies.
  • Our powerful software ensures companies in any industry will remain compliant while mastering their supply chains with end-to-end traceability and rich, actionable data mined right down to the unit level.

We’ll be posting more about what to expect with Chestny ZNAK requirements in 2021. There’s definitely a lot going on — including pilots for biologically active food additives and beer getting under way now — so check back often.

rfxcel Accredited as IT Company by Russia’s Ministry of Digital Development, Communications, and Mass Media

Reno, Nevada, March 29, 2021 (EINPRESSWIRE).rfxcel, a global leader in digital supply chain traceability solutions, today announced it had received accreditation as an IT company from Russia’s Ministry of Digital Development, Communications, and Mass Media. It is the latest in a string of official designations for the company, which last year earned official partner status with Russia’s Center for Research in Perspective Technologies (CRPT), which operates the country’s National Track and Trace Digital System (Chestny ZNAK).

rfxcel qualified for IT company accreditation as a developer and implementer of computer software and databases within Russia. Specifically, the company maintains its rfxcel Traceability System, an award-winning digital supply chain track and trace platform, and project databases for its customers, which include large, well-known pharmaceutical and consumer goods customers.

The Ministry of Digital Development, Communications, and Mass Media develops and implements national policy and legal regulations in telecommunications; mass media; publishing, printing, and distribution of printed media; IT; and personal data processing and Internet governance. As an accredited IT company under Russian law, rfxcel qualifies for certain insurance and tax benefits and access to support and programs that fall under the Ministry’s purview, including participating in domestic IT industry activities and international cooperation initiatives.

rfxcel CEO Glenn Abood said the accreditation solidified the company’s status as the leader in Russian supply chain compliance. “Our team in Moscow has reached yet another milestone,” he said. “They’ve achieved so much through hard work and a single-minded dedication to fully understanding Russia’s regulatory landscape — no simple task — and making sure our clients are always compliant, always set up for success. I’m very proud of what they’ve accomplished with this accreditation and am excited to see what’s next for us in Russia.”

Last year, rfxcel earned official partner status in 10 of the 11 industries for which the CRPT has chosen partners: medications, footwear, tires, light industry, perfumes, dairy, bottled drinking water, bicycles, wheelchairs, and tobacco. To be named an official integration, software, and tested solution partner for medications, members of the Moscow team met with the CRPT to demonstrate the rfxcel Traceability System, answer technical questions, and share examples of compliance reports. After an internal evaluation, the CRPT notified rfxcel that it had validated its solution and designated the company as an official partner on its website.

Victoria Kozlova, general director of rfxcel’s Russian operations, added that the accreditation should be another indication to companies that rfxcel was “their best option for success in the Russian market, no matter their industry. Enforcement of labeling requirements for light industry products began in January. Regulations for dairy are due to go into effect in July, September, and December. Rules for bicycles are also set for September. Recently announced pilots for beer and food additives are slated to start next month. There’s always a lot going on in Russia, and our team is always prepared to help.”

For more information about rfxcel’s solutions for Russian compliance and the rfxcel Traceability System, contact Vice President of Marketing and Strategic Initiatives Herb Wong at hwong@rfxcel.com and visit rfxcel.com.

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.

 

 

rfxcel Adopts Open Credentialing Initiative (OCI) to meet DSCSA Authorized Trading Partner (ATP) requirements

Reno, Nevada, March 24, 2021 (EINPRESSWIRE). rfxcel, a global leader in digital supply chain traceability solutions, today announced that it would use the Open Credentialing Initiative (OCI) to help customers comply with the upcoming authorized trading partner (ATP) requirements of the U.S. Drug Supply Chain Security Act (DSCSA).

By November 27, 2023, only ATPs will be permitted to exchange information in the U.S. pharmaceutical supply chain. To test the OCI solution’s effectiveness in meeting this requirement, rfxcel joined the OCI ATP pilot, initiated and supported by key industry participants, including manufacturers, a wholesaler, and a dispenser.

In the pilot, rfxcel partnered with SAP to test the OCI solution, which was built using Spherity’s identity wallet and Legisym’s identity/license verification service. It is based on open, published standards that can be implemented by providers and avoid “vendor-lock” to ensure independence and interoperability.

“Although rfxcel continues to evaluate other ATP solutions, this is the most mature and comprehensive in the industry,” said rfxcel Vice President of Marketing and Strategic Initiatives Herb Wong. “rfxcel has been championing DSCSA initiatives for years, and we actively partner with others to ensure DSCSA readiness by 2023. We were impressed to see how seamlessly the OCI solution integrated with our own. Once we received the specs, it took us only one week to implement the solution and begin testing. The support we received from Spherity and Legisym was outstanding. By any measure, the pilot was a success, and rfxcel is excited to offer OCI to our customers.”

Georg Jürgens, Spherity’s manager of industry solutions, said digitalizing ATP verification enables use cases that go beyond DSCSA regulations. “That’s just the tip of the iceberg,” he said. “We envision that trading partners won’t have to manually verify their new business partners’ process and can leverage ATP credentials in other ways, such as order to cash or drop shipment processes. Plus, the provided enterprise identity wallets and credentials will change the way trading partners digitally interact with each other. Decentralized identifiers and verifiable credentials solutions have the potential to be used and adopted as well in other supply chain use cases.”

“When approached by the Healthcare Distribution Alliance, Legisym was thrilled to take part in the DSCSA ATP pilot and work alongside industry participants and industry service providers,” said Legisym President David Kessler. “Through collaboration, forward thinking, and innovation brought to the table by all involved, the pilot team designed a successful solution to answer all requirements and guidelines. As a regulatory compliance technology solution provider, Legisym’s focus and experience in both the highly regulated Controlled Substance Ordering System space and the complex nuisances and inconsistencies trading partners are met with when attempting to verify state-level licensing among different Boards of Pharmacy lead to a natural fit for us to engage in the role of a credential issuer.”

For more information about the OCI and rfxcel’s solutions for DSCSA compliance, contact Vice President of Marketing and Strategic Initiatives Herb Wong at hwong@rfxcel.com and visit rfxcel.com.

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.

About Spherity

Spherity is building decentralized digital identity management solutions to power the fourth industrial revolution, bringing secure identities to enterprises, machines, products, data and even algorithms. We provide the enabling technology to digitize and automate compliance processes primarily on highly-regulated technical sectors like pharmaceuticals, automotive and logistics. Spherity’s decentralized cloud identity wallet empowers cyber security, efficiency and data interoperability among digital value chains. Spherity is certified according to the information security standard ISO 27001.

About Legisym, LLC

For over a decade, Legisym, LLC has successfully provided the pharmaceutical industry with affordable and effective regulatory compliance technologies. In early 2020, driven by the 2023 authorized trading partner (ATP) requirements, Legisym began leveraging their existing Controlled Substance Ordering System (CSOS) and license verification technologies and experience, to engage as a credential issuer. By performing thorough credential issuer due diligence processes, first to establish a root of trust, Legisym promotes confidence in the trading partner’s digital identity prior to the issuance of all ATP credentials.

Food Traceability Gets Precise: The State of the Art

In recent years, the food industry has been under increasing pressure to trace products from farm to table. When COVID came onto the scene, the need for food traceability only intensified, as consumers wanted assurance from retailers and their supply chain partners that they could rely on the safety of their food.

Food traceability, however, is only as good as the degree to which it is executed up and down the supply chain. In order to improve supply chain management, facilitate feedback for food quality and safety, and differentiate your food product from your competitors’, you need to get precise in your traceability efforts.

Precision food traceability

Precision food traceability refers to the in-depth tracing of supply chain data and critical tracking events (CTEs) backward (to the source of the product) and forward (everywhere a food product has been used) to facilitate the quick and effective review of every action taken related to a product at each stage. With the ability to pinpoint a particular food product’s movement and characteristics, precision traceability not only offers detailed information about a product’s freshness, nutritional values, and logistics, it also supports proactive, informed decision-making should a food safety event occur.

Serialization is an essential tool in a precision food traceability system. The process of creating a unique code for each product, serialization delivers granular data about the food product to provide significantly more end-to-end visibility. With the ability to track the product at every stage, item-level traceability makes it easy to capture key data elements (KDEs), which could be used to trigger an investigation and reduce traceback time in the event of a food safety issue.

For example, let’s say you want to track a harvest operator’s location beyond the primary farmer and farm. Serialization gives you access to data down to the person who picked a vegetable, and from which row, ranch, or plot. For meat products, you can quickly trace back to not just the exact animal, but also to its pen location, feed, and even medicines.

With the ability to track outcomes (e.g., quality inspections and safety test results) and associate them to the product beyond the original facility, you can look back at any event in a product’s lifecycle even after it’s been shipped from the original facility. Precision food traceability makes it possible to track customer feedback and connect it to supply chain data points to deliver a complete picture of the product’s safety and performance. You can also evaluate how you’re doing on a sustainability front by tracking post-consumer activity, such as recycling and waste.

Specific uses for precision food traceability

On its journey from farm to table, a food product may be exposed to disease-causing organisms and food safety hazards. As the volume of international trade expands, so does the potential for transmission of pathogens or chemical contamination.

We all know problems can arise anywhere in the supply chain. Containing ingredients — perhaps from all over the world — and processed in different facilities and handled by wholesalers, retailers, and transportation companies, a food item is handled by many actors before ending up on the consumer’s plate. A precision food traceability system is paramount to ensuring food safety and minimizing the impact should an event arise.

Precision food traceability makes it easy to investigate food safety issues, identify the source of contamination, assess the scope of impact, and resolve the problem quickly. With the ability to trace back to the health of the animal, feed production, rearing, transportation, and more, you can quickly identify the source of infection or prohibited additives and take preventive and control measures to avoid the introduction of the contaminant.

Beyond safety, precision traceability also supports profitability. With detailed food traceability data, you can intelligently evaluate your operations, optimize efficiencies, analyze yield, and even apply consumer feedback to measure return on production investment. Precision traceability can also reduce food waste by tracking and recording data through every stage of the supply chain.

Final thoughts

Maintaining food safety is critical to your overall success and, more important, consumer health. The better and more precise your tracing system, the better equipped you will be to isolate the source of an issue and address quality control problems, quickly and efficiently. By minimizing the production and distribution of substandard and perhaps even illegal products, you reduce the risk of recalls, negative publicity, and liability, and have a “firewall” to protect your brand in the process.

Keeping tabs on every event related to your food supply can seem daunting but rfxcel can help. Offering the most complete and flexible raw materials and finished goods traceability solution in the food and beverage industry, we can help optimize your supply chain operations, meet compliance requirements, track products, and increase business value.