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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: Top EPCIS Questions, Answered

When will companies start sending EPCIS? If a solution provider supports DSCSA compliance, why do users need to do anything other than ensure their products are aggregated? 

These were among the questions people asked at our second “DSCSA 2023” webinar last month, “ASN to EPCIS: Industry Change, Your Challenge.Herb Wong, rfxcel VP of Marketing and Strategic Initiatives, was the host, and we share his answers to the most-asked questions below.

Check back tomorrow, because we’ll be posting the top questions from the third and final webinar in the series, “Authorized Trading Partners: The OCI Solution.” You can also read our answers to the top questions from the first webinar, The Verification Router Service: Aligning to the Standard.

If you have other questions or want more details about DSCSA 2023, contact us today. Oh, and you can watch the entire “DSCSA 2023” webinar series and download the presentation slides here.

When will companies start sending EPCIS?

It has already started. However, the industry hasn’t achieved the volume it will need for 2023 (or right now, for that matter). There aren’t exact figures of the current volume of returns supply chain stakeholders (e.g., manufactures and wholesale distributors) are generating, but we do have anecdotal information from one of the Big 3 that they’re getting only about 10 percent. That data is a few months old, though, and that number could have increased. But overall, the industry needs to continue boosting the volume.

If a solution provider supports DSCSA compliance and industry (e.g., HDA) requirements, why do users need to do anything other than ensure their products are aggregated? 

A DSCSA solution should ensure you’re compliant and adhering to industry standards. But there’s more to it than that. For example, a solution provider needs permission from a manufacturer to send its serialized data; however, some manufacturers have chosen not to send this data, even though they have the means to do so. Right now, it’s important to be sending this data so solution providers can continue to work with the industry to ensure that all the data entering the system is clean and the VRS is working well.

So, it’s not that a solution provider can’t handle this for you. The issue is that providers need their customers to agree to send the information and communicate with their trading partners to make sure everyone’s on the same page. This needs to occur throughout the supply chain (e.g., as manufacturers send data to wholesale distributors and wholesale distributors send data to dispensers). Also, dispensers need to be able to receive the data. It’s all about communication and coordination.

What is the vision for the Center of Excellence? Will membership be open to everyone in the industry at no cost, or will membership be limited to certain organizations?

The current vision is that there will be no fees. The intention is to facilitate broader coordination among all participants to encourage data to flow through the system and to build an optimal method for resolving issues. As for membership, the reality is there has to be coordination with certain groups, because it will be difficult to succeed without some sort of organization to “rally around.” In all likelihood, the Center of Excellence will probably be coordinated through the Healthcare Distribution Alliance (HDA). But even if you’re not an HDA member, that shouldn’t preclude you from participating.

What about transformation of events of inbound to outbound serial numbers for 2023 requirements?

Here, “transformation” means, for example, sending a pallet to a wholesale distributor who then “transforms” it by opening a case and sending individual products downstream (e.g., to a dispenser). The vision is to have each entity that transforms — unpacks and repacks — products to manage that process inside their own organization. The role of EPCIS is to handle the actual communication of every transformation. It’s important for the industry to understand and be able to verify every transformation event, and EPCIS is the tool that makes this possible.

In terms of repackaging, an example would be if a company puts different medicines (with different SKUs) together in a new configuration, or package, that meets a certain need (e.g., a combination of pills to treat a specific condition). In that process, the repackager must issue a new serial number that would have to be DSCSA-compliant in terms of EPCIS data flow.

These are the kinds of scenarios the industry needs to flesh out and be ready for by 2023.

More DSCSA 2023 resources from rfxcel

rfxcel, Part of Antares Vision Group, and MVC Launch the Traceability Hub for the Kingdom of Bahrain to Track End-to-End Pharma Supply Chain

Travagliato (Brescia), June 3, 2021 (MarketScreener). Antares Vision Group, the international leader in the pharmaceutical sector for track and trace hardware and software solutions (anti-counterfeiting and supply chain transparency), with an established presence in inspection systems (quality control), and active in smart data management (production efficiency and end-to-end supply chain digitalization, from raw materials to the final consumer), announced today that its subsidiary rfxcel has successfully implemented an end-to-end Traceability Hub to monitor and secure the Kingdom of Bahrain’s global pharmaceutical supply chain process. The initial value of this contract is approximately 4-6 percent of Antares Vision FY 2020 pro-forma revenues.

Bahrain’s National Health Regulatory Authority (NHRA) and Supreme Council of Health selected Medical Value Chain (MVC) and its partner rfxcel to provide the first GS1-compliant system to track its entire pharmaceutical supply chain on a blockchain platform. The end-to-end Traceability Hub delivers complete visibility into every node of the Kingdom’s supply chain, from the manufacturer of origin, importers, wholesalers, and distributors to pharmacies, clinics, and hospitals — all the way to individual patients.

The objective of the NHRA Bahrain Traceability Hub is to achieve following:

  • End-to-end traceability for all medicine imports to Bahrain
  • Bahrain pharma supply chain to meet the global track and trace requirements and GS1 standards
  • Complete visibility and repository of medicine inventory and supply-chain info from manufacturers to agents/importers to wholesalers/distributors to pharmacies/hospitals and to patients/consumers
  • Increase patient safety
  • Detect and stop counterfeit medicines
  • Analytics of medicine imports and consumption in Bahrain
  • Manage product recalls and shortages efficiently and quickly

Glenn Abood, rfxcel CEO, said, “The end-to-end Traceability Hub offers an array of other benefits for all pharmaceutical supply chain stakeholders. The Hub is the first of its kind in the Gulf Cooperation Council. It creates a single source of truth for all medications, which means improved patient safety, better flow of information, and more accurate inventory management. It is also a powerful tool to prevent counterfeit and substandard drugs from reaching the market.”

Emidio Zorzella, Antares Vision Group CEO, said, “I am honored that the Kingdom of Bahrain chose Antares Vision Group in partnership with MVC to secure and optimize its pharma supply chain. In the near future, we expect to announce national traceability hubs in other countries to track pharmaceutical, agricultural, and consumer products.”

MVC President Leo Giacometto said, “When we set up our company to provide a blockchain-enabled track and trace platform to provide customs clearances and supply chain financing, we needed the absolute best track and trace solution and most experienced team in the market; that is rfxcel, now part of Antares Vision Group!”

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, 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. 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

Listed since April 2019 on the Italian Stock Exchange in the AIM Market, and from 14 May 2021 on Mercato Telematico Azionario (MTA) STAR segment, the Antares Vision Group guarantees protection of products, people and brands through inspection systems for quality control, Track & Trace solutions for anti-counterfeiting and supply chain transparency, smart data management tools for maximized efficiency and digitalization of the supply chain, from raw materials to the final consumer. The Antares Vision Group is active in the pharmaceutical market and in Life Science in general (biomedical devices and hospitals), in beverage, food, cosmetic and in consumer-packaged goods. The Group reaches over 60 countries in the World with complete and flexible solutions, hardware, and software, with related services and counts 7 production facilities in Italy (Brescia, Parma, Piacenza, Latina, Padua and Vicenza), 22 foreign subsidiaries (Germany [2], France [2], USA [5], Brazil [2], United Kingdom [2], India, Russia [3], Hong Kong, China, Ireland, Croatia and Serbia), 3 Innovation and Research Centers (Italy) and a worldwide network of more than 40 partners. Thanks to the twenty years of experience in vision technologies of the two founding partners, the Antares Vision Group is the supplier of 10 out of 20 leading pharmaceutical companies in the world, with more than 25.000 inspection systems, that ensure everyday product safety and quality, 6.500 quality controls and more than 3.500 serialization modules on lines installed all over the. With the aim of continuing and supporting the growth and development strategy, during 2019 participation agreements were finalized with T2 Software, a Brazilian company specialized in smart data management solutions, and Orobix, an Italian company leader in artificial intelligence services, as well as the acquisition of 100% of FT System, leader in control and inspection in the beverage sector. In 2020, Antares Vision acquired 82.83% of Tradeticity, a Croatian company specialized in software management of traceability and serialization processes, 100% of Convel, an Italian company specialized in automated inspection machines for the pharmaceutical industry, the assets of Adents High Tech International, a French company specialized in software for serialization and traceability, 100% of Applied Vision, a global leader in inspection systems for glass and metal containers in food beverage. In March 2021, Antares Vision acquired 100% of rfxcel Corporation, specialized in software solutions for digitalization and supply chain transparency based in the U.S., and 100% of Pen-Tec and Tecnel, through FT System, increasing specialization in Food & Beverage inspection sector. In 2019 Emidio Zorzella and Massimo Bonardi won the Ernst & Young “Entrepreneur of the Year” award for innovation.

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

RFXCEL

Herb Wong, Vice President of Marketing and Strategic Initiatives

Tel.: +1 925-791-3235

E-mail: hwong@rfxcel.com

IR ADVISOR

IR Top Consulting

Via Bigli, N. 19

20121 – Milano

Tel.: +39 02 45473884

Maria Antonietta Pireddu: m.pireddu@irtop.com

Antonio Buozzi: a.buozzi@irtop.com

 

 

rfxcel DSCSA 2023 Webinar Series: Sneak Peek #1

Full serialization of the U.S. pharmaceutical supply chain is coming in November 2023. That may seem like a long way off, but time flies and it will be here before you know it. To help make sure you’re working toward that deadline and doing everything you can to be prepared, we’re hosting the rfxcel DSCSA 2023 webinar series on June 15, 16, and 17.

Our Executive Global Advisor Brian Files, an expert on U.S. and international pharmaceutical compliance, will present three key aspects of the DSCSA and answer your questions. Sign up today!

  1. Tuesday, June 15: The Verification Router Service: Aligning to the Standard
  2. Wednesday, June 16: ASN to EPCIS: Industry Change, Your Challenge
  3. Thursday, June 17: Authorized Trading Partners: The OCI Solution

Here’s a sneak peek about the DSCSA Verification Router Service (VRS). Check back for more sneak peeks leading up to Brian’s other presentations in our rfxcel DSCSA 2023 webinar series!

What is the DSCSA?

The DSCSA went into effect on November 27, 2013. It calls for product tracing, product identifiers (PIs), authorized trading partners, and verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers (pharmacies). As we said above, full serialization will begin in November 2023 (the 27th, to be exact).

What is the DSCSA saleable returns verification requirement?

Under the DSCSA saleable returns verification requirement, wholesalers must verify saleable returns before they can be reintroduced to the supply chain. This is done by verifying the drug’s PI, which comprises a Standardized Numerical Identifier (National Drug Code and a unique alphanumeric serial number), a lot ID, and an expiration date.

How does the DSCSA saleable returns requirement work?

A wholesaler must initiate a verification request (to a manufacturer) to verify the returned products. The manufacturer must provide a verification response within 24 hours. Wholesalers are called requestors and manufacturers are called responders.

The VRS and the DSCSA saleable returns verification requirement

The VRS enables the rapid, secure exchange of data between requestors and responders to meet the DSCSA saleable returns verification requirement. It’s an automated service that verifies if a PI is valid. A solution provider enables the verification requests to be routed between wholesalers and manufacturers.

Final thoughts

Be sure to join Brian on June 15 for “The Verification Router Service: Aligning to the Standard,” the first in our rfxcel DSCSA 2023 webinar series. Register today and submit your questions for Brian. You can also contact us to talk with one of our supply chain experts and see how our award-winning rfxcel Traceability System can ensure you comply with the saleable returns verification requirement and other key DSCSA requirements.

See you on June 15!

DSCSA 2023 Webinar_June 15-17

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.

What Does It Mean to Be a CRPT Partner in Russia’s Supply Chain?

The Center for Research in Perspective Technologies (CRPT) operates Russia’s National Track and Trace Digital System. Known as Chestny ZNAK, the supply chain system was established by Federal Law No. 425-FZ, signed on December 29, 2017. rfxcel has been prepared for these regulations since 2018, and is now an established CRPT partner.

Let’s take a look at what it means to be a CRPT partner, including the benefits it brings to our customers.

What is the CRPT?

The CRPT is a public-private partnership akin to the European Medicines Verification Organization. Its many responsibilities include generating the serial numbers and verification codes (i.e., crypto codes) required by Chestny ZNAK.

Business giant USM is the CRPT’s principal partner, with a 51 percent stake. USM was founded in 2012 and has interests in many of Russia’s key sectors, including metals/mining, telecom, technology, and internet. According to USM, Chestny ZNAK is the country’s first public-private partnership in the IT sector and the first of its kind at the federal level. Private investments totaling more than 200 billion rubles ($2.5 billion) are expected over the next 15 years.

rfxcel as CRPT partner

Last year, rfxcel earned official CRPT partner status in 10 of the 11 industries for which the organization has chosen partners: medications, footwear, tires, light industry, perfumes, dairy, bottled drinking water, bicycles, wheelchairs, and tobacco. Furthermore, we are the only official CRPT partner for several of these industries.

To be named a CRPT partner, a solutions provider must prove it can work with Chestny ZNAK, comply with its strict serialization requirements, and support companies that do business in Russia.

For example, to be named an official integration, software, and tested solution partner for medications, members of our 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.

What does being a CRPT partner mean for our customers?

The benefits we bring as a CRPT partner are pretty straightforward. First and foremost, we have proven that our signature rfxcel Traceability System integrates seamlessly with Chestny ZNAK and meets regulatory requirements for key industries.

Russian law calls for serialization, aggregation, unit- and batch-level traceability, crypto codes, and electronic reporting and records management. Our rfxcel Serialization Processing and Compliance Management solutions ensure you’ll comply with these mandated labeling and reporting requirements. Plus, our solutions have a Russian-language user interface that makes integration and start-up much quicker.

The other benefit of being a CRPT partner is that we’re trusted. The CRPT knows our solutions, knows our team in Moscow, and knows that we take compliance very seriously. They know our customers include major pharmaceutical and consumer goods brands. They know we’re committed to making the transformation of Russia’s supply chain smooth and effective, and support the mission “to guarantee the authenticity and declared quality of goods being purchased by customers.”

So, when you work with rfxcel in Russia, you’re working with a CRPT partner that is equipped to deliver quick integration and compliance today, tomorrow — always.

Sneak peek: another recent rfxcel accomplishment in Russia

We’ll share more details about this soon, but earlier this month we received accreditation as an IT company from Russia’s Ministry of Digital Development, Communications, and Mass Media. The Ministry develops and implements national policy and legal regulations for a range of industries, from telecommunications to Internet governance.

That’s all we’ll say for now. The official IT company accreditation is another reason why we continue to be the leader in Chestny ZNAK integration, operability, and compliance.

Final thoughts

We are proud of being an official CRPT partner. It’s proof that our software ensures companies in any industry will remain compliant while they do business in Russia.

Contact us today for more information about how we can help you succeed with Chestny ZNAK. And be sure to download our white paper about Russian compliance. Fully updated for 2021, including information about new pilots for beer and beer-based drinks and biologically active food additives , it’s an easy-to-understand guide to Russia’s strict supply chain regulations for every industry.

New Russian Serialization Pilot for Biologically Active Food Additives

A new Russian serialization pilot for biologically active food additives was announced last month. It’s scheduled to run from April 1 of this year to March 1, 2022.

The government has not said much beyond about the pilot. It has revealed a lot more about the Russian serialization pilot for beer and beer-based drinks, which it announced last October. Read our blog post about that to get all the details.

Let’s take a look at what we do know about the Russian serialization pilot for biologically active food additives. After that, we’ll give you a sneak peek at what we’re doing to make sure stakeholders in every industry regulated by Russia’s National Track and Trace Digital System, known as Chestny ZNAK, know exactly what to do to comply with the strict requirements.

Russian serialization pilot for biologically active food additives

As we said above, the Russian government hasn’t said much about the new pilot, which was formalized through a draft decree entitled “On Conducting an Experiment on the Labeling of Biologically Active Food Additives by Means of Identification in the Territory of the Russian Federation.”

Chestny ZNAK has shared a list of what products will be labeled and their corresponding Eurasian Economic Union Combined Nomenclature of Foreign Economic Activity (TN VED) codes. It’s also been reported that the Center for Research in Perspective Technologies (CRPT), which operates Chestny ZNAK, will provide equipment to pilot participants.

Here are the products that will be included in the Russian serialization pilot for for biologically active food additives. It’s a long list. Be sure to scroll down to our “Final Thoughts” to read about our plans for Russian supply chain compliance!

BIOLOGICALLY ACTIVE FOOD ADDITIVES

Pilot Dates: April 1, 2021–March 1, 2022

TN VED CodeDescription
1210 20 9000Oil seeds and oleaginous fruits; miscellaneous grains, seeds, and fruit; industrial or medicinal plants; straw and fodder
1212 21 000 0Locust beans, seaweeds, and other algae, sugar beet and sugar cane, fresh, chilled, frozen or dried, whether or not ground; fruit stones and kernels and other vegetable products (including unroasted)
1504 10 1000Fish liver oils and their fractions with Vitamin A content not exceeding 2500 iu/g
1504 20 900 0Other fish fats, oils, and their fractions, other than fish liver oils, other than solid fractions
1516 10 900 0Other animal fats and oils and their fractions
1517 90 990 0Other edible mixtures or preparations of animal or vegetable fats or oils or fractions of different fats or oils of this chapter, other than edible fats or oils
1702 90 950 0Other, including invert sugar and other sugar and sugar syrup blends containing in the dry state 50% by weight of fructose
1704 90 550 0Throat and cough lozenges not containing cocoa
1806 31 0000Other product containing cocoa, in blocks, slabs, or bars, filled
1806 32 100 0Cocoa and cocoa preparations (other preparations containing cocoa, not filled, but with added cereal grains, fruits, or nuts in blocks, slabs, or bars)
1806 32 900 0Other preparations containing cocoa, but not filled, in blocks, slabs, or bars
1806 90 700 0Preparations containing cocoa and intended for manufacture (preparation) of drinks
1806 90 900 0Other preparations containing cocoa
2101 12 920 1Preparations with a basis of extracts, essences, or concentrates of coffee
2106 10 800 0Other protein concentrates and textured protein substances
2106 90 590 0Other sugar syrups with flavoring or coloring additives
2106 90 920 0Other food preparations not containing butter fat, sucrose, isoglucose (i.e., high-fructose corn syrup), glucose, and starch, or containing less than 1. 5% by weight of butter fat, 5% by weight of sucrose or isoglucose, 5% by weight
2106 90 980 3Mixtures of vitamins and minerals for use as a balanced dietary supplement
2106 90 980 9Other food preparations not elsewhere specified or included
2106 90 9801Sugar- (sucrose) free chewing gum and/or with a sugar substitute product
2202 90 100 9“Others” under Code 2202: “Beverages and spirits and vinegar”
2202 99 190 0Other beverages not containing preparations of headings 0401 to 0404 or fat obtained from preparations of headings 0401 to 0404:

  • 0401: Milk and cream, not concentrated nor containing added sugar or other sweetening matter
  • 0402: Milk and cream, concentrated or containing added sugar or other sweetening matter
  • 0403: Buttermilk, curdled milk and cream, yogurt, kephir (a.k.a. kefir), and other fermented or acidified milk and cream, whether or not concentrated or containing added sugar or other sweetening matter or flavored or…
  • 0404: Whey, whether or not concentrated or containing added sugar or other sweetening matter; products consisting of natural milk constituents, whether or not containing added sugar or other sweetening…
2936 21 000 0Vitamins A and their derivatives
3002 90 500 0Cultures of microorganisms
3204 19 000 0Synthetic organic coloring matter and preparations based thereon, including mixtures of coloring matters of the subheadings 320411 to 320419:

  • 320411: Disperse dyes and preparations based thereon
  • 320412: Acid dyes, whether or not premetallized, and preparations based thereon; mordant dyes and preparations based thereon
  • 320413: Basic dyes and preparations based thereon
  • 320414: Direct dyes and preparations based thereon
  • 320415: Vat dyes (including those usable in that state as pigments) and preparations based thereon
  • 320416: Reactive dyes and preparations based thereon
  • 320417: Pigments and preparations based thereon
  • 320419: Tanning or dyeing extracts; tannins and their derivatives; dyes, pigments, and other coloring matter; paints and varnishes; putty and other mastics; inks
3503 00 100 9Other gelatin and its derivatives
3507 90 900 0Other prepared enzymes not elsewhere specified or included

Final thoughts

Our team in Russia fields many, many questions about Chestny ZNAK, and industries that must comply with the supply chain regulations. They love hearing from people and helping them understand the rules for doing business in Russia.

If you follow our blog (and we know you do), you know we’re the leader in Russian compliance. You also know we write a lot about Russian supply chain regulations. Most recently, we covered the pilot for beer, updated labeling requirements for cheese and ice cream products, and “notification mode” in the pharma supply chain. We also did a Chestny ZNAK refresher course.

So, when we heard about the Russian serialization pilot for biologically active food additives, we thought it was time to update our white papers for 2021. There have been a lot of changes over the last year. Deadlines have changed. Other pilots have ended. Requirements and process have evolved. We’re including all the latest information from Chestny ZNAK and providing much greater detail about products and requirements.

The papers — including Russian versions — be ready soon. We’ll let you know when they’re available. In the meantime, our 2020 white papers are still online. You can also visit our website for more information about our solutions for Russian compliance and contact our team in Moscow directly.

rfxcel Enters into Acquisition Agreement with Antares Vision Group

The combination of rfxcel’s industry-leading traceability software platform and Antares Vision’s solutions for intelligent track and trace will create significant value for customers.

Reno, Nevada, Feb. 19, 2021 (EINPRESSWIRE). rfxcel, a global leader in digital supply chain traceability solutions, today announced that it had entered into an acquisition agreement with Italy’s Antares Vision Group, a leading global provider of intelligent track and trace, inspection, and smart data management solutions for the life sciences and food and beverage sectors.

rfxcel CEO Glenn Abood said the agreement marked the start of an expansive era for the company he co-founded with Chief Strategy Officer Jack Tarkoff in 2003. “This is an exciting new chapter for rfxcel,” he said, “a time for the company and our customers to look to the future.

“Becoming part of Antares Vision Group will give us new ways to strengthen our relationships with our customers and provide them with enhanced solutions as they do their important work in the life sciences, food and beverage, consumer goods, and government industries. Plus,” Abood continued, “the integration of our companies’ capabilities will enable us to drive into new markets and geographies as the undisputed leader in supply chain track and trace solutions. It really is a ‘win-win’ for our global teams and our customers.”

The Antares Vision Group will leverage rfxcel’s capabilities and signature rfxcel Traceability System (rTS) software suite to help customers accelerate their transition toward digital and sustainable supply chains characterized by full transparency and visibility. Together, the companies will provide a full stack, end-to-end digital supply chain solution that will optimize and streamline customers’ operations while providing complete end-to-end visibility, from product ingredients and raw materials to the end customer experience.

rTS is a digital supply chain visibility platform comprising up to eight discrete solutions that work in concert to harmonize, optimize, automate, and monitor virtually every aspect of supply chain operations, including serialization, regulatory compliance, Internet of Things (IoT)-enabled monitoring, and raw materials and finished goods traceability. rfxcel also offers a Mobile Traceability app that extends the power of rTS to users at every node of the supply chain, from remote fields and warehouses to retail outlets.

Emidio Zorzella, chairman and CEO of Antares Vision, said he and co-founder Massimo Bonardi were “delighted” about the agreement with rfxcel. “Demand for traceability and serialized products and services has increased significantly over the last few years,” he said, “and this transaction accelerates our ability to offer best-in-class propositions in all our key reference sectors, life science and food and beverage. We look forward to welcoming the management and employees of rfxcel to the Antares Vision Group and working together to serve our customers across the world.”

Abood added that both companies shared the same goals and Antares Vision would help rfxcel accelerate its plans. “The rfxcel management team is delighted to join with Antares Vision to offer customers the most complete end-to-end solution for track and trace on the market today.”

For more information about the acquisition agreement or the companies’ solutions, contact Herb Wong, rfxcel’s 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.

About Antares Vision

Listed since April 2019 on the AIM Italia market of the Italian Stock Exchange, Antares Vision Group guarantees the protection of products, people and brands through inspection systems for quality control, track and trace solutions for anti-counterfeiting and supply chain transparency, smart data management tools for maximized efficiency and digitalization of the supply chain, from the point of production to the end consumer. The Antares Vision Group is active in the life science sector, including the pharmaceutical, medical device, and hospital segments, as well as in other industries, including, primarily, food and beverage, cosmetics, and in consumer-packaged goods. The Group reaches over 60 countries worldwide with complete and flexible solutions, hardware, and software, with related services: it has five offices in Italy (Brescia, Parma, Piacenza, Latina and Vicenza), 15 foreign branches (Germany [2], France [2], USA [3], Latin America [2], India, Russia, Hong Kong, China, Croatia, and Serbia), three Innovation and Research Centers (Italy) and a worldwide network of more than 40 partners. With the 20 years of experience in vision technologies of the two founding partners, the Antares Vision Group is the supplier of 10 of the 20 leading pharmaceutical companies in the world (by turnover), with more than 25,000 inspection systems, which ensure everyday product safety and quality, 6,500 quality controls, and more than 3,500 serialization modules on lines installed all over the world. With the aim of continuing and supporting the growth and development strategy, during 2019, Antares Vision finalized participation agreements with T2 Software, a Brazilian company specialized in smart data management solutions, and Orobix, an Italian company leader in artificial intelligence services, and acquired 100 percent of FT System, leader in control and inspection in the beverage sector. In 2020, Antares Vision acquired 82.83 percent of Tradeticity, a Croatian company specialized in software management of traceability and serialization processes, 100 percent of Convel, an Italian company specialized in automated inspection machines for the pharmaceutical industry, the assets of Adents High Tech International, a French company specialized in software for serialization and traceability, and 100 percent of Applied Vision, a global leader in inspection systems for glass and metal containers in food and beverage. In 2019, Emidio Zorzella and Massimo Bonardi won the Ernst & Young “Entrepreneur of the Year” award for innovation. For more info: www.antaresvision.com.