September 2019 - rfxcel.com
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FDA Delays Enforcement of DSCSA Saleable Returns Verification Requirement

September 23, 2019: In a policy document released today, the FDA announced that it did “not intend to take action against wholesale distributors” that do not meet the Drug Supply Chain Security Act (DSCSA) Salable Returns Verification Requirement before November 27, 2020.

This is a 1-year delay; the original deadline for wholesale distributors to verify a product identifier before further distributing a returned product was November 27, 2019 — barely two months away.

Why the FDA Delayed the Saleable Returns Verification Requirement

The FDA has received comments and feedback from wholesale distributors and other stakeholders “expressing concern with industry-wide readiness for implementation of the verification of saleable returned product requirement for wholesale distributors.” Specifically, stakeholders were concerned about the following:

    • Large volume: Verification of saleable returns will involve “very large volume of saleable returned product requiring verification.” This statement points to the need to ensure testing with higher volumes across all VRS participants (see next bullet).
    • More testing: More testing is required with higher volumes “during actual production.” The specific FDA language identifies the “need to refine and test verification systems during actual production using real-time volumes of saleable returned product rather than simply in pilots.
    • Interoperability readiness: This highlights the “the complexities of building an interoperable … system … amid immature technologies.” In short, the VRS is new and there are multiple participants that must be tested together.

More Time to Comply but Don’t Delay

The FDA has essentially granted a 1-year grace period, recognizing that some wholesale distributors — as well as their trading partners — simply won’t be ready to verify returned products by the original November 2019 deadline. This is good news for the industry, but efforts to implement VRS must not be delayed.

The FDA’s decision for the enforcement delay gives the industry time for more testing “during actual production using real-time volumes.” The implied understanding is that the industry will use the extra time to test more production-like scenarios. Companies that continue with their planned implementation efforts will benefit from the continued testing; companies that wait will not benefit from the extended test cycles and (like previous delays in enforcement) will end up competing for limited resources when the new deadline approaches.

The FDA announcement also indicated it was “aware that several pilot participants are in the early stages of developing and testing interoperable, electronic systems to enable verification and achieve interoperability between networks.” rfxcel is a key driver in the FDA pilots and has been approved to run a pilot to quantify the readiness of the VRS ecosystem. Our commitment to the industry to ensure readiness remains steadfast, and we will use this time to step up our testing efforts with our customers and the industry.

DSCSA Requirements That Are Not Affected by Today’s Announcement

The FDA made it clear that wholesale distributors and other stakeholders must still meet other DSCSA requirements:

    1. Wholesale distributors must still have verification systems in place to determine if a returned product is a “suspect product.”
    2. Beginning November 27, 2019, wholesale distributors must still ensure that the products they deal with are encoded with a product identifier.
    3. Manufacturers must still fulfill their verification obligations when they receive a verification request from a wholesale distributor.
    4. Beginning November 27, 2019, wholesale distributors can accept a returned product from a dispenser or repackager only if it can associate the product with its specific transaction information and transaction statement.

Furthermore, the revised policy does not apply to “returns of saleable packages and sealed homogeneous cases of product without product identifiers that were in the pharmaceutical distribution supply chain before November 27, 2018.”

Be sure to check back for more news and updates. rfxcel is the pharma industry’s thought leader on VRS and the longest-tenured track and trace provider in the life sciences. You can trust us to give you expert guidance on what to expect with the VRS, as well as all aspects of DSCSA compliance.

 

rfxcel VP to Speak on Serialisation at PPMA Total Show 2019

September 24, 2019 –  rfxcel, the global leader in supply chain track and trace solutions, today announced that Vice President of International Business Mark Davison will participate in a panel discussion at PPMA Total Show 2019, the leading UK show for processing and packaging machinery. Mark will share his expertise in serialisation technology and the benefits environmental monitoring solutions can bring to companies with specific supply chain tracking needs.

rfxcel is a track and trace software provider with leading-edge solutions to help organizations track their entire supply chain, meet regulatory compliance requirements, and protect product and brand reputations.

Mark is responsible for rfxcel’s business activities outside the United States. An expert on anti-counterfeiting and traceability, he has 13 years’ experience with supply chain technology in multiple industries worldwide. Before joining rfxcel, Mark was an R&D biochemist for GSK and held commercial roles with consulting and biotech firms. He is the author of Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs.

PPMA Total Show 2019 will be held 1-3 October 2019 at the National Exhibition Centre (NEC) in Birmingham. Occurring every three years, it is the UK’s largest processing and packaging machinery exhibition. More than 400 exhibitors and 1,600 brands are expected from industries including food, beverage, pharmaceuticals, household products and toiletries, building materials and supplies, pet care, micro-brewery and distilleries, fast-moving consumer goods, and contract packers. Exhibitors will showcase the very latest products and solutions in processing and packaging machinery, robotics, and industrial vision systems.

During the panel discussion, Mark will explore topics such as why compliance with the Falsified Medicines Directive (FMD) isn’t the end of the journey for companies with serialisation requirements, and how these companies can make the most of real-time monitoring and traceability solutions. The panel will take place at 12pm on Tuesday 1st October as part of the show’s Enterprise Zone.

‘I’m excited for this opportunity to speak next month at PPMA Total Show 2019’, Mark said. ‘Serialisation and traceability are a key part of the packaging of many products, particularly in the pharmaceutical and food and beverage industries, so it’s important for companies to know exactly how they can maximise the utility of their track and trace solutions.’

 

About rfxcel

Founded in 2003, rfxcel is the first company to focus on safety of pharmaceutical supply chain and bring advanced track and trace software to manufacturers, repackagers, wholesalers, distributors, and dispensers. rfxcel’s mission is to be the thought leader in traceability technology, and to enable customers to better manage their business today and deliver value tomorrow. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs. rfxcel is headquartered in the USA and has offices in the EU, Latin America, India, Russia, the Middle East, Japan, and the Asia-Pacific region.

 

CONTACT

Herb Wong, VP of Marketing

hwong@rfxcel.com

+1 925-824-0300

rfxcel MobileTraceability App for Food and Beverage: Mobile Data Capture from Virtually Any Location and the Power of a Digital Supply Chain

rfxcel MobileTraceability App for Food and Beverage: Mobile Data Capture from Virtually Any Location and the Power of a Digital Supply Chain

We want to remove all boundaries from the food and beverage supply chain. And our new and improved rfxcel MobileTraceability application does just that.

rfxcel MobileTraceability lets you capture vital data and events no matter where you are — including places that traditionally may not have been visible in supply chains. Furthermore, it brings the power of a digital supply chain, moving you away from paper records and streamlining your operations.

The app integrates the power of our signature Traceability System (rTS) with the built-in scanning capabilities of mobile devices and scanners. It brings our industry-leading track and trace capabilities to virtually any location — farms and fields, distribution centers, warehouses, and even markets.

Rich data can now be created and accessed in a timely manner by the people who need it most. For maximum flexibility, rfxcel MobileTraceability supports multiple platforms, from ruggedized devices with optimized scanners to consumer devices with built-in cameras, such as smartphones. Now you can select devices that meet your needs and budget without comprising on performance.

The app not only adapts to any workflow, but can transform how companies manage their supply chains. Critical tracking events and key data elements can be added to a product’s record. For example, users can add a photo or use the app to capture quality inspections to enrich the data associated with any product as it moves from harvest in the field to the shelves at a market.

Other key features include:

  • Role-based access to the system for unlimited users helps manage accountability
  • Assign a unique number to a new raw material used in production
  • Record data about raw materials, including batch number, supplier, date of arrival, expiration, and analytics
  • Track any batch, movement, and handler
  • Change the status of a raw material (e.g., expired, consumed) and notify the user(s) responsible for purchasing more
  • Use the search function to quickly locate any item in your system (lot, case, unit)
  • Track any ingredient that’s part of a finished good

Today’s food and beverage supply chain is complicated. It has unique demands, and a one-size-fits-all approach just won’t work. Our MobileTraceability app allows us to be as flexible as you need us to be and to deliver granular visibility anywhere your supply chains goes. Contact us today to learn more about what the app can do for you.

Vantage Solutions Supports rfxcel FDA Pilot for VRS

Vantage Solutions, a provider of manufacturing efficiency solutions, is supporting the Food and Drug Administration (FDA) Pilot for Verification Router Service (VRS) testing sponsored by rfxcel.
The FDA-approved pilot is structured to enable transparency and open testing. The final report to the FDA will publish aggregated results of the testing. Vantage will be providing independent oversight of test execution and aggregation of the results. The company will generate a report summarizing the results of the testing. Vantage has deep experience working with a variety of track and trace equipment and solution providers on Level 1 through 4 systems, giving the company a broad and unbiased perspective on the implementation and evaluation of the pilot testing. Vantage looks forward to contributing to the pilot and helping support industry to effectively comply with the FDA’s DSCSA requirements.”We are overwhelmed by the positive response from many VRS stakeholders to the FDA Pilot,” said Herb Wong, rfxcel’s executive sponsor for the FDA pilot. “Vantage’s independent review of the results will give added confidence regarding the testing. Their commitment to this effort highlights Vantage’s commitment to the industry. rfxcel looks forward to the insight and leadership they will provide to the FDA pilot.

Read more on Contract Pharma

rfxcel Announces Updated MobileTraceability App for F&B

Reno, NV, September 18, 2019. rfxcel, the global leader in supply chain track and trace solutions, today announced that it will release new and improved features on its MobileTraceability application for food and beverage organizations. MobileTraceability integrates the power of rfxcel’s signature Traceability System (rTS) with the built-in scanning capabilities of mobile devices and scanners.

The mobile app empowers users working in a broad range of locations, from enclosed sites such as warehouses to external sites such as farms and fields. Track and trace data can now be accessed in a timely manner by the people who need it most. To give organizations maximum flexibility, the MobileTraceability app supports multiple platforms, from ruggedized devices with optimized scanners to consumer-grade devices with built-in cameras. Now companies can select devices that meet their needs and budgets.

New features include recording of information via quick scans of products; packing of trays, cases, pallets, and shipments; reporting of shipments and receipts at the source; extensive views and reports to track and trace data; and custom events and workflows for quality inspections.

“Our new MobileTraceability app brings rfxcel’s industry-leading track and trace capabilities to virtually any location, including places that traditionally may not have been visible in supply chains,” said rfxcel CEO Glenn Abood. “It’s perfect for the food and beverage industry, where real time tracking and traceability is key to brand success, but users in any industry will find that it enhances supply chain operations and security.”

Abood said the app not only adapts to any workflow, but can transform how companies manage their supply chains. Critical tracking events and key data elements can be added to a product’s record. For example, users can add a photo or integrate a quality inspection to enrich the data associated with any product as it moves from harvest in the field to the shelves at a market.

“The modern food and beverage supply chain is complicated,” Abood added. “It has unique demands, and a one-size-fits-all approach just won’t work. Our MobileTraceability app allows us to be as flexible as our customers need us to be and to deliver granular visibility anywhere their supply chains go. We’re very excited to be able to offer this solution.”

To learn more about rfxcel’s new MobileTraceability app or the company’s other innovative track and trace solutions, contact Vice President of Marketing Herb Wong or visit rfxcel.com.

 

Herb Wong, VP of Marketing

hwong@rfxcel.com

925-824-0300

 

About rfxcel

rfxcel is a track and trace software provider with leading-edge solutions to help organizations track their entire supply chain, meet regulatory compliance requirements, and protect products and brand reputations. For the last 15 years, manufacturers, wholesalers, distributors, and dispensers have trusted rfxcel to provide complete compliance and traceability solutions. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs. The company is headquartered in the United States and has offices in the EU, Latin America, India, Russia, the Middle East, Japan, and the Asia-Pacific region.

Russia Serialization Update: Changes to Crypto Code Requirements and Packaging

Note: This is an update to a September 2018 blog post about Russian serialization requirements. 

Russia has made some important changes to its pending pharma serialization regulations, set to take effect in January 2020. Decree No. 1118 of August 30 amends the procedure for applying drug labeling codes.

The most significant change concerns the length of the crypto code required on all medicine packaging: It has been cut in half, from 88 to 44 characters. The decree also removes the option of adding a batch number and expiry date. The upshot is that the data matrix will be less unwieldy for packaging and labeling processes without sacrificing security.

Russia’s Federal Service for Surveillance in Healthcare (Roszdravnadzor) developed the methodology for applying abbreviated codes. More than 30 pharmaceutical companies have tested applying revised codes, demonstrating that they simplify the process of setting quality and print speed parameters.

The second change concerns packaging logistics. Russian regulations stipulate that packaging must have “inseparability.” In other words, you should not be able to remove a code from packaging without damaging the packaging. Under the new guidelines, companies can opt to affix codes on packaging at a printing facility instead of on the production line.

Decree No. 1118 also explains why codes may be withheld from a license holder. These include if Russia’s track and trace system does not contain information about a drug or if a serialized Global Trade Item Number (GTIN) for which a crypto code is requested has already been used. The decree also provides reasons why codes would be canceled or invalidated.

Dmitry Alkhazov, Director General of Operations at CRPT, which is responsible for Russia’s Drug Circulation Monitoring System, said these changes improve the country’s serialization measures and “ensures [the] stability” of crypto codes.” He also said the decree was the result of coordinated efforts among stakeholders. “The entire regulatory framework is ready to launch the mandatory labeling of drugs. The development and adoption of these changes is the result of a constructive dialogue between the industry, the regulator, and operator[s].” Read more here.

Contact us today if you have any questions about Russia’s serialization regulations. Our team of experts working in Russia continues to grow, and they can help ensure you’re ready for January 2020, including the revised crypto code guidelines.

Get access to Serialization Requirements in Russia Webinar

Simplifying Russian Serialization & Crypto Code

The entire Russian pharma supply chain is about to change. It all started with bill No. 488-FZ, a part of Russia serialization regulation, signed by President Vladimir Putin.

The bill became law in January 2019. As implemented, the law calls for serialization codes to have a cryptographic aspect. In January 2020, serialization and crypto codes will become mandatory for all medicines imported into and traded inside Russia.

However, some in the pharma industry see it as problematic, including the representatives of the Association of International Pharmaceutical Manufacturers (AIMP). The law affects the entire global market, not only Russia. Therefore, it’s important to understand the serialization and crypto code requirements.

What is Russian Pharma Serialization?

Russia’s pharma serialization requirements are extremely complex. Other than being designed to protect consumers, Russia’s regulations are completely different from laws in other countries.

Every serialization law clearly defines unique product identification (UPID). The Russian serialization law requires every medicine that enters the country’s supply chain to have UPID. However, the Russian UPID consists of two parts: a serial number and a Global Trade Item Number (GTIN). On top of that, it has a two-part crypto “tail ” that makes it even more secure.

Defining Russian Crypto Code

Russia’s crypto code adds another layer of security to the UPID. It is designed to make the UPID safer and completely remove the risk of error from processes within the supply chain. Russian crypto code is actually a crypto tail comprising an electronic signature and a verification key.

The electronic signature is a sequence of 44 characters. The characters can be special symbols, numbers, and uppercase and lowercase letters. The verification key has four numbers and uppercase and lowercase letters.

This crypto code greatly mitigates the risk of error and makes it very difficult for counterfeit medicines to enter the supply chain. During the verification process, a medicine’s legality is established through the serial number, GTIN, electronic signature, and verification key. This data is nearly impossible to forge, guess, or reproduce.

The Impact of Russian Crypto Code on the Pharma Industry

Russia’s serialization and crypto code requirements are going to have a huge impact on the pharma industry. Such sweeping and complex changes tend to disrupt the supply chain if manufacturers and wholesale suppliers don’t work out a verification system that can process verification requests in real time.

Adding a crypto tail means an additional 48 characters have to be encoded into the data matrix. This means there will be new print and verification requirements. Furthermore, manufacturers will have to invest in equipment that can print the data matrices and verification systems that can read them.

How to Prepare

Wholesale suppliers and manufacturers can prepare by investing in printers and verification systems that can meet the new standards. Serialization is important to Russia — it’s being extended beyond the pharma industry to almost all product groups — so having the right equipment is vital to keep doing business there.

End-to-end traceability solutions also come into play, as they can be used to meet the new serialization and crypto code requirements. No matter what role your company plays in the supply chain, it would be smart to take the initiative and talk with your partners.

To ensure compliance with Russian serialization regulations, everyone in the supply chain has to work together. Contact rfxcel today to learn how you can get ahead of the curve!

How VRS Can Help the Pharma Industry Prep for the November DSCSA Deadline

The next deadline for the Drug Supply Chain Security Act (DSCSA) is November 27, so the clock is ticking for the pharma industry. To meet the DSCSA’s Saleable Returns Verification requirement, wholesale distributors (WDs) must initiate a verification request to verify returned products before reselling them, and manufacturers that receive a verification request must provide a verification response within 24 hours.

Though time is short, there is a solution: The Verification Router Service (VRS). Before we talk about that, let’s quickly see what the new DSCSA Saleable Returns Verification requirement is all about.

What Is the DSCSA Saleable Returns Verification?

Pharmaceutical manufacturers and WDs must constantly deal with saleable products that have been returned. Starting in November 2019, things will change.

The DSCSA Saleable Returns Verification requires WDs to verify the serialized product identifiers on returned products before reselling or restocking them. As we said above, when WDs submit a verification request, manufacturers must provide the verification response within 24 hours.

However, because of projected return volumes, the Big 3 and other WDs need manufacturers to provide verification responses almost instantaneously — at the sub-second level. So, in a few short months, manufacturers and WDs will have to be able to minimize the operational impact of the Saleable Returns Verification by leveraging the VRS.

What Is the Verification Router Service?

The VRS was initiated by the Healthcare Distribution Alliance (HDA) with feedback from the pharma industry. It is an automated service that verifies if a Product Identifier (PI) is valid. A PI has four components: a Global Trade Item Number (GTIN ), a unique serial number, a lot ID, and an expiration date.

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

Interoperability standards help streamline communication within the VRS network by helping all parties structure data properly and ensure it is error-free. Thanks to VRS, everyone in the pharmaceutical supply chain can exchange data quickly and securely and verify a product’s validity for sale. Ultimately, this will promote the safety of patients and consumers, and ensure the authenticity of products.

rfxcel Is Helping Companies Prepare for Deadlines

rfxcel is the industry thought leader in VRS. We extended the testing of VRS and are implementing a pilot program for the U.S. Food and Drug Administration (FDA). Applying our expertise in supply chain track and trace, serialization, and compliance solutions, we are helping the pharma industry prepare for the November DSCSA Saleable Returns Verification deadline.

We’re doing this by keeping testing completely transparent. In fact, we’re sharing pilot deliverables with all VRS providers, including WDs, manufacturers, repackagers, national/regional pharmacies, and dispensers. On top of that, rfxcel will collaborate with VRS providers to ensure that test conditions are viable.

Over the course of the last couple of months, we have learned a lot of valuable lessons from testing our VRS to help you meet DSCSA. For more information on how you can be ready for the November deadline, contact us today!