Pharma Whitepapers Archives - rfxcel.com
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Dispensers, the DSCSA, and the “3Ts”

The next DSCSA deadline for dispensers is just months away. Our white paper gets into the specifics of what dispensers will have to do to verify and authenticate drugs this November and what they’ve had to do in previous years. rfxcel has committed itself to creating educational materials about dispensers’ responsibilities under the DSCSA, including Web pages, flyers, webinars, and this white paper. If you want more information about your specific needs, please contact us today.

Russia Serialization for Pharma

This Russia serialization guide and white paper look at the massive changes coming to Russia’s supply chain, due to be completed by 2024. The transformation, designed to keep fake and substandard products out of the market, will have a huge impact on the pharmaceutical industry. For example, manufacturers and distributors must connect and comply with the National Track and Trace Digital System, Chestny ZNAK. All medications, including OTC medications, must be serialized, and there are special requirements regarding aggregation and separate serialization requirements for batches. Access this concise, easy-to-understand resource about the Russian pharma regulations.

For any other questions please reach out to our local experts:

Russia:
Victoria Kozlova
Director of Operations
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P: +7 985 7504284

USA:
Brian Bilyeu
VP of Sales
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P: +1 925 824 0300

Europe:
Simon Manley
Commercial Director
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P: +44 1223 926923

Latam:
Vinicius Bagnarolli
Commercial Director
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P: +55 11 97148 7826

India:
Arun Rao
Head of Business Development
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P: +91 982 063 9476

rfxcel VRS Pilot Program and Industry Update

rfxcel’s Verification Router Service (VRS) pilot began in mid-2018. rfxcel is the first solution provider in the United States to implement and pilot the Drug Supply Chain Security Act (DSCSA) verification solution for wholesale distributors and manufacturers. We now have test results and success to help trading partners meet the DSCSA requirements for 2019.

With a single 2D barcode scan, the rfxcel Verification Router Service (rVRS) solution verifies serialized products in 1 second. rfxcel follows the GS1 Verification Messaging standards. By following this messaging framework, which asks verification questions and receives actionable information, the requesting party is immediately able to determine whether to accept, reject, or quarantine a product instance. rVRS will ensure wholesale distributors and manufacturers meet the November 27, 2019, deadline for the DSCSA Saleable Returns Requirement.

This rfxcel webinar presents a full industry overview as of February 2019. If you would like to receive access to the webinar recording, please email us at rfxwebinar@rfxcel.com.

The webinar covers the following:

  1. Insight into the VRS
  2. Timeline/Updates on the VRS pilot
  3. Findings of rfxcel’s VRS pilot
  4. Industry Updates: What’s next for VRS?

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. rfxcel 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.

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DSCSA VERIFICATION ROUTER SERVICE (VRS) BASICS | rfxcel

DSCSA VERIFICATION: Starting in November 2020, the FDA will require wholesale distributors to verify the product identifier before re-distributing saleable returned products. By using the Verification Router Service (VRS), distributors will be able to rout the serialization data to manufacturers. In this case, when a saleable return is received, the distributor sends the product data to the third-party routing service, which then routes the information to the manufacturer.

Initiated by the Healthcare Distribution Alliance (HDA) with feedback from the pharma industry, the VRS is an interoperable solution used to manage the acceptance, formatting, and delivery of requests and responses to support DSCSA verification requirements and other business requirements as defined between trading partners.

In this webinar presentation document, you’ll learn about the VRS activities listed below. To get copy of the webinar recording, please email us rfxwebinar@rfxcel.com.

  • Accept information from an authorized requestor via an interface or manual entry using a VRS portal. This information is a called product identifier (PI).
  • The requester will provide the Global Company Prefix (GCP) or Global Trade Item Number (GTIN).
  • With the GCP or GTIN, you determine the routing location to where the verification will be submitted.
  • The verification request is sent to the responder’s master database/system directly or to a VRS used by the responder.
  • After the response is obtained, the requestor will be able to view the data and view an electronic record.

The idea is that when a return occurs, a distributor would scan the Data Matrix code, format, and send the verification request to the VRS provider. By the use of master data, which is called a Lookup Directory (LD), the request is routed to the right source. The verification request goes to the manufacturer to check if the PI is present, If it is present, the  request is verified; if it isn’t, then both parties need to investigate where the issue might be.

rfxcel is the industry thought leader in VRS. We extended the testing of VRS and implemented a pilot program for the U.S. Food and Drug Administration. 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.

3 Months to DSCSA Serialization Enforcement

With only 3 short months to go, all manufactures and repackagers need to be ready for the FDA’s DSCSA serialization enforcement. Drugs sold in the United States must comply with the FDA’s Drug Supply Chain Security Act (DSCSA) deadline to have item-level serialization affixed or imprinted on unit-of-sale prescription drugs sold in the United States.   

On June 30, 2017, the FDA issued Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. This guidance informed supply chain stakeholders that the FDA would delay DSCSA serialization enforcement of product identifiers on prescription drug packages and cases until November 2018. This delay provided manufacturers additional time to put in place technology to generate product identifiers and avoid supply chain disruptions.

While product identifiers—commonly referred to as serialization—is the backbone of the DSCSA, it is just one of many requirements. Each node within the supply chain, from manufactures all the way down to dispensers, must meet a unique set of DSCSA requirements. These unique requirements have presented new challenges to companies of all sizes within the drug supply chain. Recently, many of those challenges came to light at a Healthcare Distribution Alliance (HDA) meeting, in which industry leaders exchanged their experiences and the many challenges that still lie beyond the November 27, 2018 serialization deadline.

 

How rfxcel is helping companies get ready for DSCSA serialization enforcement:  

The November 2018 deadline accelerates the need for rfxcel’s traceability solution. In order to achieve full compliance, members of the supply chain including manufacturers and wholesalers all the way down to dispensers need collaborative technologies that track and trace a product, no matter the maker or origin, throughout the supply chain. The DSCSA details how the manufacturer must start the process of tracing a product by producing the transaction history, transaction information, and a transaction statement of the individual batches and units. This information is then passed to each actor within the supply chain to continue the drug history. Serialization is the crux of the effort allowing for the eventual tracing back up the supply chain for returns and recalls.

rfxcel understands the intricacies of the supply chain and how easily a business can be consumed by compliance efforts. This is why rfxcel closely partners with customers to understand their business strategy and objectives without losing sight of regulatory compliance. This is achieved through establishing a clear project structure, open lines of communication, collaboration, approved technical requirements, and a ‘Gold Release’ implementation effort that does not disrupt business operations.

‘Gold Release’ Implementation Plan: 

Larger pharmaceutical companies have been doing serialization for over 15 years. Even still, many of these companies had to adjust to the DSCSA serialization enforcement requirements. In late 2016, a number of these large pharmaceutical companies wrote to the FDA indicating they were facing challenges meeting the serialization deadline. The FDA wisely determined that if these large companies were having issues meeting the deadline, then smaller companies must be having similar issues. The FDA agreed to delay the deadline by one year establishing a new deadline of November 27, 2018.

Based on the issues many companies were having, rfxcel created an express on-boarding plan to expedite pharmaceutical companies’ compliance with the DSCSA. Dubbed the ‘Gold Release,’ rfxcel developed templates and compliance modules for rapid compliance implementation. The ‘Gold Release’ is a repeatable process that enables deployment events to occur faster and trouble free, providing a simple approach to meet compliance while controlling costs and minimizing business impact.

Supported with collaboration:

Historically, while the pharmaceutical supply chain has worked in a stove-piped fashion, traceability paired with the requirements of the DSCSA requires total collaboration across the industry. In that spirit, rfxcel leads collaborative efforts with working groups and classes among industry partners. Transparency and ongoing collaboration ensures that customers are able to learn and implement successful track and trace efforts. For example, rfxcel educates members on current and potential regulatory requirements, how to on-board new trading partners, and how serialization works.

Full-service approach:

Many small pharmaceutical companies face challenges with DSCSA serialization enforcement including master data management and data exchange with contract manufacturing organizations and wholesalers. rfxcel designates teams across the globe ready to support the entire serialization and track and trace process.

Regardless of size of the company, rfxcel will always find the most cost effective and easy to use solution to comply on time and build business value beyond compliance. When developing the supply chain strategy, rfxcel considers regulations like the DSCSA, and any global differences in associated product descriptions with related literature and support materials.

Awareness and understanding of guidelines and regulations for the serialization of pharmaceuticals products are critical. This awareness includes compliance with regulations (current and planned) that ensure the authenticity, safety, and security of the product.

 

About DSCSA:

The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. The goal is to  protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain.

 

About rfxcel

Headquartered in the United States, rfxcel is the leading cloud-based provider of serialization, and track and trace solutions. For over fifteen years, rfxcel has provided reliable and affordable solutions to meet global serialization and compliance requirements. With rfxcel’s relentless commitment to customer success and continuous innovation, companies can meet today’s compliance requirements and tomorrow’s business challenges.

rfxcel is the number one managed cloud company for Life Sciences. Everything rfxcel offers is managed by rfxcel not the customers. That’s because rfxcel believes:

  • Commitment to customer success promises a prompt, full-service method of addressing customers’ serialization needs.
  • Economies of scale are nice — but economies of expertise are even more valuable. The highest performance and cost-efficiency come when you combine infrastructure with specialized expertise and the exceptional customer service that we call HyperCare
  • Every customer has easy access to engineers, project managers and experts to help with planning, architecting, building, and operations.

Contact rfxcel for information how to meet your serialization, traceability and compliance requirements. rfxcel is a company committed to innovation and affordability in delivering best-in-class track and trace to Life Sciences across the globe.

 

Countdown to Complying with the Serialization Requirements of the Falsified Medicines Directive

Winning the numbers game: Countdown to complying with the serialisation requirements of the Falsified Medicines Directive

The Falsified Medicines Directive’s (FMD) February 2019 deadline is fast approaching. Those who don’t serialize by this deadline will be unable to sell their products in Europe.

The regulations set forth by the FMD state that every Marketing Authorization Holder (MAH) must upload serialization codes to the European Medicines Verification Organization.

But serialization isn’t a straightforward numbers game, and not all solutions are created equal. rfxcel has provided this document to help you determine how you need to serialize and what you need out of your serialization partner.

Serialization is a daunting, frustrating journey, but having the right solution and the right partner can make a world of difference.

This document aims to help you:

  1. Understand the regulation
  2. Identify the right partner for a serialisation solution
  3. Take these actions