DSCSA VRS: Addressing Your Top Questions with rfxcel

Posted on July 20, 2021July 25, 2023 by rfxadmin

When do I need to implement the DSCSA VRS? Are there any new developments the industry should be aware of? What are some of the “sticking points” with the VRS today?

These were just a few of the questions asked during the first of three “DSCSA 2023” webinars that we held last month. In “The Verification Router Service: Aligning to the Standard,” rfxcel VP of Marketing and Strategic Initiatives Herb Wong and Global Executive Advisor Brian Files answered these and other questions about the DSCSA VRS. Below, we give their answers to the most-asked questions.

Check back throughout the week, because we’ll be posting the top questions from the other two webinars in the series, “ASN to EPCIS: Industry Change, Your Challenge” and “Authorized Trading Partners: The OCI Solution.”

The webinars were part of our ongoing efforts to keep pharma stakeholders up to date with the DSCSA and help the industry prepare 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.

When do I need to implement the DSCSA VRS?

Manufacturers and wholesalers/distributors should be implementing right now. VRS is a cornerstone of the DSCSA; it’s not going away. As you go through the 2020 to 2023 period, working with your partners is going to be critical. You should also be working with your solution provider — or finding one if you don’t already have one. Keep your eyes on the November 27, 2023, deadline and always be working toward it so you’ll be ready and compliant. Dispensers should be looking carefully at the benefits of VRS and requirements for validating saleable returns. (See response to next question.)

Are there any new developments the industry should be aware of?

VRS is the first interoperable system in the DSCSA. Error management and handling the complexities involved with the enormous volume of returned products contributed to its delay until 2023. (Read our articles about the FDA’s decision to delay enforcement of the DSCSA saleable returns requirement.) Downstream partners only add to the volume and complexity the VRS must handle in sub-second time. So, it will be important for the industry to determine exactly how the VRS will be used and what type of volume controls and error management it will have. You must also consider what type of outcomes your partners will need, as well as what you need for your own business model.

What are some of the “sticking points” with the VRS today?

The Healthcare Distribution Alliance (HDA) collected feedback from the industry about optimizations/improvements it would like to see in the VRS network and presented its findings to solution providers on June 11, 2021. We’re now in the process of evaluating the feedback to determine next steps.

The “sticking points” fall into six categories, as shown in the graphic below. The most predominant concern is how to deal with data synchronization issues. The process for resolving all these issues needs to be streamlined among service providers.

What’s the current implementation rate and use of VRS?

That depends on which part of the supply chain you are referring to. There is no accurate estimate of this across the industry, but based on our observations, this is what we’re seeing: Manufacturers and distributors have the highest “implementation rate.” Approximately 70-80 percent of our manufacturers can support VRS and 80-90 precent of wholesalers/distributors are VRS ready. The numbers further down the supply chain are lower, but are increasing quickly as dispensers become more aware of the benefits of VRS.

My wholesale distributor takes care of VRS for me. What is my responsibility? Am I covered if I were to be audited?

This is a little tricky, because there’s a lot of information circulating about what wholesale distributors will and will not do in the VRS ecosystem.

Wholesale distributors are doing a lot of heavy lifting with VRS, but they’re not completely responsible for your DSCSA transactions. They’re responsible for your information that’s being plugged into the VRS, but they are not responsible if there are any problems with a returned product.

The simple truth is that every stakeholder is responsible for their own DSCSA compliance. Your wholesale distributor should be there to help coordinate to the extent of the arrangement and partnership you have, but they are not responsible for your compliance. It’s not their job to “take care of VRS” for you. As we get into 2023, you’re going to need hardware, software, and system updates ready to go, and you can’t “pass the buck” for VRS to your wholesale distributor — or any other trading partner.

More DSCSA 2023 resources from rfxcel

rfxcel DSCSA 2023 Webinar Series: Sneak Peek #1

Posted on June 2, 2021June 18, 2021 by rfxadmin

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!

Tuesday, June 15: The Verification Router Service: Aligning to the Standard
Wednesday, June 16: ASN to EPCIS: Industry Change, Your Challenge
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 Saleable Returns: Enhancing Efficiency in Pharmaceutical Product Returns

Posted on August 21, 2020June 22, 2023 by rfxadmin

Note about DSCSA saleable returns: On October 23, 2020, the FDA delayed enforcement of the DSCSA for dispensers and wholesale distributors. Read the details here.

The Drug Supply Chain Security Act (DSCSA) is transforming every aspect of the U.S. pharmaceutical supply chain. The law has many parts, but today we’re focusing on the DSCSA saleable returns verification requirement, one of its key mandates. Let’s jump right in.

First, what is the DSCSA?

The DSCSA went into effect on November 27, 2013. It is actually Title II of the Drug Quality and Security Act (DQSA) and calls for product tracing, product identifiers (PIs), authorized trading partners, and verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers (pharmacies).

The goal of the DSCSA is to facilitate product tracing in the pharmaceutical supply chain and, ultimately, promote patient and consumer safety and ensure the authenticity of products. Non-compliance is “prohibited … and subject to enforcement action under the [Federal Food, Drug, and Cosmetic Act].” In a nutshell, if you’re out of compliance, you’re out of business.

What is the DSCSA saleable returns verification requirement?

Millions of pharmaceutical products are returned for resale every year in the United States. These are known as “saleable returns.” Under the DSCSA saleable returns verification requirement, wholesalers must verify saleable returns before they can be reintroduced to the supply chain. In other words, every returned drug has to be vetted — declared as safe and legitimate — before it can be sold again. This is accomplished by verifying the drug’s PI, which has four components: a Global Trade Item Number (GTIN), a unique serial number, a lot ID, and an expiration date.

The DSCSA saleable returns verification requirement for distributors was originally scheduled to take effect on November 27, 2019; however, as we discussed in a previous blog post, the FDA in late September 2019 announced that it did “not intend to take action against” wholesalers that did not meet the requirement before November 27, 2020. This 1-year postponement gave pharma supply chain stakeholders more time to prepare to comply.

Of course, November 27, 2020, is only a few months away. Are you going to be ready? More on that below.

How does the DSCSA saleable returns requirement work?

The easiest way to understand the DSCSA saleable returns requirement is to think of the U.S. pharma supply chain as having only two members: wholesalers and manufacturers. And the law requires them to talk with one another about returned drugs. Here’s what we mean.

To meet the DSCSA saleable returns verification requirement, a wholesaler must initiate a verification request (to a manufacturer) to verify the returned products before it can resell them. The manufacturer that receives that request must provide a verification response within 24 hours. This is why wholesalers are called requestors and manufacturers are called responders.

The 24-hour deadline, however, doesn’t meet business realities. Why? Because, as we mentioned above, millions and millions of drugs are returned every year. The volume is just too great. Therefore, wholesalers need manufacturers to provide verification responses almost instantaneously — at the sub-second level, not in a few minutes, let alone an entire day.

Enter the Verification Router Service (VRS).

The VRS and the DSCSA saleable returns verification requirement

VRS is a huge topic, and to get into the details is outside the scope of what we’re talking about today. Put simply, the VRS enables the rapid, secure exchange of data between requestors and responders to meet the DSCSA saleable returns verification requirement.

The Healthcare Distribution Alliance (HDA) is the driving force behind the VRS, which facilitates the “talk” between wholesalers (requestors) and manufacturers (responders) to verify every drug. Here, a third member joins the DSCSA saleable returns “family”: A solution provider that enables the verification requests to be routed between wholesalers and manufacturers.

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

Final thoughts

rfxcel is the industry thought leader in the DSCSA saleable returns verification requirement and the VRS. Not only did we extend testing of VRS, we implemented a VRS pilot program for the Food and Drug Administration. We’re applying our expertise in supply chain track and trace, serialization, and compliance solutions to help the pharma industry prepare for November.

And we can help you too. Contact us today to talk with one of our supply chain experts and see how our award-winning rfxcel Traceability System can ensure you comply with the DSCSA saleable returns verification requirement — and meet all your other supply chain needs.

CONTACT US TO SEE THE VRS SOLUTION AND FDA TEST RESULTS:

FDA DSCSA Guidance Update: Transaction and Distribution Activities During COVID-19 Emergency

Posted on May 1, 2020July 24, 2020 by rfxadmin

On April 30, the U.S. Food and Drug Administration (FDA) issued guidance for “flexibility” pertaining to certain transaction and wholesale distribution activities under the Drug Supply Chain Security Act (DSCSA). This was a direct response to the COVID-19 public health emergency. Here’s what the FDA DSCSA guidance says.

Legal Basis for the FDA DSCSA Guidance

Public health emergencies in the United States are provided for under Section 319 of the Public Health Service Act (PHS Act). When an emergency is declared, two statutory provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) are automatically triggered:

1. The exemption of certain product distribution activities from the definition of transaction under the FD&C Act section 581(24)
2. The exclusion of certain product distribution activities from the definition of wholesale distribution under the FD&C Act section 503(e)(4)

What the FDA DSCSA Guidance Says

The transaction exemption and wholesale distribution exclusion provisions mean that two DSCSA requirements do not apply to some distribution activities during the COVID-19 public health emergency:

1. Distribution of “covered COVID-19 products” to address the public health emergency. The transaction exemption and wholesale distribution exclusion apply to the following:

- The distribution of prescription drug products that have been issued an Emergency Use Authorization (EAU) by the FDA. To date, this includes hydroxychloroquine sulfate, chloroquine phosphate, and, as of today, May 1, remdesivir. An EAU designation does not mean the FDA has approved a drug for a specific use; to date, the FDA has not approved any product to treat COVID-19.
- FDA-approved products to diagnose, cure, mitigate, treat, or prevent COVID-19. According to the FDA website, this includes in vitro diagnostic products; high complexity molecular-based laboratory developed tests; personal protective equipment and related devices; ventilators and other medical devices; and therapeutics.

The FDA says that companies involved in the distribution of covered COVID-19 products should “maintain the security of the supply chain as these products are distributed to address the urgent public health need.” If possible, companies should continue to fully comply with the DSCSA regulations if doing so isn’t “a barrier to timely distribution of covered COVID-19 products.”

2. Distribution of other products affected by the COVID-19 public health emergency. The transaction exemption and wholesale distribution exclusion also extend to the distribution of “other affected products in certain circumstances.” For COVID-19, these circumstances exist when:

- The distribution activities are directly affected by the COVID-19 public health emergency.
- The distribution activities are for emergency medical reasons, such as treating symptoms of COVID-19.

The FDA gives three examples of when the COVID-19 public health emergency could directly affect distribution of these other products:

- Distribution to an area where product availability is limited and there is higher demand.
- Distribution by an authorized trading partner that needs to establish a new, temporary facility for distribution.
- Dispenser-to-dispenser transfers of products that are needed, regardless of whether there is a specific patient need.

3. There are a few other parameters for the FDA DSCSA Guidance:

- They apply only to products distributed to address the COVID-19 public health emergency.
- They apply to products that were already in the supply chain when the COVID-19 public health emergency was first declared.
- They do not apply to a drug shortage unless it is caused by the public health emergency.
- They are in effect only as long as the COVID-19 public health emergency is in effect.

Final thoughts

For the record, the U.S. COVID-19 public health emergency first went into effect on January 27, 2020. A 90-day renewal took effect on April 26. And as we all know, it’s had a huge impact on people’s lives and the global economy.

rfxcel is committed to being part of the solution. We recently released our Accurate Immunization Management Solution (AIM), an automated, cloud-based solution that tracks the dispensing of vaccines in the supply chain — including potential COVID-19 vaccines. We’ve joined the COVID-19 Healthcare Coalition. We are open and operating at full capacity. Contact us today if you have any questions about our supply chain visibility solutions or our work during the COVID-19 public health emergency.

Is It Time to Change Your Supply Chain Solution Provider?

Posted on February 28, 2020July 27, 2020 by rfxadmin

Is your supply chain solution provider dropping the ball? Is it doing everything it can to help you meet global compliance like EU FMD, U.S. DSCSA, and Russia Chestny ZNAK? What about serialization, traceability, environmental monitoring, safety, data analytics, and your other key needs?

If you operate a pharma supply chain in the EU, Russia, the United States — anywhere — think about this:

An effective supply chain is like an effective athlete. It’s fast. It works toward goals. It always plays by the rules. It uses data to innovate and improve performance. It communicates with its team members. It focuses on excellence 24/7. It wins the game.

But to optimize its potential, it needs an effective coach. That coach is your solution provider, and rfxcel wants you to know that we have a 17-year track record of serialization, traceability, and supply chain excellence in the pharma industry. So, if you’re thinking it’s time for a change because your current solution provider isn’t getting you the wins you want, we want you to take a look at us.

Here’s why.

You’ll be fast and work toward goals

When you work with rfxcel, you’re fast right out of the gate and focused on your business goals. Our preconfigured and pre-validated solutions simplify the implementation process, meaning you’ll have a fully validated production solution in under 30 days. We listen to what your goals are and configure your solutions based on your guidance. You review and approve the implementation. Plus, our solutions are available in a variety of languages, which speeds implementation and boosts ease of use because people can work in their native language.

You’ll always “play by the rules” — you’ll always be compliant

rfxcel has the most comprehensive compliance reporting solution for your regulatory requirements. With us, you never have to worry if you’re compliant, no matter where you’re doing business. To illustrate, consider what we do for our pharmaceutical clients:

We deliver iron-clad global compliance: EU Falsified Medicines Directive (FMD); U.S. Drug Supply Chain Security Act (DSCSA); Russia’s National Track and Trace Digital System (Chestny ZNAK); India Drugs Authentication and Verification Application (DAVA); plus all regulations in China, South Korea, Brazil, Saudi Arabia, Turkey, and more.
We’ve sponsored pilots with U.S. Food and Drug Administration and the Brazilian Health Regulatory Agency (ANVISA)
We’ve processed more than 3 billion transactions and serial numbers.
The Top 6 pharma manufacturers in India have selected us as their solution provider.

A little more about Russia Chestny ZNAK

rfxcel is the leader in Russian compliance. We’ve been prepared for the country’s strict regulations since 2018, a year before they began rolling out. We’re one of few providers with in-country implementations. Over the last year, we tripled our workforce in Russia. That Moscow-based team provides our customers, which include major global consumer goods and pharmaceutical companies, the quickest time to market while fully automating their compliance reporting and assuring ongoing compliance. So, if you want to do business in Russia, rfxcel is your best choice for total supply chain compliance, optimization, and support.

You’ll use data to improve performance and innovate

Our full-stack rfxcel Traceability System software platform is one solution for your entire supply chain, enabling comprehensive serialization capabilities, true end-to-end traceability, compliance reporting, Internet of Things (IoT)-enabled environmental monitoring, and analytics from anywhere in the world. It can comprise up to eight discrete solutions that work in concert to harmonize, optimize, automate, and monitor virtually every aspect of your operations.

In other words, you will have around-the-clock access to rich, actionable data about everything in your supply chain, right down to the unit level. This is data you can use to improve performance, innovate your operations, and engage with consumers. Furthermore, our solutions support all industry and customized data formats, and we offer secured connections to exchange and manage/transform data.

You’ll connect and integrate with all your trading partners

With rfxcel, you’ll never be out of touch with your trading partners, no matter where they’re located. Thousands of companies are already connected to our network, which means almost instantaneous integration and communication across common trading partners. Our systems enable secure connections to exchange information, so your communications are always safeguarded. Most important, we have more than 70 data verifications that prevent bad data from entering your system. No garbage in means no garbage out.

You’ll get rfxcel’s world-class service and 24/7 support

Our industry-leading service doesn’t end after you’ve signed your contract and your system is implemented. Customer satisfaction is our No. 1 priority. We want you to be happy with our service, support, and products at all times.

Final thoughts

rfxcel is the coach you need to achieve peak supply chain performance. If your solution provider isn’t operating at this level, it’s probably time to think about switching teams. We deliver from one end of your supply chain to the other, whether it’s laboratory to patient, farm to table, or factory to retailer to point of purchase. We will help you meet compliance requirements and make your partners and customers happy. If your current provider isn’t delivering what you need, you need to contact us today.

Comprehensive DSCSA Timeline: Prepping for DSCSA Compliance

Posted on August 15, 2019December 20, 2023 by rfxadmin

Created as Title II of the Drug Quality and Security Act (DQSA), the Drug Supply Chain Security Act (DSCSA) is designed to prevent the introduction and distribution of counterfeit, stolen, contaminated, or otherwise harmful drugs in the United States. The DSCSA timeline has established requirements and deadlines to build an interoperable electronic system to identify and trace prescription drugs as they are distributed throughout the country.

In August 2023, the FDA announced a “stabilization period” that postponed enforcement of key requirements until November 27, 2024, giving pharma companies an extra year to prepare, get their systems running, and be ready for full compliance.

With this in mind, here’s a recap of the DSCSA timeline.

Understanding the DSCSA Timeline

The “end game” for the Drug Supply Chain Security Act is full interoperable electronic unit-level traceability (serialization) of every regulated drug in the United States. Key dates of the DSCSA timeline include the following:

- - November 27, 2013: DSCSA enacted
  - November 27, 2014: Third-party logistics providers (3PLs) must report licensure information to FDA annually
  - November 27, 2015: Manufacturers must print lot numbers on packaging
  - November 27, 2017: Manufacturers must serialize and verify products
  - November 27, 2018: Repackagers must serialize products
  - September 23, 2019: FDA delays enforcement of saleable returns requirement for wholesalers
  - November 27, 2019: Wholesalers/distributors can only receive and distribute serialized products
  - August 25, 2023: FDA announces extended stabilization period, postponing enforcement for one year
  - November 27, 2024: Full interoperable electronic unit-level traceability for all stakeholders

So, by November 27, 2024, manufacturers, wholesale distributors, dispensers (i.e., pharmacies, healthcare systems), repackagers, and 3PLs must have interoperable systems in place to share and verify package-level product identifier data electronically.

DSCSA Compliance Requirements

DSCSA compliance requirements vary by stakeholder, but it’s important to know how the regulations will affect both you and your trading partners.

The DSCSA requirements can be divided into several categories that apply to manufacturers, repackagers, wholesale distributors, dispensers, and 3PLs. Each is important, but four are particularly vital because they require these stakeholders to have specific systems in place to be fully compliant. These are what we’ve been calling the “four cornerstones” of DSCSA compliance:

Product identification (serialization)

Manufacturers and repackagers must put a unique product identifier (PI), such as a bar code, on certain prescription drug packages. This must be able to be read electronically.

Product tracing

Manufacturers, wholesale distributors, repackagers, and many dispensers (primarily pharmacies) must provide certain information about drug and who handled it each time it’s sold:

- - Transaction information (TI) includes the product name; its strength and dosage form; its National Drug Code (NDC); 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 transaction statement (TS) is a paper or electronic attestation by the business transfer-ring ownership of the product that it has com-plied with the DSCSA.

Verification

Manufacturers, wholesale distributors, repackagers, and dispensers must establish systems and processes to verify PIs for certain prescription drugs packages. For saleable returns, manufacturers and wholesale distributors must use the Verification Router Service (VRS).

Authorized trading partners (ATPs)

All manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers must be ATPs and be able to electronically verify that their trading partners are ATPs.

In broad terms, to be an ATP you must meet certain registration, licensing, and licensure reporting requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and comply with state licensing requirements. The definitions of ATP also include language about accepting or transferring direct ownership or possession of products.

Strategies for Compliance

Preparing for DSCSA compliance requires a lot of work, but it’s manageable with the right strategies and technologies. Start by understanding your role in the pharma supply chain and the specific requirements you’re expected to meet. Create a checklist for each requirement and make sure you have the resources needed to meet those standards.

The FDA made it clear that the stabilization period is not an excuse for pharma stakeholders to take a break from preparing. It’s quite the opposite, in fact: The Agency said the stabilization period was “not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements.”

You can read the FDA’s official document about the stabilization period here.

Technology and DSCSA Compliance

Technology is your greatest ally when it comes to achieving and maintaining DSCSA compliance. During the stabilization period, companies need to assess their readiness and implement and test serialization and data-exchange solutions. Your solution must be capable of verifying product identifiers (serialized data), aggregation, and electronic data exchange.

Resources for Ongoing Compliance

There are numerous FDA and third-party resources that can assist with your compliance efforts.

This FDA webinar, entitled “Implementing DSCSA: Stabilization Period and Expectations,” is a good place to begin. The FDA’s main DSCSA page also includes numerous resources, as well as a link to sign up for email updates.

We also highly recommend our own DSCSA Compliance Library. It has links to our articles, webinars, white papers, and other resources that will help you better understand the DSCSA requirements.

Navigate the DSCSA Timeline with rfxcel

As the DSCSA timeline leads the industry to November 27, 2024, you’ll need to ensure that your organization is ready. That’s where we can help.

If you have questions about the DSCSA timeline and your obligations or are concerned that your current provider may not have the tools you need to comply, we encourage you to contact us today to speak with one of our DSCSA experts. We can provide you with the latest information and the solutions to protect consumers, identify suspect products, and maintain compliance.

DSCSA T3 Data Requirements: Track and Trace Software Solutions

Posted on January 19, 2019August 25, 2023 by rfxadmin

Under the Drug Supply Chain Security Act (DSCSA), the T3 data for most medicines must be exchanged at change of ownership. The T3 data requirements includes the sending the Transaction history (TH), the Transaction information (TI), and the Transaction statement (TS).

Transaction History is a statement that details all information on all transactions for a product starting with the manufacturer. It is required until the final November 27, 2023, deadline.

Transaction Information includes the established name or names of the product, the strength and dosage form of the product, the national drug codes, the container, the number of containers, the lot number of the product, the date of the transaction, the date of the shipment. If more than 24 hours after the date of the transaction, the business names and address of the person from whom ownership is being transferred, and the business name and address of the person to whom ownership is being transferred.

Transaction Statement is a statement, in paper or electronic format, that states the partner is authorized to transfer ownership, received the product from an authorized entity, received the TI and TS from the prior owner of the product, did not knowingly ship a suspect or counterfeit product, had systems and processes in place to comply with verification requirements, did not knowingly provide false TI, and did not knowingly alter the TH.

What do the T3 data requirements mean for me?

Manufacturers need to start the T3 data requirements process by providing all necessary information to the new owner in a electronic format. Wholesale distributors, repackagers, and even dispensers selling products to other dispensers without the medication going to a distinct patient, must continue to produce and transfer this T3 information as they exchange ownership. At the same time, wholesale distributors, repackagers, and dispensers cannot accept ownership of a product unless they are provided with associated T3 data. The T3 data requirements mandate all parties who have ownership of a product need to keep that product’s T3 data for 6 years.

For any member of the supply chain, if a product is thought suspect, or is found to be counterfeit, the product needs to be quarantined and investigated. The product’s ownership cannot be exchanged during the time that it is quarantined or investigated. If an FDA official requests information in relation to any drug recall, the member of the supply chain needs to be able to produce the T3 data, and in most circumstances, give it to the official within 48 hours.

Dispensers have separate regulations. Dispensers are currently required to accept and maintain transactional data for 6 years. By 2020 the DSCSA will require dispensers to verify the product identifier printed on at least 3 units or 10% of all units (whichever one is bigger), and match them to the recorded T3 data – if there are less than 3 packages, then all must be checked. By November 27, 2023, all pharmacies must have an electronic, interoperable system in place trace products at the package level.

Other Insights

Dispensers may enter into agreements with 3^rd parties, where the 3^rd party would store all T3 data. However, the dispenser is still responsible for producing all T3 data if a regulatory body makes a request. Relying on another partner, whose system is out of the dispenser’s control, may not be ideal. Many of these agreements only cover the products that 3^rd party interacts with, requiring the dispenser to still track all T3 data for items that it received directly from a manufacturer or secondary wholesaler. Also, in 2020 dispensers will be required to check lot numbers regardless.

How rfxcel can help

rfxcel has been a leading traceability provider since 2003. Our expertise helps hundreds of customers achieve full regulatory compliance with the DSCSA. Our traceability system allows seamless integration with partner systems and provides no delays to your day-to-day business operations.

With DSCSA looming around the corner it is important to find a solutions provider who focuses on data integrity and flexibility. rfxcel’s system provides over a hundred data checks to ensure that there is no garbage data going in or going out, and with thousands of T3 data reports being created every day, ensuring that data is correct is top priority.

To learn more about the DSCSA, and how rfxcel can help you achieve compliance, click here.