DSCSA Saleable Returns Verification Requirement Archives - rfxcel.com
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DSCSA VRS: Top Verification Router Service Questions, Answered

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.

Industry Feedback on DSCSA VRS

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

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

Industry Reaction to Delayed Enforcement of DSCSA Saleable Returns

The Healthcare Distribution Alliance (HDA) sponsored a meeting on October 28 with more than 100 pharma industry stakeholders to discuss how the Food and Drug Administration’s (FDA) 3-year delay of enforcing the U.S. Drug Supply Chain Security Act (DSCSA) Saleable Returns Verification Requirement will affect its constituents.

This was the first formal meeting about the FDA announcement and marked the beginning of industry discussion that will no doubt continue well into the future. Below are some of the key points raised at the meeting:

Continue with the VRS. The prevailing sentiment is to continue the Verification Router Service (VRS) effort. The enforcement delay was not intended to stop progress, but to give the industry time to ensure readiness.

The industry needs a plan. As one meeting participant correctly called out, the intent to make progress is not good enough. “We need a plan,” they said. To jumpstart this effort, rfxcel and other VRS providers will draft a 2021 road map to work toward DSCSA readiness. The road map will focus on the VRS, but may also address authorized trading partners (ATPs) and other requirements.

VRS is still a “go.” Will the pharma industry really need the VRS in 2023, the year the DSCSA stipulates full serialization of the pharma supply chain? After a healthy discussion, the consensus was that, yes, the VRS will most likely be necessary. Some in the industry anticipated the “retirement” of VRS in 2023 because wholesale distributors would at that time be performing their own verification of serial numbers. However, not all wholesale distributors agreed with this assessment.

Final thoughts

For details about the FDA’s October 23 announcement, see our blog post. And visit our website regularly for more updates about the Saleable Returns Verification Requirement and the VRS.

rfxcel is the industry leader in DSCSA compliance and the VRS. If you have any questions about the delay and what you need to do to be ready for 2023, contact us today.

FDA Delays Enforcement of DSCSA Saleable Returns Requirement

Note: For the latest industry reaction to the FDA’s announcement, read our update here.

In a policy document published on October 23, the U.S. Food and Drug Administration (FDA) announced it was delaying enforcement of key aspects of the Drug Supply Chain Security Act (DSCSA) that will affect wholesale distributors and dispensers. The regulations were due to go into effect on November 27 of this year; now they won’t be enforced until November 27, 2023.

The delay, the second since 2019, pertains to the requirement to verify saleable returns under the DSCSA law. It also included guidance for wholesale distributors concerning transaction statements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Here are the details.

Wholesale distributors: product identifiers

The FDA announced that it did “not intend to take action against” wholesale distributors that did not verify product identifiers before further distributing returned products as required under the DSCSA.

It explained that wholesale distributors, other trading partners, and stakeholders had expressed concern about industry readiness to implement the Saleable Returns Verification Requirement since the delay in November 2019. Specifically:

  • Challenges developing interoperable, electronic systems to enable verification and achieve interoperability between networks
  • More time needed to test verification systems using real-time volumes of returned product with all trading partners
  • Significant delays testing verification systems due to the COVID-19 pandemic, especially because logistics and supply chain experts were reassigned from DSCSA preparation to responding to the pandemic

Wholesale distributors: transaction statements

The FDA also addressed transaction statements under the FD&C Act. This is a little complicated, so we’ll take it one step at a time.

Section 582 of the FD&C Act requires manufacturers, repackagers, wholesale distributors, and dispensers to exchange transaction information, transaction history, and a transaction statement — known collectively as “T3 information” — for transactions involving certain prescription drugs.

Section 581 of the FD&C Act requires transaction statements to include a statement that the entity transferring ownership — wholesale distributors in this case — had systems and processes in place to comply with verification requirements under Section 582.

Now, “prior to November 27, 2023, [the] FDA does not intend to take action against” wholesale distributors whose transaction statements do not include the statement required under Section 581. See pp. 7–8 of today’s announcement for full details about this change.

Distributors & Dispensers: product identifiers for suspect/illegitimate products

Distributors have also received a 3-year reprieve concerning requirements for product identifiers. The FDA said it did “not intend to take action against distributors that do not verify product identifiers prior to further distributing returned product.

Furthermore, the FDA won’t take action against dispensers that “do not verify the statutorily designated portion of product identifiers of suspect or illegitimate product before November 27, 2023.” Section 582 of the FD&C Act stipulates how dispensers must investigate suspect and illegitimate products.

Final thoughts

If you’re a wholesale distributor or dispenser and have questions about these changes to the saleable returns verification requirement — or anything else about the DSCSA — we can help. rfxcel is the industry thought leader in DSCSA compliance, including the Verification Router Service (VRS), and we are ready to help you make the most of this extra time.

Contact us today and our supply chain experts will show you how our award-winning rfxcel Traceability System will fully prepare you for the DSCSA. We’ll answer your questions, address your concerns, and customize a solution that will ensure you’re compliant. The extra breathing room is nice, but the time to act is now.

DSCSA 2020: November Is Coming & It’s Time to Comply

Note: The FDA has delayed enforcement of the DSCSA for dispensers and wholesale distributors. Read the details here.

The next deadline for the U.S. Drug Supply Chain Security Act (DSCSA) is November 27. That means there’s only a little more than a month to comply. DSCSA 2020 means different things to different stakeholders. Here’s what you have to do if you’re a dispenser or a wholesale distributor.

DSCSA 2020 for dispensers (pharmacies, clinics, hospitals, healthcare systems, etc.)

If you’re a dispenser — an independent pharmacy or a pharmacy in a hospital, clinic, grocery store, or anywhere else — DSCSA 2020 means that you must be able to authenticate and verify all the medicines you buy before you can sell them to consumers.

You must meet two key requirements by November 27:

  1. You can buy and sell only products encoded with product identifiers (PIs). A PI contains a lot number, an expiration date, and the product’s standardized numerical identifier (SNI). The SNI includes the National Drug Code and a unique alphanumeric serial number.
  2. You must verify every product at the package level, including the SNI.

Because the clock is ticking and we want to help, our DSCSA Strategic Advisor Brian Files is hosting a special DSCSA 2020 Q&A session this Thursday, Oct. 15, at 12 p.m. PST/3 p.m. EST. Send your questions today, and Brian will answer them in this live Zoom event.

If you haven’t begun to prepare, Brain will tell you it’s critical to start now. Contact us. We have a proven a track record of success with DSCSA compliance. We have in-house DSCSA experts who will analyze your needs, explain what you need to do, and build a scalable solution tailored to your operations.

Also keep in mind that you must also be able to exchange “T3” information about every drug you buy and who handled it each time it changes ownership in the United States. T3 information” includes Transaction Information (TI) about a product (e.g., proprietary or established name or names and the strength and dosage form); Transaction History (TH), an electronic statement with the TI for every transaction going back to the manufacturer; and a Transaction Statement (TS), which is an electronic statement confirming the entity transferring ownership. We know all about T3 information. Read more about it here.

DSCSA 2020 for wholesale distributors

If you’re a wholesale distributor, DSCSA 2020 means must verify returned products before you can reintroduce them to the supply chain. You’ll do this through the Verification Router Service (VRS), an automated system that verifies if a PI is valid. You’ll initiate a verification request to a manufacturer to verify the PI of the returned product.

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

rfxcel is the thought leader in the DSCSA saleable returns verification requirement and the VRS. We implemented a VRS pilot for the Food and Drug Administration and extended industry testing of the VRS. Contact us today, and we’ll share our expertise in supply chain track and trace, serialization, and compliance solutions to make sure you’re ready for DSCSA 2020. We’ll also be happy to share our final report about the FDA pilot.

Final thoughts

The DSCSA was enacted to promote patient and consumer safety by facilitating product tracing in the pharma supply chain and ensuring the authenticity of products. DSCSA 2020 is the next step in verifying drugs.

November 27 will be here before you know it. If you’re a dispenser or a wholesale distributor, we can help. Reach out to us now and our supply chain experts will show you how our award-winning rfxcel Traceability System can ensure you comply with DSCSA 2020.

DSCSA Saleable Returns Verification Requirement: Just the Facts

Note: 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:


New GS1 Guidance for Product Identifiers in the DSCSA Saleable Returns Verification Requirement

On March 31, GS1 released new guidance concerning product identifiers (PIs) in the DSCSA Saleable Returns Verification Requirement. The 60-page document describes different scenarios for how pharma supply chain stakeholders can treat the PI status of a returned serialized product in the Verification Router Service (VRS).

Let’s take a look at what new GS1 guidance says about dealing with PIs.

The Basics of the DSCSA Saleable Returns Verification Requirement

The DSCSA Saleable Returns Verification Requirement says that wholesale distributors must verify the PIs on sealed homogeneous cases or packages before they can resell a returned product. This went into effect on November 27, 2019. However, as we reported last September, the FDA delayed enforcement by one year to allow additional time for industry readiness.

The PI contains a Global Trade Item Number (GTIN), a serial number, a lot ID, and an expiration date (for the lot).

In a nutshell, the VRS has requestors and responders. A requestor, often a wholesale distributor, sends a verification request to a responder, usually a manufacturer. The VRS routes the request to the appropriate responder for verification of the PI against its repository. The responder returns the following values:

    • Response status: Do all four components of the PI match?
    • Failure reason: If they don’t match, why?
    • Other information about the PI status: This can be used to identify concerns about the product (e.g., if it has been recalled or is suspect).

A strict interpretation of the DSCSA provides a verification “pass” or “fail” based only on matching all four PI elements. In other words, the DSCSA does not require a responder to consider the PI status as part of its verification. However, many manufacturers believe the PI status must be considered. This is why GS1 developed its new guidance for PIs in the DSCSA Saleable Returns Verification Requirement.

What the GS1 Guidance Says

The guidance describes seven scenarios for saleable return responses, summarized below. For full details, contact us and review the GS1 guidance.

SCENARIO A: The PI matches the manufacturer’s repository and there is no information to indicate that the product is unfit for distribution. The product is verified for resale.

SCENARIO B1: The PI matches. However, the manufacturer has reason to believe the product is recalled/withdrawn or expired. The product DOES pass verification for resale (based on the manufacturer’s internal policy) and the manufacturer provides “Recalled” or “Expired” as additional information in the Output Response.

SCENARIO B2: Same as B1, but the product DOES NOT pass verification for resale (based on the manufacturer’s internal policy) and the manufacturer provides “Recalled” or “Expired” as additional information in the Output Response.

SCENARIO C1: The PI matches, but the manufacturer has reason to believe the product is suspect. The product DOES NOT pass verification for resale and the manufacturer provides “Not_for_re-distribution” as a reason for the failure with “Suspect” as additional information in the Output Response.

SCENARIO C2: The PI matches, but the manufacturer has reason to believe the product is unfit for distribution. The product DOES NOT pass verification for resale and the manufacturer provides “Manufacturer_policy” as a reason for the failure without additional information in the Output Response.

SCENARIO D: The PI DOES NOT match. The product DOES NOT pass verification for resale and the manufacturer provides “No_reason_provided” as a reason for the failure.

SCENARIO E: The PI DOES NOT match. The product DOES NOT pass verification for resale. In addition to “No_reason_provided,” there are four other possible reasons the manufacturer can give for the PI mismatch in the Output Response:

    1. “No_match_GTIN_Serial”
    2. “No_match_GTIN_Serial_Lot_Expiry”
    3. “No_match_GTIN_Serial_Lot”
    4. “No_match_GTIN_Serial_Expiry”

Final thoughts

As of May 6, 2020, rfxcel is the only VRS provider to comply with the updated GS1 specifications and fully support all of its scenarios and response options. We also implemented the FDA’s VRS pilot. When you work with us, you’ll know you’re working with the industry’s foremost authority on VRS and the DSCSA Saleable Returns Verification Requirement.

Contact us today to speak with one of our supply chain experts. We can help you understand the intricacies of VRS and the DSCSA, how they might affect your business, and how to be fully prepared for compliance now and always.