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Join Antares Vision Group at the HDA 2022 Traceability Seminar in October

Posted on by rfxadmin

Antares Vision Group will be at the HDA 2022 Traceability Seminar October 12-14 at the Marriott Marquis in Washington, D.C. We’re an official sponsor, and our team will be there with our latest technologies and solutions. Stop by to meet us!

The HDA 2022 Traceability Seminar brings together healthcare supply chain leaders to learn more about implementation milestones of the DSCSA as distributors, manufacturers, and dispensers implement serialization and traceability technologies.

Attendees also discuss innovative approaches and lessons learned from the first 9 years of the DSCSA rollout and what to expect during the “last mile” of implementation until the November 2023 deadline.

Get the latest DSCSA intel from our experts at the HDA 2022 Traceability Seminar

If you’re reading this, chances are you know that we’ve been leading on the DSCSA since Day 1 and have collaborated with the pharma industry to test key systems, work out kinks, and help all stakeholders prepare. Here are just a few examples:

And it should come as no surprise that Herb Wong, our SVP of product and strategy, will be at the Seminar. He’ll be at our booth, of course, but he’s also doing the “EPCIS Onboarding Across the Supply Chain” panel discussion on Thursday, Oct. 13, from 1:30 to 2:30 p.m.

Herb will also host a Friday morning roundtable about DSCSA readiness. Antares Vision Group is sponsoring the day’s Roundtable Discussions (9:35-10:50 a.m.), where you can discuss operational issues associated with traceability implementation. Choose a topic that interests you and rotate through the tables with your peers. Highlights from the discussions will be shared at the end of the session.

With this experience and knowledge, our team wants to answer your questions and show you our solutions while you’re at the Seminar. No matter how far along you are in your DSCSA preparations, time with our team will be time well spent — informative, interesting, and maybe even game-changing.

Final thoughts

We’re just a year away from the final DSCSA deadline and the full serialization of the U.S. pharmaceutical supply chain. The HDA 2022 Traceability Seminar is really the place to be when it comes to the “right now” of the DSCSA for product identification, product tracing, product verification, and requirements for authorized trading partners.

So bring your DSCSA questions for our team and let us know how things are going. Visit our booth. Sit in on Herb’s Thursday EPCIS panel discussion and his Friday roundtable. If you have 3 minutes, take our DSCSA Readiness Survey. You can also check out our DSCSA Compliance Library for all of our resources about the law.

We hope to see you in October!

Understanding FDA DSCSA Guidance for the Pharmaceutical Industry

Posted on by rfxadmin

The Drug Supply Chain Security Act (DSCSA) was passed 10 years ago in November 2013. Congress created the legislation to secure the U.S. pharmaceutical supply chain through unit-level product identification (serialization) and electronic exchange of product information.

Over the years, the FDA has issued updates and revised DSCSA guidance for manufacturers, dispensers, wholesale distributors, and other pharma stakeholders. If your products and/or operations are regulated by the law, it is vital to remain aware of requirements, changes, and deadlines.

Let’s explore the DSCSA guidance and requirements and what the FDA has done in recent years.

What Is the DSCSA?

Created as Title II of the Drug Quality and Security Act (DQSA), passed by Congress in November 2013, the DSCSA is an initiative to prevent the introduction and distribution of counterfeit, stolen, contaminated, or otherwise harmful drugs in the United States. It outlines steps to build an interoperable electronic system to identify and trace prescription drugs as they are distributed throughout the country.

Who Must Comply with the DSCSA?

Manufacturers, wholesale distributors, repackagers, dispensers (i.e., pharmacies, healthcare systems), and third-party logistics providers (3PLs) all have requirements with which they must comply.

Recent DSCSA Guidance Updates

Recently, the most notable action from the FDA was its announcement in August 2023 that it was delaying by one year enforcement of key DSCSA requirements. This “extended stabilization period” moves the enforcement date to November 27, 2024.

This DSCSA guidance primarily affects manufacturers, wholesale distributors, dispensers, and repackagers; delayed enforcement pertains to product identifiers (PIs) at the package level; saleable returns; interoperable, electronic product tracing; and investigating suspect and illegitimate products.

Though this gives the industry more time to comply, the Agency has made it clear that the postponement doesn’t amount to a grace period. It 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.

Other Noteworthy DSCSA Guidance Updates

July 25, 2022: The FDA published a proposed rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements.” The National Drug Code, or NDC, is the Agency’s “standard for uniquely identifying drugs marketed in the United States.” The codes are usually found on product labeling and might be part of the universal product code (UPC). Read more about the NDC and what the FDA said here.

October 23, 2021: In a policy document, the FDA announced it was delaying enforcement of key requirements to verify saleable returns. It also included guidance for wholesale distributors concerning transaction statements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The timeline below provides an at-a-glance view of DSCSA guidance as the law has been rolled out over the last decade.

A timeline showing key dates of the U.S. Drug Supply Chain Security Act (DSCSA) from 2013 to 2024

DSCSA Guidance in Context, Today

The stabilization period announced in August 2023 did not, in fact, change the original compliance deadline of November 27, 2023; it is up to individual states to decide if they’re going to enforce the requirements before November 2024.

However, the FDA said extending enforcement will give supply chain stakeholders the extra time that may be necessary “to continue to develop and refine appropriate systems and processes to conduct interoperable, electronic tracing at the package level, to achieve robust supply chain security under the DSCSA while helping ensure continued patient access to prescription drugs.”

What DSCSA Requirements Are in Effect Right Now?

It follows from what we just said that there is DSCSA guidance in effect right now. Some digressions are prohibited per the FD&C Act and can be enforced — with consequences ranging from product seizure to fines to imprisonment. Both federal and state authorities may take action against DSCSA violations.

What Was Enforceable Before Nov. 27, 2023?

Here are a few regulations that can be enforced now. For a full list, see the National Association of Boards of Pharmacy’s (NABP’s) excellent article here. (And also be sure to read about how we were the first DSCSA solution provider to join NABP’s Pulse Interoperable Partner Program. Learn more here!)

  • All trading partners must be authorized trading partners (ATPs) and can only buy, sell, or trade with other ATPs.
  • ATPs must be able to identify and manage suspect and illegitimate products.
  • A product identifier (PI) must be placed on all regulated drug packages and homogenous cases — except for grandfathered products or products with an FDA waiver, exception, or exemption.
  • ATPs must provide certain information about a drug and who handled it each time it’s sold: transaction information (TI), transaction statement (TS), and transaction history (TH).

What Went into Effect on Nov. 27, 2023?

The November 2023 deadline was when enhanced security requirements went into effect. We’ve written extensively about this for years (in our recently updated DSCSA white paper, for example), but here’s a summary of what companies must do to comply:

  • Exchange TI and TS securely, electronically, and interoperably. TI must include each package’s unique identifier.
  • Verify PIs at the package level.
  • Respond to appropriate tracing requests and trace products at the package level (serialization).
  • Associate saleable returns with the TI and TS associated with its initial sale.

Final Thoughts About DSCSA Guidance

So what’s the upshot of all this information? It’s simple: Don’t stop preparing.

Use your extra time during the stabilization period to evaluate your systems, communicate and coordinate with your trading partners, and — importantly — ensure you’re working with a solution provider that knows the DSCSA guidance inside and out.

If you have questions about the DSCSA 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 are committed to meeting DSCSA compliance for all our customers in a timely manner.

Drug Supply Chain Security Act (DSCSA) Pharmacy Responsibilities

Posted on by rfxadmin

Drug Supply Chain Security Act pharmacy responsibilities are complex. They can be confusing. But the clock continues to count down to the final compliance deadline.

On August 25, 2023, the U.S. Food and Drug Administration (FDA) announced that it was delaying by one year enforcement of key DSCSA requirements. This “extended stabilization period” moves the enforcement date to November 27, 2024. Read our blog post here for all the details.

If you want to ensure that your business processes comply with DSCSA pharmacy regulations, the first step is to familiarize yourself with the nuances of the law. With that in mind, let’s do a quick recap for pharmacies.

What is the U.S. Drug Supply Chain Security Act?

The U.S. Drug Supply Chain Security Act, enacted on November 27, 2013, establishes a system to track and trace prescription drugs in a fully serialized supply chain. It calls for end-to-end traceability and electronic interoperability to prevent counterfeit, stolen, contaminated, or otherwise harmful drugs from entering the U.S. supply chain.

So far, the DSCSA has mostly focused on lot-level traceability — exchanging information about every package of medication so stakeholders can see exactly where it has been. Enactment will culminate next year with complete unit-level serialization of the U.S. drug supply chain. This means stakeholders will have to electronically track products at the individual package level.

As the final link in the pharmaceutical supply chain, pharmacies are the last safeguard between suspect products and patients. They are responsible for gathering transaction information and reviewing supply chain data to verify the legitimacy of products (more on that below).

Drug Supply Chain Security Act pharmacy responsibilities: definitions

Pharmacies are referred to as “dispensers” in the DSCSA. The legislation defines a dispenser as “a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor.”

If you dispense only products to be used in animals, you are not a dispenser under the DSCSA. The DSCSA pharmacy requirements apply only to dispensers that provide medication to patients or end-users. If your pharmacy is providing medications to another dispenser or another member of the pharmaceutical supply chain, it is acting as a distributor, which means other DSCSA requirements would apply.

How to comply with the DSCSA

Compliance is mandatory if you are a dispenser under DSCSA pharmacy requirements. Failure to comply will raise flags with the FDA and open your organization to penalties, including fines.

As we said above, the Drug Supply Chain Security Act pharmacy responsibilities are complex. Let’s break them down into easy-to-understand pieces.

You must exchange information about every drug you buy and who handled it each time it changes ownership in the United States.

The DSCSA calls this “product tracing information,” and it has three components, collectively referred to as “T3 information”:

  1. Transaction Information (TI) about a product (e.g., proprietary or established name or names and the strength and dosage form)
  2. Transaction Statement (TS), which is an electronic statement confirming the entity transferring ownership.
  3. Transaction history (TH), an electronic statement with the TI for every transaction going back to the manufacturer. TH is required only until the November 27, 2024, deadline.

Under DSCSA pharmacy requirements, you have to obtain and exchange this data for every transaction. The purpose of these traceability requirements is to promote drug distribution security and to identify potential discrepancies in the supply chain records. If a product cannot be traced back to a legitimate source, it is considered “suspect.”

Adhering to these transaction requirements will help pharmacies protect their consumers from illegitimate drug products. Traceability standards also help the FDA ensure that suspect prescription drugs do not enter the supply chain in the first place.

You must receive, store, and provide product tracing documentation

You can accept prescription drugs only if they have proper tracing information, and you must store the information for six years. You must also generate and provide all information when you sell a prescription drug to a trading partner.

If the FDA conducts a DSCSA pharmacy audit, it can examine records dating back six years. If information is missing, you will be found in violation of the DSCSA and could face substantial penalties.

Providing product traceability information is another important part of DSCSA pharmacy requirements, as pharmacies frequently send inventory to other companies within their healthcare networks. When you engage in these activities, you are acting as a distributor and must adhere to all relevant standards regarding the creation of lot numbers and product-level tracing.

You can only do business with authorized trading partners (ATPs)

And speaking of trading partners, if you can’t confirm your they’re licensed or registered, you can’t do business with them. If they’re not authorized, their access to the U.S. pharma supply chain will be severely restricted or denied altogether. Read our in-depth ATP blog series for all the details.

For now, we will provide a brief recap of what constitutes an ATP under the DSCSA guidelines. The FDA states that an authorized partner is:

  • A manufacturer or repackager that has a valid registration with the FDA
  • A wholesale distributor that has a valid license under state law
  • A third-party logistics provider (3PL) that has a valid license in accordance with state law
  • A dispenser that has a valid license in accordance with state law

The FDA defines a trading partner as:

  • An entity (i.e., manufacturer, distributor, repackager, or dispenser) that accepts director ownership of a product from a manufacturer
  • An entity that transfers direct ownership of a product
  • A 3PL that accepts or transfers products to another entity in the supply chain

In other words, an ATP is an entity that is appropriately licensed and accepts or transfers direct ownership of a regulated pharmaceutical product. Before a pharmacy does business with a repackager, wholesaler, or distributor, it must verify the organization’s ATP status.

You must investigate and properly handle suspect and illegitimate drugs

Suspect and illegitimate drugs include drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution — the problem the DSCSA was designed to eliminate. Pharmacies must quarantine and investigate these drugs to determine if they are fake. If you make this determination, the next step is to work with the manufacturer and take specific action to ensure the bad drug does not reach patients/consumers. You must also notify the FDA and your trading partners about the drug.

Identifying illegitimate products is one of the most important roles of pharmacists under DSCSA requirements. It is also one of the most challenging tasks, as each pharmacist and pharmacy technician must be trained on how to identify illegitimate or suspect products. All pharmacies should train their employees about the DSCSA requirements (e.g., abnormalities in transaction information) and other methods to identify suspect products.

You must authenticate and verify drugs

This is what’s coming in 2024. You’ll have to be able to authenticate and verify all the medicines you buy before you can sell them. The fundamental requirement is that TI (transaction information) must include a product identifier (PI), which includes serial numbers and expiration dates. The Electronic Product Code Information Services (EPCIS) is likely to be the standard the industry will use to enable this exchange.

EPCIS is a standard from GS1, an international organization responsible for creating and maintaining operational standards for key industries, including healthcare. EPCIS is a means to electronically share the “what, when, where, why, and how” information about pharmaceutical products, promoting end-to-end traceability and interoperability among supply chain actors.

Final thoughts

Navigating complex compliance requirements and adapting to new standards can present challenges. Fortunately, you have options — like partnering with rfxcel to help you meet DSCSA pharmacy requirements.

Even though the enforcement deadline has been extended until November 2024, the time to act is now. If you aren’t sure you’ll be ready, contact us to schedule a short demo of our DSCSA pharmacy compliance solutions, which include robust traceability tools, data management solutions, and more. As an rfxcel partner, you’ll tap into the expertise of our DSCSA pharmacy compliance experts, who will collaborate with you to design a solution to ensure you meet all DSCSA requirements and remain compliant forever.

We also invite you to download our DSCSA compliance white paper. It drills down into what we talked about today and is a great reference tool to have on hand as you prepare for the full serialization of the U.S. pharma supply chain. Also bookmark our DSCSA compliance library, which has all our resources about the law.

DSCSA Serialization Implementation and Compliance Guidelines

Posted on by rfxadmin

Note: This article was originally published in November 2021. We’ve since updated some language after the FDA announced on August 25, 2023, that it was delaying by one year enforcement of key DSCSA requirements.

November 27, 2023 — the date the pharmaceutical industry has had its sights on since the U.S. Drug Supply Chain Security Act (DSCSA) was enacted eight years ago. With only two years until the deadline, we thought it was a good time to recap what’s in store for DSCSA serialization.

What is DSCSA serialization?

DSCSA serialization is not different from serialization any other industry: It means that certain drugs must traceable at the unit level. Specifically, 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. Furthermore, 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.
    • A third type of information, Transaction history (TH), is an electronic statement with the TI for every transaction going back to the manufacturer. It is not required after the law goes into effect on November 27, 2023; however, as we wrote about before, there is a “stabilization period” in effect until November 27, 2024, during which the FDA does not intend to take enforcement action. Read more about that here and below.

Meeting DSCSA serialization requirements is vital for all pharmaceutical supply chain members. Whether you are a manufacturer, wholesale distributor, or dispenser, DSCSA 2023 requirements apply to your business. The question is, are you ready?

The DSCSA 2023 deadline

As we just said, the DSCSA 2023 compliance deadline is still November 27. But the FDA postponed enforcement by one year to November 27, 2024. This change does not affect past deadlines on the DSCSA enforcement timeline, but does have implications for DSCSA requirements, including serialization.

This means that pharma stakeholders — manufacturers, wholesale distributors, repackagers, dispensers, and third-party logistics providers (3PLs) — now have an extra 12 months to get their systems in order. However, the FDA has made it clear that these entities should not regard the “stabilization period” as a delay of the 2023 requirements: It expects companies to have implemented the mandated systems and work to ensure they are operating correctly, smoothly, etc. The Agency’s Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies states:

This guidance is 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 under section 582(g)(1) of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements. 

The DSCSA timeline

November 27, 2023, will be 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.” In other words, DSCSA 2023 serialization.

DSCSA 2023 Serialization Timeline

DSCSA serialization: recent developments

No more delays. On August 9, 2021, the FDA signaled that the DSCSA 2023 deadline for interoperability would not change. Leigh Verbois, the director of the FDA’s Office of Drug Security, Integrity, and Response, made the comments during a webinar hosted by the Healthcare Distribution Alliance (HDA).

Draft and final guidance on product identifiers (PIs) and more. On June 3, 2021, the FDA published “new guidance to further enhance the security of prescription drugs in the U.S. supply chain.” Guidance was released for PIs, suspect and illegitimate products, and enhanced drug distribution security.

Full serialization

For DSCSA serialization, certain drug packages must be labeled with a unique Product Identifier (PI). The PI comprises the National Drug Code, a serial number, a lot number, and an expiration date.

Furthermore, every time a product changes hands (i.e., between trading partners), supply chain actors must use the Electronic Product Code Information Services (EPCIS) to share Transaction Information (TI) and a Transaction Statement (TS) with their partners. A third requirement, Transaction History (TH), will not be required after the November 2023 deadline.

Even with the stabilization period until November 27, 2024, there’s no stopping the fact that significant changes are coming for pharmaceutical traceability under DSCSA. The primary focus? Serialization. Serialization involves assigning unique identifiers to each pharmaceutical product, enabling precise tracking and data reporting at every stage of its journey through the supply chain.

Authorized trading partners

Under the DSCSA, authorized trading partners (ATPs) may engage in transactions only with other ATPs. In other words, all manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers and their trading partners must be ATPs. If they’re not authorized, their access to the U.S. pharma supply chain will be severely restricted or denied altogether. Read our in-depth ATP blog series here.

Verification Router Service (VRS)

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. A wholesaler must initiate a verification request (to a manufacturer) to verify the returned products, and the manufacturer must provide a verification response within 24 hours. The VRS enables the rapid, secure exchange of data between these parties. Get more details here.

Final thoughts: DSCSA Serialization

We have been talking about and reporting on the DSCSA Day 1. We’ve been active in industry initiatives, particularly the VRS and the Open Credentialing Initiative (OCI) to meet ATP requirements. We’re ensuring the Ohio Department of Veterans Affairs is DSCSA-compliant. And we’ll soon be announcing another exciting initiative in the move toward full serialization of the U.S. pharma supply chain. Keep an eye out for that.

This year, we hosted a “Plan for DSCSA Readiness” webinar in March and a DSCSA 2023 webinar series in June that covered ATPs, EPCIS, and the VRS. We also published a “Dispensers and DSCSA 2023” white paper in May.

We’ve also been helping pharma companies and public-sector organizations comply with the DSCSA and other pharma regulations around the world. From our Serialization Processing and Compliance Management solutions to the full-scale power of our Traceability System, we ensure compliance no matter your role in the supply chain.

Take another look at our DSCSA timeline. A lot has happened since 2013 — and the pace will only intensify over the next two years. Contact us today if you need to know more. Our supply chain and DSCSA experts are here to help and make sure you’re ready for 2023

 

DSCSA 2023: Unlocking the Future of Pharmaceutical Traceability in the USA

Posted on by rfxadmin

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.

 

 

 

 

 

 

Industry Reaction to Delayed Enforcement of DSCSA Saleable Returns

Posted on by rfxadmin

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

Posted on by rfxadmin

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 Saleable Returns: Enhancing Efficiency in Pharmaceutical Product Returns

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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:


DSCSA: Preparing for the Full Serialization of the U.S. Pharmaceutical Supply Chain

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The U.S. Drug Supply Chain Security Act (DSCSA) will fundamentally change how pharmaceutical companies do business in the United States. Though the U.S. Food and Drug Administration on August 25, 2023, announced an extended stabilization period that will be in effect until November 27, 2024, giving the industry more time to comply, the key takeaway is, Don’t stop preparing.

This paper gets into the specifics of the DSCSA and what all actors in the U.S. pharmaceutical supply chain must do to comply. If you’re a manufacturer, wholesale distributor, dispenser (i.e., pharmacy or healthcare system), repackager, or third-party logistics provider (3PL), download it today and contact us to discuss your needs for DSCSA compliance.

What Do Pharma Dispensers Have to Do for the DSCSA?

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If you’re a pharma dispenser, the Drug Supply Chain Security Act (DSCSA) is going to fundamentally change how you do business. What do pharma dispensers have to do for the DSCSA, you ask? There’s a big deadline coming up this November, but let’s take things in order. Here we go!

First things first: What is the DSCSA?

The DSCSA was created as Title II of the Drug Quality and Security Act (DQSA), passed by Congress in November 2013. It’s an initiative to prevent the introduction and distribution of counterfeit, stolen, contaminated, or otherwise harmful drugs in the United States. It outlines steps to build an interoperable electronic system to identify and trace prescription drugs as they are distributed throughout the country.

The DSCSA is being rolled out in two phases:

    • Phase I (2015–2023) addresses lot-level traceability. This means exchanging information about every package of medication so supply chain stakeholders can see exactly where it has been.
    • Phase II (2023) is complete unit-level serialization of the U.S. drug supply chain. This means stakeholders will have to electronically track products at the individual package level.

Are you considered a dispenser under the DSCSA?

According to the DSCSA, a dispenser is “a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor.”

If you dispense only products to be used in animals, you are not a dispenser under the DSCSA.

2016-present: What do pharma dispensers have to do for the DSCSA?

Here’s a no-frills answer to our question, What do pharma dispensers have to do for the DSCSA? This is everything you must be doing right now.

Exchange “T3” information. Dispensers must be able to exchange “T3” information about every drug they buy and who handled it each time it changes ownership in the United States. This “product tracing 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. TH is required until the final November 27, 2023, deadline.

Confirm trading partners are licensed or registered. If you can’t confirm your partners are licensed or registered, you can’t do business with them. There’s an FDA database to check the registration of manufacturers and repackagers and the licensing of wholesale distributors and third-party logistics providers. For dispenser-to-dispenser transactions, you must check licensing through state authorities.

Receive, store, and provide product tracing documentation. This is all about the T3 information. You must accept only prescription drugs with proper T3 information. You must store the T3 information for six years. And you must generate and provide all T3 information when you sell a prescription drug to a trading partner.

Investigate and properly handle suspect and illegitimate drugs. As you might imagine, this is a big part of the answer to our question, What do pharma dispensers have to do for the DSCSA? Suspect and illegitimate drugs include drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution.

As a pharma dispenser, you must quarantine and investigate these drugs to determine if they are fake. If they are determined to be fake, you should work with the manufacturer and take specific action to ensure they do not reach patients/consumers. You must also notify the FDA and trading partners (i.e., those they bought the drug from and those they sold it to) about the compromised drug.

November 2020 deadline: What do pharma dispensers have to do for the DSCSA?

The DSCSA deadline for pharma dispensers is November 27, and it’s about authenticating and verifying drugs. You’ll have to be able to authenticate and verify all the medicines you buy before selling them. This comes down to two key requirements:

    1. You may buy and sell only products encoded with product identifiers (PIs). A PI is a standardized graphic with three elements: the product’s standardized numerical identifier (SNI), which comprises the National Drug Code plus a unique alphanumeric serial number); a lot number; and an expiration date. PIs must be in human- and machine-readable formats.
    2. You must verify every product at the package level, including the SNI. The FDA defines a package as “the smallest unit placed into interstate commerce by the manufacturer or the repackager that is intended by that manufacturer or repackager, as applicable, for individual sale to the pharmacy or other dispenser of the drug product.”

Final Thoughts

Traceability and serialization technology is the cornerstone of the DSCSA — it is also the cornerstone of our business. rfxcel has been developing leading-edge track and trace and serialization solutions since 2003. Our supply chain experts have the DSCSA in their DNA. What do pharma dispensers have to do for the DSCSA? Let us go beyond the basics we’ve explained here and help you be compliant forever.

Contact us today to learn more about how we can help you with the DSCSA and your other supply chain needs. ANd be sure to download our “Dispensers and the DSCSA white paper.”

 

 

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