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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.

 

 

 

 

 

 

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 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:


Dispensers and DSCSA 2023

Are you a dispenser? If so, you have a lot to think about between now and November 27, 2023, when you’ll be required to verify and authenticate drugs in a fully serialized U.S. pharmaceutical supply chain.

This white paper gets into the specifics of the DSCSA and dispensers — what you’ve had to do in previous years and what you’ll have to do to be ready for 2023. It’s also a handy reference tool, with relevant DSCSA definitions and requirements quoted verbatim and a full list of rfxcel’s other DSCSA resources, including blog posts, webinars, and articles.

rfxcel has committed itself to being a leader in DSCSA compliance and a resource all supply chain stakeholders can rely on for reliable solutions and accurate information. If you want to learn more and discuss your needs for DSCSA 2023 or anything else related to your supply chain needs, please contact us today.

What Do Pharma Dispensers Have to Do for the DSCSA?

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. We know all about T3 information. Read more about it here.

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!

DOWNLOAD DSCSA FOR DISPENSER WHITE PAPER

 

 

What Dispensers Need to Know About the DSCSA in 2020

Between 2015 and 2019, manufacturers, repackagers, wholesale distributors, and dispensers (i.e., pharmacies in hospitals, clinics, supermarkets, or elsewhere) have had to meet different compliance requirements of the Drug Supply Chain Security Act (DSCSA). Now, in 2020, another deadline is looming for dispensers: On November 27, they must be able to authenticate and verify the drugs they sell to consumers.

The DSCSA was enacted on November 27, 2013, as a means to secure the U.S. supply of medications. Phased rollout of regulations began in January 2015 and is scheduled to conclude on November 27, 2023. In a nutshell, the law mandates product serialization and traceability to stop harmful drugs from entering the supply chain, spot them if they do get in, and facilitate rapid response if any are detected.

Let’s take a quick look at how the DSCSA has affected dispensers to date — and what’s coming up in November.

Are You a Dispenser?

As we noted above, dispensers are pharmacies. However, to make sure we’re all on the same page (and that you know if the law applies to you), here’s how the DSCSA defines “dispenser”:

    • 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.
    • Does not include a person who dispenses only products to be used in animals.

The First DSCSA Deadline for Dispensers

The first important deadline for dispensers was July 1, 2015, when they had to begin exchanging “T3” information about every drug they bought and who handled it each time it changed ownership in the United States. (Manufacturers, repackagers, and wholesale distributors had to do this starting January 1, 2015). For every transaction, they’re required to exchange “product tracing information” that includes three things:

1. Transaction Information (TI) about a product:

    • Proprietary or established name or names
    • Strength and dosage form
    • National Drug Code number
    • Container size
    • Number of containers
    • Lot number (certain wholesale distributor transactions were excluded from this requirement)
    • Transaction date
    • Shipment date (if more than 24 hours after the transaction date)
    • Transfer of ownership (the name and addresses of the business/person from whom and to whom ownership is being transferred)

2. Transaction History (TH): An electronic statement with the TI for every transaction going back to the manufacturer

3. Transaction Statement (TS): An electronic statement confirming the entity transferring ownership:

    • Is authorized as required under DSCSA
    • Received the product from a person that is authorized as required under DSCSA
    • Received TI and a TS from the prior owner of the product, as required under the law
    • Did not knowingly ship a suspect or illegitimate product
    • Had systems and processes in place to comply with verification requirements under the law
    • Did not knowingly provide false TI or alter the transaction history.

2016-2019 Milestones

There were three key requirements for dispensers between 2016 and 2019:

1. They must confirm their trading partners are licensed or registered.

2. They must receive, store, and provide product tracing documentation.

    • Accept only prescription drugs with proper T3 information.
    • Store the T3 information for six years.
    • Generate and provide all T3 information when they sell a prescription drug to a trading partner.

3. They must investigate and properly handle suspect and illegitimate drugs

    • This includes drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution.
    • Quarantine and investigate suspect drugs to determine if they are fake. If they are determined to be fake, dispensers should work with the manufacturer and take specific action to ensure they do not reach patients/consumers. Pharmacies must also notify the FDA and relevant trading partners (i.e., those they bought the drug from and those they sold it to) about the compromised drug.

Preparing for November 2020

The next phase of DSCSA implementation for dispensers concerns authenticating and verifying drugs. They will have to have processes in place to authenticate and verify all the medicines they buy before selling them to consumers. (Wholesale distributors have been required to do this since November 2019.) This boils down to two key requirements:

1. Dispensers 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. 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

We know: It can be confusing. That’s why you have to work with a supply chain solution provider that knows the DSCSA inside and out and can help you navigate the deadlines and unexpected changes or delays.

rfxcel has the DSCSA in its DNA. The solutions in our signature platform have DSCSA compliance built in. Our supply chain experts will, ahem, dispense their knowledge when you need it. They will advise, guide, and support you as you grow your business while safeguarding your customers. Contact us today to learn more about how we can help you with the DSCSA and your other supply chain needs.