DSCSA 2023 Archives - rfxcel.com
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DSCSA ATPs: Top Authorized Trading Partner Questions, Answered

What’s being discussed to ensure interoperability of different credentialing solutions for authorized trading partners (ATPs)? Is GS1 going to set standards for ATP credentialing solutions? If a solution provider supports DSCSA compliance and customers will aggregate serial numbers, why do users need to do anything else? 

These were the Top 3questions from “Authorized Trading Partners: The OCI Solution,the third and final presentation in the “DSCSA 2023” webinar series we hosted last month. rfxcel Global Executive Advisor Brian Files was hosting that day, and we share his answers below.

We also shared our answers to the top questions from the two other webinars, The Verification Router Service: Aligning to the Standardand ASN to EPCIS: Industry Change, Your Challenge.” There’s a lot of good information there, so be sure to check them out!

Our “DSCSA 2023” webinars were part of our ongoing efforts to keep the pharma industry updated about the DSCSA and help all stakeholders be ready 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.

What’s being discussed to ensure interoperability of different ATP credentialing solutions?

The same industry stakeholders are involved in developing the different solutions, whether it’s the Open Credentialing Initiative (OCI), .MED, or XATP. It’s important to have systems that connect and exchange information. The HDA has been hosting meetings with the three ATP providers to determine how/if interoperability can be achieved. Great progress has been made in a short time but there are still many open issues to be resolved as of mid-July 2021.

Is GS1 going to set standards for ATP credentialing solutions?

GS1 is not setting the standards; however, as part of the HDA effort to ensure interoperability, the teams are keeping GS1 updated on their efforts to ensure any GS1 specifications are updated/clarified as needed. For example, ATP will leverage the VRS messaging standards, which may need to be updated/clarified to include ATP.

If a solution provider supports DSCSA compliance and customers will aggregate serial numbers, why do users need to do anything else? 

For DSCSA 2023, the onus is on companies to ensure they’re getting their data in the proper format. Just having a DSCSA solution will not make you compliant. You have to go through your operational protocols and procedures and design your internal systems so they’ll be DSCSA-compliant.

Some companies have been working with solution providers since the early days of the DSCSA rollout, but have yet to optimize how their compliance software works with their internal systems, how they work with their provider, and, critically, how they communicate with their trading partners. Companies need to optimize internally to get the most out of their solutions — and to ensure compliance.

More DSCSA 2023 resources from rfxcel

DSCSA 2023: Top EPCIS Questions, Answered

When will companies start sending EPCIS? If a solution provider supports DSCSA compliance, why do users need to do anything other than ensure their products are aggregated? 

These were among the questions people asked at our second “DSCSA 2023” webinar last month, “ASN to EPCIS: Industry Change, Your Challenge.Herb Wong, rfxcel VP of Marketing and Strategic Initiatives, was the host, and we share his answers to the most-asked questions below.

Check back tomorrow, because we’ll be posting the top questions from the third and final webinar in the series, “Authorized Trading Partners: The OCI Solution.” You can also read our answers to the top questions from the first webinar, The Verification Router Service: Aligning to the Standard.

If you have other questions or want more details about DSCSA 2023, contact us today. Oh, and you can watch the entire “DSCSA 2023” webinar series and download the presentation slides here.

When will companies start sending EPCIS?

It has already started. However, the industry hasn’t achieved the volume it will need for 2023 (or right now, for that matter). There aren’t exact figures of the current volume of returns supply chain stakeholders (e.g., manufactures and wholesale distributors) are generating, but we do have anecdotal information from one of the Big 3 that they’re getting only about 10 percent. That data is a few months old, though, and that number could have increased. But overall, the industry needs to continue boosting the volume.

If a solution provider supports DSCSA compliance and industry (e.g., HDA) requirements, why do users need to do anything other than ensure their products are aggregated? 

A DSCSA solution should ensure you’re compliant and adhering to industry standards. But there’s more to it than that. For example, a solution provider needs permission from a manufacturer to send its serialized data; however, some manufacturers have chosen not to send this data, even though they have the means to do so. Right now, it’s important to be sending this data so solution providers can continue to work with the industry to ensure that all the data entering the system is clean and the VRS is working well.

So, it’s not that a solution provider can’t handle this for you. The issue is that providers need their customers to agree to send the information and communicate with their trading partners to make sure everyone’s on the same page. This needs to occur throughout the supply chain (e.g., as manufacturers send data to wholesale distributors and wholesale distributors send data to dispensers). Also, dispensers need to be able to receive the data. It’s all about communication and coordination.

What is the vision for the Center of Excellence? Will membership be open to everyone in the industry at no cost, or will membership be limited to certain organizations?

The current vision is that there will be no fees. The intention is to facilitate broader coordination among all participants to encourage data to flow through the system and to build an optimal method for resolving issues. As for membership, the reality is there has to be coordination with certain groups, because it will be difficult to succeed without some sort of organization to “rally around.” In all likelihood, the Center of Excellence will probably be coordinated through the Healthcare Distribution Alliance (HDA). But even if you’re not an HDA member, that shouldn’t preclude you from participating.

What about transformation of events of inbound to outbound serial numbers for 2023 requirements?

Here, “transformation” means, for example, sending a pallet to a wholesale distributor who then “transforms” it by opening a case and sending individual products downstream (e.g., to a dispenser). The vision is to have each entity that transforms — unpacks and repacks — products to manage that process inside their own organization. The role of EPCIS is to handle the actual communication of every transformation. It’s important for the industry to understand and be able to verify every transformation event, and EPCIS is the tool that makes this possible.

In terms of repackaging, an example would be if a company puts different medicines (with different SKUs) together in a new configuration, or package, that meets a certain need (e.g., a combination of pills to treat a specific condition). In that process, the repackager must issue a new serial number that would have to be DSCSA-compliant in terms of EPCIS data flow.

These are the kinds of scenarios the industry needs to flesh out and be ready for by 2023.

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.