DSCSA authorized trading partners 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: Understanding DSCSA Authorized Trading Partners, Part 2

Welcome to Part 2 of our discussion about DSCSA authorized trading partners. The 10-year rollout of the U.S. Drug Supply Chain Security Act — the DSCSA — is scheduled to conclude on November 27, 2023, so now’s a good time to take stock of where we are and what to expect over the coming months.

As we said in Part 1, everybody’s talking about DSCSA authorized trading partners — manufacturers, wholesale distributors, repackagers, third-party logistics providers (3PLs), and dispensers. From now until November 2023, it’s really all about ensuring these supply chain actors are ready to comply with the regulations.

Remember, under the DSCSA, authorized trading partners may engage in transactions only with other authorized trading partners. In other words, if you’re not a DSCSA authorized trading partner, your access to the U.S. pharma supply chain will be severely restricted or denied altogether.

Below, we finish our discussion of DSCSA authorized trading partners by defining who qualifies as a repackager, a 3PL, and a dispenser.

Repackagers

Repackagers own or operate an establishment that repacks and relabels a product or package for further sale or distribution without a further transaction.

Generally, dispensers (specifically pharmacies) are not considered repackagers. By this definition, a dispenser/pharmacy only packs and labels a product for dispensation to a person who has a valid prescription for that product; they do not do “bulk” repackaging.

Repackagers are considered trading partners if they accept or transfer direct ownership of a product from or to a manufacturer, another repackager, a wholesale distributor, or a dispenser. To be a DSCSA authorized trading partner, repackagers, like manufacturers, must be registered with the U.S. Food and Drug Administration (FDA) in accordance with Section 510 of the Food, Drug, and Cosmetics Act (FD&C Act), “§360. Registration of producers of drugs or devices.”

3PLs

The DSCSA defines a 3PL as an “entity that provides or coordinates warehousing or other logistics services with regard to a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.”

3PLs are considered trading partners if they accept or transfer direct possession of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser. Returns processors and reverse logistics providers are considered 3PLs. There are two reasons for this:

  1. They provide other logistics services for other trading partners in a facility they own, rent, or lease.
  2. They do not take ownership of the product and do not direct the sale or disposition of the product.

Generally, brokers, solution providers, common carriers, and logistics or administrative services contractors are not considered 3PLs because they don’t provide or coordinate warehousing and don’t accept or transfer direct possession of the product. These stakeholders do not have to be licensed.

To be a DSCSA authorized trading partner, 3PLs must have a valid license under state law or FD&C Act Section 584(a)(1), “National Standards for Third-Party Logistics Providers,” in accordance with Section 582(a)(7), “Requirements, Third-party logistics provider licenses”, as amended by the DSCSA and in compliance with reporting requirements under Section 584(b).

Dispensers

To be considered a dispenser, you must meet one of three criteria:

  1. You’re a retail pharmacy, a hospital pharmacy, or a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor.
  2. You’re a person legally authorized to dispense or administer prescription drugs.
  3. You’re an affiliated warehouse or distribution center of a dispenser under common ownership and control that does not act as a wholesale distributor.

A dispenser is considered a trading partner if they accept or transfer direct possession of a product from or to a manufacturer, repackager, wholesale distributor, or another dispenser. To be a DSCSA authorized trading partner, a dispenser must have a valid state license.

Generally, veterinarians are not considered dispensers, per FD&C Act Section 512(a)(5).

Final thoughts

The table below summarizes everything we’ve laid out above and in Part 1 of our DSCSA authorized trading partners series. It’s adapted from an August 2017 FDA publication.

As you’re reading, remember that all of our stakeholders are considered to be trading partners if they accept or transfer direct ownership of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser. To be an DSCSA authorized trading partner, however, they must meet the criteria explained in the table.

There’s one last installment of our “DSCSA 2023” series coming soon. In it, we’ll talk about the key requirements for 2023 and the future of traceability in the pharma supply chain. While you’re waiting for that, take a moment to check out our webinars, white papers, pharmaceutical compliance solutions, and other resources about the DSCSA. If you feel inspired, contact us to schedule a demo to see our solutions in action.

DSCSA Authorized Trading Partners

DSCSA Authorized Trading Partners

DSCSA 2023: Understanding DSCSA Authorized Trading Partners, Part 1

The Drug Supply Chain Security Act (DSCSA), enacted in 2013, was envisioned as a 10-year plan to secure the U.S. pharmaceutical supply chain through enhanced track and trace systems and processes. Milestones have come and gone, 2023 isn’t that far off, and now everybody is talking about DSCSA authorized trading partners.

Why are DSCSA authorized trading partners on everyone’s mind? It’s because these supply chain stakeholders — manufacturers, wholesale distributors, repackagers, third-party logistics providers (3PLs), and dispensers — are pivotal to the regulatory rollout, which is scheduled to conclude on November 27, 2023. From here on out, the focus will be getting DSCSA authorized trading partners ready to comply with the regulations.

The U.S. Food and Drug Administration (FDA) has clarified the definitions of and guidance for DSCSA authorized trading partners, but we want to distill that further into an easy-to-understand explanation. In Part 1 of our “DSCSA 2023” series, we’ll take a look at manufacturers and wholesalers; Part 2 will talk about repackagers, 3PLs, and dispensers. In Part 3, we’ll break down the specific requirements for 2023.

DSCSA authorized trading partners: an overview

Under the DSCSA, authorized trading partners may engage in transactions only with other authorized trading partners. In other words, manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers and their trading partners must all be authorized trading partners. If you are not a DSCSA authorized trading partner, your access to the U.S. pharma supply chain will be severely restricted or denied altogether.

Below, we explain how the DSCSA defines manufacturers and wholesale distributors.

Manufacturers

To be considered a manufacturer, you must meet one of three criteria:

  1. You manufactured the product.
  2. You’re an approved application holder or a co-licensed partner of the approved application holder; if the latter, you must have obtained the product directly from the application holder or entity that manufactured the product.
  3. You’re an affiliate of the manufacturer and obtained the product directly from the application holder or entity that manufactured the product.

A manufacturer is considered a trading partner if it accepts or transfers direct ownership of a product from or to another manufacturer, a repackager, a wholesale distributor, or a dispenser. As defined in 1-3 above, a manufacturer is a DSCSA authorized trading partner if it:

  1. Is registered with the FDA in accordance with Section 510 of the Food, Drug, and Cosmetics Act, Ҥ360. Registration of producers of drugs or devices
  2. Is compliant with Section 510 of the FD&C Act
  3. Is compliant with Section 510 of the FD&C Act

Wholesale distributors

To be considered a wholesale distributor, you must distribute a drug to a person other than a consumer or patient.

A wholesale distributor is considered a trading partner if it accepts or transfers direct ownership of a product from or to another wholesale distributor, a manufacturer, a repackager, or a dispenser. To be a DSCSA authorized trading partner, a wholesale distributor must have a valid license under state law or FD&C Act Section 583, “National Standards for Prescription Drug Wholesale Distributors,” in accordance with Section 582(a)(6), “Wholesale distributor licenses,” as amended by the DSCSA and in compliance with reporting requirements under Section 503(e), “Licensing and reporting requirements for wholesale distributors.”

Of note: manufacturers that distribute their own drugs are not required to meet licensure requirements for wholesale distributors. In fact, the FDA excluded several other entities from the definition:

  • A manufacturer’s co-licensed partner
  • A 3PL
  • A repackager
  • Entities excluded from “wholesale distribution” pursuant to Section 503(e)(4) — a dispenser, a dispenser-affiliated warehouse or distribution center, or a dispenser who transfers product to another dispenser for a specific patient need

However, “jobbers” are considered wholesale distributors. The FDA defines jobbers as those who do wholesale distribution on a small scale or sell products only to retailers and institutions. Dispensers that transfer product to another dispenser without a specific patient need are also jobbers — which means they’re also considered wholesale distributors.

Final thoughts

If you follow our blog, you know we’ve been covering the DSCSA for a long, long time. We’ve hosted webinars, including the recent “Plan for DSCSA Readiness,” written white papers , and been active in industry initiatives, particularly the Verification Router Service (VRS), for which we led an FDA-approved pilot to extend testing of the system, and the Open Credentialing Initiative (OCI) to meet the requirements for DSCSA authorized trading partners.

So check back soon for Part 2 of our “DSCSA 2023” series, which will discuss repackagers, 3PLs, and dispensers. In the meantime, contact us if you have questions about the DSCSA. Our supply chain experts will be happy to speak with you and demonstrate how our solutions have made us the leader in pharmaceutical compliance.