Körber Supply Chain Achieves Gateway Certified® Accreditation

Posted by bryan hanley On March 23, 2026 at 10:48 pm | Comments Closed

Gateway Checker® is excited to announce Körber Consulting has successfully attained Gateway
Certified® EPCIS Verify™ accreditation. A leading global technology group, Körber has been
providing innovative supply chain solutions for decades. As the industry’s leading independent
GS1 Conformance Testing Service, Gateway Checker applauds Körber’s accomplishment, which
demonstrates their commitment to pharmaceutical supply chain integrity, data interoperability,
and overall patient safety.

Koerber and Gateway Checker at the 2026 DMC Conference

Körber Supply Chain Team (Matt Deep, left, and Steve Markham, right) with Gateway Checker
President, Gary Lerner, at the 2026 HDA Distribution Management Conference in Austin, Texas.

Leveraging its TraceReady™ application for drug quality assurance, Gateway Checker launched
the Gateway Certified conformance program after producing files pursuant to the strict GS1 US
Implementation Guideline. By earning the Gateway Certified seal of approval, supply chain
partners can be confident in data quality while providing their customers file integrity
confidence.

“The certification process helped us take a closer look at how our outbound files are structured,
validated, and delivered,” said Sherri Bauman, Quality and Testing Manager at Körber. “This
allows Körber to produce fully conformant files aligned with GS1 standards, highlighting
improvements that support greater consistency and accuracy.”

Bauman added, “This milestone better positions Körber to meet current requirements and adapt more easily to future compliance needs, while supporting smoother data exchange for our partners and customers. This is a foundational step that improves data quality, supports scalability, and reinforces our commitment to standards-based compliance now and in the future.”

“When EPCIS solution providers commit to testing and compliance to interoperability
application standards, like Körber, pharmaceutical supply trade partners benefit,” said Gary
Lerner, President of Gateway Checker Corporation. “As more suppliers follow Körber’s lead,
drug transaction records will flow faster with fewer inaccuracies, minimizing supplier
disruption.”

To learn more about the Gateway Certified program, reach out to our team or visit our
website.

Click here to read the Körber press release.

Trump’s Tariffs and the Price of Prescription Drugs

Posted by bryan hanley On May 13, 2025 at 7:58 pm | Comments Closed

Tariffs and the Pharma Supply Chain

The impact of the Trump Administration’s tariffs extends across numerous industries. While the reality of tariffs is yet to hit Finished Pharmaceutical Products (FPPs), the threat has become more and more real. Tariffs on FPPs have largely been avoided over the past decades as a result of the 1994 Pharmaceutical Agreement between the United States, the European Union, China, and a few other participants; the agreement was established to eliminate trade barriers on a large number of pharmaceutical substances.

A few weeks ago, however, the Trump administration proceeded with probes into pharmaceutical imports, setting the stage for potential tariff implementation. The administration has argued these tariffs will incentivize companies to bring production back into the U.S., helping make the supply chain more robust and decreasing the potential for disruptions. A few major pharmaceutical companies have already indicated plans to invest in the U.S. in response to this threat, including Roche, Novartis, AstraZeneca, and Eli Lilly.

Higher Costs, Higher Prices

However, many pharmaceutical leaders have spoken out against tariffs, arguing that tariffs could lead to supply chain disruptions and higher prices. According to Giovanni Barbella, the global head of strategy at Sandoz, because the margins of generic pharmaceuticals are so small, higher production costs stemming from these tariffs would directly increase the prices paid by consumers.

Barbella added that if tariffs further reduce these already tight margins, some players within the pharmaceutical supply chain may elect to leave the U.S. market altogether, instead focusing on more profitable markets. This will threaten the supply of U.S. pharmaceuticals, and in turn, lead to higher prices for drugs that remain in the U.S. as competition subsides.

Ernst & Young analyzed the potential increase in drug costs in the U.S. if tariffs are implemented, and the results are quite significant: a 25% tariff would increase drug costs by almost $51 billion annually. If companies choose to pass these tariffs onto consumers, Americans would be expected to pay 12.9% more (on average) for their prescription medications.

Remain Focused on Compliance

With the DSCSA Deadline just around the corner (May 27th, 2025, for manufacturers), the threat of tariffs and the additional costs associated with them are another added burden. Don’t let the threat of tariffs take away from compliance efforts – the penalties for noncompliance are substantial.

Gateway Checker’s suite of traceability and conformance testing services provides trading partners the confidence that their exchanges meet strict DSCSA requirements, all at a fraction of the cost. With the threat of tariffs and compliance demands on the rise, see how Gateway Checker makes compliance both simple and affordable.

To learn more, contact us or visit our website:

Coming Up Next

Trump’s recent executive order, which gave drugmakers a 30-day deadline for lowering the price of prescription drugs, will likely have a big impact on all stakeholders within the supply chain.

In the coming days, as the dust settles, I will provide some insights on how this legislation may play out alongside potential FPP tariffs.

With tariffs expected to raise prices, and the executive order seeking to lower them, what will the outcome be?

Conversation with GS1 to be Released January 22nd – Next Level Supply Chain Podcast

Posted by bryan hanley On January 17, 2025 at 5:37 pm | Comments Closed

Gateway Checker founder and president Gary Lerner recently had the opportunity to speak on the Next Level Supply Chain Podcast, hosted by GS1 US. His conversation focused on DSCSA guidelines and their benefits on the supply chain, best practices for conformance, and tons more. The episode will be released on January 22nd—to watch the full episode when it releases, visit this link.

Trump’s Tariffs and Drug Prices

Posted by bryan hanley On December 11, 2024 at 12:18 pm | Comments Closed

Following his election victory, president-elect Donald Trump announced intentions of implementing tariffs on Canada, Mexico, and China; these tariffs include 25% tax on imports from both Mexico and Canada, and an additional 10% increase on the tariffs already in place on Chinese exports to the United States. The goals of these imports, according to the Trump administration, are to protect U.S. manufacturing; incentivize companies to build facilities in the U.S. (and create American jobs); provide billions to the federal reserve to help offset the cost of tax cuts; and deter the flow of illegal immigrants, fentanyl, and other illicit drugs.

However, those opposed to the tariffs (including many economists) emphasize how taxing goods could result in price increases for consumers, including prescription drugs. About 85% of the Active Pharmaceutical Ingredients (APIs) used by U.S. manufacturers for generic pharmaceuticals are from India and China; Mexico and Canada are also exporters of these materials. Taxing these APIs as they enter the United States could result in higher prices for finished goods. Companies importing these goods may simply pass the cost of the tariffs to end consumers, who are already burdened by inflation.

According to the Active Pharmaceutical Ingredient Innovation Center (APIIC), this overreliance on China, India, and other foreign nations for most of our APIs is detrimentally impacting the supply of essential medications in the United States. The APIIC also believes rising imports of pharmaceuticals to the U.S. “creates serious risks to national security and patient safety.” In the past decade, the number of API-facility locations has decreased by 61%, while foreign nations continue to scale their operations. Reshoring the manufacturing process could help mitigate these concerns, and eliminate the financial risk of higher costs associated with tariffs; could Trump’s tariff plan present further opportunity to invest in domestic API production facilities?

What do you think about the impact of tariffs on drug prices? Will tariffs raise prescription drug prices, or could the benefits of in-country production outweigh the potential-price hikes in the long run?

What Is Exempt, per recent DSCSA Update

Posted by bryan hanley On November 22, 2024 at 8:45 pm | Comments Closed

According to the DSCSA Exemption Announcement from the FDA on October 9th, here are the specific components of the legislation that eligible trading partners are exempt from.

Section 582(g)(1)(A-F) for Manufacturers and Repackagers, Wholesale distributors, and Dispensers

‘‘(A) The transaction information and the transaction statements as required under this section shall be exchanged in a secure, interoperable, electronic manner in accordance with the standards established under the guidance issued pursuant to paragraphs (3) and (4) of subsection (h), including any revision of such guidance issued in accordance with paragraph (5) of such subsection.

‘‘(B) The transaction information required under this section shall include the product identifier at the package level for each package included in the transaction.

‘‘(C) Systems and processes for verification of product at the package level, including the standardized numerical identifier, shall be required in accordance with the standards established under the guidance issued pursuant to subsection (a)(2) and the guidances issued pursuant to paragraphs (2), (3), and (4) of subsection (h), including any revision of such guidances issued in accordance with paragraph (5) of such subsection, which may include the use of aggregation and inference as necessary.

‘‘(D) The systems and processes necessary to promptly respond with the transaction information and transaction statement 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 product or an illegitimate product shall be required.

‘‘(E) The systems and processes necessary to promptly facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer, as applicable, shall be required—

‘‘(i) in the event of a request by the Secretary (or other appropriate Federal or State official), on account of a recall or for the purposes of investigating a suspect product or an illegitimate product; or

‘‘(ii) 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 (i).

‘‘(F) Each person accepting a saleable return shall have systems and processes in place to allow acceptance of such product and may accept saleable returns only if such person can associate the saleable return product with the trans- action information and transaction statement associated with that product.

Section 582(c)(4)(D) For Wholesale Distributors

(D) VERIFICATION OF SALEABLE RETURNED PRODUCT: Beginning 6 years after the date of enactment of the Drug Supply Chain Security Act, upon receipt of a returned product that the wholesale distributor intends to further distribute, before further distributing such product, the wholesale distributor shall verify the product identifier, including the standardized numerical identifier, for each sealed homogeneous case of such product or, if such product is not in a sealed homogeneous case, verify the product identifier, including the standardized numerical identifier, on each package.

Section 582(d)(4)(A)(ii)(II) and (B)(iii) for Dispensers with 26 of more full-time employees*

‘‘(II) Dispenser must promptly conduct an investigation in coordination with trading partners, as applicable, to determine whether the product is an illegitimate product beginning 7 years after the date of enactment of such Act, verifying that the product identifier, including the standardized numerical identifier, of at least 3 packages or 10 percent of such suspect product, whichever is greater, or all pack- ages, if there are fewer than 3, corresponds with the product identifier for such product

‘‘(iii) RESPONDING TO A NOTIFICATION —Upon the receipt of a notification from the Secretary or a trading partner that a determination has been made that a product is an illegitimate product, a dispenser shall identify all illegitimate product subject to such notification that is in the possession or control of the dispenser, including any product that is subsequently received, and shall perform the activities described in subparagraph (A).

*Recall that an exemption was given to dispensers with 25 or less full-time employees already until November 27th, 2026. This is one year after the dispensers with 26 or more full time employees.

For any questions regarding the exemption, feel free to contact the Gateway Checker team

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