Movilitas.Cloud Earns Gateway Certified™ Accreditation for VRS Solution

Posted by bryan hanley On March 14, 2025 at 2:43 pm | Comments Closed

Movilitas.Cloud: VRS Verify™ Accreditation

Lexington, MA, March 14, 2025 – Gateway Checker, the industry’s leading independent GS1 Conformance Testing Service, today announced Movilitas.Cloud, as part of Engineering Industries eXcellence, has become the first product verification solution provider to successfully attain both Level 1 and Level 2 Gateway Certified™ VRS Verify™ accreditation.

The FDA Drug Supply Chain Security Act (DSCSA) requires Pharmaceutical trade partners to have systems to facilitate saleable returns verification. In response to regulation, the Verification Router Service (VRS) was developed by the Healthcare Distribution Alliance (HDA), aiming to automate verification requests and achieve near real-time responses.

With VRS systems, authorized pharmaceutical trading partners can confirm that the unique set of product information (lot number, expiration date, trade identifier, and serial number) assigned to a drug matches the information recorded by the manufacturer.

Successful system-to-system interoperability requires extensive testing and validation, and the cooperation and resource commitment of competitive systems. Up until now, VRS testing results are typically self-executed and reported by the solution provider, a tedious and often inaccurate approach to testing and validation. Gateway Checker developed an independent, unbiased VRS conformance testing platform, VRS Verify™, that quickly, robustly and reliably executes VRS test scenarios.

Demonstrating a commitment to supply chain integrity and DSCSA compliance, Movilitas.Cloud has become the first DSCSA solution provider to be awarded Gateway Certified VRS Verify™ accreditation.

“Gateway Checker has always been heavily involved in the development of the VRS standards and builds tools to measure the health of this multivendor platform,” said Marc Blekkink, Founder and Managing Director of Movilitas.Cloud. “We are very pleased that an independent organization has begun certifying these solutions, allowing the market to select a trusted partner for DSCSA verification requirements.”

Next Steps

For more information on VRS Verify™ and to receive a free product verification assessment, please complete the form at this link.
To check out Gateway Checker’s other suite of services designed for DSCSA Compliance, click this link.
To read the full press release from Movilitas.Cloud, click this link.
Media Contact: Gary Lerner – glerner@nullgatewaychecker.com

About Gateway Checker

Gateway Checker™ is a Software as a Service platform that facilitates product traceability, DSCSA compliance, and unambiguously verifies the interoperability readiness of serialized pharmaceutical transaction records. Drug manufacturers, repackagers, and distributors can quickly and continuously test, validate, and certify adherence to GS1 US Rx EPCIS and VRS product verification application standards. Gateway Checker is certified by the GS1 US RX EPCIS Testing Service Certification Program and is owned and operated by the Gateway Checker Corporation, a wholly-owned subsidiary of BrandSure, LLC.

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

Revisiting Florida’s Plan to Import Drugs from Canada

Posted by bryan hanley On October 23, 2024 at 11:07 am | Comments Closed

An FDA-Approved Plan with Major Implications

Earlier this year, the FDA authorized Florida’s proposal to import select drugs from Canada under section 804 of the FD&C Act. The law allows companies to import prescription drugs in bulk if doing so saves Americans money and doesn’t put the health and safety of Americans at risk.

According to the office of Florida Governor Ron DeSantis, the proposal will save the state an estimated $180 million annually. More specifically, this program will reduce the price the state pays for medications used by certain groups, including older populations, foster children, and incarcerated individuals. Florida will begin with importing small cases of chronic medication, including those treating HIV/AIDS, mental illness, prostate cancer, and urea cycle disorder.

The FDA has emphasized that for Canadian drugs to be imported into the US, Canadian partners and American companies receiving them must adhere to additional security requirements. These include specifying the drugs they plan on importing, verifying drug authenticity and compliance with FDA-approved specifications, and relabeling these drugs in accordance with FDA policy.

Not Everyone Sees the Potential Benefits

However, despite the cost-saving claims from Florida as well as the FDA’s approval of the change, many question the decision and the proposed benefits. Many experts believe this policy change will not solve the high-price issue of prescription drugs in the US. Critics argue the Canadian drug supply is too small, which means the change will not only have a minor impact on price reduction in the US, but could lead to major shortages throughout Canada. Four days after the policy change, the Canadian Government released the following statement:

“The Government of Canada is taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need and has been clear in its position: bulk importation will not provide an effective solution to the problem of high drug prices in the US.”

Accordingly, prominent members within the pharmaceutical industry have counteracted against the ruling; Stephen Ubl, President and CEO of Pharmaceutical Research and Manufacturers of America (PhRMA), believes the ruling has detrimental implications on American pharmaceutical supply chains. “The importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health,” Ubl claimed following the approval.

What Does this Mean for Compliance?

As to how these Canadian imports will comply with DSCSA Requirements, in particular Enhanced Drug Distribution Requirements, remains questionable. With Enhanced Drug Distribution Requirements delayed for connected trading partners in the US, will Canadian pharmaceutical manufacturers be expected to fully comply with DSCSA in November or will they be eligible for additional time for completion?

Is anyone aware of any Canadian pharmaceutical importation plans or activity since the policy change took effect in early January 2024? Have Floridians spent $50 million implementing the plan? If yes, how did that ‘investment’ benefit American patients? Since more states may adopt a similar policy in the future, understanding fiscal costs and benefits is essential.

Finally, though Canadian imports must meet additional drug security requirements, will counterfeiters see this policy change as a money-making opportunity? Considering the numerous instances of domestic counterfeiting, we can’t count this out as a possibility.

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