What Isn’t Included in the Recent Exemption

Posted by bryan hanley On November 27, 2024 at 2:16 pm | Comments Closed

Published November 26th, 2024

Who Does It Apply To?

Recently, I shared that eligible trading partners were temporarily exempted from specific components of the Drug Supply Chain Security Act, “Latest DSCSA Exemption”. However, considering the stabilization period ends tomorrow, I thought I’d share some further insights on what isn’t part of the recent exemption.

First, as noted in my previous posts, the recent exemption doesn’t apply to everyone. As the FDA emphasized in their release, trading partners who are eligible for the exemption include “those who have initiated their systems and processes by successfully completing data connections with their immediate trading partners”, and “those who initiated processes including documentation of efforts to establish data connections but were not able to fully complete them with all immediate trading partners.” In other words, now is not time for trading partners to start initiating their systems and processes (that ship has sailed)—it’s time for trading partners to refine them.

Progress Necessary

The FDA wants to see progress made toward finalizing systems and processes capable of exchanging DSCSA transaction information and transaction statements with one another. Key enablers of this progress include:

Reconciling receipts of digital and physical representations of Serialized Information

Investigating suspect process

Verifying product for saleable returns

Responding to a trace request

In addition to documentation of progress, the FDA expects trading partners who plan to rely on the extension to communicate their intentions with immediate trading partners.

The FDA, similarly to when they announced their decision to implement the stabilization period, does not want trading partners to view this exemption as a “justification for delaying efforts to implement enhanced drug distribution security requirements.”

The deadline for compliance will come sooner than many expect, especially for manufacturers. In fact, there are only 129 working days until the May 27th, 2025 EDDS deadline.

Risks of Noncompliance

For those who haven’t initiated these systems and processes, punishments could be severe, and include:

Regulatory Risks: Potential for regulatory actions like warning letters, import alerts, or product seizures.

Operational Disruptions: Potential for supply chain disruptions and delays in product acceptance.

Market Exclusion: Risk of being completely excluded from the supply chain

Partners who do not meet the exemption criteria will need to submit a Waiver, Exception, or Exemption, or will more than likely face the consequences outlined above.

Stabilization Behind Us

Navigating DSCSA compliance amidst the constant changes to legislation can be tricky. However, one thing is for sure: if your business lacks systems and processes in place to implement EDDS requirements, the business is at risk.

With stabilization behind us, let Gateway Checker put you on the fast path towards supply integrity and regulatory compliance. Visit our website to view our services, or contact our team with any questions.

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

DSCSA Exemptions from Section 582 and Other Requirements of the FD&C Act for Certain Trading Partners

Posted by bryan hanley On October 10, 2024 at 5:18 pm | Comments Closed

Published October 10th, 2024

The FDA announced on October 9th that they are granting eligible pharmaceutical trading partners exemptions from Enhanced Drug Distribution Security (EDDS) requirements of the FD&C Act. Eligible trading partners include those who have initiated systems and processes and successfully completed data connections with immediate trading partners, or those who have initiated processes (with documentation) to establish data connections, but were unable to fully complete them with all of their immediate trading partners, by November 27th, 2024.

Specifically, eligible trading partners will be exempt from key portions of Section 582 of the FD&C Act. These exemptions and their respective sections of the FD&C include:

Enhanced drug distribution requirements– section 582(g)(1)

Verification requirements for wholesale distributors concerning saleable returned product– section 582(c)(4)(D)*

Verification requirements for dispensers concerning illegitimate or suspect product– sections 582(d)(4)(A)(ii)(II) and (d)(4)(B)(iii)**

*Eligible wholesale distributors are still obligated to meet all other verification requirements of section 582(c)(4) of the FD&C Act, including package-level product verification to investigate suspect/illegitimate product.

**Eligible dispensers are still obligated to meet all other verification requirements of section 582(d)(4) of the FD&C Act, including package-level product verification to investigate suspect/illegitimate product.

The FDA has implemented these exemptions based on pharmaceutical trading partner feedback. Particularly, trading partners have described challenges resolving issues related to missing or erroneous data in electronic DSCSA transactions, without delaying drug movement downstream. This, partners have argued, could contribute to drug shortages and prevent pharmacies and patients from receiving the drugs they need.

These exemptions vary in length based on trading partner type:

Manufacturers and Repackagers: May 27, 2025

Wholesale Distributors: August 27, 2025

Dispensers with 26 or more full-time employees: November 27, 2025

It will be interesting to see how these exceptions are enforced, and how eligible trading partners will be identified:

What “documentation of evidence to establish data connections” will make a trading partner exempt?
How will the FDA ask for this “documentation”, and how will they check for progress?
What will this mean for those who haven’t made efforts to comply?

HDA DSCSA Guidance

Posted by bryan hanley On October 9, 2024 at 12:36 pm | Comments Closed

Following the recent HDA Traceability Seminar between August 26th-28th, I had the opportunity to lead a conversation amongst dozens of pharmaceutical partners and solution providers; we discussed various important topics related to the DSCSA, from Waiver, Exception, and Exemptions, to Verification Routing Services, and more. Emphasizing the importance of transparency and open conversation, I thought I’d highlight some important insights.

It’s All About the Data

The FDA understands there are conflicts in terms of data quality and integrity. Downstream integrity is impossible without manufacturers ensuring their data and products align with updated standards. The FDA has stressed the importance of pharmaceutical partners, particularly manufacturers, meeting these standards by the end of the stabilization period (next month). However, for certain exceptions, including product/no data, WEEs must be considered.

Waivers, Exceptions, Exemptions

Since mid-June, there have been over 324 requests for package-level requirements WEEs, with more likely to be submitted as we approach the deadline. Dispensers are most frequently requesting WEEs, followed by wholesalers, manufacturers, and repackages. The issue many partners are experiencing is that downstream partners cannot get accurate data from suppliers without upstream partners providing it to them efficiently. The FDA believes it is adequately staffed to handle WEEs, and if they find consistent requests for handling WEE scenarios, they will announce how partners should handle them.

Easier Said than Done

Navigating the complexities of Waivers, Exceptions, and Exemptions is oftentimes easier said than done. While the FDA has provided various recommendations for handling tricky exceptions, oftentimes, partners still find themselves facing challenges in practice.

VRS on the Rise

VRS is gaining popularity as an effective means to ensure interoperability between supply chain partners, helping pharmaceutical partners conform to product identification and authorization requirements under the DSCSA. Apart from saleable returns for pharmaceutical partners, VRS can provide additional verification in medical emergencies, though it’s not intended to bypass EPCIS verification.

If you have any questions about these insights, please don’t hesitate to contact us.

How Ozempic Counterfeits Demonstrate the Urgent Need for a Secure Supply Chain

Posted by bryan hanley On March 8, 2024 at 11:30 am | Comments Closed

When demands soars for prescription pharmaceuticals and supply falls short, drug pirates get to work.

The bad actors manufacture and package fake drugs to look just like the legitimate brand-name medication. And many times, these counterfeits make their way into legitimate supply chains.

Counterfeit versions of Novo Nordisk’s diabetes drug Ozempic pose severe risks to patients worldwide, prompting CEO Lars Fruergaard Jorgensen to collaborate with authorities in various countries to address the issue.

Various reports reveal instances of patient harm, including dangerous drops in blood sugar, after consuming fake Ozempic, highlighting the urgent need for action.

Only a secure supply chain that is under constant surveillance can keep fraudulent drugs out of the legitimate supply chain. The FDA is protecting patients from adulterated or counterfeit medications through the Drug Supply Chain Security Act (DSCSA).

See how Gateway Checker can help you get there.

Blog Archives