Daily Archives: November 22, 2024

So, You Think You’re Exempt

Posted by bryan hanley On November 22, 2024 at 9:09 pm | Comments Closed

DSCSA Deadline: Just Days Away

The deadline for DSCSA stabilization is just days away, mandating Enhanced Drug Distribution Security (EDDS) requirements for manufacturers, repackagers, wholesale distributors, and dispensers. While the FDA announced an extension from certain components of the FD&C in the form of a phased approach, this extension only applies to certain eligible trading partners. Eligible trading partners include those who have either completed connections with immediate trading partners, or who have initiated efforts (with documented evidence) but could not complete them by the November 27th deadline.

The phased approach to exemptions arose after industry stakeholders and House of Representatives members called for additional reform, emphasizing how a lack of government intervention can lead to drug shortages. The deadline for eligible trading partners is as follows:

  • Manufacturers and Repackagers: May 27th, 2025
  • Wholesale Distributors: August 27th, 2025
  • Large Dispensers (>25 fulltime employees): November 27th, 2025
  • Small Dispensers (<25 fulltime employees): November 27th, 2026

In light of these exemptions, it’s important that we understand the details: who is and isn’t exempt, and from what specific requirements are eligible trading partners exempt from?

Who Is Actually Exempt? For How Long?

Unlike the 1-year stabilization period announced in August of 2023, this exemption only applies to certain eligible trading partners. To be eligible for the exemption, trading partners must have initiated their systems and processes in alignment with requirements outlined in section 582(g)(1) of the FD&C Act by the November 27th, 2024, start date. Section 582(g)(1) mandates the exchange of transaction data in an electronic and interoperable manner, implements procedures for product verification, and requires partners to keep transaction records in the case of a recall or in case product may be illegitimate or counterfeit. The announcement states,

“In order to prevent confusion, the FDA made it very clear in their announcement who they consider eligible for the exemption; they stated, “eligible trading partners are 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.”

Additionally, this exemption “extends to trading partners throughout the pharmaceutical distribution supply chain who subsequently transact such product.” In other words, if a manufacturer is exempt and sends product downstream to a wholesale distributor, then that partner would be exempt for that product as well.

It’s also important to highlight the specific regulations eligible partners are exempt from. The announcement clarifies eligible partners are only exempt from certain subsections of 582(g)(1), 582(c)(4), and 582(d)(4). These specific regulations are as follows:

  • Section 582(g)(1) (A-F) for manufacturers and repackagers, wholesale distributors, and dispensers with 26 or more full-time employees
  • Section 582(c)(4)(D) For Wholesale Distributors
  • Section 582(d)(4)(A)(ii)(II) and (B)(iii) for Dispensers with 26 of more full-time employees

To read these specific requirements in full, click here.

How to Prepare for November 27th and Beyond

With FDA inquiries and audits to confirm compliance on the horizon, here’s a few steps you can take to ensure you aren’t at risk:

  1. Confirm the “Who” and “What” of the Recent Exemption:Understand if you are eligible, and if so, from what specific regulations you are exempt from.
  2. Test your exchanges: Testing exchanges is the best way to ensure your organization meets federal requirements. Gateway Checker’s TraceReady™ platformevaluates DSCSA conformance and compliance in line to the receiving and fulfillment process, enabling continuous quality assurance for your transactions.
  3. Prepare ahead of time: don’t see these exemptions as an excuse to delay compliance efforts. By preparing your systems before the deadline, you prevent disruptions to supply chains down the line, avoid potential penalties of noncompliance, and demonstrate your commitment to supply chain security.
  4. Communicate Consistently: by communicating your challenges consistently with your trading partners, you can address any complications before the deadline.
  5. Ask questions: The Gateway Checker team is here to support compliance efforts, no matter where you are in the process. Whether you need help providing evidence of data exchanges to trading partners, support communicating extension reliance, or need help meeting extension eligibility requirements, don’t hesitate to contact us.

 

 

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