DSCSA 2024 Ten-Count: Number 3 – FDA Grants Exemption to Connected Trading Partners
Ten Count Consulting reflects on 2024 with our list of top DSCSA moments and stories from 2024.
Number 3:
FDA Grants Exemption to Connected Trading Partners
In a significant move to support the pharmaceutical supply chain, the U.S. Food and Drug Administration (FDA) issued an exemption from certain enhanced drug distribution security requirements under the Drug Supply Chain Security Act (DSCSA). This exemption was designed to assist trading partners who have established, or are actively working to establish, electronic data connections with their immediate trading partners but continue to face challenges in data exchange. (FDA)
Scope and Duration of the Exemption
The exemption applies to any product transacted by eligible trading partners—those who have successfully completed or made documented efforts to complete data connections with their immediate trading partners by November 27, 2024. The duration of the exemption varies by trading partner type:
- Manufacturers and Repackagers: Until May 27, 2025
- Wholesale Distributors: Until August 27, 2025
- Dispensers with 26 or more full-time employees: Until November 27, 2025
This phased timeline acknowledged the varying complexities and readiness levels across different sectors of the supply chain. (FDA)
Current DSCSA Requirements All Trading Partners Should be Meeting Now (Not a part of Exemption)
As summarized in a blog post by National Association of Boards of Pharmacy (NABP), all DSCSA trading partners must comply with the following requirements:
- Authorized Trading Partners (ATPs): Trading partners must be authorized and may only engage in transactions with other authorized trading partners.
- Suspect and Illegitimate Product Investigation: ATPs must have processes in place to detect, investigate, and handle suspect and illegitimate products.
- Product Identifiers: Covered prescription drug packages and homogenous cases must bear product identifiers unless they are grandfathered or subject to an FDA waiver, exception, or exemption.
- Transaction Data Exchange: ATPs must provide, receive, and maintain lot-level transaction data, including transaction information and transaction statements, with each product transfer.
- Regulatory Requests: ATPs must supply lot-level transaction data in their possession to regulatory authorities upon request.
- Product Returns: Dispensers may only return products to the original seller. The upstream trading partner must connect the return to the previously provided transaction data if intending to resell.
- Product Verification: Manufacturers and repackagers must verify product identifiers upon request from authorized trading partners and regulators.
- Recordkeeping: All trading partners are required to maintain DSCSA-related compliance records for six years.
(NABP)
Implications for the Pharmaceutical Supply Chain
The FDA's decision aimed to prevent potential disruptions in the supply chain, ensuring that patients maintain access to necessary medications. By granting this exemption, the FDA recognized the progress made by trading partners in establishing electronic systems and data connections while providing additional time to address remaining challenges without compromising drug distribution. (NABP)
Next Steps for Trading Partners
Trading partners should continue to advance their electronic data exchange capabilities and resolve any outstanding issues to comply fully with DSCSA requirements by the specified deadlines. It's crucial for these partners to communicate their reliance on the exemption to their immediate trading partners to maintain transparency and coordination throughout the supply chain. (FDA)
If you have any questions or need assistance navigating these requirements, please don’t hesitate to reach out.
The List Revealed So Far:
Number 9: FDA 483s Issued for DSCSA Requirements
Number 8: Two-Year Exemption for Small Dispensers
Number 7: DSCSA Stabilization Period Checkpoint PDG-FDA Joint Public Meeting
Number 6: DSCSA Exception Handling: Building Resilient Processes for 2025 and Beyond
Number 5: Counterfeit Drug Threats in the US Supply Chain
Number 4: PDG-FDA-Industry Listening Sessions
Stay tuned to our blog over the coming days as we share the remaining 2 highlights of 2024
Number 2
Number 1
