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# Consider Phased DSCSA Enforcement: PhRMA
- URL: https://www.fdaweb.com/consider-phased-dscsa-enforcement-phrma/
- Published: 2024-09-17T12:00:00.000Z
- Updated: 2026-09-14T14:41:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157794

Pharmaceutical Research and Manufacturers of America (PhRMA) is asking FDA to consider a phased approach to enforcing the Drug Supply Chain Security Act (DSCSA) in light of the mutual dependence among trading partners in the supply chain. The association’s 9/12 [comment letter](https://downloads.regulations.gov/FDA-2023-N-4806-0029/attachment%5F1.pdf?ref=fdaweb.com) says its members have been working to implement the enhanced requirements under DSCSA for more than 10 years.

“However,” it says, “the drug distribution system is interconnected. Movement of medicines depends on the readiness of all stakeholders across this system, not just the manufacturing sector. The shared responsibility for enhanced drug tracking and interoperable information systems is distributed among thousands of trading partners, many of whom may not be ready to comply with the law’s requirements.”

PhRMA says its members have experienced challenges with downstream trading partners not providing feedback on data misalignment. ‘They found that while such misalignment and clerical errors between trading partners were common, the investigation and correction of discrepancies are often time-consuming. If trading partners cannot continue to move products through the distribution chain while simultaneously working to resolve data discrepancies, there could be quarantine and return of products as well as lengthy delays of shipments.”