FDA is following through on requirements, under the Drug Supply Chain Security Act (DSCSA), to hold public meetings on where it is going with the law, whose implementation started in 2015 and will continue (under current timetables) until 2023. A Federal Register announcement provides details on three scheduled meetings: Aug. 23, Dec. 5-6 and Feb. 28. Past participants of earlier meetings know that FDA is getting more than giving during these meetings, meaning that it is soliciting input from industry rather than providing guidance on where DSCSA implementation is going. Nevertheless, it’s a clear sign that FDA recognizes that making DSCSA work will involve active industry input.
The meeting solicitation gives a good sense of the looming problems that FDA is contending with to meet the legislated deadlines:
- What supply chain security should look like in 2023
- What is needed for enhanced drug distribution security
- What is needed for electronic interoperability
- Standards for product tracing
- Data architecture options for an electronic interoperable system
- The management and maintenance of product tracing data
- The use of aggregation and inference for enhanced product tracing and verification
- Building capacity for a unit-level system for product tracing and verification.
Instructions for registering for the meetings, and for submitting either publicly accessible or confidential information to FDA, are available in the Federal Register notice.