At a virtual meeting on Tuesday, November 16, the Food and Drug Administration will go over changes to the Drug Supply Chain Security Act that the agency hopes will better protect consumers by detecting and/or preventing illegitimate products from getting into circulation. Illegitimate products are described as “counterfeit,” “diverted,” “stolen,” “fraudulent transaction” and “unfit for distribution.”
Changes to the DSCSA go into effect November 2023 and include enhanced drug distribution security at the package level. This can be achieved various ways, such as through serialization and other traceability technologies.
The agency has set aside time on Tuesday, November 16, from 9:00 a.m. to 4:00 p.m. to go over questions from stakeholders. Among the questions FDA wants input on are:
1. How is implementation of the 2023 enhanced system requirements progressing for your organization?
2. What challenges does your organization face?
3. Are the proposed recommendations in FDA’s guidance on enhanced drug distribution security at the package level helpful to achieve compliance with 2023 enhanced system requirements? If not, what additional information would be useful?
4. Are there areas in which FDA could provide more clarity?
If you cannot attend but are still interested in the topic, FDA will provide a recording and materials from the meeting afterwards at www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security.