FDA Asks Small Dispensers to Report Drug Tracking Info
Published Date: 11/21/2025
Notice
Summary
The FDA is asking small medicine dispensers to share info about how they track prescription drugs to keep the supply chain safe and secure. This new info collection is part of a law that helps trace medicines electronically, making sure they’re real and safe. Comments on this plan are open until December 22, 2025, and it could affect small dispensers’ paperwork and processes.
Analyzed Economic Effects
4 provisions identified: 0 benefits, 4 costs, 0 mixed.
Small dispensers asked to complete DSCSA assessment
If you run a medicine dispenser with 25 or fewer full‑time employees, FDA is asking you (or an entity representing you) to answer an assessment questionnaire about electronic package‑level drug tracing. FDA estimates 922 respondents will complete the questionnaire, that it will take about 2 hours to compile answers and respond, and that respondents will have 45 days to complete the questionnaire after the link is posted.
Required coordination with third‑party partners
FDA expects respondents to coordinate with third‑party entities (like solution providers, wholesale distributors, or consultants). For screener questions, FDA estimates 692 respondents will make 1,384 disclosures at about 0.1 hour each; for full assessment responses, FDA estimates 461 respondents will coordinate with two partners at about 2 hours per coordination.
Large email outreach to industry contacts
FDA plans to send 18,430 invitation emails to firms on its industry stakeholder list asking them to consider the assessment. The agency estimates it will take about 0.1 hour (6 minutes) to read each invitation and decide whether to participate.
Recordkeeping recommendation for one year
FDA recommends that respondents keep records generated while answering the assessment and retain questionnaire responses for at least 1 year after FDA publishes its final report. FDA estimates recordkeeping will take about 0.5 hour per responding entity.
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