# 2025-20643: FDA Asks Small Dispensers to Report Drug Tracking Info

2025-20643, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Small Dispensers Assessment Under the Drug Supply Chain Security Act, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-11-21, effective FDA intends to begin the DSCSA Small Dispensers Assessment upon Office of Management and Budget (OMB) approval of the proposed collection of information. (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-20643
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-20643
- Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Small Dispensers Assessment Under the Drug Supply Chain Security Act
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 52678
- Published: 2025-11-21
- Effective: FDA intends to begin the DSCSA Small Dispensers Assessment upon Office of Management and Budget (OMB) approval of the proposed collection of information.
- Comments close: 2025-12-22
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Asks Small Dispensers to Report Drug Tracking Info

## 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.

## Abstract

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

## Effects PRIA read

- Small dispensers asked to complete DSCSA assessment: cost, medium. 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 t…
- Large email outreach to industry contacts: cost, low. 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.
- Required coordination with third‑party partners: cost, medium. 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 w…
- Recordkeeping recommendation for one year: cost, low. 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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## Sources
- [2025-20643 on federalregister.gov](https://www.federalregister.gov/documents/2025/11/21/2025-20643/agency-information-collection-activities-submission-for-office-of-management-and-budget-review)
- [2025-20643 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-11-21/pdf/2025-20643.pdf)

## Related
- [Previous: 2025-20642, Agency Information Collection Activities; Submission to the Office of Managemen…](https://policyrisk.com/federal-register/2025-20642)
- [Next: 2025-20644, Agency Information Collection Activity: Civil Rights Discrimination Complaint](https://policyrisk.com/federal-register/2025-20644)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-20643 (as of 2026-06-08).