DSCSA implementation has shifted enough times that it is reasonable to be unsure which requirements currently apply to you. As of August 2026 the picture is clearer than it has been, and it splits pharmacies into two groups.
The two groups
| Group | Enhanced electronic tracing |
|---|---|
| Dispensers with 26 or more full-time employees | In effect since November 27, 2025 |
| Small dispensers (25 or fewer) | Exempt from certain requirements until November 27, 2027 |
How the small dispenser test works
The threshold is not about store count or revenue. FDA defines a small dispenser, for the purposes of the exemptions, by reference to the company that owns the dispenser having 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians, measured as of November 27, 2026.
- The count is at the owning company level, not per location
- It counts licensed pharmacists and qualified pharmacy technicians, not all staff
- A group of small stores under one owner can exceed the threshold collectively
If you operate several locations under one company, check the aggregate count before assuming the exemption applies to you.
What the exemption does not do
The exemption covers certain enhanced requirements. It does not remove the underlying product tracing obligation that applies when product moves between trading partners. FDA also states plainly that it urges small dispensers to continue implementing the measures needed for the enhanced requirements rather than treating the extension as a pause.
No filing required to use it
Small dispensers and their trading partners relying on the exemptions do not need to submit anything to FDA or notify the agency. Trading partners who do not qualify and cannot meet the requirements may request a waiver, exception, or exemption, and are expected to keep working toward compliance while a request is pending.
What to do with the remaining time
- Establish which side of the employee threshold your company falls on
- Confirm you are receiving tracing documentation on every inbound transfer, not just wholesaler purchases
- Confirm you can produce that documentation on request, and know where it is stored
- Treat November 2027 as a working deadline rather than a distant one
This article is provided for general information only and is not legal or regulatory advice. Requirements depend on your specific circumstances and change over time. Consult the current FDA guidance and your own counsel or compliance advisor before acting on it.