DoseTrace checks whether a pharmacy is still DSCSA exempt, and the day FDA measures the staff count on has not happened yet

An independent pharmacy owner counts twenty four full time licensed staff, decides the FDA exemption still covers them, and puts the question away. Then they hire two technicians in the spring. The day FDA actually takes that headcount has not arrived yet, and when it does they are over the line and outside the exemption they believed they held.

DoseTrace builds the written record that the federal drug supply chain law asks an independent pharmacy for, and the exemption checker on its front page is free, needs no account, and settles who the rule reaches before anyone pays for anything.

Watch the DoseTrace, The DSCSA record an inspector actually reads demo

Two ways the 25 employee line gets misread

The threshold counts pharmacists and technicians across the whole corporate entity, not per store. A multi store owner who counts one location and comes in under 25 is the single most common misreading, and the checker calls it out by name whenever more than one location is entered.

The second one is newer. On 6 August 2026 FDA granted a second exemption year, because the Assessment of Small Dispensers it is waiting on, the independent feasibility study and the public comment period and the public meeting, is unfinished. The sunset moved, and the day the headcount is frozen moved with it, into the future. So the question changed shape. It used to be whether you were under the line on a day that had passed. It is now whether you will be under it on a day that has not. The checker says so in those words rather than handing back a status that reads as settled.

The same address, a different document

FDA republished over the old letter in place. The old text is not retrievable at any FDA address, and the new letter's own footnotes cite that address as "the 2024 Exemptions", which will hand anyone looking for the older document the newer one. The only tell is the byte count and the issue date printed at the top. Every dated claim DoseTrace makes is re-read from the document itself for exactly this reason.

What the exemption never covered

It covered the electronic, interoperable tracing requirements, plus one narrow step: verifying the product identifier on the designated proportion of suspect product. Every other verification duty, knowing your authorized trading partners, keeping transaction information, quarantining suspect product, answering a tracing request, applied the whole time and is already on state board inspection surfaces. There was also never a blanket exemption for pharmacies at 26 or more staff. The general one for partners who requested by November 2024 ran only to November 2025, and that date is behind us.

The paid side is one binder, $99, charged once, no subscription and no per transaction fee: the dated determination, the verified trading partner log, the written procedures, and the retention plan naming where each record lives.

Run the free check first: DoseTrace

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