What does full-time mean for the DSCSA small-dispenser exemption?

FDA uses the IRS definition: an employee who averages at least 30 hours of service per week, or 130 hours per month. A part-timer who averages above that counts.

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On 27 November, FDA counts. Which side of 25 are you on?

FDA decides every pharmacy company's DSCSA status with one number: its full-time pharmacists plus pharmacy technicians, counted as of 27 November 2026. 25 or fewer gets one more year. 26 or more gets no extra time. Most teams count the wrong people. Count yours here, the way FDA does.

Across every pharmacy your company owns

Pharmacists averaging 30+ hours a week counted Or 130+ hours a month. Include PICs, staff and floaters on payroll.

Pharmacy technicians averaging 30+ hours a week counted This is the group people forget. Techs count the same as pharmacists.

Pharmacists and techs averaging under 30 hours not counted Only if their average really is under 30. A “part-timer” who averages 32 is full-time here.

Everyone else not counted Cashiers, drivers, admin, nurses, managers who aren't pharmacists or techs.

Our pharmacy is owned by a parent company that also owns other pharmacies. FDA counts at the level of the corporate entity that owns the dispenser, not store by store. We expect to hire or move pharmacists or techs before 27 November.

Why this number matters

One count, two very different years.

25 or fewer

Exempt from the enhanced DSCSA requirements — package-level electronic tracing, verification and the related response duties — until 27 November 2027. Other DSCSA duties, such as buying only from authorized trading partners, sit outside this exemption.

26 or more

No small-dispenser exemption. The exemption for larger dispensers ended on 27 November 2025, so the enhanced requirements already apply. If FDA asks for a product's tracing information, a dispenser has two business days.

The two readings

FDA's test counts pharmacists and technicians. The statute's wording says “25 or fewer full-time employees” without that limit. If your total staff is above 25 but your licensed count is not, that gap is a question for your counsel. We will show you both readings; we will not pick one for you.

Common questions

On the 25 line.

Who counts?

Full-time employees licensed as pharmacists or qualified as pharmacy technicians, across the whole corporate entity that owns the dispenser. Other staff are not counted under FDA's test.

What is full-time?

FDA uses the IRS definition: an average of at least 30 hours of service a week, or 130 hours a month. It is about the average, not the job title.

When is the count taken?

As of 27 November 2026. That is why the next few weeks matter: before that date the number can still change; after it, it is fixed for the year.

We're above the line. What now?

Test whether you can actually produce a product's tracing history inside two business days. You can do it yourself: pick a unit received 90 days ago and time it. If it is slow, our fixed-fee audit runs that test properly and writes down what is missing.

Based on FDA, DSCSA small business dispenser exemptions (issued 6 August 2026), including footnote 14 on the count date, and 21 U.S.C. §360eee-1. Reviewed 23 September 2026. Informational only; not legal advice.