DSCSA small dispenser: frequently asked questions
What is a small dispenser under DSCSA?
For FDA's exemption, a dispenser is a small dispenser if, as of November 27, 2026, the company that owns it has 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians (FDA).
When does the DSCSA small dispenser exemption end?
November 27, 2027, under FDA's August 6, 2026 letter, which extended the earlier exemption that ran until November 27, 2026 (FDA letter).
Do I count every employee?
No. Only full-time employees licensed as pharmacists or qualified as pharmacy technicians, counted across the whole company that owns the pharmacy. Front-store, delivery and other staff are not part of FDA's count.
What counts as full-time?
FDA adopted the IRS definition: on average at least 30 hours of service per week, or 130 hours of service per month, for a calendar month (IRS).
We own several pharmacies. Is each store counted separately?
No. FDA counts at the level of the corporate entity that owns the dispenser, so all stores owned by that company are added together.
Do I have to apply or notify FDA to use the exemption?
No. FDA says small dispensers and their trading partners using the exemptions do not need to submit anything to FDA. FDA does recommend telling your trading partners if you rely on it (FDA letter).
Does the exemption mean DSCSA doesn't apply to my pharmacy?
No. It covers the enhanced electronic, package-level requirements of section 582(g)(1) and one verification step. Buying only from authorized trading partners, accepting and keeping tracing documents for six years, and handling suspect and illegitimate product still apply. See requirements.
What if we have more than 25 full-time pharmacists and technicians?
The small-dispenser exemption does not apply. FDA's earlier exemption for eligible dispensers with 26 or more full-time employees ran until November 27, 2025 (FDA letter, Oct 9 2024). Trading partners that cannot meet the requirements can request a waiver, exception or exemption (FDA).
Could the date move again?
FDA tied the extension to finishing its small dispensers assessment, publishing it for comment and holding a public meeting. Whether there will be further changes is up to FDA; this site checks FDA's pages for changes (see change log).