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DSCSA timeline for pharmacies and small dispensers
Every date below links to the FDA document it comes from. Filled dots are dates still ahead.
- 2013
The Drug Supply Chain Security Act (DSCSA) is enacted, setting up a phased path to interoperable, electronic, package-level tracing of prescription drugs.
Source: FDA: DSCSA Law and Policies - November 27, 2023
Enhanced drug distribution security requirements (section 582(g)(1)) take effect; transaction history requirement effectively ends (section 582(k)(1)).
Source: FDA letter, Aug 6 2026, footnote 17 - June 12, 2024 (re-issued July 12, 2024)
FDA grants small dispensers (25 or fewer full-time pharmacists + technicians) exemptions from section 582(g)(1) until November 27, 2026.
Source: FDA letter, Oct 9 2024 (background section) - October 9, 2024
FDA grants time-limited exemptions to eligible manufacturers/repackagers (to May 27, 2025), wholesale distributors (to Aug 27, 2025) and dispensers with 26 or more full-time employees (to Nov 27, 2025).
Source: FDA letter, Oct 9 2024 - November 27, 2025
Exemption for eligible dispensers with 26 or more full-time employees ends.
Source: FDA letter, Oct 9 2024 - August 6, 2026
FDA issues a new letter extending the small business dispenser exemptions for one more year, to November 27, 2027, while the small dispensers assessment is completed.
Source: FDA letter, Aug 6 2026 - September 22, 2026
FDA encouraged small dispensers to complete the small dispensers assessment survey by this date.
Source: FDA exemptions page - November 27, 2026
Headcount date: the small-dispenser definition is applied to the owning company's full-time pharmacists and technicians as of this date. The 2024 exemption would have ended here.
Source: FDA exemptions page; letter footnote 14 - November 27, 2027
Current small business dispenser exemption ends. Before this, FDA must publish its final small dispensers assessment for public comment and hold a public meeting.
Source: FDA letter, Aug 6 2026
What FDA still has to do before November 27, 2027
Under section 582(g)(3), FDA must contract an independent assessment of whether small dispensers can do interoperable, electronic, package-level tracing (whether the software and hardware are accessible, affordable and can be integrated into business practices), publish the final assessment for public comment and hold a public meeting (FDA small dispensers assessment; FDA letter). The law also tells FDA to consider alternative methods of compliance, including a waiver process and compliance timelines where the requirements would cause undue economic hardship.