Small-Sized Facilities
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Small Facilities - Definitions & Requirements
What is "Small"?
A Dispenser is considered a small dispenser "if the corporate entity that owns the dispenser has a total of 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians."
Who is a "Dispenser"?
The DSCSA defines a "dispenser" to include pharmacies and any other person authorized to dispense or administer prescription drugs. (Sec. 581 (3)(A) of Title II of the Drug Quality and Security Act)
Current Exemptions
The FDA has extended exemptions for small business dispensers only for certain product tracing requirements until November 27, 2027. All other sections of the DSCSA are currently enforceable and documentation must be produced upon request.
Current Requirements
Small Dispensers are currently required to follow all other regulatory laws outlined in the DSCSA SEC. 582. REQUIREMENTS (d)(1) - (5).