Pharmacy Operations, Personnel, and Facility Requirements
The responsible person
Every TDDD has a named responsible person accountable for compliance - for a pharmacy, a pharmacist. That person ensures adequate staffing, written policies, security, recordkeeping, and prompt reporting of changes. The pharmacist on duty at any moment is responsible for the dispensing that occurs.
Personnel
Technicians and interns must hold current Board credentials and work within a defined task list. Training is documented. Staffing must be sufficient that verification and counseling are not rushed; the pharmacist cannot be everywhere at once, and the workflow design must reflect that reality.
Facility expectations
- Secure storage: drugs off the floor, controlled substances locked, access limited to authorized staff.
- Refrigerator with a monitored thermometer and documented temperature logs.
- A sink for handwashing and clean space where compounding occurs.
- A designated counseling area that affords privacy.
- Clean, orderly, pest-free, adequately lit environment.
Changes and closures
Notify the Board of ownership changes, relocations, closures, and responsible-person changes within the required time, and amend or surrender the TDDD accordingly. Do not carry inventory to a new address before the license follows.
Worked example
A pharmacy remodels and moves its pickup counter and counseling window 20 feet. The address, footprint, and security are essentially unchanged: this is a remodel, and the responsible person updates the floor plan and notifies the Board as the rules require. If instead the pharmacy moves next door, that is a new location needing a new TDDD before stock moves.
Traps
- Assuming a technician's certification satisfies Board registration.
- Leaving the refrigerator unmonitored overnight or not logging readings.
- Moving controlled substances to a new address ahead of licensure.
- Failing to name a new responsible person when the pharmacist-in-charge leaves.