Opening Inspection Checklist


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November 8, 2019

Opening Inspection Checklist

At the time of the inspection of the new pharmacy or the inspection for the relocation of an existing pharmacy, the following items will be checked and must be in place. The pharmacist in charge of the new or relocated pharmacy should be present for this initial inspection.

  1. General Pharmacy Practice Requirements - 657 IAC 6
    1. Complete reference library suitable to your practice setting
    2. Counseling area and counseling notice(s) at each pick-up location
    3. Security suitable for your operation
    4. Patient record system
    5. Prescription label requirements
  2. Universal Practice Standards - 657 IAC 8
    1. Environment and equipment requirements - 8.5
      1. Suitable refrigeration unit (with thermometer and documentation plan)
      2. Sink with hot and cold running water
      3. Suitable clean and orderly space, equipment and supplies
      4. Adequate lighting and ventilation
      5. Other equipment necessary for your particular pharmacy
      6. Temperature control
    2. Established policies and procedures for all operations of the pharmacy; recalls, out-of-date drugs, technician/PSP training and utilization, delivery/shipping, drug distribution and control, influenza and pneumococcal vaccines, drug information, and controlled substances -
    3. Training program in place for all registered pharmacy staff - 8.14
    4. CQI program event analysis procedure - 8.26
    5. Perpetual inventory log for schedule II drugs including incident report sheet 
    6. Ability to submit PSE sales to the real-time electronic PTS
    7. Procedure for RPh daily verification of CS fills

*NOTE: If this is a relocation of a currently licensed pharmacy to a new location, these items may be viewed and verified at the old location.

Failure to have the listed items ready at the time of the inspection will result in a failed inspection.