Pharmacy Inspection FAQs

Frequently Asked Questions – Pharmacy Inspections

What prompts an inspection of a pharmacy?

A pharmacy inspection is required under the following circumstances:

• A new pharmacy is opening.

• There is a change in ownership of a pharmacy.

• There is a change of location of a pharmacy.

A pharmacy notifies DPSP that it will be operating as a remotely supervised pharmacy.

If a complaint case is opened against a pharmacy, the DSPS attorney assigned to the case may request that an inspection take place.

Lastly, a re-inspection will occur if a complaint case was opened after a previous inspection.

Are inspections announced or unannounced?

In general, inspections are unannounced. Pharmacies may be given a date range during which the inspection may occur. All inspections occur during normal business hours Monday – Friday.

The time/date of inspections of remotely supervised pharmacies will be coordinated with the managing pharmacist as it is highly desirable that the pharmacist be present for the inspection.

What is the DSPS investigator/inspector looking at during an inspection?

The investigator/inspector has an inspection form to complete outlining the areas that have been identified as important for compliance. During the inspection, the investigator will ask questions about workflow, etc. which may lead to additional areas being investigated for compliance. Not every statute or administrative rule will be evaluated.

If the pharmacy personnel administer immunizations, compound non-sterile products, compound sterile products, or handle hazardous drugs, the investigator will be reviewing policies/procedures, other required documentation, and training records.

How can we prepare for an inspection?

Prior to an inspection, the managing pharmacist can review the pharmacy self-inspection form (DSPS Form #2550).

The investigator will request a copy of a pharmacy label and a list of pharmacy personnel prior to the inspection so that these can be reviewed.

What happens if the investigator/inspector identifies areas of noncompliance?

The investigator will review the areas of noncompliance with the managing pharmacist or pharmacist on duty when the inspection is complete. The managing pharmacist will receive a summary document after the inspection entitled “Notice of Compliance”. The document outlines the areas of non-compliance and provides space for the managing pharmacist to document how the issue was addressed and resolved.

The expectation is that the areas of non-compliance are corrected immediately. The notice of compliance form should be completed and returned to the investigator by the agreed upon date.

Do inspections ever lead to disciplinary action?

A case referral may be made to the Pharmacy Examining Board by the investigator if there are a large number of areas of non-compliance or there is a potential for harm to the public based on the observations of the investigator during the inspection.

If a complaint case is opened, the Pharmacy Examining Board may take disciplinary action against licensees after review of the evidence.