The Board reviews and evaluates all grievances against licensees. The filing of a grievance is not considered a plea for restitution, but rather a tool to initiate an investigation into possible violations of Kentucky pharmacy laws to ensure the citizens of the Commonwealth are safe.
All materials related to the grievance are collected and placed into an investigative file. The file is considered confidential and while under investigation, it is not available for review or copying per KRS Chapter 61. Generally, once an investigation is complete, the Case Review Panel has reviewed the file and the case is dismissed, closed after a final order is rendered or a settlement agreement is reached, the file becomes available for review as a matter of public record; however, certain documents may not be available for inspection if they are recognized as exceptions under the Open Records Law. Due to the investigative work required to review grievances, it is not uncommon for a file to remain open for 120 days or longer.
How to Report an Adverse Event to the FDA
MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.
Report HERE.
For more information on MedWatch, visit the FDA's website HERE.
Submitting a Grievance to the Kentucky Board of Pharmacy
Grievances may be submitted online or by submitting a paper, Grievance Form. All grievances are taken seriously and acted upon provided the following criteria are met:
- The pharmacy involved is properly identified as well as a complete description of the violation.
- The dates surrounding the alleged circumstances are furnished.
- Details relative to the violation are identified and constitute a violation of Kentucky pharmacy law.
You will receive a response within 30 business days of submission. If no response is received within that time frame, please contact Eden Davis, Board Counsel at eden.davis@ky.gov .
The Kentucky Board of Pharmacy does not arbitrate prescription drug prices. Consumers seeking recourse on such matters should contact the management of the pharmacy or seek legal advice.
Investigation and Resolution
Upon receipt of the grievance, the Executive Director and General Counsel screen the grievance to determine if it is accompanied by sufficient corroborating evidence that there is a reasonable probability of a violation of pharmacy law. If the grievance does meet that criteria, a case is opened and assigned to a Board inspector to initiate an investigation into the alleged violation. The inspector may then contact the complainant, pharmacy, witnesses, and licensee for further information or clarification. Moreover, notice to the licensee, permit holder or registrant of the grievance will be provided. The licensee, permit holder or registrant that is the subject of the grievance will have thirty days to provide a written statement to the Board. Once the Board inspector completes their investigation, a report is then submitted to the Case Review Panel (CRP) who reviews the case and makes a determination. The CRP is comprised of three board members.
The Board will dismiss cases where a preponderance of the evidence does not demonstrate a violation of pharmacy law. The Board may reprimand a licensee, set a case for hearing, or direct the matter to staff for resolution without a hearing. Any questions regarding this procedure may be directed to the Board Office.
Online Grievance Form