Manufacturers

Updated 8/5/2024

Pursuant to KRS 315.036, a manufacturer permit is required to operate as a manufacturer in Kentucky. Manufacturer permits are issued to resident facilities only. Non-resident facilities shipping into Kentucky should submit an application for a Wholesale Distributor license.  Manufacturer permits expire annually on September 30th. Renewal postcards will be mailed at the end of July. Online renewals will be available beginning in August. A delinquent fee of $150 is assessed if permit has lapsed.

Medical Device Frequently Asked Questions September 2021


Requirements for a New Manufacturer Permit

  • Complete the Manufacturer Permit Application​ and indicate that you are a "New Manufacturer".
  • A payment of $150, by check, made out to the "Kentucky State Treasurer".
  • Mail the completed application and check (or proof of payment) to
    State Office Building Annex, Suite 300
    125 Holmes Street
    Frankfort, KY 40601
  • Inspection. Inspection template is provided to prepare for inspection.
​​Manufacturer Inspection Template​

Requirements for a Change of Ownership for an existing Manufacturer Permit

  • Complete the Manufacturer Permit Application​ and indicate a "Change of Ownership".
  • A payment of $150, by check, made out to the "Kentucky State Treasurer".
  • A signed document of previous owner or legal documentation of the ownership change.
  • Mail the completed application, check (or proof of payment) and signed document to
    State Office Building Annex, Suite 300
    125 Holmes Street
    Frankfort, KY 40601

If you have any questions regarding what constitutes an ownership change, please call the Board office. If you are restructuring your ownership, please provide a letter of notification and details regarding this restructuring to determine if this is classified as a change of ownership.


Requirements for Change of Address/Location for an existing Manufacturer Permit

  • Complete the Manufacturer Permit Application and indicate a "Change of Address/Location".
  • A payment of $150, by check, made out to the "Kentucky State Treasurer".
  • Mail the completed application and check (or proof of payment)​ to
    State Office Building Annex, Suite 300
    125 Holmes Street
    Frankfort, KY 40601

Remodels within an existing location [no change in existing approved perimeter wall structure or security] are not required to submit an application. They should contact their inspector and notify them of this change. Remodels within an existing location [changes will be made to their existing approved perimeter wall structure or security] are required to submit an application and receive Board approval prior to the change.


Requirements for a Name Change for an existing Manufacturer Permit

  • Submit an email to the Board, pharmacy.board@ky.gov requesting the change; or
  • Complete the Manufacturer Permit Application and indicate a "Name Change", or a personal letter of request.
  • Mail the completed application or letter to
    State Office Building Annex, Suite 300
    125 Holmes Street
    Frankfort, KY 40601

Requirements for Change of Pharmacist-In-Charge

Pharmacist-In-Charge changes should be submitted to the Board within 14 business days to avoid any disciplinary actions.

  • Complete the Change of Pharmacist-In-Charge.
  • Mail the completed application to
    State Office Building Annex, Suite 300
    125 Holmes Street
    Frankfort, KY 40601
 
  
  
  
94 KB
  
992 KB
  
954 KB
Manufacturers