Manufacturers

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. 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

Pursuant to KRS 315.0351 (2)(b)(1 and 2), A manufacturer or manufacturer's agent who sells or distributes dialysate solutions or devices under this subsection shall employ or contract with a pharmacist who is licensed to engage in the practice of pharmacy by the Commonwealth to conduct a retrospective audit on ten percent (10%) of the orders processed by that manufacturer or manufacturer's agent each month. On or before February 1 of each year, an annual summary of the monthly audits shall be prepared and submitted to the board. This audit can be submitted via the Licensure Gateway.

Annual Summary of Monthly Audits of Dialysate Solutions or Devices ​​

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Requirements for a New Manufacturer Permit

1. Complete the Manufacturer Initial Application via Licensure Gateway 
2. A payment of $150, paid online or by check, made out to the "Kentucky State Treasurer".
3. If paying by check, mail to:
   

​State Office Building Annex, Suite 300

125 Holmes Street

Frankfort, KY 40601

​​Manufacturer Inspection Templ​ate​

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The following can be completed via Licensure Gateway under Permit Options:

Change of Ownership​ for an existing permit/license

Change of Address/Location for an existing permit/license

Name Change for an existing permit/license

Facility Renewal 

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