Outsourcer Facilities

Pursuant to KRS 315.340 and KRS 315.342, an Outsourcer Facility license is required to operate as an Outsourcer Facility in Kentucky. Outsourcer Facility licenses expire annually on June 30th. Online renewals will be available beginning in May via Licensure Gateway.

An outsourcing facility licensed in Kentucky is required to have a Kentucky-licensed pharmacist in charge (PIC). 201 KAR 2:400(1)(1)(g) requires a pharmacist in charge to be employed at the outsourcing facility. 201 KAR 2:205 requires a pharmacist in charge to be licensed in Kentucky.

201 KAR 2:400(1)(1)(g) “An explanation if an applicant, owner, officer, or pharmacist-in-charge has ever been convicted of a felony or had a professional license or permit disciplined under federal, state, or local law."

Requirements for an Outsourcer Facility License

Complete the Outsourcer Initial Application via Licensure Gateway.
A payment of $250, paid online or by check, made out to the "Kentucky State Treasurer".
For non-resident facilities, submit the following additional documentation:

Copy of resident state outsourcer license/permit
Copy of DEA registration (if applicable)
Copy of most recent inspection
License verification from resident state or primary source verification from resident state
Copy of FDA Outsourcer registration
Disciplinary history (if applicable)

If paying by check, mail to:

State Office Building Annex, Suite 300 125 Holmes Street Frankfort, KY 40601