Outsourcing Facility License

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Every facility registered with the FDA as an outsourcing facility that intends to distribute non-patient-specific compounded product into or within Iowa is required to be licensed by the Board prior to commencing operations.

Code Citation 155A.13C

Who Applies Anyone intending to distribute non-patent-specific compounded drug products within or into Iowa, who is registered as an outsourcing facility with the FDA, must license with the Board prior to commencing regulated activities. A facility that intends to utilize controlled substances in the compounding processes must also register for a business Controlled Substances Act registration. A location that will also be dispensing patient-specific compounded products must also license as a pharmacy.

When To Apply Prior to commencing the regulated compounding activities.

Initial Requirements License application, Controlled Substances Act registration, criminal history background check.

Duration Expires December 31, annually.

Processing Time Application processing in 15 business days; criminal history background check usually takes about two months. Processing time is also dependent on submission of all information required in the application.

Fee Structure License fee is $400. License renewal within the first 30 days following expiration add $400 late payment penalty. Reactivation more than 30 days following license expiration requires reactivation fee of $1,600.

Renewal Requirements Renewal application, renewal fee, criminal history background check if the responsible pharmacist has changed, and any other supporting documentation required in the application.

Exam Does not apply.

Additional Information Criminal history background check will be required of any responsible pharmacist identified as such on the license application. Online license renewal is available for currently licensed outsourcing facilities. Check the Board of Pharmacy\\’s website for additional information about online services.