Every facility registered with the FDA as an outsourcing facility that intends to distribute product into or within Iowa is required to be licensed by the Board prior to commencing operations.
Department of Public Health
Iowa Board of Pharmacy
400 S.W. 8th Street, Suite E
Des Moines IA, 50309-4688(map)Cassie Leecassie.email@example.com
P: (515) 242-3272
F: (515) 281-4609
- Code Citation
- 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 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.
- Expires December 31, annually.
- Processing Time
- Application processing in 15 business days; criminal history background check usually takes about two months.
- 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 application requires reactivation fee of $1,600.
- Renewal Requirements
- Renewal application, renewal fee, criminal history background check if the responsible pharmacist has changed.
- Does not apply.
- Additional Information