Every compounding facility registered as an outsourcing facility with the FDA, wherever located, that engages in the distribution of non-patient specific compounded preparations into, out of, or within Iowa must be licensed by the Board in accordance with the laws and regulations of Iowa before engaging in the distribution of such preparations. An Outsourcing Facility license expires on December 31 of each year.
Additionally, every outsourcing facility, regardless of location, engaged in the distribution of controlled substances in Iowa is required to have a Controlled Substance Act (CSA) registration.
Where operations are conducted at more than one location by a single outsourcing facility, each location must be licensed. An outsourcing facility which also intends to distribute patient-specific prescriptions in or into Iowa shall also be licensed as a pharmacy.
“Outsourcing facility” means any compounding facility that is registered as an outsourcing facility, as defined in 21 U.S.C. Section 353b, that distributes sterile compounded human drug products without a patient-specific prescription to an authorized agent or practitioner in this state.
If your facility has been inspected within the past 5 years by the FDA, additional information will be required. Contact the Board office for further information. New applicants located in Iowa will be inspected before the license is issued.
DO NOT SUBMIT FINGERPRINT CARDS WITH THE APPLICATION. They will be shredded. Once a completed application is received, a fingerprint packet will be sent to the mailing address indicated on the application. The fingerprint packet is to be completed by the supervising pharmacist and returned to the Board for processing
For more information, see 657 IAC Chapter 41.