“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.
For more information, see 657 IAC Chapter 41.
Please familiarize yourself with the applicable rules and laws regarding outsourcing facilities prior to the submission of any application. An application will be considered complete upon receipt of all required information as determined by the Board, applicable fees and documents; including a completed background check packet.
Each 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.
Additionally, each outsourcing facility, regardless of location, engaged in the distribution of controlled substances in or into Iowa is required to have a Controlled Substances 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.
Nonresident outsourcing facility license applicants shall comply with Board rules except when a waiver has been granted.
If an outsourcing facility has a change of name, ownership, location or supervising pharmacist, the facility is required to submit to the Board an outsourcing facility license application and applicable fee within ten days of the FDA’s issuance of an updated registration.
A change of ownership occurs when the owner listed on the outsourcing facility’s most recent application changes.
The supervising pharmacist of an outsourcing facility is required to complete an FBI background check.
Upon receipt of an initial outsourcing facility license application or a change of supervising pharmacist application, a background check packet will be sent to the mailing address indicated on the application. The background check packet is to be completed by the supervising pharmacist and returned to the Board for processing.
Do not submit any waiver or fingerprint card with this application. Do not submit a waiver or fingerprint card, by any delivery method, before receiving a background check packet from the Board. Any waiver and/or fingerprint card received before the Board’s packet is sent will be destroyed.
The background check takes approximately 4-6 weeks to complete.
An outsourcing facility license expires on December 31 of each year. A license renewal cannot be completed if the licensee has an incomplete change application pending.
An outsourcing facility submitting any application for licensure, except when related to a change in location or except when the outsourcing facility is located in Iowa and will be subject to an opening inspection prior to issuance of an initial license, is required to submit an inspection report that satisfies the following requirements:
- Less than two years have passed since the date of the inspection and the inspection report is the most recent inspection report available that satisfies the requirements of the Board’s rules.
- The inspection occurred while the outsourcing facility was in operation. Except when the facility is located in Iowa and seeking initial licensure, an inspection prior to the initial opening of the facility does not satisfy this requirement.
- The inspection report demonstrates compliance with good manufacturing practices and addresses all aspects of the outsourcing facility’s business that will be conducted in Iowa.
- The inspection was performed by or on behalf of the home state licensing authority, if available.
If the home state licensing authority has not conducted an inspection satisfying the inspection requirements identified in subrule 41.3(6), the outsourcing facility must submit an inspection report issued by one of the following:
- Another qualified entity, if the entity is preapproved by the Board.
- An authorized agent of the board. The Board may recover from an outsourcing facility, prior to the issuance of an outsourcing facility license, the costs associated with conducting an inspection.
If an outsourcing facility ceases to be registered as an outsourcing facility with the FDA, the facility shall immediately cease distribution of non-patient-specific compounded drug products in or into this state and is required to return its Iowa Outsourcing Facility license to the Board within ten days of such occurrence. Upon receipt, the Board will administratively cancel the Outsourcing Facility license. If an outsourcing facility intends to discontinue business in this state, the facility shall notify the Board in writing of its intent at least 30 days in advance of the discontinuation of services and request that the license be administratively canceled. To the extent possible to avoid unnecessary delays in obtaining product for patients, an outsourcing facility that intends to discontinue services in Iowa should provide advance notice to its customers of the date that the outsourcing facility intends to cease distributing products in this state. The notice requirements do not apply in the case of a Board-approved emergency or unforeseeable closure, including but not limited to emergency Board action, foreclosure, fire, or natural disaster.
An outsourcing facility is required to provide written notice to the Board of any disciplinary or enforcement action imposed by any licensing or regulatory authority on any license or registration held by the facility. Written notice shall be received no later than 30 days after the final action. Discipline may include, but is not limited to, fine or civil penalty, citation or reprimand, probationary period, suspension, revocation, and voluntary surrender.
An outsourcing facility is required to provide written notice to the Board of any criminal conviction of the facility or of any owner that is related to the operation of the facility no later than 30 days after the conviction. The term “criminal conviction” includes instances when the judgment of conviction or sentence is deferred.
License certificates are available for printing from within the licensee’s online profile.
- Online License Renewal Portal A valid credit or debit card (Visa, Mastercard, or Discover) is required for online renewal. There will be a $2.00 convenience fee charged for online renewal and payment. Online renewals open November 1 annually.
- Online Renewals - Required Documents - Please review prior to accessing the online renewal portal.
- Acknowledgment and Attestation (for PIC, Facility Manager, Supervising Pharmacist, and Responsible Individual)
- License Renewal Application (Do not submit prior to November 1)
- New License and Change Application
- Supervising Pharmacist Change Application