Outsourcing Facility Licensure

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Outsourcing facilities that ship sterile compounded human drug products into, out of, or within Iowa without patient-specific prescriptions must hold an Iowa Outsourcing Facility License. This applies to facilities registered with the FDA under 21 U.S.C. §353b. Facilities that distribute controlled substances or dispense prescriptions to patients in Iowa have additional licensing requirements.

Summary

  • Code Citation:
  • Nonrefundable Fee:
    • $400 Outsourcing Facility License (Initial and annual renewal)
    • $45 Background check fee (for each new Supervising Pharmacist)
    • $90 CSA-Business Registration, if applicable (Initial and biennial renewal)
  • Additional Information:
    • Each separate location where operations are conducted must be separately licensed.
    • If intending to dispense compounded preparations into Iowa pursuant to patient-specific prescriptions, the firm must also obtain an Iowa Pharmacy License.
    • The Supervising Pharmacist will be subject to a criminal history background check, unless the pharmacist is serving in the role on a temporary basis no longer than 90 days.

Discontinuing Services

 In any event that your facility does not have current and active FDA registration, the facility must immediately discontinue distributing sterile compounded preparations in or into Iowa. The facility may submit a request to voluntarily cancel the registration.

Updating Your License

  • Notification of the following changes will be within 30 days of the change, except as provided, on the Board's Acknowledgement and Attestation Form:
    • The designation of a temporary Supervising Pharmacist (not subject to criminal history record check)
    • Ownership
  • Notification of the following changes will be within the identified time frames via submission of an outsourcing facility application and fee:
    • For resident facilities, at least 30 days prior to the change
    • For nonresident facilities, submission within 30 days of the change to the FDA registration or home state license, if applicable, reflecting the change
    • Name
    • Location
    • Permanent Supervising Pharmacist
      • An application will be submitted within 30 days of the identification of the new permanent Supervising Pharmacist and within 90 days of the initial vacancy

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