As of 12/1/19, the Iowa Board of Pharmacy will require full compliance with United States Pharmacopoeia (USP) General Chapters <795>, <797>, and <800>. Compliance with USP <800> will be required for both compounding and non-compounding pharmacies (657 IAC 8.5(11)). Compounding pharmacies that are unable to meet certain requirements within USP may apply to the Board to request a delay to the enforcement date. If granted, the maximum amount of time for delayed enforcement will be 18 months. Additional time extensions will not be permitted.
Petitioners are required to submit a completed Delayed Compliance Petition Form and all required supporting documentation by 9/1/19. Decisions will be made prior to the Board meeting scheduled for 10/29/19-10/30/19; the potential exists for a requested appearance at this meeting if the application requires full Board approval. Please plan accordingly.