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The inspection report required pursuant to clause (ii) shall be deemed current for the purposes of this section if the inspection was performed (a) no more than one yr prior to the date of submission of an software for registration with the Board or (b) not more than two years previous to the date of submission of an software for renewal of a registration with the Board. Nonetheless, if the outsourcing facility has not been inspected by the U.S. Food and Drug Administration within the required interval, the Board may settle for an inspection report or different documentation from one other entity that is passable to the Board, or the Board might trigger an inspection to be conducted by its duly authorized agent and should charge an inspection payment in an amount adequate to cowl the prices of the inspection.
Special coaching for pharmacists will not be required as pharmacists are taught in class tips on how to compound medicines, however many who work in specialty compounding pharmacies have undergone formalized coaching such as the Skilled Compounding Centers of America (PCCA) Complete Compounding Course or Aseptic Training Course.
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