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FDA Releases Outsourcing Facility Fee Rates for Fiscal Year (FY) 2015
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The Food and Drug Administration (FDA) has announced the rates for FY 2015 for the establishment fees and reinspection fees for 503(B) registered outsourcing facilities (OFs). The recent Drug Quality and Security Act (DQSA) authorizes FDA to collect an annual establishment fee from each OF including a reduced establishment fee for those OFs meeting the requirements of a small business as defined by FDA. Also, please note according to the DQSA, a facility will not be deemed an OF until it has paid the annual establishment fee.  In addition, FDA is also authorized to collect reinspection fees for each reinspection of an OF.

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