New Compounding Rule Effective June 22, 2014

Posted in Latest News on July 3, 2014.

Effective June 22, 2014, Board of Pharmacy (Board), Rule 64B16-27.700(3)(g), Florida Administrative Code, requires all pharmacies that engage in office use compounding of sterile products intended for human use be in full compliance with 21 United States Code § 353b, which includes being registered as an outsourcing facility.

The Board has amended this rule so it will not be in conflict with Title I of the Drug Quality and Security Act of 2013 (DQSA) as signed by the President on November 27, 2013. You may view a copy of the adopted rule on the Board’s website at: https://floridaspharmacy.gov/resources/.   For more information on the DQSA, including how to apply as an outsourcing facility, you may access the U.S. Food and Drug Administration website at: http://www.fda.gov/.

Thank you for helping the Board of Pharmacy to protect, promote and improve the health of all people in Florida. If you have any questions you may contact our office by email at info@floridaspharmacy.gov.



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