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: http://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.



More Latest News

Medical Marijuana Update
November 18, 2016

For information please contact the office of compassionate use. Office of Compassionate Use Website: http://www.floridahealth.gov/programs-and-services/office-of-compassionate-use/ Main line: 850-245-4657


FDA meeting on September 20-21, 2016
September 23, 2016

On September 20-21, 2016 Allison Dudley, Executive Director and David Flynn, Counsel to the Board attended an inter-governmental working meeting at the Food and Drug Administration to discuss the oversight of drug compounding and the relationship between the activities of … Continue reading