Immediate Notification of Compounding Status and Inspections

Posted in Latest News on June 12, 2013.

SUMMARY: The rule requires all permitted and registered pharmacies immediately notify the board of its compounding activities. Based on the data, the board requires prioritizing inspections based on the risk level to the citizens of the state of Florida.
THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS: Mark Whitten, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

THE FULL TEXT OF THE EMERGENCY RULE IS:

64B16ER12-1 Immediate Notification of Compounding Status and Inspections.

All permitted and non-resident pharmacies shall, within 14 days of the effective date of this rule, report their compounding activities.

  1. All Pharmacies: The compounding status of all permitted and registered pharmacies shall be reported on form number DH-MQA 1308, Compounding Survey, herein adopted and incorporated by reference. The form is available at http://survey.doh.state.fl.us/survey/entry.jsp?id=1353086689950;
  2. Permitted Pharmacies: Based on the compilation of the data reported, inspections of permitted pharmacies required by Rule 64B16-28.101 shall be prioritized as follows: 1) Those pharmacies which only engage in compounding sterile products; 2) Those pharmacies which engage in the compounding of sterile and non-sterile products; 3)Those pharmacies which only engage in non-sterile compounding and those pharmacies which do not engage in compounding;
  3. Registered Non-Resident Pharmacies: All registered pharmacies must immediately provide a copy of their last two inspection reports that were required by the state in which the pharmacy is physically located and licensed. The board must receive the report within 14 days of the effective date of this rule.
  4. A failure to timely comply with this section shall constitute the basis for disciplinary action.

Rule Making Authority: 465.005; 465.0155; 465.022, F.S. Law Implemented: 465.0155; 465.0156(1)(c) and (2); 465.017; 465.022; 465.023, F.S. History – New.

THIS RULE TAKES EFFECT UPON BEING FILED WITH THE DEPARTMENT OF STATE UNLESS A LATER TIME AND DATE IS SPECIFIED IN THE RULE.
EFFECTIVE DATE: November 26, 2012



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