Florida Board Of Pharmacy Clarifies That Pharmacies Can't Compound Sterile Human Drugs For "Office Use"


The Florida Board of Pharmacy rules allow pharmacies to engage in office-use compounding. Rule 64B16-27.700, FAC. This allows pharmacies to compound drugs for physicians to use in treating their patients in the office without writing a patient-specific prescription. It does not allow the physician to dispense the office-use drugs to their patients (i.e. give the patient a supply to take with them).

The Federal Quality Compounding Act enacted on November 27, 2013, at 21 USC 353a and 353b, states that, other than registered outsourcing facilities that compound sterile human products for office use, such compounding by state licensed pharmacies should be patient specific.  The Board and its legal counsel wanted to place Florida pharmacies holding the Sterile Compounding Permit on notice of this change in federal law so these pharmacies did not mistakenly rely on Florida's rule and engage in office use sterile human compounding in possible violation of federal law. The Board of Pharmacy voted to approve language amending the Florida Compounding Rule at its meeting on May 1, 2014. The amendment adds new Subsection (3)(g) to the Compounding Rule to provide:

64B16-27.700(3)(g) In the case of compounded sterile products intended for human use, the pharmacy must be in full compliance with 21 U.S.C. § 353b, including being registered as an Outsourcing Facility. 21 U.S.C. § 353b (eff. Nov. 27, 2013) is hereby adopted and incorporated by reference.

This rule change will still need to go through the rulemaking process before becoming law, but because it relies on existing federal law, pharmacies should not wait to comply.

Key Takeaways:

  • Florida pharmacies cannot compound sterile human products for office use;
  • Florida pharmacies holding the sterile compounding pharmacy permit may continue to compound patient-specific sterile products;
  • Florida physicians and hospitals should acquire office-use sterile human products from registered outsourcing facilities, rather than facilities licensed only as sterile compounding pharmacies; and
  • The Board's rule does not change other office-use compounding.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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