Special Sterile Compounding Permit

Posted in Latest News on September 11, 2013.

Effective September 23, 2013 Rule 64B16-28.100(8), Florida Administrative Code (F.A.C.), requires most pharmacies that engage or intend to engage in the preparation of sterile compounded products within the State of Florida to obtain a Special Sterile Compounding Permit. Pharmacies required to obtain this permit must compound sterile products in strict compliance with the standards set forth in rules 64B16-27.797, F.A.C. and 64B16-27.700, F.A.C., copies of which may be viewed at http://floridaspharmacy.gov/licensing/sterile-compounding-permit/#tab-statutes-rules.

The only exceptions to this new permitting requirement are: 1) Stand-alone Special Parenteral/Enteral pharmacies; 2) Special Parenteral/Enteral Extended Scope pharmacies; 3) pharmacies that only perform non-sterile compounding; and 4) non-resident pharmacies.

Pharmacies that are compounding sterile products under their current pharmacy permit may continue to do so, but must obtain the new Special Sterile Compounding Permit on or before March 21, 2014 in order to continue sterile compounding.

If you want to operate a pharmacy in Florida that engages in sterile compounding and other pharmacy activities that require a permit, you must have two permits. To obtain the new Special Sterile Compounding Permit, an applicant must already hold another pharmacy permit and must submit an application for a Special Sterile Compounding Permit. Once approved, the Board will issue you a new Special Sterile Compounding Permit. Remember, this permit will be in addition to your existing pharmacy permit.

If you currently hold a combined Community/Special Parenteral & Enteral, or a combined Special Closed/Parenteral & Enteral permit you will also be required to apply for the Special Sterile Compounding Permit and maintain two separate permits. Your current permit will become your Community Permit or your Special Closed Pharmacy Permit. Upon approval of your application, you will be issued a separate Special Sterile Compounding Permit. When you renew your existing permit it will be reprinted with just Community or Special Closed Pharmacy.

FAQs → Application (PDF)

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