Section 64B16-28.802 - Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities(1) A Special Sterile Compounding Permit (SSCP) is required before any pharmacy may engage in the preparation of compounded sterile products. For purposes of this rule, an outsourcing facility shall be deemed a pharmacy.(2) An SSCP shall be issued by the department as an additional permit with a separate permit number that differs from the permit number of the pharmacy obtaining the SSCP.(3) All sterile compounding shall be done in strict compliance with the standards set forth in Rules 64B16-27.700 and 64B16-27.797, F.A.C.(4) An outsourcing facility shall comply with current good manufacturing practices pursuant to the applicable United States Code and Code of Federal Regulations. (a) If a pharmacy is not registered as an outsourcing facility at the time the pharmacy applies for an SSCP, the applicant shall amend the application within 7 business days if the pharmacy becomes a registered outsourcing facility before the SSCP is issued.(b) If a pharmacy is issued an SSCP and later becomes registered as an outsourcing facility, the pharmacy will not be required to obtain a new or additional SSCP. However, the pharmacy shall comply with current good manufacturing practices to be eligible to retain the issued SSCP and the pharmacy shall notify the department in writing within 7 business days of becoming a registered outsourcing facility.(c) An outsourcing facility that does not engage in patient specific sterile compounding and dispensing pursuant to such prescription shall only be required to obtain the SSCP. However, if the outsourcing facility engages in patient-specific sterile compounding, in addition to the SSCP, the outsourcing facility shall be required to obtain a pharmacy permit specific to the type of patient dispensing that the pharmacy will be engaged in (i.e., community pharmacy permit or institutional pharmacy permit).(5) The SSCP is not required for a Special Parenteral/Enteral or Special Parenteral/Enteral Extended Scope pharmacy if that pharmacy is not registered as an outsourcing facility.(6) The SSCP is not required for a Pharmacy permittee engaging in sterile compounding under the following conditions: (a) The pharmacy only compounds immediate use compounded sterile preparations; and,(b) The pharmacy only compounds those immediate use compounded sterile preparations pursuant to the applicable provisions of the United States Pharmacopeia as required in Rule 64B16-27.797, F.A.C.(7) This rule shall be reviewed, and if necessary, repealed, modified, or renewed through the rulemaking process five years from the effective date.Fla. Admin. Code Ann. R. 64B16-28.802
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.0196 FS.
New 6-18-13, Amended 10-20-13, Amended by Florida Register Volume 42, Number 081, April 26, 2016 effective 5/8/2016, Amended by Florida Register Volume 42, Number 235, December 6, 2016 effective 12/18/2016, Amended by Florida Register Volume 43, Number 206, October 24, 2017 effective 11/5/2017, Amended by Florida Register Volume 50, Number 202, October 15, 2024 effective 10/29/2024.New 6-18-13, Amended 10-20-13, 5-8-16, 12-18-16, 11-5-17.