variance or waiver filed by Belcher Pharmaceuticals, LLC and BPI Labs, LLC, seeking a waiver of the requirement of Rule 64B16-28.802(1), Florida Administrative Code, which states that a Special Sterile Compounding Permit ....
RULE NO.:RULE TITLE:
64B16-28.802Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities
NOTICE IS HEREBY GIVEN that on January 25, 2024, the Board of Pharmacy, received a petition for variance or waiver filed by Belcher Pharmaceuticals, LLC and BPI Labs, LLC, seeking a waiver of the requirement of subsection 64B16-28.802(1), Florida Administrative Code, which states that 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.
A copy of the Petition for Variance or Waiver may be obtained by contacting: Allison Dudley, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C08, Tallahassee, Florida 32399-3258 or at info@Floridaspharmacy.gov. Comments on this petition should be filed with the Board of Pharmacy/MQA, within 14 days of publication of this notice.
Document Information
- Related Rules: (1)
- 64B16-28.802. Special Sterile Compounding Permits