of the issuance of an Order regarding the Petition for Waiver or Variance, which was filed on January 25, 2024, by Belcher Pharmaceuticals, LLC and BPI Labs, LLC. The Notice of Petition for Waiver or Variance was published ....
RULE NO.:RULE TITLE:
64B16-28.802Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities
The Board of Pharmacy hereby gives notice: of the issuance of an Order regarding the Petition for Waiver or Variance, which was filed on January 25, 2024, by Belcher Pharmaceuticals, LLC and BPI Labs, LLC. The Notice of Petition for Waiver or Variance was published in Volume 50, Number 21, of the January 31, 2024, Florida Administrative Register. The Petitioner was seeking a waiver of the requirement of subsection 64B16-28.802(1), Florida Administrative Code, entitled, “Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities” 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.
The Board considered the instant Petition at a duly-noticed public meeting held February 22, 2024, in St. Petersburg, Florida. The Petitioner requested to withdraw the petition.
A copy of the Order or additional information 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.
Document Information
- Related Rules: (1)
- 64B16-28.802. Special Sterile Compounding Permits