of the issuance of an Order regarding the Petition for Waiver or Variance, which was filed on May 1, 2020, by Guardian Pharmacy LLC. The Notice of Petition for Waiver or Variance was published in Volume 46, Number 88, of the May 5, 2020, Florida ...

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.830Special - Closed System Pharmacy

The Board of Pharmacy hereby gives notice:

of the issuance of an Order regarding the Petition for Waiver or Variance, which was filed on May 1, 2020, by Guardian Pharmacy LLC. The Notice of Petition for Waiver or Variance was published in Volume 46, Number 88, of the May 5, 2020, Florida Administrative Register. The Petitioner was seeking a waiver or variance of Rule 64B16-28.830(1), F.A.C, that states a Special – Closed System Pharmacy permit is a type of special pharmacy as provided for by section 465.0196, F.S., which dispenses medicinal drugs, utilizing closed delivery systems, to facilities where prescriptions are individually prepared for the ultimate consumer, including nursing homes, jails, ALF’s (Adult Congregate Living Facilities), ICF-IIDs (Intermediate Care Facilities – Developmentally Delayed, also known as ICF – Individuals with Intellectual Disabilities), or other custodial care facilities when defined by AHCA rules and which the Board may approve.

The Board considered the instant Petition at a duly-noticed public telephonic meeting held June 4, 2020. The Board’s Order, filed on July 2, 2020, granted the petition with conditions finding that Petitioner had established that the purpose of the underlying statute would be met by granting a variance or waiver from Rule 64B16-28.830(1), Florida Administrative Code. The Board further finds that Petitioner established that applying the requirements of the aforementioned rule to Petitioner’s circumstances would violate principles of fairness and impose substantial hardship.

A copy of the Order or additional information may be obtained by contacting: Jessica Sapp, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254.