of the issuance of an Order regarding the Petition for Waiver or Variance, which was filed on January 12, 2018, by Moffitt Cancer Center. The Notice of Petition for Waiver or Variance was published in Volume 44, Number 14, of the January 22, 2018, ...

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-27.797:The Standards of Practice for Compounding Sterile Products

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 12, 2018, by Moffitt Cancer Center. The Notice of Petition for Waiver or Variance was published January 22, 2018 in Volume 44, Number 14 of the Florida Administrative Register. The Petitioner was seeking a waiver or variance of the requirement of Rule 64B16-27.797, Florida Administrative Code, entitled, “The Standards of Practice for Compounding Sterile Products,” and the rule’s incorporated documents USP Chapter 797. The Petitioner was requesting to be able to utilize leftover drugs for subsequent patients’ admixtures from SDVs that are stable for 6 hours or less at 2-8°C after initial opening or entry in an ISO 5 environment that is moved to an ISO 7 environment using the PhaSeal CSDTD.

The Board considered the instant Petition at a duly-noticed public meeting held February 7, 2018, in Gainesville, Florida. The Board’s Order, filed on March 9, 2018, granted the petition, finding that Petitioner had established that the purpose of the underlying statute would be met by granting a temporary variance or waiver from Rule 64B16-27.797, Florida Administrative Code. The Board further finds that Petitioner established that applying the requirements of the aforementioned rule to its circumstances would violate principles of fairness and impose substantial hardship.

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