that it has issued an Order on the Petition for Variance or Waiver filed on May 1, 2015, by Michael J. Glazer, on behalf of Tenet Good Samaritan, Inc. d/b/a Good Samaritan Medical Center. Petitioner was seeking a variance or waiver of Rule 64B16-27....

 

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 that it has issued an Order on the Petition for Variance or Waiver filed on May 1, 2015, by Michael J. Glazer, on behalf of Tenet Good Samaritan, Inc. d/b/a Good Samaritan Medical Center. Petitioner was seeking a variance or waiver of Rule 64B16-27.797, Florida Administrative Code, entitled “The Standards of Practice for Compounding Sterile Products,” that requires non-low volume oncology, chemotherapeutic and hazardous sterile preparations be performed in a negative pressure room in lieu of in a properly vented barrier isolator.

The Board of Pharmacy considered the Petition at a duly-noticed public meeting held June 9, 2015, in Lake Buena Vista, Florida. The Board’s Order, filed on July 15, 2015, granted the petition for temporary waiver, finding that Petitioner established that the purpose of the underlying statute, would be met by granting a variance or waiver from Rule 64B16-27.797, F.A.C. The Board further finds that the 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: Allison Dudley, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254.