variance or waiver filed by Thomas E. Henry III, MBA, RPh, CPh, Chief Pharmacy Officer, on behalf of Moffitt Cancer Center seeking a variance or waiver of the requirement of Rule 64B16-27.797, Florida Administrative Code, and the rule’s ...
RULE NO.:RULE TITLE:
64B16-27.797The Standards of Practice for Compounding Sterile Products
NOTICE IS HEREBY GIVEN that on January 12, 2018, the Board of Pharmacy, received a petition for variance or waiver filed by Thomas E. Henry III, MBA, RPh, CPh, Chief Pharmacy Officer, on behalf of Moffitt Cancer Center seeking a variance or waiver of the requirement of Rule 64B16-27.797, Florida Administrative Code, and the rule’s incorporated documents USP Chapter 797. The Petitioner is 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.
A copy of the Petition for Variance or Waiver may be obtained by contacting: C. Erica White, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254 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
- Contact:
- C. Erica White, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254 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.
- Related Rules: (1)
- 64B16-27.797. Standards of Practice for Compounding Sterile Preparations (CSPs)