AGENDA
DEPARTMENT OF HEALTH
BOARD OF PHARMACY
FULL BOARD MEETING
November 20, 2012
Renaissance at SeaWorld
6677 Sea Harbor Drive
Orlando, FL 32821
(407) 351-5555
PLEASE TURN OFF ALL CELL PHONES, PAGERS, AND BEEPERS DURING THE MEETING. THANK YOU.
Board Members:
Cynthia Griffin, PharmD, Chair, Jacksonville
Albert Garcia, BPharm, MHL, Vice-Chair, Miami
Michele Weizer, PharmD, Boca Raton
Gavin Meshad, Consumer Member, Sarasota
Jeffrey J. Mesaros, PharmD, Tampa
Lorena Risch, Consumer Member, Bradenton
DeAnn Mullins, BPharm, Lynn Haven
Debra B. Glass, BPharm, Tallahassee
Leo J. “Lee” Fallon, BPharm, PhD, The Villages
Board Staff:
Mark Whitten, Executive Director
Tammy Collins, Program Operations Administrator
Board Counsel:
David Flynn, Assistant Attorney General
Department of Health Staff:
John J. Truitt, Assistant General Counsel
William Miller, Assistant General Counsel
Participants in this public meeting should be aware that these proceedings are being recorded and that an audio file of the meeting will be posted to the board’s website.
Tuesday, November 20, 2012 – 9:00 a.m. time p.m.
TAB 1 COMPOUNDING IN PHARMACIES LICENSED AND REGULATED BY THE FLORIDA BOARD OF PHARMACY AND THE FLORIDA DEPARTMENT OF HEALTH, (Cynthia Griffin, PharmD, Chair & Mark Whitten, Executive Director)
1. Overview of Pharmacy Compounding
a. Chapter 465, Florida Statutes
b. Rule 64B16-27.700, Florida Administrative Code, Definition of Compounding
2. Compounding of Sterile Preparations
a. United States Pharmacopeia (USP) 797
b. Rule 64B16-27.797, Florida Administrative Code, Standards of Practice for Compounding Sterile Preparations
c. Rule 64B16-28.820, Florida Administrative Code, Sterile Products and Special Parenteral/Enteral Compounding3. Compounding of Non-sterile Preparations
a. United States Pharmacopeia (USP) 795
b. Rule 64B16-28.450, Florida Administrative Code, Centralized Prescription Filling, Delivering and Returning
4. Non-resident Pharmacies
TAB 2 PHARMACY COMPOUNDING SURVEYS, (David Flynn, Assistant Attorney General)
1. Florida Pharmacy Compounding Survey, October 2012 Survey
2. Proposed Florida Mandatory Pharmacies Compounding Survey
TAB 3 DOH PHARMACY INSPECTION PROCESS, (Jeane Clyne, Chief of Investigative Services Unit)
1. Inspection Forms
2. Inspector Education and Training
TAB 4 DEPARTMENT OF HEALTH’S PUBLIC PROTECTION CONCERNS, (Cassandra Pasley, BSN, JD, Chief, Bureau of Health Care Practitioner Regulation)
1. Representative from the Department of Health
TAB 5 ADDITIONAL REFERENCE MATERIALS
1. Chapter 499, Florida Statutes
2. Federal Food, Drug, and Cosmetic Act
3. The Committee On Energy And Commerce – Briefing Document- Hearing on “The Fungal Meningitis Outbreak: Could It Have Been Prevented?”
4. Massachusetts Compounding Survey
5. Correspondence, Florida Pharmacy Association
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