Here is the outline on the agenda:
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
i. Understanding Revisions – USP 797
b. Rule 64B16-27.797, Florida Administrative Code, Standards of
Practice for Compounding Sterile Preparations
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c. Rule 64B16-28.820, Florida Administrative Code, Sterile Products and
Special Parenteral/Enteral Compounding
3. 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 – NO DOCUMENTS
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
a. Current Inspection Form
b. Draft Inspection Form
2. Inspector Education and Training – NO DOCUMENTS
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 – NO DOCUMENTS
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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