AGENDA ITEM 18 – Update concerning the FDA’s Intergovernmental Working Meeting on Compounding on December 19, 2012
President Milovich asked Mr. Wand to address this agenda item.
Mr. Wand stated that the meeting was held in Washington D.C. with the FDA to discuss compounding. Mr. Wand stated that the participants were divided into districts and discussed
what they believed constituted compounding and manufacturing.
Mr. Wand stated that they discussed compounding of medications due to shortages and if some of the larger firms were compounding or manufacturing.
Mr. Wand stated that some states had not inspected facilities in their states for 5 years.
Mr. Wand stated that it was discussed about developing training programs to train the inspectors
Mr. Van Hassel stated that they discussed certifying the inspectors. Mr. Van Hassel stated that
standards would be set for inspections.
Mr. Wand stated that there were concerns about doctors hiring technicians to compound medications since doctor’s offices are not inspected by the Boards.
Mr. Van Hassel stated that it why the Board is forming a task force to review the rules.
AGENDA ITEM 19 – Selection of Compounding Task Force Members
President Milovich opened the discussion by stating that the Board would select a chairman and members of the task force.
Dr. Foy stated that there should be an adequate number of people on the task force and should represent all the different areas of compounding.
Mr. McAllister stated that the selection of a compounding task force would show that the Board is thinking about the changes and not overacting to the problems.
On motion by Mr. McAllister and seconded by Dr. Foy, the Board unanimously approved the following individuals to serve on the task force:
1. John Musil – Chairman
2. Tom Van Hassel – Co-Chairman
3. Danielle Evans
4. Rich Monty
5. Eric Bauer
6. Dennis Waggoner
7. Dana Reed
8. Linda Carboni
9. Sandra Sutcliffe
Mr. McAllister stated that some of the topics that he feels the task force should consider is
PCAB accreditation, non-resident compounders, compounding for office use, and a separate license for sterile compounding
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