Draft of Florida Board of Pharmacy Minutes for April 2-3, 2013 Meeting Includes Compounding Rules Committee Update

2.
Michele Weizer – Compounding Rules Committee Update
Dr. Weizer provided an update and results from the March 22nd Rules Workshop in Orlando, specifically in regards to permitting. Dr. Weizer introduced proposed language changes to Section 465.017, which are intended to eliminate the restrictions on inspecting non-resident pharmacies annually.
Motion: by Dr. Weizer, seconded by Dr. Griffin, to accept the changes to Section 465.017. Motion carried
Dr. Weizer introduced language for a proposed legislative change to Section 465.0158 which would create a new permit titled “Non-Resident Sterile Compounding Permit”. Dr. Weizer states a need for this permit to ensure the safety of the products entering the state as well as the safety of the public.
Motion: by Dr. Weizer, seconded by Ms. Mullins, to accept the language of Section 465.0158 Non-Resident Sterile Compound Permit as presented. Motion carried.
Dr. Weizer introduced additions to rule 64B16-28.100 that include detailed language incorporating the new sterile compounding permit and qualifications for acquiring said permit.
Dr. Weizer clarifies to the Board and audience that there is no initial inspection required for this permit.
Mr. Flynn provided clarification to the rules regarding being a Prescription Department Manager at multiple locations and the requirement of Board approvaMotion: by Dr. Weizer, seconded by Ms. Mullins, to support Rule 64B16-28.100. Motion carried.
Motion: by Dr. Weizer, seconded by Ms. Mullins, to allow Special P&E permits to transfer license number to new Sterile Compounding permit. Motion carried.
Motion: by Dr. Weizer, seconded by Dr. Fallon, that the new rules will not have an effect on small business. Motion carried.
Motion: by Dr. Weizer, seconded by Ms. Glass, to add (h)-Special Sterile Compounding as a special pharmacy to rule 64B16-28.800. Motion carried.
Dr. Weizer introduced language of proposed new Rule 64B16-28.802 Special Sterile Compounding.
Motion: by Dr. Weizer, seconded by Dr. Fallon, to support new rule 64B16-28.802 Special Sterile Compounding. Motion carried.
Motion: by Dr. Weizer, seconded by Dr. Fallon, that there is no additional economic impact on the practice of pharmacy. Motion carried.
3.
Correspondence – Charles Slonim, MD / Rebecca Chater
Mr. Whitten introduced a letter of support from Dr. Sternberg and Dr. Slonim regarding office use compounding.
Mr. Garcia suggested sending a letter of appreciation for reaching out to the Board.
Rebecca Chater provided her background and requested clarification from the Board regarding Florida Statutes 465.189 regarding an absence of a recommendation for administering shingles vaccine on the age group of 50-59. Ms. Chater then asked the Board if they have the ability to interpret the statute to allow for administration in that particular age group.
Mr. Flynn provided an interpretation of Florida Statutes 465.189 regarding the administering of shingles vaccine on the age group of 50-59. Mr. Flynn advised the board on what authority they have in making a recommendation on the matter Ms. Chater inquired about.
Motion: by Ms. Mullins, seconded by Dr. Weizer, to support the recommendation of Mr. Flynn’s interpretation of Florida Statute 465.189. Motion carried.
Ms. Chater then thanked the Board for their patience and diligence in tending to her request.

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