Saturday, February 9, 2013

Florida's Department of Health Board of Pharmacy: Anazao Health Corp and forming Compounding Rule Making CommitteeDiscussion regarding Discussion Re


ii. Anazao Health Corp
Ms. Mullins inquired why there was such a large gap time regarding this case.
Edwin Bayo, Esq. and David Joseph, Director of Pharmacy for Anazao approached the Board and stated that
Anazao did not have a problem with sterile compounding and discussed the case in more detail.
Ms. Mullins recommended our review of the current inspection process to avoid another outbreak.
Mr. Garcia suggested the inclusion of an expert witness in complex cases can give the Board a better sense of
reference and for the application of the rule and understanding of the practice.
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Dr. Weizer requested the Board to consider, in regards to disciplining pharmacies, to require a pharmacy to
stop practice if they can not meet the physical requirements for what they are doing, and that this be
reiterated in final orders.
Dr. Griffin asked the Board for feedback regarding whether or not pharmacies engaging in compounding
should be required to obtain a special permit.
Brian Kahan, Esq. presented a memo to the Board and led the Board into a discussion on suggested possible
revisions to Section 64B16-28.800, F.A.C. and possibly the creation of a new 64B16-28.802, F.A.C.
Motion: by Dr. Fallon, second by Dr. Mesaros, to open 64B16-28.800, F.A.C., and 64B16-28.820, F.A.C., for rule
development.
Mr. Flynn requested a Compounding Rule Making Committee be formed.
Dr. Weizer, Ms. Glass, and Ms. Mullins were appointed to the new Compounding Rule Making Committee with
Dr. Weizer as the Chair.
Dr. Griffin requested feedback from the Board on whether or not accreditation should be standard.
Ms. Mullins stated that accreditation may give the Board assurance knowing that the pharmacy is following
policy and procedure and has been inspected once, but may not be enough or any easy fix. Mandatory
accreditation will also create a tremendous amount of expense but may not necessarily increase patient
safety.
Dr. Weizer stated that accrediting bodies do not accredit hospitals, so how would the Board require
accreditation of hospitals.
Mr. Garcia suggested the Compounding Committee look deeper into accreditation to include a review of
requirements by other State Boards.
Ms. Mullins suggested making USP 797 standard and minimum annual inspection requirements for in-state
and out-of-state sterile compounding pharmacies.
Motion: by Dr. Mesaros, seconded by Dr. Weizer, to delegate authority to the Compounding Committee to
open Rules that reference compounding for rule development. Motion carried.

Source found here

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