Wednesday, December 18, 2013

Florida Board of Pharmacy Looking at Office-Use Rule in Light of HR 3204, DQSA

Compounding Rules Committee – Michele Weizer, PharmD

Dr. Weizer provided a report from the December 2, 2013 Compounding Rules Committee and stated that
the committee is ready to give two recommendations to the Board. Dr. Weizer highlighted the two
different exceptions that were discussed at the committee meeting including facility design and the
cleaning of a workspace.

Dr. Weizer introduced Federal Legislation titled “HR 3204 Drug Quality and Security Act” that had
recently been signed into law by the President and requested that the Board open up the office-use
compounding rule to look at quantity issues as well as find any conflicts that may be present due to the
new Federal legislation.

Mr. Flynn gave a high level summary of “HR 3204Drug Quality and Security Act” and gave a brief
description of how this legislation could potentially affect the practice and profession of pharmacy in
Florida.

Motion: by Dr. Weizer, seconded by Mrs. Glass, to open up House Bill 3204 to look at limited quantities
and to look at the Board’s rule with implications from the FMs. Collins provided an update on the sterile compounding permits. Ms. Collins stated that 28
quoted from December 3-4, 2013 Minutes
applications had been submitted with 12 currently under review in the Board office and 16 having already
been issued. Ms. Collins stated that all Pharmacies that currently engage in sterile compounding have
until March 21, 2014 to obtain this permit free of charge.DA. Motion carried.

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