Utah Board of Pharmacy January 22, 2013 minutes addressing compounding issues

Minnesota Board of Pharmacy
Compounding Memo:
Dr. Hobbins questioned whether the Board would like
to issue a statement similar to the Minnesota Board of
Pharmacy Memo. The Minnesota notice was a
reminder of their current rules and regulations for
compounding.
Dr. Young reported that the NABP represented the
Boards of Pharmacy at the U.S. Senate Committee
Hearing regarding compounding pharmacies. Dr.
Young stated that each state board has their own laws
and rules governing compounding and there is not a
nationwide definition. Utah requires compounding
pharmacies follow the USP 797 and 795 and there are
some states have sent out a notice to stop
compounding all together. Dr. Young also reported
that Iowa is requiring out-of-state inspections and has
entered into a contract with NABP to conduct those
inspections. NABP has already issued some
significant citations for not following state and federal
rule in several states.
Massachusetts Board of Registration in
Pharmacy:
Board members reviewed the article that indicates the
Massachusetts Board of Registration in Pharmacy is
considering eight potential solutions for improving the
state’s regulation of compounding pharmacies. Dr.
Hobbins indicated it appears the Massachusetts
Board’s intention is not to take compounding away
from pharmacies, but to find solutions to make sure
the compounding pharmacies are safe. Dr. Hoffman
stated a number of states are developing a taskforce to
review compounding issues. Dr. Hoffman suggested
the Board work with the compounding pharmacies to
provide the additional education necessary to practice
within the law. Dr. Hoffman also stated the pharmacy
investigator should also obtain additional training.
Mr. Walker stated a taskforce could be established that
would meet outside of the Board meeting and discuss
compounding issues. Mr. Walker also indicated an
advisory committee could be established by rule if
necessary. Dr. Lundberg stated the Board could begin
with a taskforce and put the issues on the table. The
taskforce could bring the information back to the
Board for discussion. Dr. Young suggested Dr.
Hoffman be the Board contact for the taskforce and
requested Dr. Hoffman provide the Division with a list
of individuals who will be on the taskforce. The
taskforce shall consist of representatives from
independent compounding pharmacies, institutional
pharmacies, the Utah Hospital Association, UPHA
and any other interested party.
A guest requested the Division investigators give the
compounding pharmacies a length of time to come
into compliance or a letter of warning instead of
issuing fines. He also suggested further education
would be helpful. Mr. Jones stated that the USP 797
and 795 requirement for compounding pharmacies has
been in Rules for a long time and those pharmacists
should be familiar with the law. Dr. Hoffman
indicated there are different interpretations of USP
795 and he questioned where the investigators receive
their training on USP 795. Mr. Jones stated that
setting a standard for the investigator but not the
practitioner does not make sense. The training should
be for the practitioner.
Mark Munger,
Presentation:
Mr. Munger will give the presentation next month.

To read the complete January 22, 2013 minutes click here