August 2014 Minutes Contained in Public Binder for Louisiana Board of Pharmacy Provide Insight into Compounding Rule Changes and Rule Pharmacist Not selecting an equivalent drug product but to dispense as writtent

Committee Reports
H. Regulation Revision Committee
Mr. Aron called upon Mr. McKay for the committee report. He reported
the committee met in July and that the committee had voted to recommend
the approval of two new regulatory proposals as well as a proposal for a pilot
project. Prior to considering those, he suggested reviewing the comments
and testimony offered during the July 28 public hearing.
Mr. McKay directed the members to the meeting binder containing a
summary of the comments and testimony offered during the July 28 public
hearing concerning Regulatory Project 2014-5 ~ Prescriptions
Resolved, on consideration of the public comments and testimony,
the Board authorizes the amendment of the original proposal by
amending §2511.E.2 to read as follows:
. He noted the
letter received from NACDS after the deadline for receipt of comments, and
in particular, he noted the two requests for suggested changes to the original
proposal. Following some discussion, Mr. McKay moved to reject the first
suggested change to §2511.C.4. The motion was adopted after a
unanimous vote in the affirmative. Following additional discussion, Mr.
McKay suggested the propriety of accepting some of the second set of
revisions suggested by NACDS, and he moved,
“The pharmacist shall not select an equivalent drug product
when the prescriber indicates “Dispense as Written”, “DAW”,
or “Brand Medically Necessary” and transmits his electronic
signature. Otherwise, the pharmacist may select an
equivalent drug product, provided the patient has been
informed of, and consents to, the proposed cost saving
interchange.”;
and further, authorize staff to respond to the public commentators
in the manner directed by the Board, and further, to submit the
proposed revisions to the original proposal for publication in the - 14 –
State Register, and to schedule a public hearing on the proposed
revisions.
 The motion was adopted after a unanimous vote in the affirmative.
Mr. McKay reminded the members of their past work on the issue
of pharmacy compounding, beginning with the New England Compounding
Center (NECC) tragedy in late 2012He reported the committee had
completed its work on a revision to the Board’s compounding rules at about
the same time the US Congress adopted the new federal legislation. Staff
had suggested a delay until the FDA issued its final guidance to
compounding pharmacies, which was recently released. He then moved,
Resolved, to approve Regulatory Proposal 2014-C ~
Compounding (Draft #4)
The motion was adopted after a unanimous vote in the affirmative. Mr.
McKay then reminded the members the Emergency Rule first adopted in
January 2013 had been re-published continuously since then but had
recently expired on August 2. With the expiration of the Emergency Rule,
that left the Board’s current rule, which contains no limits on the
compounding of preparations for office use, in effect. He suggested the
potential for some pharmacists to believe they had authority to resume
unlimited compounding for office use under the state rule even though the
more stringent federal law prohibits such activity. Given the potential hazard
to public health from unlimited compounding for office use, he suggested the
propriety of declaring an emergency and then adopting the proposed revision
just adopted as a new emergency rule. He then moved,
, and further, to authorize the Executive
Director to promulgate the proposed rule amendments upon the
instruction of the President, and further, to authorize the President
to approve acceptable amendments as may become necessary
during the promulgation process.
Resolved, to approve the
The motion was adopted after a unanimous vote in the affirmative. Mr.
McKay then moved,
Declaration of Emergency ~ Pharmacy
Compounding.
Resolved, to approve Regulatory Proposal 2014-C ~
Compounding (Draft #4)
 The motion was adopted after a unanimous vote in the affirmative.
, to become effective as an Emergency
Rule effective August 8, 2014, and further, to authorize the
Executive Director to re-publish this Emergency Rule as may
become necessary during the promulgation process.
 Mr. McKay reminded the members of the request from the Louisiana
Dental Association (LDA) during the Board’s previous meeting to develop a
special event pharmacy permit to assist the LDA during a planned medical
mission event scheduled for February 2015 in New Orleans. Mr. McKay
reported staff had developed a proposal that appeared to address those
needs as well as several other types of potential events that need a pharmacy
permit for a short period of time. The committee voted to recommend the
approval of the proposal. Therefore, he moved,
quoted from  Public Meeting Binder   (revised 11-13)