Discussing Prescriber's Use or Office Use of Compounded Drugs.
4. Consideration of Replacement Emergency Rule re Compounding for Prescriber Use
Mr. Aron reminded the members of the disposition of their December 13, 2012
emergency rule and the January 18, 2013 legislative directive to issue a replacement
emergency rule within two weeks. He reported the Regulation Revision Committee had
met the previous week and prepared a regulatory proposal for a replacement
emergency rule. Mr. Aron asked Mr. McKay, the committee chairman, to report on the
committee’s meeting and proposal.
Mr. McKay reported the committee met on January 23 and that approximately
twenty five guests were in attendance. He indicated the committee invited and received
substantial input from the guests, which included a number of pharmacists practicing at
several compounding pharmacies across the state. He directed the members to two
documents in their meeting packet: the regulatory proposal developed by the
committee, and a proposed declaration of emergency developed by staff. Following a
brief discussion, Mr. McKay moved,
Resolved, that the Board approve the
Prior to the vote, Ms. Hall offered a clarifying amendment, which was approved without
objection by the members. The motion for approval of the amended document was
adopted after a unanimous roll call vote in the affirmative. Mr. McKay then directed the
members to the regulatory proposal.
Declaration of Emergency –
Compounding for Prescriber Use – LAC 46:LIII.2535.
In order to facilitate the discussion, Mr. McKay moved,
Resolved, that the Board approve Regulatory Proposal 2013-E-C
~ Compounding for Prescriber Use (Draft #1)
To authorize the Executive Director to submit the proposed
amendment for promulgation upon the instruction of the President, and
further, to authorize the President to approve acceptable amendments as
may become necessary during the promulgation process; and further,
, to become effective as an
Emergency Rule on January 31, 2013: and further,
To authorize the Executive Director to re-publish the Emergency
Rule as may become necessary during the promulgation process.
During the discussion of that proposal, staff offered a suggested clarifying
amendment within the paragraph relative to compounding commercial products not
available. Mr. McKay moved to approve that clarifying amendment. The motion for
approval of the clarifying amendment was adopted after a unanimous vote in the
affirmative. Following additional discussion and comments from guests present, Mr.
Aron called the question to a vote. The motion for approval of the amended regulatory
proposal was adopted after a majority roll call vote in the affirmative. Mr. Adams, Mr.
Bond, Mr. Burch, Mr. Dartez, and Mr. Valentine objected.
Following the vote, staff suggested a potential conflict in the interpretation of the
regulatory proposal and the declaration of emergency. In particular, the regulatory
proposal identified a limitation of ten percent of a pharmacy’s total dispensing and
distribution activity, whereas the declaration of emergency identified a limitation of ten
percent of a pharmacy’s compounding activity. The members reiterated their intent the - 5 –
limitation should be applicable to a pharmacy’s entire dispensiing and distribution
activity and not just the compounding activity. Mr. Adams moved to direct the staff to
prepare the appropriate amendment(s) for the declaration of emergency to reflect the
language and intent of the regulatory proposal. That motion was adopted after a
unanimous vote in the affirmative.
To view the entires minutes click here
4. Consideration of Replacement Emergency Rule re Compounding for Prescriber Use
Mr. Aron reminded the members of the disposition of their December 13, 2012
emergency rule and the January 18, 2013 legislative directive to issue a replacement
emergency rule within two weeks. He reported the Regulation Revision Committee had
met the previous week and prepared a regulatory proposal for a replacement
emergency rule. Mr. Aron asked Mr. McKay, the committee chairman, to report on the
committee’s meeting and proposal.
Mr. McKay reported the committee met on January 23 and that approximately
twenty five guests were in attendance. He indicated the committee invited and received
substantial input from the guests, which included a number of pharmacists practicing at
several compounding pharmacies across the state. He directed the members to two
documents in their meeting packet: the regulatory proposal developed by the
committee, and a proposed declaration of emergency developed by staff. Following a
brief discussion, Mr. McKay moved,
Resolved, that the Board approve the
Prior to the vote, Ms. Hall offered a clarifying amendment, which was approved without
objection by the members. The motion for approval of the amended document was
adopted after a unanimous roll call vote in the affirmative. Mr. McKay then directed the
members to the regulatory proposal.
Declaration of Emergency –
Compounding for Prescriber Use – LAC 46:LIII.2535.
In order to facilitate the discussion, Mr. McKay moved,
Resolved, that the Board approve Regulatory Proposal 2013-E-C
~ Compounding for Prescriber Use (Draft #1)
To authorize the Executive Director to submit the proposed
amendment for promulgation upon the instruction of the President, and
further, to authorize the President to approve acceptable amendments as
may become necessary during the promulgation process; and further,
, to become effective as an
Emergency Rule on January 31, 2013: and further,
To authorize the Executive Director to re-publish the Emergency
Rule as may become necessary during the promulgation process.
During the discussion of that proposal, staff offered a suggested clarifying
amendment within the paragraph relative to compounding commercial products not
available. Mr. McKay moved to approve that clarifying amendment. The motion for
approval of the clarifying amendment was adopted after a unanimous vote in the
affirmative. Following additional discussion and comments from guests present, Mr.
Aron called the question to a vote. The motion for approval of the amended regulatory
proposal was adopted after a majority roll call vote in the affirmative. Mr. Adams, Mr.
Bond, Mr. Burch, Mr. Dartez, and Mr. Valentine objected.
Following the vote, staff suggested a potential conflict in the interpretation of the
regulatory proposal and the declaration of emergency. In particular, the regulatory
proposal identified a limitation of ten percent of a pharmacy’s total dispensing and
distribution activity, whereas the declaration of emergency identified a limitation of ten
percent of a pharmacy’s compounding activity. The members reiterated their intent the - 5 –
limitation should be applicable to a pharmacy’s entire dispensiing and distribution
activity and not just the compounding activity. Mr. Adams moved to direct the staff to
prepare the appropriate amendment(s) for the declaration of emergency to reflect the
language and intent of the regulatory proposal. That motion was adopted after a
unanimous vote in the affirmative.
To view the entires minutes click here