Louisiana Board of Pharmacy Special Meeting Tuesday, January 29, 2013 at 8:30 a.m.--Compounding for Prescriber Use Consideration of Replacement Emergency Rule

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

limitation should be applicable to a pharmacy’s entire dispensing 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.
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Assessment by Compliance Officers of Compounding Pharmacies of Emegency Rule in Louisiana Begins on January 14, 2013

Board Adopts Emergency Rule re Compounding for Prescriber's Use

Sunday, December 16, 2012

The Board has taken note of the recent tragedies associated with fungal meningitis traced to medications dispensed by a compounding pharmacy in Massachusetts.  That pharmacy was licensed to do business in Louisiana, although none of the cases - to date - have been located within the state.  Further, the Board has learned there are other similar types of pharmacies operating across the country that are also licensed to do business in Louisiana.  Some of these pharmacies specialize in the large-scale preparation of practitioner-administered compounds without a prescription as opposed to compounding medications pursuant to patient-specific prescriptions.  Further, the Board has recently learned that other state boards of pharmacy may have resource limitations that restrict their ability to inspect such facilities on a sufficiently regular basis.

The preparation of compounds in the absence of a patient-specific prescription is construed as manufacturing as opposed to compounding, which is defined in Louisiana pharmacy law as the preparation of medications pursuant to a patient-specific prescription.  Compounding by pharmacies is regulated by the Board of Pharmacy, and manufacturing is regulated by the federal Food & Drug Administration (FDA).  In an abundance of caution for the health, safety and welfare of Louisiana citizens, the Board seeks to repeal the rules which allows pharmacies to compound preparations without the necessity of a patient-specific prescription.  The business entity that wishes to continue the preparation of such products without a prescription may apply to the federal FDA for a manufacturer's registration.

During their December 13, 2012 meeting, the Board adopted this Declaration of Emegency and Emergency Rule.  In recognition of the necessity for practitioners to develop alternative business procedures to acquire needed medications for their patients, the Board has instructed its compliance officers to delay their assessment of compounding pharmacies for compliance with this emergency rule until January 14, 2013.

 

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