Friday, July 13, 2012

Flordia Department of Health Board of Pharmacy Discussing Compounding Done at Hospitals

The approved meeting minutes from the Florida Department of Health Board of Pharmacy for February 7-8, 2012, found here contain a discussion regarding compounding done by hospitals.  The matter was referred to the board's attorney to determine whether the practice was legal under Florida laws.  The minutes provide:

C.   Executive Director’s Report – Mark Whitten
1. Board Correspondence
a. Hospital Pharmacy Compounding Practices - Marty Dix
Dr. Charzetta James was present and sworn in by the court reporter. Dr. James was represented by Marty Dix. 
Marty Dix discussed with the Board a specific practice of prescription filling for hospitals: Marty Dix
relayed a practice where a pharmacy fills prescriptions for a hospital such as in powder form that the
hospital would hold. Then upon an order from a physician the material is used for patients and for
example compounded to a particular strength per the physicians order. The purpose of the discussion was to determine if this practice was permissible. Marty Dix and Mike McQuone, from the Florida Society of Health-System Pharmacists, expressed that based on discussions with pharmacies this model was exactly what multiple entities currently practice.
After discussion by the Board, issues were raised that included the following:
-An expectation was expressed that when medicine is received it is received in its final form and
manipulation is not allowed; There was concern that there may not be regulation that allows the
hospital to further manipulate it
- Questions regarding where data verification exists in the process were raised
- Issues with writing prescriptions for drugs to be received by an entity such as a hospital instead of
an individual
- Who is responsible for the final patient product 
Based on the Board discussion, Dr. Griffin suggested the issue be referred to the Board attorney for
review and further discussion regarding the statutes and rules around this practice scenario. After review and discussion by the Board attorney, Board office, and inquiring parties, the determination will be brought back before the Board. 

During the April 10-11th meeting the board's attorney stated she felt this practice was acceptable.  Those board minutes are found here and state:

3. Hospital Pharmacy Compounding Practices – Marty Dix – Addendum
Mrs. Dudley re-introduced the correspondence received from Marty Dix regarding hospital compounding that was on the agenda of the last Board meeting. Mrs. Dudley relayed that she did not see anything that prevents the practice outline in the letter but felt they need a community pharmacy permit. Marty Dix responded that they do have a community pharmacy permit. After some discussion, Mrs. Dudley stated that as the Board attorney she felt this was an acceptable practice.

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