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Oct 8th Board of Pharmacy Meeting Summary

Monday, November 4, 2013   (0 Comments)
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On Tuesday October 8, 2013 the Board of Pharmacy conducted a full board meeting in Panama City, Florida. A variety of topics were discussed as summarized below.

The morning session opened with a brief discussion surrounding "office use compounding”. Two areas brought up that are felt to be in need of more attention are: the compounding of non-commercially available drugs (and the issue of patient-specific prescriptions), and a more precise definition of non-patient-specific compounding.

The discussion then turned to sterile compounding with board member Michele Weizer, PharmD leading this part of the meeting. Highlights of the previous board meeting were offered first, in which an NABP representative provided an in-depth presentation. Key issues reiterated were non-resident pharmacy systems, inspector training, and the Iowa pilot program. Dr. Weizer then noted the many individuals who participated in that last meeting, and the fact that they had read USP 797 and gave examples of what works and doesn’t work within their own practice settings. She then touched on a variety of topics such as office-use compounding, introducing a non-patient-specific example (cardioplegic solution) and opened dialogue for others to give examples as well. Dr. Weizer vocalized the need for some type of documentation in case of a recall and a response to the letter from the Department of Health as king for clarification. Several comments followed, including examples the board found concerning. All were focused on protecting patient safety as well as physician quality of care. Another meeting centered on office-use compounding is likely to be on the horizon.

As the meeting continued, ideas such as a "FAQ” section related to USP 797 were introduced to possibly address or clarify things like beyond-use dating. Other concerns were voiced over inspections and pharmacist training, cleansing of the workspace, donning of sterile gloves, environmental testing, and the process of "wordsmithing” the Florida rule under development.

After the break, George Malone, FSHP Chair of the Legal and Regulatory Affairs Council, went on record stating that the Florida Society of Health-System Pharmacists was in favor of adopting USP 797. Next the board discussed at length the topic and meaning of direct supervision of pharmacy technicians. A brief introduction by MedAvail Technologies followed, presenting on their product and services surrounding a remote medication dispensing machine system. Many questions arose from the board members with Mr. Flynn, Board Counsel, concluding the dialogue with the possibility of further discussions in the future surrounding such technology.

Regarding Senate Bill 248, a pre-filed 2014 bill identical to one considered last session to raise the tech ratio to 6:1, a motion was offered to reaffirm the board’s position in favor of keeping the current standard "as is” and the motion carried.

The Attorney General’s report was then offered by Lynette Norr, Board Co-Counsel as follows:
Rules Status Report:
• 64B16-28.100 Pharmacy Permits - Applications & Permitting; Adopted Sept 3; Effective Sept 23, 2013
• 64B16-28.802 Special Sterile Compounding Permits; Adopted Sept 27; Effective Oct 17, 2013

Rules Notice:
• 64B16-26.206 Application for Pharmacist License by Endorsement (Foreign Pharmacy Graduates) – being worked on

Rules Board Approved Language for:
• 64B16-28.450 Centralized Prescription Filling, Delivering and Returning – noticed published Sept 24, 2013
• 64B16-28.901 Nuclear Pharmacy - General Requirements – noticed published Sept 24, 2013
• 64B16-30.001 Disciplinary Guidelines; Range of Penalties; Aggravating and Mitigating Circumstances – noticed published Sept 24, 2013

Board of Health Staff, Yolonda Green, Assistant General Counsel presented the following Prosecuting Attorney Report:
• There has been a downtrend in cases, with prosecution being done as quickly as possible
• Re-inspections of sterile compounding pharmacies and addressing of findings and emergency actions is also being done as quickly as possible

A motion from the board to investigate the number of cases older than 1 year carried.

Special recognition from the Department of Health was given to board member DeAnn Mullins, BPharm who she has concluded her term of appointment. We also offer our thanks to her excellent service on the Board of Pharmacy!

*Note: This report was prepared by FSHP consultant, Troy Batterton, PharmD, who attended the meeting while I was in Tallahassee attending interim legislative committee meetings.

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