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Board of Pharmacy Meeting Notes | April 1-3 2019

Monday, April 29, 2019   (1 Comments)
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Report from the April 1-3 Board of Pharmacy Meeting

Submitted by Heather Fuller, Member of the Legal and Regulatory Council


Chair Report: Discussed the formulary committee that met on April 1 and that they last met 10 years ago. Committee consists of 3 Board of Pharmacy members, 2 Osteopathic Physicians, 2 Physicians from the Board of Medicine and one at large member with background in Healthcare.   Goal is to clean up confusing wording in 64B 16-27.220 and to review medications on formulary. They voted to add Narcan automatically to formulary when FDA approves it for pending OTC status.

Investigative services report: Mr. DiFiore reported that going into their final fiscal quarter 75% non-sterile inspections completed and 86% sterile compounding. On track for full completion even though the Orlando inspector position was vacant for 7 months. The new Orlando inspector, Swanee Brook was introduced. July 1 will enact the punitive aspect of inspections. Question was posed how will this citation process work? This has not been completed at this time so will be added to the website to notify all.



Rebecca Poston: Presented stats and impact of HB 21

6932 died in Florida in 2017. 4% decrease from 2016. In 2017, 6 states declared state of emergency from Opioid epidemic including Florida. Florida was the 42 state to develop a PDMP in 2010. Top 3 prescribed in Fl: hydrocodone, oxycodone and alprazolam. Impact HB 21: 15.5% decrease in schedule II prescriptions. 9.7% increase in 1-3-day supply. 5.5% reduction in 4-7-day supply of schedule II. 1.8% decrease in morphine equivalents. 79.1% decrease in Dr shopping. Queries to PDMP increased from 35M to 45M. PDMP data share states NC, SC, Al, GA, MS, TN. Facilities able to integrate into their EMR (costs are associated).

The Florida Pharmacy Association asked that rule 64B16-27.4001 be opened back up and proposed language for Rule 64B16-27.4001 Direct Supervision of technicians which would place some guardrails in the language.   Their suggested language would allow for no more than 2 of the technicians to be remote.   Conversation included that 4 states have a 0 ratio and allow work from home. Example was Arizona which has had this in place since 2011. New Mexico has more scripted language but allows work from home. Conversation around the issue is virtual considered the same as physically present.  The Board voted on Tuesday to deny the petition to open the rule with a final vote being 4 to open the rule back up and 5 to deny.   The Board members who voted against opening the rule felt that there had been plenty of time for interested parties to submit their comments during the 21-day period when the Board asks for public input into the language of the rule.

However, at the Wednesday morning Board Meeting, the Board decided to reopen the all the rules regarding pharmacy technicians including 64B16-27.4001 and assign the newly formed Pharmacy Practice Subcommittee of the Board to look at these rules  in conjunction with other rules impacted by pharmacy technicians which could impact the practice of pharmacy.

The Board of Pharmacy also heard the results from a petition for waiver of Rule 64B16-27.797 that was granted one year ago that allows beyond use time that does not exceed 6 hours when using a closure sealed single dose containers in ISO Class 5 after initial opening.

The Board moved to reconsider the 1-year waiver and to make the waiver a 3-year proposal after seeing the results of the studies. 


Rules committee

Language was suggested to 64B 16-27.797 (5)( a) that was recommended by a special Board appointed subcommittee that deals with lyophilization of sterile products since the Boards investigators did not feel that the current language addressed this process.     At Wednesday’s Board Meeting, it was decided to go forward and publish the rule language for adoption.     Board of Pharmacy Chairman Jeffrey Mesaros named a Compounding Subcommittee with Blanca Rivera to chair along with Board Members Mark Mikhael, Richard Montgomery, David Wright and Jonathan Hickman.

Automated Systems bill: The Board of Pharmacy was working on language regarding automation but are holding off for now until they see where possible legislation may land.   Board of Pharmacy Chairman Mesaros appointed Richard Montgomery to chair a special subcommittee dealing with pharmacy automation along with Board Members Jonathan Hickman, Jeenu Phillip, Blanca Rivera and Consumer Member David Bisaillon.

Discussed the technician process more in a holistic approach. Rules to be opened are 64B16-27:4001 (Delegation and supervision of technicians), 64B16-27:410 (Registered Pharmacy technician to Pharmacist ratio) and 64B16-27:420 (Pharmacy technician; Delegable and non-delegable tasks) Pharmacy practice, formulary and technician duties.  There will be a Pharmacy Practice Subcommittee formed with Board Member Jonathan Hickman to Chair with other members from the Board of Pharmacy being Jeenu Phillip, David Wright, Mark Mikhael and Consumer Member David Bisaillon. This has been approved by the board to reopen. The notice for rule development will be the next step.

Other rules to be opened 64B16-27:210, 64B16-27:220 and 64B16-27-830.


Michael J. McQuone says...
Posted Thursday, May 2, 2019
Dr. Fuller: Thank you for a comprehensive and informative report. FSHP members in the Orlando area may wish to note that the FL BOP will be holding public meetings at the Rosen Plaza Hotel as follows: Compounding Committee 2PM on Monday, June 17; Rules Committee 9AM on Tuesday, June 18; and the General Board Meetings 1:30 PM on Tuesday, June 18 and 9AM on Wednesday, June 19.

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