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Take-Aways from the December 2018 Board of Pharmacy Meetings

Saturday, January 5, 2019   (0 Comments)
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Take-Aways from the December 2018 Board of Pharmacy Meetings

Written by Gary Dalin


The Florida Board of Pharmacy concluded its December meeting passing various rules that they had been working on from their previous meetings in the Fall.

Rule 64B16-26.351 – Standards for Approval of Registered Pharmacy Technician Programs - was streamlined by deleting the names of the various national or regional pharmacy technician agencies and then adding language that specifies all programs which will be recognized in Florida should be accredited by a regional, national or institutional accrediting agency or a specialized accrediting agency recognized by the Secretary of the United States Department of Education or is eligible to participate in Title IV Student Financial Assistance Programs or programs for pharmacy technicians within the Public School System of the State of Florida which comply with the Florida Department of Education Curriculum Framework for pharmacy technician training.

The Board also tweaked the above rule for employer sponsored training programs which will now limit how long a technician may take to complete the program, based upon the number of hours of training, with a maximum of 12 months to complete the program with the program director being able to extend the hours for an individual employee.


Rule 64B16-28.110 – Outdated Pharmaceuticals - was revised to now read that under no circumstances may prescription drugs, pharmaceuticals or devices which bear upon the container an expiration or “beyond use date” which has been reached, be sold or dispensed to the public. All outdated items shall be removed or quarantined from active stock. This rule used to be descriptive and stated that the stock in the prescription department had to be examined at a minimum interval of four months. That reference is now gone and it’s up to the prescription department manager to assure that no outdates are found. The Board also discussed but did not make a final decision on if outdates are found during an inspection, if a citation would be noted under Rule 64B16-30.003 versus a minor violation with no citation noted. The Board had earlier addressed this rule by adding various citations for violating various components of the new controlled substances laws such as failure to consult the PDMP prior to dispensing a controlled substance.

The Board also made sure that with 64B16-27.410 – Registered Pharmacy Technician to Pharmacist Ratio – that the rule now spells out that any pharmacist or pharmacy engaged in sterile compounding shall not exceed a ratio of up to three (3) registered technicians to one (1) pharmacist since the previous version of this rule did limit the ratio for non-sterile compounding as well as sterile compounding.


Another rule that passed that deals with pharmacy technicians is Rule 64B16-27.4001 – Delegation to and Supervision of Pharmacy Technicians; Responsibility of Supervising PharmacistThis rule now defines what direct supervision means as well as defines the pharmacist’s use of technology to communicate with or observe the pharmacy technician so as to meet the standard of practice for the delegated tasks. Therefore, the pharmacist need not be on the premises to supervise what a pharmacy technician is doing as long as there is technology involved for the pharmacist to supervise and approve the work of the technician.


The Board also updated 64B16-30.001 – Disciplinary Guidelines; Range of Penalties: Aggravating and Mitigating Circumstances – by adding penalty ranges for a first violation of F.S.465 or F.S.893 as well as a second and subsequent violations of the pharmacy laws and rules.


The various Boards of Medicines and Dentistry finally passed 64B15-14.005 - Standards for the Prescribing of Controlled Substances for Treatment of Acute Pain that defines standards for prescribing of controlled substances that includes evaluation of the patient, treatment plans, informed consent and agreement for treatment, periodic review of progress, medical records and utilizing the PDMP.


Finally, all the rules regarding Class III Institutional Pharmacies (64B16-28.750) have been implemented. Class III institutional pharmacy permits were created for hospital affiliated institutional pharmacies, including central distribution facilities, that provide the same services as authorized by a Class II permit as long as the entities are under common control.


The Board of Pharmacy had an emergency conference call on December 27th and passed, as part of the Emergency Order declared by Governor Scott for Hurricane Michael, an extension for the renewal deadlines for Registered Pharmacy Technicians and Consultant Pharmacists from December 31, 2018 to March 31, 2019.


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