By McQuone Consulting
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Mike McQuone, President of McQuone Consulting, participated in the meeting of the Rules Committee of the Florida Board of Pharmacy. The principal discussion involved proposed new language regarding Automated Filling Systems. In addition the Committee introduced language to facilitate discharge dispensing of multi-dose medications as part of a revised Limited Community Permit and offered practical solutions to the destruction of controlled substances.
The beautiful Wyndham Bay Point Resort in Panama City Beach did not distract Committee Chair, Jeffrey Mesaros, PharmD and voting members Michele Weizer, PharmD and Debra Glass, BPharm from their task of reviewing the proposed wording for 64B16-28.608 Automated Filling Systems. This proposed rule is intended to provide several definitions including, but not limited to, “automated filling systems,” “electronic verification process” and an important distinction between “loading” and “refilling/ restocking” these units. Committee members entertained several comments from fellow Board members and the general audience regarding the pharmacist verification process, the essentials of the policy and procedure manual, quality assurance program and recordkeeping.
Language to facilitate the dispensing of multi-dose medicinal drugs to patients about to be discharged from a hospital was proposed for 64B16-28.810 Special Pharmacy – Limited Community Permit. The proposed amendment offers specific requirements for labeling and requires the participating hospital to develop specific protocols for infection control procedures and patient/caregiver education.
The timely destruction of unwanted / expired controlled substances is of prime importance to all pharmacy permit holders. The Committee determined that it was authorized to establish rules for Florida pharmacy permits separate from the Drug Enforcement Administration (DEA) Section 1307.21 Procedure for disposing of controlled substances. The proposed language identifies additional individuals authorized to witness the proper destruction of these items. The Committee will consider an alternative to the DEA Form 41 for recording the items that are destroyed.