On August 14, 2013 the Florida Board of Pharmacy voted to approve central fill pharmacy in a hospital setting. Centralized prescription filling or “central fill” is where two pharmacies separate the duties and responsibilities of dispensing a prescription. Generally, one pharmacy will receive the prescription and send it to, or share it with, another pharmacy with which it has an ownership or contractual relationship. The second pharmacy will then fill the prescription.
The draft rule was brought before the Board earlier this year by Akerman attorneys on behalf of Adventist Health System with support of several hospitals and the Florida Society for Health-System Pharmacists. The rule, to be published as an amendment to the existing central fill rule (Rule 64B16-28.450, FAC), will allow the hospitals to formulate a policy and procedure manual addressing the central fill arrangement. The existing requirements of the centralized prescription filling statute, including common ownership or a contractual relationship, still apply. The draft rule must complete the rulemaking process before it is adopted and becomes effective, but so far there has been no opposition to the draft rule, and it is expected that the rule will be adopted.
The approval of the rule language allowing central fill has a long history. The statute allowing central fill pharmacy, Section 465.0265, FS, was enacted in 2002 and does not differentiate among the types of pharmacies that can engage in central fill. However, the primary impetus for the passage of the statute and the initial rule was to allow community pharmacies to engage in centralized prescription filling. In discussions with Board of Pharmacy staff in late 2010, they would not say whether the Board interpreted the statute such that hospital pharmacies could engage in central fill, and they asked that the issue be brought before the Board. For that reason, Akerman filed a petition for declaratory statement later that year requesting that the Board formally approve a hospital central fill arrangement proposed by Orlando Health.
In 2011, the Board heard the petition, but indicated that it was unwilling to approve it; primarily because the Board’s rule at that time was focused on central fill in a community pharmacy setting and did not specifically address the hospital situation. The Board agreed to undertake rulemaking on hospital central fill. Therefore, Orlando Health withdrew its petition such that the Board could proceed by way of rulemaking. The Board appointed a committee to address the rule and was provided a draft rule to begin this process. For reasons not entirely clear, the Board never went forward with this project in 2011.
Finally in 2013, the above referenced rule was brought before the Board, assigned to the Rules Committee for review, and approved by both the Rules Committee and the Full Board. We expect that it will be adopted by the end of the year.