Ohio Board of Pharmacy Formalizes a Pathway for Approval of Innovative Pharmacy Arrangements
Health & Life Sciences 03/14/22 Simone Colgan Dunlap, Shaylynn L. Veeder
Effective March 11, 2022, Ohio Board of Pharmacy (“Board”) enacted a new regulation, Ohio Admin. Code 4729:5-3-20, that creates a procedure for licensees to petition the Board for approval of pilot or research projects (“Rule”). The Rule creates the opportunity for licensees to implement innovative systems that are not currently permitted under Ohio pharmacy law.
We have provided answers to some key questions regarding the new Rule in this alert.
Are there any limitations on the types of projects that may be approved?
Yes. There are some notable limitations in the Rule. First, the rule only permits the Board to consider projects that “expand pharmaceutical care services and contribute to positive patient outcomes”. The rule does not further define these terms. Second, the Rule specifically excludes establishments under the Ohio Medical Marijuana Control Program from utilizing the pilot and research programs procedures. While not contained in the Rule text, the Board has also stated that it is not permitted to approve projects that might jeopardize public health or welfare. Finally, the Rule does not permit licensees to expand the definition of "practice of pharmacy" under Ohio regulation. This last limitation is likely the most significant since the Board has latitude to interpret whether or not a specific proposal expands the practice of pharmacy.
How does an interested licensee apply for approval of a pilot or research project?
Interested licensees must submit a petition to the Board specifying: (1) the responsible pharmacist overseeing the project; (2) the location of the project; and (3) and a summary of the project's details. The Rule specifies additional project review and approval procedures that address timing and documentation requirements, as well as appeals. Applicants should use the form provided by the Board.
Once approved, may a project continue indefinitely?
No, not after initial approval. Under the Rule, the Board may approve a project for no more than twenty-four months initially. Upon expiration of the initial twenty-four month period, the Board may approve the project in perpetuity, extend, or renew the project and/or require changes made to the originally approved project, or refuse to extend or renew the project.
However, if the Board determines that an approved project is not complying with the requirements of the Rule or the conditions of approval, the Board may terminate an approved project (including projects approved in perpetuity), upon notice to the responsible pharmacist, if it determines the licensee is not complying with the conditions of approval. If the licensee is able to address any deficiencies within sixty days following receipt of the notice that approval was rescinded and such deficiencies did not create a threat of immediate or serious harm to the public, the Board may reinstate the proposed project. If the Board has reasonable cause to believe that a project poses a threat of immediate or serious harm to the public, it will terminate the project immediately upon notice.
In sum, the Rule provides a formal mechanism for licensees to explore innovative arrangements that previously may not have been permitted by Ohio.
For more information on the Ohio Board of Pharmacy's new regulation, please contact your Quarles & Brady attorney or: