Current through all regulations passed and filed through September 16, 2024
(A)
The purpose of
this rule is to specify the process and procedures to be followed when a
licensee petitions for approval of a pilot or research project for innovative
system applications in the practice of pharmacy that are not currently
permitted under agency 4729 of the Administrative Code. In reviewing projects,
the board shall consider only projects that expand pharmaceutical care services
that contribute to positive patient outcomes.
(B)
A project shall
not expand the definition of the practice of pharmacy as set forth in Chapter
4729. of the Revised Code and shall not apply to licensees regulated under
Chapter 3796. of the Revised Code.
(C)
Approval of a
project by the board may include the grant of a limited exception to or a
waiver of rules adopted under Chapter 4729. of the Revised Code. Project
approval, including limited exception to or waiver of board rules, shall
initially be for a specified period of time not exceeding twenty-four months
from commencement of the project.
(D)
Following the
completion of the project period, the board may do any of the following based
upon a review of the final project report submitted in accordance with
paragraph (I) of this rule and any other factors or information the board deems
necessary:
(1)
Refuse to extend or renew the project;
(2)
Approve the
extension or renewal of a project following consideration of a petition that
clearly identifies the need for extension and must include a report similar to
the final project report, which should describe and explain any proposed
changes to the originally approved and implemented project, and that justifies
the need for extending or renewing the term of the project; or
(3)
Approve the
project in perpetuity following a consideration of a petition that clearly
identifies and justifies the need to continue the project
indefinitely.
(E)
A licensee who wishes the board to consider approval of
a project shall submit to the board a petition for approval that contains at
least the following information:
(1)
Responsible pharmacist. Name, address, telephone
number, and pharmacist license number of each pharmacist responsible for
overseeing the project.
(2)
Location of project. Name, address, and telephone
number of each specific location and, if a location is a pharmacy, the
pharmacy's terminal distributor of dangerous drugs license number where the
proposed project will be conducted.
(3)
Project summary.
A detailed summary of the proposed project that includes at least the following
information:
(a)
The goals, hypothesis, and objectives of the proposed
project.
(b)
A full explanation of the project and how it will be
conducted.
(c)
The time frame for the project including the proposed
start date and length of the project. The time frame may not exceed eighteen
months from the proposed start date of the project.
(d)
Background
information or literature review to support the proposed
project.
(e)
The rule or rules to be waived in order to implement
the project, an explanation of why such a waiver would not be a detriment to
the public, to include procedures to be used during the project to ensure that
the public health and safety are not compromised as a result of the waiver, and
a request to waive the rule or rules.
(F)
Projects
submitted shall be reviewed as follows:
(1)
Staff review.
Upon receipt of a petition for approval of a project, board staff shall
initially review the petition. If the petition is incomplete or fails to meet
the board's outlined purpose, staff shall return the petition to the requestor
with a letter explaining the reason the petition is being returned. A petition
that has been returned pursuant to this paragraph may be amended or
supplemented as necessary and submitted for reconsideration. A petition that is
deemed appropriate and complete shall move on the board member review
process.
(2)
Board member review. After initial staff review, two
members of the board, appointed by the board president, shall be provided the
petition and any additional materials. Board members shall conduct a review, in
consultation with appropriate staff, and make a recommendation to the full
board. Board members conducting a review may request additional documentation
and information from the petitioner as part of this review
process.
(3)
Board review. Following the board member review, the
board shall consider the project request at a regularly scheduled meeting of
the board. Upon review, the board shall either approve or deny the petition.
The board shall not approve any such project if such proposal might jeopardize
public health or welfare. If the board approves the petition, the
approval:
(a)
Shall be specific for the project requested, with any
modifications the Board deems necessary for patient safety;
(b)
Shall approve the
project for a specific time period; and
(c)
May include
conditions or qualifications applicable to the project, including limited
waivers of applicable/related rules.
(G)
The project site
and project documentation shall be available for inspection and review by the
board or its representative(s) at any time during the approval or denial
processes and, if a project is approved, throughout the approved term of the
project.
(H)
Project documentation shall be maintained in a readily
retrievable manner and available for inspection, review, and copying by the
board or its representative for at least three years following completion or
termination of the project.
(I)
The pharmacist
responsible for overseeing a project shall be responsible for submitting to the
board any reports required as a condition of a project, including the final
project report.
(1)
The final project report shall include a written
summary of the results of the project and the conclusions drawn from those
results. The final project report shall be submitted to the board within ninety
days after completion or termination of the project.
(2)
The board shall
review any required report regarding the progress of a project and the final
project report at a regularly scheduled meeting of the board.
(J)
The
board may rescind approval and terminate projects, including those it has
approved in perpetuity, pursuant to the following:
(1)
If the board
deems the project does not the comply with the requirements of this rule or the
conditions of its approval, the board shall provide notice to the pharmacist
responsible for the project indicating the project's approval has been
rescinded. The notice shall provide sixty days for the pharmacist to address
any deficiencies prior to the termination of the project. If the deficiencies
cited in the notice are addressed, the board may reinstate the project prior to
its proposed termination date.
(2)
If the board has
reasonable cause to believe the project poses a threat of immediate or serious
harm to the public, the board shall provide notice to the pharmacist
responsible for the project indicating the project's approval has been
rescinded. The termination of the project shall take effect
immediately.
(K)
The petitioner and/or project's responsible person may
terminate the project earlier than requested but shall provide notice within
three business days of termination and a final project report to the board to
include an explanation of why the project was terminated early. Upon either
recission of approval or early project termination, any waivers granted will be
immediately revoked and the licensee will be required to adhere to those rules
that had been excepted or waived.
(L)
All documents
pertaining to the application, project, and reports are considered a public
record under section 149.43 of the Revised Code and
will be provided upon request, without notice to the project's petitioners
and/or responsible person. Petitioners asserting that some or all of an
application contains information exempt from disclosure under Ohio law shall
comply with the following:
(1)
Submit a memorandum identifying the content not subject
to disclosure under section
149.43 of the Revised Code,
including supporting legal authority for each assertion.
(2)
Submit a redacted
version of the materials that the applicant agrees may be released without
prior notice to the applicant.
(M)
By submitting the
application, the petitioner understands, acknowledges, and agrees to all of the
following:
(1)
The board may independently assess the merits of any public
records exception claims made by the petitioner.
(2)
The board may
reject a claim that information in an application is trade secret or a security
or infrastructure record if it determines that the petitioner has not
established that the content in question meets a delineated exception to public
disclosure under Ohio law, including the use of generic language encompassing
substantial portions of the application submission or simple assertions of a
document containing information exempt from public disclosure, without
substantive explanation of the basis.
(3)
The state of Ohio
does not assume liability for the use or disclosure of any unredacted
material.
(4)
The board is required to comply with section
149.43 of the Revised Code,
which is construed liberally in favor of broad access, and any doubt shall be
resolved in favor of disclosure of public records.
(N)
The board will
make reasonable efforts to determine the initial approval or denial of a
project submission within ninety days of the submission of a completed project
petition in accordance with paragraph (E) of this rule.
The board shall be required to make the
initial approval or denial of a project submission within one hundred and
eighty days of the submission of a completed project petition in accordance
with paragraph (E) of this rule. This timeframe may be extended by the board
for good cause.
(O)
Unless otherwise approved by the board, a petition
shall be deemed abandoned if the petitioner fails to submit any requested
documentation or information within thirty days after being notified by the
board. The board shall not be required to act on any abandoned petition and the
petition may be destroyed by board staff. If the petition is abandoned, the
petitioner shall be required to resubmit a new petition for consideration
pursuant to the requirements of this rule.
Effective: 3/11/2022
Five Year
Review (FYR) Dates: 03/11/2022
Promulgated Under: 119.03
Statutory Authority: 4729.26,
4729.54, 4729.541, 3719.28
Rule Amplifies: 4729.26, 4729.54,
4729.541, 3719.28
