Bill Text: MI SB0373 | 2013-2014 | 97th Legislature | Introduced
Bill Title: Health; pharmaceuticals; board of pharmacy to approve pilot project for innovative applications; allow. Amends 1978 PA 368 (MCL 333.1101 - 333.25211) by adding sec. 17723.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Passed) 2013-12-31 - Assigned Pa 0267'13 With Immediate Effect [SB0373 Detail]
Download: Michigan-2013-SB0373-Introduced.html
SENATE BILL No. 373
May 21, 2013, Introduced by Senator HANSEN and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
(MCL 333.1101 to 333.25211) by adding section 17723.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 17723. (1) Beginning 90 days after the effective date of
this section, the board, in consultation with the department, shall
establish and administer a process by which the board may approve
pilot projects as provided in this section. The board shall not
approve more than 25 pilot projects under this section. The board
shall not approve more than 1 pilot project to a person that
petitions for a pilot project under this section.
(2) The board shall only approve a pilot project that is
designed to utilize new or expanded technology or processes and to
provide patients with better pharmacy products or provide pharmacy
services in a more efficient manner. The board shall not approve a
pilot project under this section that does any of the following:
(a) Expands the definition of the practice of pharmacy.
(b) Provides for the therapeutic substitution or substitution
of medical devices used in patient care.
(c) Provides to the person petitioning for a pilot project a
competitive edge over any other person engaged in the practice of
pharmacy.
(3) The board may grant to a person conducting an approved
pilot project under this section an exception to a rule promulgated
by the board under this part. The board shall not grant an
exception under this subsection from any law relating to the
practice of pharmacy. An exception to a rule promulgated under this
part granted under this subsection must be for a specified period
of time, which period must not exceed 18 months unless extended
under subsection (9).
(4) A person who wishes the board to consider a pilot project
for approval under this section shall submit to the department a
petition that contains all of the following information:
(a) The name, address, telephone number, electronic mail
address, and pharmacist's license number of the pharmacist
responsible for overseeing the proposed pilot project.
(b) The specific location and, if a pharmacy, the pharmacy
license number where the proposed pilot project will be conducted.
(c) A detailed summary of the proposed pilot project that
includes all of the following:
(i) The goals, hypothesis, and objectives, as applicable, of
the proposed pilot project.
(ii) A full explanation of the proposed pilot project and how
the project will be conducted.
(iii) The initial time frame for the pilot project, including
the proposed start date and length of the project, which initial
time frame must not exceed 18 months.
(iv) All background information and literature review, as
applicable, to support the proposed pilot project.
(v) If applicable, identification of the rules promulgated by
the board under this part from which the petitioner is requesting
an exception as provided in subsection (3) in order to complete the
proposed pilot project and a request for that exception.
(vi) If applicable, procedures the petitioner will use during
the proposed pilot project to ensure that the public's health and
safety are not compromised as a result of the board's granting an
exception to a rule as provided in subsection (3).
(5) Upon receipt of a petition for approval of a pilot
project, the department shall initially review the petition for
completeness and appropriateness. If the petition is incomplete or
inappropriate for consideration for any reason, including violation
of law, the department shall return the petition with a letter of
explanation. The department shall perform the review under this
subsection within 30 business days after receipt of the petition.
(6) Upon determination under subsection (5) that a petition is
complete and appropriate, the department shall create a review
committee that consists of appropriate department staff, 1 or more
members of the board, and, if considered necessary by the
department or the board, other resource personnel. The review
committee shall review the petition and submit a written
recommendation to the board regarding approval or denial of the
proposed pilot project. The review committee shall submit a copy of
its written recommendation to the petitioner at least 2 weeks
before the board meeting at which the recommendation will be
considered by the board. The board shall allow the petitioner and a
representative of the review committee equal time for presentations
to the board if requested by the review committee or board. Upon
hearing the presentations, if applicable, the board shall approve
or deny the petition. If the board approves the petition, the
approval shall be specific for that pilot project and for a
specified period of time, which period must not exceed 18 months
unless extended under subsection (9). The board may include
conditions or qualifications on its approval of a pilot project if
considered appropriate by the board.
(7) The petitioner shall allow the department or the board to
inspect and review pilot project documentation and the pilot
project site at any time during the review process and after the
pilot project is approved. The pharmacist responsible for
overseeing an approved pilot project shall forward to the board
progress reports at intervals specified by the board in addition to
a summary of the results of the project and conclusions drawn from
the results of the project within 3 months after completion of the
pilot project.
(8) The review committee for the pilot project under
subsection (6) or similar review committee created by the board
shall review the summary of the results of the pilot project
submitted under subsection (7) and shall submit a written report to
the board regarding the results of the pilot project. The review
committee shall submit a copy of its written report to the
petitioner at least 2 weeks before the board meeting at which the
report will be considered by the board. The board shall allow the
petitioner and a representative of the review committee equal time
for presentations to the board if requested by the review committee
or board.
(9) If determined appropriate, the board may extend the
specified period of time for the conduct of a pilot project under
subsection (6) for an additional period of 18 months. The board
shall not grant an extension that would result in a specified
period of time for the conduct of a pilot project under this
section that exceeds 36 months. If the board determines that a
pilot project for which an exception to a rule has been granted
under subsection (3) should be extended so that rules may be
promulgated in order to allow the pilot project to be conducted on
a permanent basis, the board may extend the exception to the rule
for an additional period of 18 months. The board and the department
may utilize the review committee process under subsection (6) for
the purpose of authorizing extensions under this subsection.
