March 10, 2015, Introduced by Senator HUNE and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending section 17748 (MCL 333.17748), as amended by 2014 PA
413.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 17748. (1) To do business in this state, a pharmacy,
manufacturer, or wholesale distributor, whether or not located in
this state, must be licensed under this part. To do business in
this state, a person that provides compounding services must be
licensed as a pharmacy or manufacturer under this part and, if a
pharmacy, authorized to provide compounding services under this
section and sections 17748a and 17748b. To do business in this
state, an outsourcing facility must be licensed as a pharmacy under
this part. Licenses are renewable biennially.
(2) A pharmacy shall designate a pharmacist licensed in this
state as the pharmacist in charge for the pharmacy. Except as
otherwise provided in this subsection, a manufacturer shall
designate a pharmacist licensed in or outside of this state as the
pharmacist in charge for the manufacturer. Except as otherwise
provided in this subsection, a wholesale distributor shall
designate a pharmacist licensed in or outside of this state as the
pharmacist in charge for the wholesale distributor or shall
designate an employee with the appropriate education or experience,
or both, to assume responsibility for compliance with licensing
requirements as facility manager for the wholesale distributor. The
pharmacy, manufacturer, or wholesale distributor and the individual
designated as the PIC or facility manager under this subsection are
jointly responsible for the pharmacy's, manufacturer's, or
wholesale distributor's compliance with this part and rules
promulgated under this part. A person that is a manufacturer or
wholesale distributor with respect to a device salable on
prescription only but not with respect to any drug salable on
prescription only is exempt from this subsection.
(3) Subject to this subsection, a pharmacist may be designated
as the PIC for more than 1 pharmacy. A PIC described in this
subsection shall work an average of at least 8 hours per week at
each pharmacy for which he or she is the PIC. The pharmacy and the
PIC shall maintain appropriate records and demonstrate compliance
with this subsection upon the request of the board or its designee.
(4) A pharmacy, manufacturer, or wholesale distributor shall
report to the department a change in ownership, management,
location, or its PIC or facility manager designated under
subsection (2) not later than 30 days after the change occurs.
(5) A pharmacist designated as the PIC for a pharmacy shall
supervise the practice of pharmacy for the pharmacy. The duties of
the PIC include, but are not limited to, the following:
(a) Supervision of all activities of pharmacy employees as
they relate to the practice of pharmacy including the purchasing,
storage, compounding, repackaging, dispensing, and distribution of
drugs and devices to ensure that those activities are performed in
compliance with this part and the rules promulgated under this
part.
(b) Enforcement and oversight of policies and procedures
applicable to the employees of the pharmacy for the procurement,
storage, compounding, and dispensing of drugs and the communication
of information to the patient in relation to drug therapy.
(c) Establishment and supervision of the method and manner for
storage and safekeeping of pharmaceuticals, including maintenance
of security provisions to be used when the pharmacy is closed.
(d) Establishment and supervision of the record-keeping system
for the purchase, sale, delivery, possession, storage, and
safekeeping of drugs and devices.
(e) Establishment of policies and procedures for individuals
who are delegated responsibilities for any of the tasks described
in this subsection by the PIC.
(6)
Except as otherwise provided in this subsection, an
applicant
for a new pharmacy, manufacturer, or wholesale
distributor
license under this part who is not a health
professional
licensed or otherwise authorized to engage in a health
profession
under this article or who is a health professional but
was
licensed or otherwise authorized to engage in his or her health
profession
under this article before October 1, 2008 shall submit
fingerprints
in the same manner as required in section 16174 for
the
purpose of a criminal history check. The board, department, and
department
of state police shall comply with section 16174 for the
purpose
of a criminal history check on an applicant described in
this
subsection. This subsection does not apply if a criminal
history
check that meets the requirements of section 16174 was
obtained
for the applicant within the 2 years preceding the date of
the
application. To qualify for the exception under this
subsection,
the applicant shall submit proof of the previous
criminal
history check with his or her application for a new
pharmacy,
manufacturer, or wholesale distributor license under this
part.
If the department or board determines that the criminal
history
check does not meet the requirements of section 16174 or
was
not obtained within the time period prescribed, the applicant
shall
submit fingerprints in the same manner as required in section
16174.
(6) (7)
If, as authorized or required under
this article, the
department inspects or investigates an applicant for a new pharmacy
license for a pharmacy that will provide compounding services or a
compounding pharmacy, and the applicant or compounding pharmacy is
located outside of this state, the applicant or compounding
pharmacy shall reimburse the department for its expenses incurred
in carrying out its authority or duty to inspect or investigate the
applicant or licensee under this article.
Enacting section 1. This amendatory act takes effect March 30,
2015.