SB-0195, As Passed House, October 1, 2015

HOUSE SUBSTITUTE FOR

SENATE BILL NO. 195

     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) Except as otherwise provided in subsection (8),

fingerprints for the following individuals shall be submitted with

an application for a new pharmacy, manufacturer, or wholesale

distributor license in the same manner as required in section 16174

for the purpose of a criminal history check:

     (a) If the application is from an individual, 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, fingerprints for that individual.

     (b) If the application is from a partnership, fingerprints for

all partners and any individual who will manage the day-to-day

operations of the new pharmacy, manufacturer, or wholesale

distributor.

     (c) If the application is from a privately held corporation,

fingerprints for any individual who will manage the day-to-day

operations of the new pharmacy, manufacturer, or wholesale

distributor. This subdivision only applies to a privately held

corporation that in the aggregate owns fewer than 75 pharmacies,

manufacturers, or wholesale distributors on the date the

corporation submits its license application.

     (7) The board, department, and department of state police

shall conduct the criminal history check on the individuals

described in subsection (6) in the same manner as described in

section 16174.

     (8) Subsection (6) does not apply if a criminal history check

that meets the requirements of section 16174 has been obtained for

the individuals described in subsection (6) within the 2 years

preceding the date of the application for a new pharmacy,

manufacturer, or wholesale distributor license under this part. To

qualify for the exception under this subsection, an applicant shall

submit proof of the previous criminal history check for each

individual described in subsection (6), as applicable, with the

application for a new pharmacy, manufacturer, or wholesale

distributor license under this part. If the department or board

determines that a criminal history check for an individual

described in subsection (6) does not meet the requirements of

section 16174 or was not obtained within the time period

prescribed, fingerprints shall be submitted for the individual as

required under subsection (6).

(9) (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 30 days

after the date it is enacted into law.