HB-5877, As Passed House, December 15, 2016

HB-5877, As Passed Senate, December 14, 2016

SUBSTITUTE FOR

HOUSE BILL NO. 5877

A bill to amend 1978 PA 368, entitled

"Public health code,"

by amending sections 17702, 17703, and 17707 (MCL 333.17702,

333.17703, and 333.17707), section 17702 as amended by 2014 PA 280

and sections 17703 and 17707 as amended by 2014 PA 285, and by

adding section 17760.

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

Sec. 17702. (1) "Agent" means an individual designated by a

prescriber to act on behalf of or at the discretion of that

prescriber as provided in section 17744.

(2) "Automated device" means a mechanical system that performs

an operation or activity, other than compounding or administration,

relating to the storage, packaging, dispensing, or delivery of a

drug and that collects, controls, and maintains transaction

information.

(3) ~~(2)~~ "Brand name" means the registered trademark name given

to a drug product by its manufacturer.

(4) ~~(3)~~ Except as otherwise provided in subsection ~~(4),~~ (5),

"compounding" means the preparation, mixing, assembling, packaging,

and labeling of a drug or device by a pharmacist under the

following circumstances:

(a) Upon the receipt of a prescription for a specific patient.

(b) Upon the receipt of a medical or dental order from a

prescriber or agent for use in the treatment of patients within the

course of the prescriber's professional practice.

medical or dental order based on routine, regularly observed

prescription or medical or dental order patterns.

(d) For the purpose of or incidental to research, teaching, or

chemical analysis and not for the purpose of sale or dispensing.

(5) ~~(4)~~ "Compounding" does not include any of the following:

(a) Except as provided in section 17748c, the compounding of a

drug product that is essentially a copy of a commercially available

product.

(b) The reconstitution, mixing, or other similar act that is

performed pursuant to the directions contained in approved labeling

provided by the manufacturer of a commercially available product.

products.

(6) ~~(5)~~ "Compounding pharmacy" means a pharmacy that is

licensed under this part and is authorized to offer compounding

services under sections 17748, 17748a, and 17748b.

(7) ~~(6)~~ "Current selling price" means the retail price for a

prescription drug that is available for sale from a pharmacy.

Sec. 17703. (1) "Deliver" or "delivery" means the actual,

constructive, or attempted transfer of a drug or device from 1

person to another.

(2) ~~(1)~~ "Device" means an instrument, apparatus, or

contrivance, including its components, parts, and accessories,

intended for use in the diagnosis, cure, mitigation, treatment, or

prevention of disease in human beings or other animals, or to

affect the structure or function of the body of human beings or

other animals.

(3) ~~(2)~~ "Dispense" means ~~to issue 1 or more doses of a drug~~

~~for subsequent administration to, or use by, a patient.~~the

preparation, compounding, packaging, or labeling of a drug pursuant

to a prescription or other authorization issued by a prescriber.

(4) ~~(3)~~ "Dispensing prescriber" means a prescriber, other than

a veterinarian, who dispenses prescription drugs.

(5) Except as otherwise provided in section 17780,

"distribute" or "distribution" means to sell, offer for sale,

deliver, offer to deliver, broker, give away, or transfer a drug,

whether by passage of title or physical movement. The term does not

include any of the following:

(a) Dispensing or administering a drug.

(b) The delivery of a drug, or offering to deliver a drug, by

a common carrier in the usual course of business as a common

carrier.

section 17760.

(6) ~~(4)~~ "Drug" means any of the following:

(a) A substance recognized or for which the standards or

specifications are prescribed in the official compendium.

(b) A substance intended for use in the diagnosis, cure,

mitigation, treatment, or prevention of disease in human beings or

other animals.

structure or a function of the body of human beings or other

animals.

(d) A substance intended for use as a component of a substance

specified in subdivision (a), (b), or (c), but not including a

device or its components, parts, or accessories.

(7) ~~(5)~~ "Electronic signature" means an electronic sound,

symbol, or process attached to or logically associated with a

record and executed or adopted by a person with the intent to sign

the record.

(8) ~~(6)~~ "Electronically transmitted prescription" means the

communication of an original prescription or refill authorization

by electronic means including computer to computer, computer to

facsimile machine, or electronic mail transmission that contains

the same information it contained when the prescriber or his or her

agent transmitted the prescription. Electronically transmitted

prescription does not include a prescription or refill

authorization transmitted by telephone or facsimile machine.

Sec. 17707. (1) "Personal charge" means the immediate physical

presence of a pharmacist or dispensing prescriber.

(2) "Pharmacist" means an individual licensed under this

article to engage in the practice of pharmacy.

(3) "Pharmacist in charge" or "PIC" means the pharmacist who

is designated by a pharmacy, manufacturer, or wholesale distributor

as its pharmacist in charge under section 17748(2).

(4) "Pharmacist intern" or "intern" means an individual who

satisfactorily completes the requirements set forth in rules

promulgated by the department in consultation with the board and is

licensed by the board for the purpose of obtaining instruction in

the practice of pharmacy from a preceptor approved by the board.

(5) "Pharmacy" means a ~~building~~ facility or part of a ~~building~~

~~in which the practice of pharmacy is conducted.~~ facility that is

licensed under this part to dispense prescription drugs or prepare

prescription drugs for delivery or distribution. Pharmacy does not

include the office of a dispensing prescriber or an automated

device. For the purpose of a duty placed on a pharmacy under this

part, "pharmacy" means the person to which the pharmacy license is

issued, unless otherwise specifically provided.

(6) "Pharmacy technician" means an individual who is required

to hold a health profession subfield license under this part to

serve as a pharmacy technician.

(7) "Practice of pharmacy" means a health service, the

clinical application of which includes the encouragement of safety

and efficacy in the prescribing, dispensing, administering, and use

of drugs and related articles for the prevention of illness, and

the maintenance and management of health. Practice of pharmacy

includes the direct or indirect provision of professional functions

and services associated with the practice of pharmacy. Professional

functions associated with the practice of pharmacy include:

(a) The interpretation and evaluation of the prescription.

(b) Drug product selection.

distribution of drugs and devices.

(d) The maintenance of legally required records.

(e) Advising the prescriber and the patient as required as to

contents, therapeutic action, utilization, and possible adverse

reactions or interactions of drugs.

Sec. 17760. (1) A pharmacy that is owned and operated by a

hospital licensed under article 17 may operate an automated device

at a location that is affiliated with the hospital but that is not

located at the same physical address as the pharmacy. A pharmacy

that operates an automated device under this section shall notify

the department of the automated device's location.

(2) An automated device that is operated under this section

must be under the control and supervision of the pharmacist in

charge for the pharmacy described in subsection (1). The pharmacist

in charge for the pharmacy described in subsection (1) may, in

accordance with the requirements for delegation and supervision in

this article, delegate the stocking of the automated device, the

removal of medication from the automated device, the maintenance of

the automated device, and other tasks related to the operation of

the automated device, but he or she is not required to be

immediately physically present to supervise a delegated task. The