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HB-6323, As Passed House, December 14, 2006

SUBSTITUTE FOR

HOUSE BILL NO. 6323

A bill to amend 1978 PA 368, entitled

"Public health code,"

by amending sections 7405, 17702, 17703, 17708, 17709, 17745,

17751, and 17763 (MCL 333.7405, 333.17702, 333.17703, 333.17708,

333.17709, 333.17745, 333.17751, and 333.17763), section 7405 as

amended by 2004 PA 536, section 17702 as amended by 1986 PA 304,

section 17703 as amended by 1992 PA 281, sections 17708, 17751, and

17763 as amended by 2005 PA 85, and section 17745 as amended by

1997 PA 186, and by adding section 17754.

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

Sec. 7405. (1) A person:

(a) Who is licensed by the administrator under this article

shall not distribute, prescribe, or dispense a controlled substance

in violation of section 7333.

(b) Who is a licensee shall not manufacture a controlled

substance not authorized by his or her license or distribute,

prescribe, or dispense a controlled substance not authorized by his

or her license to another licensee or other authorized person,

except as authorized by rules promulgated by the administrator.

inspection authorized by this article.

(d) Shall not knowingly keep or maintain a store, shop,

warehouse, dwelling, building, vehicle, boat, aircraft, or other

structure or place, that is frequented by persons using controlled

substances in violation of this article for the purpose of using

controlled substances, or that is used for keeping or selling

controlled substances in violation of this article.

(e) Who is a practitioner shall not dispense a prescription

for a controlled substance written and signed or transmitted by

facsimile, electronic transmission, or other means of communication

by a physician prescriber licensed to practice in a state other

than Michigan, unless the prescription is issued by a physician

prescriber who resides adjacent to the land border between this

state and an adjoining state or resides in Illinois or Minnesota

and who is authorized under the laws of that state to practice

medicine or osteopathic medicine and surgery and to prescribe

controlled substances and whose practice may extend into this

state, but who does not maintain an office or designate a place to

meet patients or receive calls in this state.

(2) A person who violates subsection (1) is subject to the

penalties prescribed in section 7406.

Sec. 17702. (1) "Agent" means an authorized person who acts on

behalf of or at the discretion of a prescriber.

(2) "Brand name" means the registered trademark name given to

a drug product by its manufacturer.

(3) ~~(2)~~ "Current selling price" means the retail price for a

prescription drug which is available for sale from a pharmacy.

Sec. 17703. (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.

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

subsequent administration to, or use by, a patient.

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

veterinarian, who dispenses prescription drugs.

(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.

(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.

(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 authorized

agent transmitted the prescription. Electronically transmitted

prescription does not include a prescription or refill

authorization transmitted by telephone or facsimile machine.

Sec. 17708. (1) "Preceptor" means a pharmacist approved by the

board to direct the training of an intern in an approved pharmacy.

(2) "Prescriber" means a licensed dentist, a licensed doctor

of medicine, a licensed doctor of osteopathic medicine and surgery,

a licensed doctor of podiatric medicine and surgery, a licensed

optometrist certified under part 174 to administer and prescribe

therapeutic pharmaceutical agents, a licensed veterinarian, or

another licensed health professional acting under the delegation

and using, recording, or otherwise indicating the name of the

delegating licensed doctor of medicine or licensed doctor of

osteopathic medicine and surgery.

(3) "Prescription" means an order for a drug or device written

and signed or transmitted by facsimile, electronic transmission, or

other means of communication by a prescriber to be filled,

compounded, or dispensed. Prescribing is limited to a prescriber.

An order transmitted in other than written form shall be

electronically recorded, printed, or written and immediately dated

by the pharmacist, and that record constitutes the original

prescription. In a health facility or agency licensed under article

17 or other medical institution, an order for a drug or device in

the patient's chart constitutes for the purposes of this definition

the original prescription. Subject to section 17751(2),

prescription includes, but is not limited to, an order for a drug,

not including a controlled substance as defined in section 7104

except under circumstances described in section 17763(e), written

and signed or transmitted by facsimile, electronic transmission, or

other means of communication by a physician prescriber licensed to

practice in a state other than Michigan.

(4) "Prescription drug" means 1 or more of the following:

(a) A drug dispensed pursuant to a prescription.

(b) A drug bearing the federal legend "CAUTION: federal law

prohibits dispensing without prescription".

dispensed pursuant to a prescription.

Sec. 17709. (1) "Sign" means to affix one's signature manually

to a document or to use an electronic signature when transmitting a

prescription electronically.

(2) ~~(1)~~ "Substitute" means to dispense, without the

prescriber's authorization, a different drug in place of the drug

prescribed.

(3) ~~(2)~~ "Wholesale distributor" means a person, other than a

manufacturer, who supplies, distributes, sells, offers for sale,

barters, or otherwise disposes of, to other persons for resale,

compounding, or dispensing, a drug or device salable on

prescription only that the distributor has not prepared, produced,

derived, propagated, compounded, processed, packaged, or

repackaged, or otherwise changed the container or the labeling

thereof.

Sec. 17745. (1) Except as otherwise provided in this

subsection, a prescriber who wishes to dispense prescription drugs

shall obtain from the board a drug control license for each

location in which the storage and dispensing of prescription drugs

occur. A drug control license is not necessary if the dispensing

occurs in the emergency department, emergency room, or trauma

center of a hospital licensed under article 17 or if the dispensing

involves only the issuance of complimentary starter dose drugs.

(2) A dispensing prescriber shall dispense prescription drugs

only to his or her own patients.

(3) A dispensing prescriber shall include in a patient's chart

or clinical record a complete record, including prescription drug

names, dosages, and quantities, of all prescription drugs dispensed

directly by the dispensing prescriber or indirectly under his or

her delegatory authority. If prescription drugs are dispensed under

the prescriber's delegatory authority, the delegatee who dispenses

the prescription drugs shall initial the patient's chart, clinical

record, or log of prescription drugs dispensed. In a patient's

chart or clinical record, a dispensing prescriber shall distinguish

between prescription drugs dispensed to the patient and

prescription drugs prescribed for the patient. A dispensing

prescriber shall retain information required under this subsection

for not less than 5 years after the information is entered in the

patient's chart or clinical record.

(4) A dispensing prescriber shall store prescription drugs

under conditions that will maintain their stability, integrity, and

effectiveness and will assure that the prescription drugs are free

of contamination, deterioration, and adulteration.

(5) A dispensing prescriber shall store prescription drugs in

a substantially constructed, securely lockable cabinet. Access to

the cabinet shall be limited to individuals authorized to dispense

prescription drugs in compliance with this part and article 7.

(6) Unless otherwise requested by a patient, a dispensing

prescriber shall dispense a prescription drug in a safety closure

container that complies with the poison prevention packaging act of

1970, Public Law 91-601, 84 Stat. 1670.

(7) A dispensing prescriber shall dispense a drug in a

container that bears a label containing all of the following

information:

(a) The name and address of the location from which the

prescription drug is dispensed.

(b) The patient's name and record number.

(d) The prescriber's name.

(e) The directions for use.

(f) The name and strength of the prescription drug.

(g) The quantity dispensed.

(h) The expiration date of the prescription drug or the

statement required under section 17756.

(8) A dispensing prescriber who dispenses a complimentary

starter dose drug to a patient shall give the patient at least all

of the following information, either by dispensing the

complimentary starter dose drug to the patient in a container that

bears a label containing the information or by giving the patient a

written document which may include, but is not limited to, a

preprinted insert that comes with the complimentary starter dose

drug, that contains the information:

(a) The name and strength of the complimentary starter dose

drug.

(b) Directions for the patient's use of the complimentary

starter dose drug.

or the statement required under section 17756.

(9) The information required under subsection (8) is in

addition to, and does not supersede or modify, other state or

federal law regulating the labeling of prescription drugs.

(10) In addition to meeting the requirements of this part, a

dispensing prescriber who dispenses controlled substances shall

comply with section 7303a.

(11) The board may periodically inspect locations from which

prescription drugs are dispensed.

(12) The act, task, or function of dispensing prescription

drugs shall be delegated only as provided in section 16215 and this

part.

(13) A supervising physician may delegate in writing to a

pharmacist practicing in a hospital pharmacy within a hospital

licensed under article 17 the receipt of complimentary starter dose

drugs other than controlled substances as defined by article 7 or

federal law. When the delegated receipt of complimentary starter

dose drugs occurs, both the pharmacist's name and the supervising

physician's name shall be used, recorded, or otherwise indicated in

connection with each receipt. A pharmacist described in this

subsection may dispense a prescription for complimentary starter

dose drugs written or transmitted by facsimile, electronic

transmission, or other means of communication by a prescriber.

(14) As used in this section, "complimentary starter dose"

means a prescription drug packaged, dispensed, and distributed in

accordance with state and federal law that is provided to a

dispensing prescriber free of charge by a manufacturer or

distributor and dispensed free of charge by the dispensing

prescriber to his or her patients.

Sec. 17751. (1) A pharmacist shall not dispense a drug

requiring a prescription under the federal act or a law of this

state except under authority of an original prescription or an

equivalent record of an original prescription approved by the

board.

(2) A pharmacist may dispense a prescription written and

signed or transmitted by facsimile, electronic transmission, or

other means of communication by a physician prescriber in a state

other than Michigan, but not including a prescription for a

controlled substance as defined in section 7104 except under

circumstances described in section 17763(e), only if the pharmacist

in the exercise of his or her professional judgment determines all

of the following:

(a) That the prescription was issued pursuant to an existing

physician-patient relationship.

(b) That the prescription is authentic.

the treatment of an acute, chronic, or recurrent condition.

(3) A pharmacist or a prescriber shall dispense a prescription

only if the prescription falls within the scope of practice of the

prescriber.

(4) A pharmacist shall not knowingly dispense a prescription

after the death of the prescriber or patient.

Sec. 17754. (1) Except as otherwise provided under article 7

and the federal act, a prescription may be transmitted

electronically as long as the prescription is transmitted in

compliance with the health insurance portability and accountability

act of 1996, Public Law 104-191, or regulations promulgated under

that act, 45 CFR parts 160 and 164, by a prescriber or the

prescriber's authorized agent and the data are not altered or

modified in the transmission process. The electronically

transmitted prescription shall include all of the following

information:

(a) The name, address, and telephone number of the prescriber.

(b) The full name of the patient for whom the prescription is

issued.

specifically identifies and authenticates the prescriber or the

prescriber's authorized agent.

(d) The time and date of the transmission.

(e) The identity of the pharmacy intended to receive the

transmission.

(f) Any other information required by the federal act or state

law.

(2) The electronic equipment or system utilized in the

transmission and communication of prescriptions shall provide

adequate confidentiality safeguards and be maintained to protect

patient confidentiality as required under any applicable federal

and state law and to ensure against unauthorized access. The

electronic transmission of a prescription shall be communicated in

a retrievable, recognizable form acceptable to the intended

recipient. The electronic form utilized in the transmission of a

prescription shall not include "dispense as written" or "d.a.w." as

the default setting.

(3) Prior to dispensing a prescription that is electronically

transmitted, the pharmacist shall exercise professional judgment

regarding the accuracy, validity, and authenticity of the

transmitted prescription.

(4) An electronically transmitted prescription that meets the

requirements of this section is the original prescription.

Sec. 17763. In addition to the grounds set forth in part 161,

the disciplinary subcommittee may fine, reprimand, or place a

pharmacist licensee on probation, or deny, limit, suspend, or

revoke the license of a pharmacist or order restitution or

community service for a violation or abetting in a violation of

this part or rules promulgated under this part, or for 1 or more of

the following grounds:

(a) Permitting the dispensing of prescriptions by an

individual who is not a pharmacist, pharmacist intern, or

dispensing prescriber.

(b) Permitting the dispensing of prescriptions by a pharmacist

intern, except in the presence and under the personal charge of a

pharmacist.

unless the sale has been approved in accordance with rules of the

board.

(d) Promoting a prescription drug to the public in any manner.

(e) In addition to the prohibition contained in section

7405(1)(e), dispensing a prescription for a controlled substance as

defined in section 7104 that is written and signed or transmitted

by facsimile, electronic transmission, or other means of

communication by a physician prescriber in a state other than