HB-5131, As Passed House, January 19, 2012

SUBSTITUTE FOR

HOUSE BILL NO. 5131

     A bill to amend 1978 PA 368, entitled

"Public health code,"

by amending sections 7405, 17702, 17703, 17708, 17751, 17754, and

17763 (MCL 333.7405, 333.17702, 333.17703, 333.17708, 333.17751,

333.17754, and 333.17763), sections 7405, 17708, 17751, and 17763

as amended by 2011 PA 155 and sections 17702 and 17703 as amended

and section 17754 as added by 2006 PA 672, and by adding section

17744.

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.

     (c) Shall not refuse an entry into any premises for an

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 under a prescription written and signed;

or written or created in an electronic format, signed, and

transmitted by facsimile; , electronic transmission, or transmitted

electronically or by other means of communication by a physician

prescriber or dentist prescriber licensed to practice in a state

other than Michigan, unless the prescription is issued by a

physician prescriber or dentist prescriber who is authorized under

the laws of that state to practice dentistry, medicine, or

osteopathic medicine and surgery and to prescribe controlled

substances.

     (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

individual designated by a prescriber to act on behalf of or at the

discretion of a that prescriber as provided in section 17744.

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

a drug product by its manufacturer.

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

prescription drug which that 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.

     (c) A substance, other than food, intended to affect the

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

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. 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 by a prescriber to fill,

compound, or dispense a drug or device written and signed; or

written or created in an electronic format, signed, and transmitted

by facsimile; , electronic transmission, or transmitted

electronically or by 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 or hard-copy

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) and (5), 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 written or created in an

electronic format, signed, and transmitted by facsimile; ,

electronic transmission, or transmitted electronically or by other

means of communication by a physician prescriber or dentist

prescriber licensed to practice dentistry, medicine, or osteopathic

medicine and surgery 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" or "Rx only".

     (c) A drug designated by the board as a drug that may only be

dispensed pursuant to a prescription.

     Sec. 17744. (1) A prescriber may designate an agent to act on

behalf of or at the discretion of that prescriber. A designation of

an agent by a prescriber under this section is not required to be

in writing to be a valid designation. If a designation of an agent

by a prescriber under this section is contained in a written

document, the prescriber or the agent may transmit that document to

a pharmacy that will dispense a prescription issued by that

prescriber.

     (2) Only a prescriber acting within the scope of his or her

practice may issue a prescription. An agent may prepare and

transmit a prescription that has been signed by the prescriber,

including a signature that meets the requirements of section 17754.

The prescriber issuing a prescription and the pharmacist dispensing

a drug or device under a prescription is responsible for all of the

requirements of state and federal law, rules, and regulations

regarding the issuance of prescriptions and dispensing of drugs or

devices under prescriptions.

     (3) A prescriber or his or her agent may transmit to a

pharmacy a prescription that is contained within a patient's chart

in a health facility or agency licensed under article 17 or other

medical institution. A prescription that is contained within a

patient's chart in a health facility or agency licensed under

article 17 or other medical institution and that is created in an

electronic format may contain more than 6 prescriptions and may

contain prescriptions for schedule 3 through 5 controlled

substances and noncontrolled substances on the same form.

     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 Subject to subsection (5), a pharmacist may dispense a

prescription written and signed; or written or created in an

electronic format, signed, and transmitted by facsimile; ,

electronic transmission, or transmitted electronically or by other

means of communication by a physician prescriber or dentist

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 or dentist-patient relationship.

     (b) That the prescription is authentic.

     (c) That the prescribed drug is appropriate and necessary for

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.

     (5) A pharmacist shall not dispense a drug or device under a

prescription transmitted by facsimile or created in electronic

format and printed out for use by the patient unless the document

is manually signed by the prescriber. This subsection does not

apply to a prescription that is transmitted by a computer to a

facsimile machine if that prescription complies with section 17754.

     (6) After consultation with and agreement from the prescriber,

a pharmacist may add or change a patient's address, dosage form,

drug strength, drug quantity, directions for use, or issue date

with regard to a prescription. A pharmacist shall note the details

of the consultation and agreement required under this subsection on

the prescription and shall maintain that documentation with the

prescription as required in section 17752. A pharmacist shall not

change the patient's name, controlled substance prescribed unless

authorized to dispense a lower cost generically equivalent drug

product under section 17755, or the prescriber's signature with

regard to a prescription.

     (7) A prescription that is contained within a patient's chart

in a health facility or agency licensed under article 17 or other

medical institution and that is transmitted to a pharmacy under

section 17744 is the original prescription. If all other

requirements of this part are met, a pharmacist shall dispense a

drug or device under a prescription described in this subsection. A

pharmacist may dispense a drug or device under a prescription

described in this subsection even if the prescription does not

contain the quantity ordered. If a prescription described in this

subsection does not contain the quantity ordered, the pharmacist

shall consult with the prescriber to determine an agreed-upon

quantity. The pharmacist shall record the quantity dispensed on the

prescription and shall maintain that documentation with the

prescription as required in section 17752.

     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 his or her 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.

     (c) An electronic signature or other identifier that

specifically identifies and authenticates the prescriber or the

prescriber's authorized his or her 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.

     (c) Selling at auction drugs in bulk or in open packages

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 written or

created in an electronic format, signed, and transmitted by

facsimile; , electronic transmission, or transmitted electronically

or by other means of communication by a physician prescriber or

dentist prescriber in a state other than Michigan, unless the

prescription is issued by a physician prescriber or dentist

prescriber who is authorized under the laws of that state to

practice dentistry, medicine, or osteopathic medicine and surgery

and to prescribe controlled substances.