Bill Text: MI SB0802 | 2017-2018 | 99th Legislature | Introduced

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Bill Title: Health; controlled substances; requirement for opioid and benzodiazepine prescriptions to be electronically transmitted to pharmacies; provide for effective January 1, 2020. Amends secs. 7333, 7405 & 17763 of 1978 PA 368 (MCL 333.7333 et seq.) & adds sec. 7333c.

Spectrum: Partisan Bill (Republican 1-0)

Status: (Introduced - Dead) 2018-01-31 - Referred To Committee On Health Policy [SB0802 Detail]

Download: Michigan-2017-SB0802-Introduced.html

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SENATE BILL No. 802

 

 

January 31, 2018, Introduced by Senators ZORN, NOFS, MARLEAU and HERTEL and referred to the Committee on Health Policy.

 

 

 

     A bill to amend 1978 PA 368, entitled

 

"Public health code,"

 

by amending sections 7333, 7405, and 17763 (MCL 333.7333, 333.7405,

 

and 333.17763), section 7333 as amended by 2017 PA 251 and sections

 

7405 and 17763 as amended by 2016 PA 49, and by adding section

 

7333c.

 

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

 

     Sec. 7333. (1) As used in this section, "good faith" means the

 

prescribing or dispensing of a controlled substance by a

 

practitioner licensed under section 7303 in the regular course of

 

professional treatment to or for an individual who is under

 

treatment by the practitioner for a pathology or condition other

 

than that individual's physical or psychological dependence upon or

 

addiction to a controlled substance, except as provided in this

 

article. Application of good faith to a pharmacist means the

 

dispensing of a controlled substance pursuant to a prescriber's

 

order which, in the professional judgment of the pharmacist, is

 

lawful. The pharmacist shall be guided by nationally accepted

 

professional standards including, but not limited to, all of the

 

following, in making the judgment:

 

     (a) Lack of consistency in the doctor-patient relationship.

 

     (b) Frequency of prescriptions for the same drug by 1

 

prescriber for larger numbers of patients.

 

     (c) Quantities beyond those normally prescribed for the same

 

drug.

 

     (d) Unusual dosages.

 

     (e) Unusual geographic distances between patient, pharmacist,

 

and prescriber.

 

     (2) Except as otherwise provided in this section and section

 

7333c, a practitioner, in good faith, may dispense a controlled

 

substance included in schedule 2 upon receipt of a prescription of

 

a practitioner licensed under section 7303 on a prescription form.

 

A practitioner may issue more than 1 prescription for a controlled

 

substance included in schedule 2 on a single prescription form.

 

     (3) In Except as otherwise provided in section 7333c, in an

 

emergency situation, as described in R 338.3165 of the Michigan

 

Administrative Code, a controlled substance included in schedule 2

 

may be dispensed upon the oral prescription of a practitioner if

 

the prescribing practitioner promptly fills out a prescription form

and forwards the prescription form to the dispensing pharmacy

 

within 7 days after the oral prescription is issued. A prescription

 

for a controlled substance included in schedule 2 must not be

 

filled more than 90 days after the date on which the prescription

 

was issued. A pharmacist, consistent with federal law and

 

regulations on the partial filling of a controlled substance

 

included in schedule 2, may partially fill in increments a

 

prescription for a controlled substance included in schedule 2.

 

     (4) A Except as otherwise provided in section 7333c, a

 

practitioner, in good faith, may dispense a controlled substance

 

included in schedule 3, 4, or 5 that is a prescription drug as

 

determined under section 503(b) of the federal food, drug, and

 

cosmetic act, 21 USC 353, or section 17708, upon receipt of a

 

prescription on a prescription form or an oral prescription of a

 

practitioner. A prescription for a controlled substance included in

 

schedule 3 or 4 must not be filled or refilled without specific

 

refill instructions noted by the prescriber. A prescription for a

 

controlled substance included in schedule 3 or 4 must not be filled

 

or refilled later than 6 months after the date of the prescription

 

or be refilled more than 5 times, unless renewed by the prescriber

 

in accordance with rules promulgated by the administrator.

 

     (5) A controlled substance included in schedule 5 must not be

 

distributed or dispensed other than for a medical purpose, or in

 

any manner except in accordance with rules promulgated by the

 

administrator.

 

     (6) If a prescription is required under this section, the

 

prescription must contain the quantity of the controlled substance

prescribed in both written and numerical terms. A prescription is

 

in compliance with this subsection if, in addition to containing

 

the quantity of the controlled substance prescribed in written

 

terms, it contains preprinted numbers representative of the

 

quantity of the controlled substance prescribed next to which is a

 

box or line the prescriber may check.

 

     (7) A prescribing practitioner shall not use a prescription

 

form for a purpose other than prescribing. A prescribing

 

practitioner shall not postdate a prescription form that contains a

 

prescription for a controlled substance. A Except as otherwise

 

provided in section 7333c, a prescriber may transmit a prescription

 

by facsimile of a printed prescription form and by electronic

 

transmission of a printed prescription form, if not prohibited by

 

federal law. If, Except as otherwise provided in section 7333c, if,

 

with the patient's consent, a prescription is electronically

 

transmitted, it must be transmitted directly to a pharmacy of the

 

patient's choice by the prescriber or the prescriber's authorized

 

agent, and the data must not be altered, modified, or extracted in

 

the transmission process.

 

     (8) Notwithstanding subsections (1) to (5), an animal control

 

shelter or animal protection shelter registered with the department

 

of agriculture and rural development pursuant to 1969 PA 287, MCL

 

287.331 to 287.340, or a class B dealer may acquire a limited

 

permit only for the purpose of buying, possessing, and

 

administering a commercially prepared, premixed solution of sodium

 

pentobarbital to practice euthanasia on injured, sick, homeless, or

 

unwanted domestic pets and other animals, if the animal control

shelter or animal protection shelter or class B dealer does all of

 

the following:

 

     (a) Applies to the administrator for a permit in accordance

 

with rules promulgated under this part. The application must

 

contain the name of the individual in charge of the day-to-day

 

operations of the animal control shelter or animal protection

 

shelter or class B dealer's facilities and the name of the

 

individual responsible for designating employees who will be

 

practicing euthanasia on animals pursuant to this act.

 

     (b) Complies with the rules promulgated by the administrator

 

for the storage, handling, and use of a commercially prepared,

 

premixed solution of sodium pentobarbital to practice euthanasia on

 

animals. A record of use must be maintained and must be available

 

for inspection.

 

     (c) Certifies that an employee of the animal control shelter

 

or animal protection shelter or class B dealer has received, and

 

can document completion of, a minimum of 8 hours of training given

 

by a licensed veterinarian in the use of sodium pentobarbital to

 

practice euthanasia on animals pursuant to rules promulgated by the

 

administrator, in consultation with the Michigan board of

 

veterinary medicine as these rules relate to this training, and

 

that only an individual described in this subdivision or an

 

individual otherwise permitted to use a controlled substance

 

pursuant to this article will administer the commercially prepared,

 

premixed solution of sodium pentobarbital according to written

 

procedures established by the animal control shelter or animal

 

protection shelter or class B dealer.

     (9) The application described in subsection (8) must include

 

the names and addresses of all individuals employed by the animal

 

control shelter or animal protection shelter or class B dealer who

 

have been trained as described in subsection (8)(c) and the name of

 

the veterinarian who trained them. The list of names and addresses

 

must be updated every 6 months.

 

     (10) If an animal control shelter or animal protection shelter

 

or class B dealer issued a permit pursuant to subsection (8) does

 

not have in its employ an individual trained as described in

 

subsection (8)(c), the animal control shelter or animal protection

 

shelter or class B dealer shall immediately notify the

 

administrator and shall cease to administer any commercially

 

prepared, premixed solution of sodium pentobarbital until the

 

administrator is notified that 1 of the following has occurred:

 

     (a) An individual trained as described in subsection (8)(c)

 

has been hired by the animal control shelter or animal protection

 

shelter or class B dealer.

 

     (b) An employee of the animal control shelter or animal

 

protection shelter or class B dealer has been trained as described

 

in subsection (8)(c).

 

     (11) A veterinarian, including a veterinarian who trains

 

individuals as described in subsection (8)(c), is not civilly or

 

criminally liable for the use of a commercially prepared, premixed

 

solution of sodium pentobarbital by an animal control shelter or

 

animal protection shelter or class B dealer unless the veterinarian

 

is employed by or under contract with the animal control shelter or

 

animal protection shelter or class B dealer and the terms of the

veterinarian's employment or the contract require the veterinarian

 

to be responsible for the use or administration of the commercially

 

prepared, premixed solution of sodium pentobarbital.

 

     (12) A person shall not knowingly use or permit the use of a

 

commercially prepared, premixed solution of sodium pentobarbital in

 

violation of this section.

 

     (13) This section does not require that a veterinarian be

 

employed by or under contract with an animal control shelter or

 

animal protection shelter or class B dealer to obtain, possess, or

 

administer a commercially prepared, premixed solution of sodium

 

pentobarbital pursuant to this section.

 

     (14) Notwithstanding subsections (1) to (5), an animal control

 

shelter registered with the department of agriculture and rural

 

development pursuant to 1969 PA 287, MCL 287.331 to 287.340, may

 

acquire a limited permit only for the purpose of buying,

 

possessing, and administering a commercially prepared solution of

 

an animal tranquilizer to sedate a feral, wild, difficult to

 

handle, or other animal for euthanasia, or to tranquilize an animal

 

running at large that is dangerous or difficult to capture, if the

 

animal control shelter does all of the following:

 

     (a) Applies to the administrator for a permit in accordance

 

with the rules promulgated under this part. The application must

 

contain the name of the individual in charge of the day-to-day

 

operations of the animal control shelter and the name of the

 

individual responsible for designating employees who will be

 

administering an animal tranquilizer pursuant to this act.

 

     (b) Complies with the rules promulgated by the administrator

for the storage, handling, and use of a commercially prepared

 

solution of an animal tranquilizer. A record of use must be

 

maintained and must be available for inspection by the department

 

of agriculture and rural development.

 

     (c) Certifies that an employee of the animal control shelter

 

has received, and can document completion of, a minimum of 16 hours

 

of training, including at least 3 hours of practical training, in

 

the use of animal tranquilizers on animals from a training program

 

approved by the state veterinarian, in consultation with the

 

Michigan board of veterinary medicine, and given by a licensed

 

veterinarian pursuant to rules promulgated by the administrator, in

 

consultation with the Michigan board of veterinary medicine as

 

these rules relate to this training, and that only an individual

 

described in this subdivision or an individual otherwise permitted

 

to use a controlled substance pursuant to this article will

 

administer the commercially prepared solution of an animal

 

tranquilizer according to written procedures established by the

 

animal control shelter.

 

     (15) Notwithstanding subsections (1) to (5), an animal

 

protection shelter registered with the department of agriculture

 

and rural development pursuant to 1969 PA 287, MCL 287.331 to

 

287.340, may acquire a limited permit only for the purpose of

 

buying, possessing, and administering a commercially prepared

 

solution of an animal tranquilizer to sedate a feral, wild,

 

difficult to handle, or other animal for euthanasia, if the animal

 

protection shelter does all of the following:

 

     (a) Applies to the administrator for a permit in accordance

with the rules promulgated under this part. The application must

 

contain the name of the individual in charge of the day-to-day

 

operations of the animal protection shelter and the name of the

 

individual responsible for designating employees who will be

 

administering an animal tranquilizer pursuant to this act.

 

     (b) Complies with the rules promulgated by the administrator

 

for the storage, handling, and use of a commercially prepared

 

solution of an animal tranquilizer. A record of use must be

 

maintained and must be available for inspection by the department

 

of agriculture and rural development.

 

     (c) Certifies that an employee of the animal protection

 

shelter has received, and can document completion of, a minimum of

 

16 hours of training, including at least 3 hours of practical

 

training, in the use of animal tranquilizers on animals from a

 

training program approved by the state veterinarian, in

 

consultation with the Michigan board of veterinary medicine, and

 

given by a licensed veterinarian pursuant to rules promulgated by

 

the administrator, in consultation with the Michigan board of

 

veterinary medicine as these rules relate to this training, and

 

that only an individual described in this subdivision or an

 

individual otherwise permitted to use a controlled substance

 

pursuant to this article will administer the commercially prepared

 

solution of an animal tranquilizer according to written procedures

 

established by the animal protection shelter.

 

     (16) The application described in subsection (14) or (15) must

 

include the names and business addresses of all individuals

 

employed by the animal control shelter or animal protection shelter

who have been trained as described in subsection (14)(c) or (15)(c)

 

and must include documented proof of the training. The list of

 

names and business addresses must be updated every 6 months.

 

     (17) If an animal control shelter or animal protection shelter

 

issued a permit pursuant to subsection (14) or (15) does not have

 

in its employ an individual trained as described in subsection

 

(14)(c) or (15)(c), the animal control shelter or animal protection

 

shelter shall immediately notify the administrator and shall cease

 

to administer any commercially prepared solution of an animal

 

tranquilizer until the administrator is notified that 1 of the

 

following has occurred:

 

     (a) An individual trained as described in subsection (14)(c)

 

or (15)(c) has been hired by the animal control shelter or animal

 

protection shelter.

 

     (b) An employee of the animal control shelter or animal

 

protection shelter has been trained as described in subsection

 

(14)(c) or (15)(c).

 

     (18) A veterinarian, including a veterinarian who trains

 

individuals as described in subsection (14)(c) or (15)(c), is not

 

civilly or criminally liable for the use of an animal tranquilizer

 

by an animal control shelter or animal protection shelter unless

 

the veterinarian is employed by or under contract with the animal

 

control shelter or animal protection shelter and the terms of the

 

veterinarian's employment or the contract require the veterinarian

 

to be responsible for the use or administration of the commercially

 

prepared solution of an animal tranquilizer.

 

     (19) A person shall not knowingly use or permit the use of an

animal tranquilizer in violation of this section.

 

     (20) This section does not require that a veterinarian be

 

employed by or under contract with an animal control shelter or

 

animal protection shelter to obtain, possess, or administer a

 

commercially prepared solution of an animal tranquilizer pursuant

 

to this section.

 

     (21) As used in this section:

 

     (a) "Animal tranquilizer" means xylazine hydrochloride or

 

other animal tranquilizing drug as approved by the United States

 

Food and Drug Administration and by the state department of

 

agriculture and rural development for use as described in this

 

section.

 

     (b) "Class B dealer" means a class B dealer licensed by the

 

United States Department of Agriculture pursuant to the animal

 

welfare act, 7 USC 2131 to 2159 and the department of agriculture

 

and rural development pursuant to 1969 PA 224, MCL 287.381 to

 

287.395.

 

     Sec. 7333c. (1) Except as otherwise provided in this section,

 

beginning January 1, 2020, a prescription for a controlled

 

substance that is an opioid or a benzodiazepine must be transmitted

 

electronically to a pharmacy in a manner that complies with section

 

17754. An electronically transmitted prescription must include the

 

information described in section 17754 and must be transmitted

 

directly to a pharmacy of the patient's choice by the prescriber or

 

the prescriber's authorized agent.

 

     (2) If a prescriber cannot meet the requirements of subsection

 

(1), the prescriber may apply to the department of health and human

services for a waiver. The department of health and human services

 

shall grant the prescriber a waiver if the prescriber does not have

 

the electronic equipment or system that meets the requirements of

 

section 17754 for transmitting a prescription electronically.

 

     (3) As used in this section, "electronically transmitted

 

prescription" means that term as defined in section 17703.

 

     Sec. 7405. (1) A person shall not do any of the following:

 

     (a) If the person is licensed by the administrator under this

 

article, distribute, prescribe, or dispense a controlled substance

 

in violation of section 7333 or 7333c.

 

     (b) If the person is a licensee, 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) Refuse an entry into any premises for an inspection

 

authorized by this article.

 

     (d) 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) If the person is a practitioner, subject to this

 

subdivision, dispense a controlled substance under a prescription

 

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

 

signed, and transmitted by facsimile; or transmitted electronically

or by other means of communication by a physician prescriber,

 

dentist prescriber, or veterinarian prescriber licensed to practice

 

in another state, unless the prescription is issued by a physician

 

prescriber, dentist prescriber, or veterinarian prescriber who is

 

authorized under the laws of that state to practice dentistry,

 

medicine, osteopathic medicine and surgery, or veterinary medicine

 

and to prescribe controlled substances. If the prescription is for

 

a controlled substance described in section 7333c, the practitioner

 

shall not dispense the controlled substance unless the prescription

 

also complies with, and is transmitted to the practitioner in the

 

manner required by, section 7333c.

 

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

 

penalties prescribed in section 7406.

 

     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), subject to this subdivision, dispensing a prescription

 

for a controlled substance as defined in section 7104 that is

 

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

 

signed, and transmitted by facsimile; or transmitted electronically

 

or by other means of communication by a physician prescriber,

 

dentist prescriber, or veterinarian prescriber in another state,

 

unless the prescription is issued by a physician prescriber,

 

dentist prescriber, or veterinarian prescriber who is authorized

 

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

 

osteopathic medicine and surgery, or veterinary medicine and to

 

prescribe controlled substances. If the prescription is for a

 

controlled substance described in section 7333c, the pharmacist

 

shall not dispense the controlled substance unless the prescription

 

also complies with, and is transmitted to the pharmacist in the

 

manner required by, section 7333c.