Bill Text: MI HB4662 | 2011-2012 | 96th Legislature | Introduced

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Bill Title: Health; pharmaceuticals; dispensing of ephedrine and pseudoephedrine; allow by prescription only. Amends secs. 7340, 17708 & 17766d of 1978 PA 368 (MCL 333.7340 et seq.) & repeals secs. 17766c, 17766e & 17766f.

Spectrum: Bipartisan Bill

Status: (Introduced - Dead) 2011-05-24 - Printed Bill Filed 05/19/2011 [HB4662 Detail]

Download: Michigan-2011-HB4662-Introduced.html

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HOUSE BILL No. 4662

 

May 19, 2011, Introduced by Reps. Lori and Meadows and referred to the Committee on Health Policy.

 

     A bill to amend 1978 PA 368, entitled

 

"Public health code,"

 

by amending sections 7340, 17708, and 17766d (MCL 333.7340,

 

333.17708, and 333.17766d), section 7340 as added by 2006 PA 261,

 

section 17708 as amended by 2009 PA 150, and section 17766d as

 

added by 2004 PA 329; and to repeal acts and parts of acts.

 

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

 

     Sec. 7340. (1) A person shall not sell, distribute, deliver,

 

or otherwise furnish a product that contains any compound, mixture,

 

or preparation containing any detectable quantity of ephedrine or

 

pseudoephedrine, a salt or optical isomer of ephedrine or

 

pseudoephedrine, or a salt of an optical isomer of ephedrine or

 

pseudoephedrine to an individual if the sale is transacted through

 

use of the mail, internet, telephone, or other electronic means.

 

     (2) This section does not apply to any of the following:

 

     (a) A pediatric product primarily intended for administration

 

to children under 12 years of age according to label instructions.

 

     (b) A product containing pseudoephedrine that is in a liquid

 

form if pseudoephedrine is not the only active ingredient.

 

     (a) (c) A product that the state board of pharmacy, upon

 

application of the manufacturer or certification by the United

 

States drug enforcement administration as inconvertible, exempts

 

from this section because the product has been formulated in such a

 

way as to effectively prevent the conversion of the active

 

ingredient into methamphetamine.

 

     (b) (d) A person who dispenses a product described in

 

subsection (1) pursuant to a prescription.

 

     (c) (e) A person who, in the course of his or her business,

 

sells or distributes products described in subsection (1) to either

 

of the following:

 

     (i) A a person licensed by this state to manufacture, deliver,

 

dispense, or possess with intent to manufacture or deliver a

 

controlled substance, prescription drug, or other drug.

 

     (ii) A person who orders those products described in subsection

 

(1) for retail sale pursuant to a license issued under the general

 

sales tax act, 1933 PA 167, MCL 205.51 to 205.78.

 

     (d) (f) A manufacturer or distributor who donates product

 

samples to a nonprofit charitable organization that has tax-exempt

 

status pursuant to under section 501(c)(3) of the internal revenue

 

code of 1986, a licensed practitioner, or a governmental entity.

 

     (3) A person who violates this section is guilty of a felony

 

punishable by imprisonment for not more than 4 years or a fine of

 

not more than $5,000.00, or both.

 

     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" or "Rx only".

 

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

 

dispensed pursuant to a prescription.

 

     (d) Ephedrine, a salt of ephedrine, an optical isomer of

 

ephedrine, a salt of an optical isomer of ephedrine, or a compound,

 

mixture, or preparation containing ephedrine, a salt of ephedrine,

 

an optical isomer of ephedrine, or a salt of an optical isomer of

 

ephedrine.

 

     Sec. 17766d. (1) Notwithstanding section 17766(f), a A

 

pharmacy operated by the department of corrections or under

 

contract with the department of corrections or a county jail may

 

accept for the purpose of resale or redispensing a prescription

 

drug that has been dispensed and has left the control of the

 

pharmacist if the prescription drug is being returned by a state

 

correctional facility or a county jail that has a licensed

 

physician's assistant, a registered professional nurse, or a

 

licensed practical nurse, who is responsible for the security,

 

handling, and administration of prescription drugs within that

 

state correctional facility or county jail and if all of the

 

following are met:

 

     (a) The pharmacist is satisfied that the conditions under

 

which the prescription drug has been delivered, stored, and handled

 

before and during its return were such as to prevent damage,

 

deterioration, or contamination that would adversely affect the

 

identity, strength, quality, purity, stability, integrity, or

 

effectiveness of the prescription drug.

 

     (b) The pharmacist is satisfied that the prescription drug did

 

not leave the control of the registered professional nurse or

 

licensed practical nurse responsible for the security, handling,

 

and administration of that prescription drug and that the

 

prescription drug did not come into the physical possession of the

 

individual for whom it was prescribed.

 

     (c) The pharmacist is satisfied that the labeling and

 

packaging of the prescription drug are accurate, have not been

 

altered, defaced, or tampered with, and include the identity,

 

strength, expiration date, and lot number of the prescription drug.

 

     (d) The prescription drug was dispensed in a unit dose package

 

or unit of issue package.

 

     (2) A pharmacy operated by the department of corrections or

 

under contract with the department of corrections or a county jail

 

shall not accept for return prescription drugs as provided under

 

this section until the pharmacist in charge develops a written set

 

of protocols for accepting, returning to stock, repackaging,

 

labeling, and redispensing prescription drugs. The written

 

protocols shall be maintained on the premises and shall be readily

 

accessible to each pharmacist on duty. The written protocols shall

 

include, at a minimum, each of the following:

 

     (a) Methods to ensure that damage, deterioration, or

 

contamination has not occurred during the delivery, handling,

 

storage, and return of the prescription drugs which would adversely

 

affect the identity, strength, quality, purity, stability,

 

integrity, or effectiveness of those prescription drugs or

 

otherwise render those drugs unfit for distribution.

 

     (b) Methods for accepting, returning to stock, repackaging,

 

labeling, and redispensing the prescription drugs returned under

 

this section.

 

     (c) A uniform system of recording and tracking prescription

 

drugs that are returned to stock, repackaged, labeled, and

 

redistributed under this section.

 

     (3) If the integrity of a prescription drug and its package is

 

maintained, a prescription drug returned under this section shall

 

be returned to stock and redistributed as follows:

 

     (a) A prescription drug that was originally dispensed in the

 

manufacturer's unit dose package or unit of issue package and is

 

returned in that same package may be returned to stock, repackaged,

 

and redispensed as needed.

 

     (b) A prescription drug that is repackaged into a unit dose

 

package or a unit of issue package by the pharmacy, dispensed, and

 

returned to that pharmacy in that unit dose package or unit of

 

issue package may be returned to stock, but it shall not be

 

repackaged. A unit dose package or unit of issue package prepared

 

by the pharmacist and returned to stock shall only be redispensed

 

in that same unit dose package or unit of issue package and shall

 

only be redispensed once. A pharmacist shall not add unit dose

 

package drugs to a partially used unit of issue package.

 

     (4) This section does not apply to any of the following:

 

     (a) A controlled substance.

 

     (b) A prescription drug that is dispensed as part of a

 

customized patient medication package.

 

     (c) A prescription drug that is not dispensed as a unit dose

 

package or a unit of issue package.

 

     (d) A prescription drug that is not properly labeled with the

 

identity, strength, lot number, and expiration date.

 

     (e) A prescription drug that is dispensed in a medical

 

institution and returned to stock for redistribution in accordance

 

with R 338.486 of the Michigan administrative code.

 

     (5) As used in this section:

 

     (a) "County jail" means a facility operated by a county for

 

the physical detention and correction of persons charged with, or

 

convicted of, criminal offenses or ordinance violations or persons

 

found guilty of civil or criminal contempt.

 

     (b) "Customized patient medication package" means a package

 

that is prepared by a pharmacist for a specific patient that

 

contains 2 or more prescribed solid oral dosage forms.

 

     (c) "Repackage" means a process by which the pharmacy prepares

 

a unit dose package, unit of issue package, or customized patient

 

medication package for immediate dispensing pursuant to a current

 

prescription.

 

     (d) "State correctional facility" means a facility or

 

institution that houses a prisoner population under the

 

jurisdiction of the department of corrections.

 

     (e) "Unit dose package" means a package that contains a single

 

dose drug with the name, strength, control number, and expiration

 

date of that drug on the label.

 

     (f) "Unit of issue package" means a package that provides

 

multiple doses of the same drug, but each drug is individually

 

separated and includes the name, lot number, and expiration date.

 

     Enacting section 1. Sections 17766c, 17766e, and 17766f of the

 

public health code, 1978 PA 368, MCL 333.17766c, 333.17766e, and

 

333.17766f, are repealed.

 

     Enacting section 2. This amendatory act takes effect January

 

1, 2012.