Bill Text: MI HB6339 | 2017-2018 | 99th Legislature | Introduced

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Bill Title: Health; pharmaceuticals; dispensing of ephedrine and pseudoephedrine; allow by prescription only. Amends secs. 7220, 7340 & 17708 of 1978 PA 368 (MCL 333.7220 et seq.) & repeals secs. 7340a, 17766c, 17766e & 17766f of 1978 PA 368 (MCL 333.7340a et seq.). TIE BAR WITH: HB 6340'18, HB 6341'18

Spectrum: Partisan Bill (Republican 1-0)

Status: (Introduced - Dead) 2018-09-25 - Bill Electronically Reproduced 09/06/2018 [HB6339 Detail]

Download: Michigan-2017-HB6339-Introduced.html

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HOUSE BILL No. 6339

 

 

September 6, 2018, Introduced by Rep. LaFave and referred to the Committee on Health Policy.

 

     A bill to amend 1978 PA 368, entitled

 

"Public health code,"

 

by amending sections 7220, 7340, and 17708 (MCL 333.7220, 333.7340,

 

and 333.17708), section 7220 as amended by 1999 PA 144, section

 

7340 as added by 2006 PA 261, and section 17708 as amended by 2016

 

PA 499; and to repeal acts and parts of acts.

 

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

 

     Sec. 7220. (1) The following controlled substances are

 

included in schedule 5:

 

     (a) The following drugs and other substances, by whatever

 

official name, common or usual name, chemical name, or brand name

 

designated:

 

     Loperamide

 

     (b) Any compound, mixture, or preparation containing any of

 

the following limited quantities of narcotic drugs or salts of

narcotic drugs, which includes 1 or more nonnarcotic active

 

medicinal ingredients in sufficient proportion to confer upon the

 

compound, mixture, or preparation valuable medicinal qualities

 

other than those possessed by the narcotic drug alone:

 

     (i) Not more than 200 milligrams of codeine, or any of its

 

salts, per 100 milliliters or per 100 grams and not more than 10

 

milligrams per dosage unit.

 

     (ii) Not more than 100 milligrams of dihydrocodeine, or any of

 

its salts, per 100 milliliters or per 100 grams and not more than 5

 

milligrams per dosage unit.

 

     (iii) Not more than 100 milligrams of ethylmorphine, or any of

 

its salts, per 100 milliliters or per 100 grams and not more than 5

 

milligrams per dosage unit.

 

     (iv) Not more than 2.5 milligrams of diphenoxylate and not

 

less than 25 micrograms of atropine sulfate per dosage unit.

 

     (v) Not more than 100 milligrams of opium per 100 milliliters

 

or per 100 grams and not more than 5 milligrams per dosage unit.

 

     (c) Except as otherwise provided in this subdivision,

 

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.

 

However, the following are not included in schedule 5:

 

     (i) A product containing ephedrine, a salt of ephedrine, an

 

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

 

ephedrine if the drug product may lawfully be sold over the counter

 

without a prescription under federal law, is labeled and marketed

in a manner consistent with the pertinent OTC tentative final or

 

final monograph, is manufactured and distributed for legitimate

 

medical use in a manner that reduces or eliminates the likelihood

 

for abuse, and is not marketed, advertised, or labeled for an

 

indication of stimulation, mental alertness, energy, weight loss,

 

appetite control, or muscle enhancement and if the drug product is

 

1 of the following:

 

     (A) A solid dosage form, including but not limited to a soft

 

gelatin caplet, that combines as active ingredients not less than

 

400 milligrams of guaifenesin and not more than 25 milligrams of

 

ephedrine per dose, packaged in blister packs with not more than 2

 

tablets or caplets per blister.

 

     (B) An anorectal preparation containing not more than 5%

 

ephedrine.

 

     (ii) A food product or a dietary supplement containing

 

ephedrine, if the food product or dietary supplement meets all of

 

the following criteria:

 

     (A) It contains, per dosage unit or serving, not more than the

 

lesser of 25 milligrams of ephedrine alkaloids or the maximum

 

amount of ephedrine alkaloids provided in applicable regulations

 

adopted by the United States food Food and drug administration Drug

 

Administration and contains no other controlled substance.

 

     (B) It contains no hydrochloride or sulfate salts of ephedrine

 

alkaloids.

 

     (C) It is packaged with a prominent label securely affixed to

 

each package that states the amount in milligrams of ephedrine in a

 

serving or dosage unit; the amount of the food product or dietary

supplement that constitutes a serving or dosage unit; that the

 

maximum recommended dosage of ephedrine for a healthy adult human

 

is the lesser of 100 milligrams in a 24-hour period or the maximum

 

recommended dosage or period of use provided in applicable

 

regulations adopted by the United States food Food and drug

 

administration; Drug Administration; and that improper use of the

 

product may be hazardous to a person's health.

 

     (2) Inclusion of the substances described in subsection (1)(c)

 

into schedule 5 does not preclude prosecution for a crime involving

 

those schedule 5 substances under former section 17766c.

 

     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 Michigan board of pharmacy,

 

upon application of the manufacturer or certification by the United

 

States drug enforcement administration 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, 26 USC 501, 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

 

physician's assistant, a licensed optometrist certified under part

174 to administer and prescribe therapeutic pharmaceutical agents,

 

an advanced practice registered nurse as that term is defined in

 

section 17201 who meets the requirements of section 17211a, 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 by a prescriber to fill,

 

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

 

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

 

facsimile; or transmitted electronically or by other means of

 

communication. An order transmitted in other than written or hard-

 

copy form must be electronically recorded, printed, or written and

 

immediately dated by the pharmacist, and that record is considered

 

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 is considered for the purposes of

 

this definition the original prescription. For purposes of this

 

part, prescription also includes a standing order issued under

 

section 17744e. Subject to section 17751(2) and (5), prescription

 

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

 

a controlled substance except under circumstances described in

 

section 17763(e), 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 who is licensed to practice dentistry, medicine,

osteopathic medicine and surgery, or veterinary medicine in another

 

state.

 

     (4) "Prescription drug" means a drug to which 1 or more of the

 

following: apply:

 

     (a) The A drug that is dispensed pursuant to a prescription.

 

     (b) The A drug that bears the federal legend "CAUTION: federal

 

law prohibits dispensing without prescription" or "Rx only".

 

     (c) The A drug that is designated by the board as a drug that

 

may only be dispensed pursuant to a prescription.

 

     (d) Ephedrine or pseudoephedrine, a salt or optical isomer of

 

ephedrine or pseudoephedrine, a salt of an optical isomer of

 

ephedrine or pseudoephedrine, or a compound, mixture, or

 

preparation containing ephedrine or pseudoephedrine, a salt of

 

ephedrine or pseudoephedrine, an optical isomer of ephedrine or

 

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

 

pseudoephedrine.

 

     Enacting section 1. Sections 7340a, 17766c, 17766e, and 17766f

 

of the public health code, 1978 PA 368, MCL 333.7340a, 333.17766c,

 

333.17766e, and 333.17766f, are repealed.

 

     Enacting section 2. This amendatory act takes effect 90 days

 

after the date it is enacted into law.

 

     Enacting section 3. This amendatory act does not take effect

 

unless all of the following bills of the 99th Legislature are

 

enacted into law:

 

     (a) Senate Bill No.____ or House Bill No. 6340 (request no.

 

04955'17 a).

 

     (b) Senate Bill No.____ or House Bill No. 6341 (request no.

04955'17 b).