BillCam

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.

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.

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.

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".

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).