February 12, 2013, Introduced by Reps. Kivela, Dianda and Cavanagh 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 2012
PA 209; 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 and 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 and 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 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, 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
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, or licensed doctor of podiatric
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 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; 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 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.
(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.
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 January
1, 2014.