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.