April 14, 2015, Introduced by Rep. Yonker and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 17702, 17704, 17709, and 17755 (MCL 333.17702,
333.17704, 333.17709, and 333.17755), sections 17702, 17704, and
17709 as amended by 2014 PA 280.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 17702. (1) "Agent" means an individual designated by a
prescriber to act on behalf of or at the discretion of that
prescriber as provided in section 17744.
(2) "Biological drug product" means a biological product as
defined in 42 USC 262.
(3) "Biosimilar" means that term as defined in 42 USC 262.
(4) "Biosimilar drug product" means a biological drug product
that the FDA has determined to be biosimilar to a reference
product.
(5) (2)
"Brand name" means the
registered trademark name given
to a drug product by its manufacturer.
(6) (3)
Except as otherwise provided in
subsection (4), (7),
"compounding" means the preparation, mixing, assembling, packaging,
and labeling of a drug or device by a pharmacist under the
following circumstances:
(a) Upon the receipt of a prescription for a specific patient.
(b) Upon the receipt of a medical or dental order from a
prescriber or agent for use in the treatment of patients within the
course of the prescriber's professional practice.
(c) In anticipation of the receipt of a prescription or
medical or dental order based on routine, regularly observed
prescription or medical or dental order patterns.
(d) For the purpose of or incidental to research, teaching, or
chemical analysis and not for the purpose of sale or dispensing.
(7) (4)
"Compounding" does not
include any of the following:
(a) Except as provided in section 17748c, the compounding of a
drug product that is essentially a copy of a commercially available
product.
(b) The reconstitution, mixing, or other similar act that is
performed pursuant to the directions contained in approved labeling
provided by the manufacturer of a commercially available product.
(c) The compounding of allergenic extracts or biologic
products.
(8) (5)
"Compounding pharmacy"
means a pharmacy that is
licensed under this part and is authorized to offer compounding
services under sections 17748, 17748a, and 17748b.
(9) (6)
"Current selling price"
means the retail price for a
prescription drug that is available for sale from a pharmacy.
Sec. 17704. (1) "Federal act" means the federal food, drug,
and cosmetic act, 21 USC 301 to 399f.
(2)
"Food and drug administration" Drug Administration" or
"FDA"
means the United States food and drug administration.Food and
Drug Administration.
(3) "Generic name" means the established or official name of a
drug or drug product.
(4) "Harmful drug" means a drug intended for use by human
beings that is harmful because of its toxicity, habit-forming
nature, or other potential adverse effect; the method of its use;
or the collateral measures necessary to its safe and effective use
and that is designated as harmful by a rule promulgated under this
part.
(5) "Interchangeable" means that term as defined in 42 USC
262.
(6) "Interchangeable biological drug product" means a
biological drug product that has met the safety standards for
determining interchangeability under 42 USC 262 and is therefore
determined to be interchangeable with a reference product by the
FDA.
(7) (5)
"Internship" means an
educational program of
professional and practical experience for an intern.
Sec. 17709. (1) "Reference product" means that term as defined
in 42 USC 262.
(2)
(1) "Sign" means to affix one's signature
manually to a
document or to use an electronic signature when transmitting a
prescription electronically.
(3) (2)
"Sterile pharmaceutical"
means a dosage form of a drug
that is essentially free from living microbes and chemical or
physical contamination to the point at which it poses no present
risk to the patient, in accordance with USP standards. As used in
this subsection, "dosage form" includes, but is not limited to,
parenteral, injectable, and ophthalmic dosage forms.
(4) (3)
"Substitute" means to
dispense, without the
prescriber's authorization, a different drug in place of the drug
prescribed.
(5) (4)
"USP standards" means the
pharmacopeial standards for
drug substances, dosage forms, and compounded preparations based on
designated levels of risk as published in the official compendium.
(6) (5)
"Wholesale distributor"
means a person, other than a
manufacturer, who supplies, distributes, sells, offers for sale,
barters, or otherwise disposes of, to other persons for resale,
compounding, or dispensing, a drug or device salable on
prescription only that the distributor has not prepared, produced,
derived, propagated, compounded, processed, packaged, or
repackaged, or otherwise changed the container or the labeling of
the drug or device.
Sec.
17755. (1) When Except as
otherwise provided in this
section, a pharmacist who receives a prescription for a brand name
drug
product , the pharmacist may, or when a purchaser requests a
lower
cost generically equivalent drug product, the pharmacist
shall
or a biological drug product may
dispense a lower cost but
not
higher cost generically equivalent
drug product or lower cost
interchangeable biological drug product if available in the
pharmacy. ,
except as provided in subsection (3). If Except as
otherwise provided in this section, upon the request of the
purchaser, a pharmacist who receives a prescription for a brand
name drug product or a biological drug product shall dispense a
lower cost generically equivalent drug product or lower cost
interchangeable biological drug product if available in the
pharmacy. The pharmacist shall notify the purchaser if a drug is
dispensed
which that is not the prescribed brand ,
the purchaser
shall
be notified and the prescription label name drug product or
the prescribed biological drug product. Except as otherwise
provided in section 17756, the pharmacist shall indicate both the
name
of the brand name of the drug product prescribed or
the
biological drug product prescribed and the generic name or
interchangeable
biological drug product name of the brand
drug
product dispensed and designate each respectively on the
prescription
label. If Except as otherwise provided in section
17756, if the dispensed drug does not have a brand name, the
prescription
label pharmacist shall indicate the generic name or
interchangeable biological drug product name of the drug product
dispensed ,
except as otherwise provided in section 17756.on the
prescription label.
(2) If a pharmacist dispenses a generically equivalent drug
product or an interchangeable biological drug product under
subsection (1), the pharmacist shall pass on the savings in cost to
the purchaser or to the third party payment source if the
prescription purchase is covered by a third party pay contract. The
savings in cost is the difference between the wholesale cost to the
pharmacist of the 2 drug products.
(3) If a pharmacist dispenses an interchangeable biological
drug product under subsection (1), the pharmacist shall indicate
the interchangeable biological drug product name and the full name
of the manufacturer, if available, of the interchangeable
biological drug product dispensed on the file copy of the
prescription.
(4) (3)
The pharmacist shall not dispense a
generically
equivalent drug product or an interchangeable biological drug
product under subsection (1) if any of the following applies:
(a) The prescriber, in the case of a prescription in writing
signed by the prescriber, writes in his or her own handwriting
"dispense as written" or "d.a.w." on the prescription.
(b) The prescriber, having preprinted on his or her
prescription blanks the statement "another brand of a generically
equivalent drug product or an interchangeable biological drug
product, identical in dosage, form, and content of active
ingredients, may be dispensed unless initialed d.a.w.", writes in
his or her own handwriting, the initials "d.a.w." in a space, box,
or square adjacent to the statement.
(c) The prescriber, in the case of a prescription other than
one
1 in writing signed by the prescriber, expressly
indicates the
prescription is to be dispensed as communicated.
(5) (4)
A pharmacist may shall not
dispense a drug product
with a total charge that exceeds the total charge of the drug
product originally prescribed, unless agreed to by the purchaser.
(6) Except as otherwise provided in subsection (1), a
pharmacist must notify the prescriber before dispensing a
biosimilar drug product in place of a biological drug product.
Enacting section 1. This amendatory act takes effect 90 days
after the date it is enacted into law.