Bill Text: MI HB4472 | 2017-2018 | 99th Legislature | Engrossed
Bill Title: Health; pharmaceuticals; food and drug administration-designated interchangeable biological drug products; allow pharmacists to dispense under certain circumstances. Amends secs. 17702, 17704 & 17755 of 1978 PA 368 (MCL 333.17702 et seq.).
Spectrum: Partisan Bill (Republican 1-0)
Status: (Passed) 2018-03-01 - Assigned Pa 41'18 With Immediate Effect [HB4472 Detail]
Download: Michigan-2017-HB4472-Engrossed.html
HB-4472, As Passed House, January 25, 2018
SUBSTITUTE FOR
HOUSE BILL NO. 4472
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 17702, 17704, and 17755 (MCL 333.17702,
333.17704, and 333.17755), section 17702 as amended by 2016 PA 528
and section 17704 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) "Automated device" means a mechanical system that performs
an operation or activity, other than compounding or administration,
relating to the storage, packaging, dispensing, or delivery of a
drug and that collects, controls, and maintains transaction
information.
(3) "Biological drug product" means a biological product as
that term is defined in 42 USC 262.
(4)
(3) "Brand name" means the registered
trademark name given
to a drug product by its manufacturer.
(5) (4)
Except as otherwise provided in
subsection (5), (6),
"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.
(6) (5)
"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.
(7) (6)
"Compounding pharmacy"
means a pharmacy that is
licensed under this part and is authorized to offer compounding
services under sections 17748, 17748a, and 17748b.
(8) (7)
"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.399h.
(2)
"Food and drug administration" Drug Administration" or
"FDA"
means the United States food Food
and drug
administration.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 biological drug product" means either of
the following, as applicable:
(a) A biological drug product that is licensed by the FDA and
that the FDA has determined meets the standards for
interchangeability under 42 USC 262(k)(4).
(b) Until March 23, 2021, a biological drug product that the
FDA has determined to be therapeutically equivalent as set forth in
"Approved Drug Products with Therapeutic Equivalence Evaluations",
an FDA publication that is commonly referred to as the "Orange
House Bill No. 4472 as amended January 24, 2018
Book".
(6)
(5) "Internship" means an educational program
of
professional and practical experience for an intern.
Sec.
17755. (1) When Except as
provided in subsection [(3),]
when a pharmacist receives a prescription for a brand name drug
product or biological drug product, the pharmacist may, or when a
purchaser requests a lower cost generically equivalent drug product
or interchangeable biological drug product, the pharmacist shall
dispense a lower cost but not higher cost generically equivalent
drug product or interchangeable biological drug product if
available
in the pharmacy. , except as provided in subsection (3).
If
a drug or biological drug product
is dispensed which that is
not
the
prescribed brand, the purchaser shall must be notified and the
prescription
label shall must indicate both the name of the brand
prescribed and the name of the brand dispensed and designate each
respectively.
If Except as otherwise
provided in section 17756, if
the dispensed drug or biological drug product does not have a brand
name,
the prescription label shall must
indicate the generic name
of
the drug dispensed , except as otherwise provided in section
17756.or the proprietary name of the biological drug
product
dispensed.
(2) If a pharmacist dispenses a generically equivalent drug
product or interchangeable biological drug product, 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) The pharmacist shall not dispense a generically equivalent
drug product or interchangeable biological drug product under
subsection
(1) if any of the following applies:apply:
(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 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 in writing signed by the prescriber, expressly indicates that
the prescription is to be dispensed as communicated.
(4) A pharmacist may 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.
(5) Except as otherwise provided in subsection (6), within 5
days after dispensing an interchangeable biological drug product,
the dispensing pharmacist or his or her designee shall communicate
to the prescriber the specific interchangeable biological drug
product provided to the patient, including the name of the
interchangeable biological drug product and its manufacturer. The
communication required under this subsection must be made as
follows:
House Bill No. 4472 as amended January 24, 2018
(a) By making an entry that is electronically accessible to
the prescriber through an interoperable electronic medical records
system, an electronic prescribing technology, a pharmacy benefit
management system, [a health information exchange,] or a pharmacy record.
An entry made as described
in this subdivision is presumed to provide notice to the
prescriber.
(b) If the methods described in subdivision (a) are not
available, then by facsimile, telephone, electronic transmission,
or other prevailing means.
(6) Subsection (5) does not apply if either of the following
occurs:
(a) There is no FDA-licensed interchangeable biological drug
product for the product prescribed.
(b) A refill authorization does not change the product that
was dispensed on the prior filling of the prescription.
(7) The board shall maintain a link on its website to the
current Purple Book.
(8) Beginning June 1, 2018 and annually thereafter, the
department shall submit a report on all of the following to the
house and senate standing committees on health policy, the speaker
of the house of representatives, and the senate majority leader:
(a) A list of each biological drug product that the FDA had
previously determined to be therapeutically equivalent as set forth
in the Orange Book that is now included in the Purple Book.
(b) The anticipated date that every biological drug product
that the FDA has determined to be therapeutically equivalent as set
forth in the Orange Book will be included in the Purple Book.
House Bill No. 4472 as amended January 24, 2018
(9) As used in this section:
(a) "Orange Book" means "Approved Drug Products with
Therapeutic Equivalence Evaluations," an FDA publication that is
commonly referred to as the "Orange Book".
(b) "Purple Book" means "Lists of [licensed] Biological Products
with
Reference Product Exclusivity and Biosimilarity or
Interchangeability Evaluations", an FDA publication that is
commonly referred to as the "Purple Book".
Enacting section 1. This amendatory act takes effect 90 days
after the date it is enacted into law.
