Bill Text: MI HB4472 | 2017-2018 | 99th Legislature | Introduced
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-Introduced.html
HOUSE BILL No. 4472
March 30, 2017, Introduced by Rep. Bizon and referred to the Committee on Health Policy.
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), sections 17702 and 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) "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)
(2) "Brand name" means the registered
trademark name given
to a drug product by its manufacturer.
(5) (3)
Except as otherwise provided in
subsection (4), (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) (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.
(7) (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.
(8) (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 biological drug product" means either of
the following:
(a) A biological drug product that is licensed by the FDA and
determined to be interchangeable with the prescribed drug product
pursuant to 42 USC 262(k)(4).
(b) A biological drug product that is approved by the FDA
pursuant to an application filed under 21 USC 355(b)(2) and that
the FDA has determined to be therapeutically equivalent to the
prescribed drug product.
(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 be notified and the
prescription label shall 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 indicate the generic name of the
drug
or biological drug product dispensed.
, except as otherwise
provided
in section 17756.
(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 provided in subsection (6), within 5 business
days after dispensing a biological drug product, the pharmacist who
dispensed the biological drug product, a pharmacy technician, or a
pharmacist intern shall communicate to the prescriber the specific
biological drug product dispensed, including, but not limited to,
the name of the biological drug product and the manufacturer of the
biological drug product. The communication required under this
subsection shall be made as follows:
(a) By making an entry in an interoperable electronic medical
records system, through the use of electronic prescribing
technology, through the use of a pharmacy benefits management
system, or through the use of a pharmacy record, that is
electronically accessible by the prescriber.
(b) If the methods described in subdivision (a) are not
available, then by facsimile, telephone, electronic transmission,
or other prevailing means. The information received by a prescriber
under this subdivision must be included in the patient's medical
record.
(6) Subsection (5) does not apply if either of the following
occurs:
(a) There is no interchangeable biological drug product for
the drug product prescribed.
(b) The prescription was refilled with the same drug product
that was dispensed on the prior filling of the prescription.
(7) The board shall maintain a link on its website to the
current list of all biological drug products that the FDA has
determined to be interchangeable biological drug products.
Enacting section 1. This amendatory act takes effect 90 days
after the date it is enacted into law.
