Bill Text: IA HF305 | 2017-2018 | 87th General Assembly | Enrolled
Bill Title: A bill for an act relating to the prescribing of biological products and making penalties applicable. (Formerly HSB 38.) Effective 7-1-17.
Sponsorship: Committee Bill
Status: (Passed) 2017-03-10 - Signed by Governor. H.J. 626. [HF305 Detail]
Download: Iowa-2017-HF305-Enrolled.html
House File 305 - Enrolled
HOUSE FILE
BY COMMITTEE ON HUMAN
RESOURCES
(SUCCESSOR TO HSB 38)
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A BILL FOR
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House File 305
AN ACT
RELATING TO THE PRESCRIBING OF BIOLOGICAL PRODUCTS AND MAKING
PENALTIES APPLICABLE.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
Section 1. Section 155A.3, Code 2017, is amended by adding
the following new subsections:
NEW SUBSECTION. 2A. "Biological product" means the same
as defined in 42 U.S.C. {262.
NEW SUBSECTION. 19A. "Interchangeable biological product"
means either of the following:
a. A biological product that the United States food and
drug administration has licensed and has determined meets
the standards for interchangeability pursuant to 42 U.S.C.
{262(k)(4).
b. A biological product that the United States food and
drug administration has determined to be therapeutically
equivalent to another biological product as set forth in the
latest edition or supplement of the United States food and
drug administration approved drug products with therapeutic
equivalence evaluations publication.
Sec. 2. Section 155A.28, Code 2017, is amended to read as
follows:
155A.28 Label of prescription drugs ==== interchangeable
biological product list.
1. The label of any drug, biological product, or device
sold and dispensed on the prescription of a practitioner shall
be in compliance with rules adopted by the board.
2. The board shall maintain a link on its internet site to
the current list of all biological products that the United
States food and drug administration has determined to be
interchangeable biological products.
Sec. 3. Section 155A.32, Code 2017, is amended to read as
follows:
155A.32 Drug product selection ==== restrictions.
1. a. If an authorized prescriber prescribes, in
writing, electronically, by facsimile, or orally, a drug
by its brand or trade name, the pharmacist may exercise
professional judgment in the economic interest of the patient
by selecting a drug product with the same generic name
and demonstrated bioavailability as the one drug product
prescribed for dispensing and sale to the patient. If the
cost of the prescription or any part of it will be paid by
expenditure of public funds authorized under chapter 249A, the
pharmacist shall exercise professional judgment by selecting
a drug product with the same generic name and demonstrated
bioavailability as the one drug product prescribed for
dispensing and sale. If the pharmacist exercises drug product
selection, the pharmacist shall inform the patient of the
savings which the patient will obtain as a result of the drug
product selection and pass on to the patient no less than
fifty percent of the difference in actual acquisition costs
between the drug prescribed and the drug substituted.
b. If an authorized prescriber prescribes a biological
product, the pharmacist may exercise professional judgment
in the economic interest of the patient by selecting a
biological product that is an interchangeable biological
product for the biological product prescribed for dispensing
and sale to the patient. If the cost of the prescription or
any part of it will be paid by expenditure of public funds
authorized under chapter 249A, the pharmacist shall exercise
professional judgment by selecting a biological product that
is an interchangeable biological product for the biological
product prescribed for dispensing and sale.
2. The pharmacist shall not exercise the drug or biological
product selection described in this section if either any of
the following is true:
a. The prescriber specifically indicates that no drug or
biological product selection shall be made.
b. The person presenting the prescription indicates that
only the specific drug product prescribed should be dispensed.
However, this paragraph does not apply if the cost of the
prescription or any part of it will be paid by expenditure of
public funds authorized under chapter 249A.
3. If selection of a generically equivalent drug product
or an interchangeable biological product is made under this
section, the pharmacist making the selection shall inform the
patient and note that fact and the name of the manufacturer of
the selected drug on the prescription presented by the patient
or the patient's adult representative or transmitted by the
prescriber or the prescriber's authorized agent.
4. a. Within five business days following the dispensing
of a biological product, the dispensing pharmacist or the
pharmacist's designee shall make an entry of the specific
biological product provided to the patient, including the name
of the biological product and the manufacturer. The entry
shall be electronically accessible to the prescriber through
one of the following means:
(1) An interoperable electronic medical records system.
(2) An electronic prescribing technology.
(3) A pharmacy benefit management system.
(4) A pharmacy record.
b. An entry into an electronic records system as described
in this subsection is presumed to provide notice to the
prescriber. If the entry is not made electronically, the
pharmacist shall communicate the name and manufacturer of
the biological product dispensed to the prescriber using
facsimile, telephone, electronic transmission, or other
prevailing means.
c. Communication under this subsection shall not be
required in either of the following circumstances:
(1) There is no federal food and drug
administration=approved interchangeable biological product
for the product prescribed.
(2) A refill prescription is not changed from the product
dispensed on the prior filling of the prescription.
LINDA UPMEYER
Speaker of the House
JACK WHITVER
President of the Senate
I hereby certify that this bill originated in the House and
is known as House File 305, Eighty=seventh General Assembly.
CARMINE BOAL
Chief Clerk of the House
Approved , 2017
TERRY E. BRANSTAD
Governor
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