Rep. Norm Thurston — Voting Record

Bill

Number

H.B. 279 Second Substitute (2015GS)

Sponsor

Rep. Gibson, F.

Final action

Governor Signed 3/27/2015

Outcome

Became law — signed by Gov. Gary R. Herbert

Summary

What it does

• This bill:
• deletes the definition of biosimilar;
• defines interchangeable biological product;
• requires a pharmacist to notify the prescriber when a biological product is dispensed if an interchangeable biological product is available;
• establishes the methods of notifying a prescriber; and
• amends repealer language.

Every vote on this bill

Bill text

PRESCRIPTION NOTIFICATION AMENDMENTS
GENERAL SESSION
STATE OF UTAH
Chief Sponsor: Francis D. Gibson
Senate Sponsor: 
J. Stuart Adams
LONG TITLE
General Description:
This bill amends provisions related to biosimilar products in the Pharmacy Practice Act.
Highlighted Provisions:
This bill:
▸ deletes the definition of biosimilar;
▸ defines interchangeable biological product;
▸ requires a pharmacist to notify the prescriber when a biological product is dispensed
if an interchangeable biological product is available;
▸ establishes the methods of notifying a prescriber; and
▸ amends repealer language.
Money Appropriated in this Bill:
None
Other Special Clauses:
None
Utah Code Sections Affected:
AMENDS:
58-17b-605.5
, as enacted by Laws of Utah 2013, Chapter 423
63I-2-258
, as last amended by Laws of Utah 2013, Chapter 423
Be it enacted by the Legislature of the state of Utah:
Section 1. Section 
58-17b-605.5
 is amended to read:
58-17b-605.5.
Interchangeable biological products.
(1) For the purposes of this section:
(a) "Biological product" [
is as
] 
means the same as that term is
 defined in 42 U.S.C.
Sec. 262[
;
]
.
[
(b) "biosimilar" is as defined in 42 U.S.C. Sec. 262; and
]
[
(c) "interchangeable" is as defined in 42 U.S.C. Sec. 262.
]
(b) "Interchangeable biological product" means a biological product that the federal
Food and Drug Administration:
(i) has:
(A) licensed; and
(B) determined meets the standards for interchangeability pursuant to 42 U.S.C. Sec.
262(k)(4); or
(ii) has determined is therapeutically equivalent as set forth in the latest edition of or
supplement to the federal Food and Drug Administration's Approved Drug Products with
Therapeutic Equivalence Evaluations.
(2) A pharmacist or pharmacy intern dispensing a prescription order for a specific
biological product by brand or proprietary name may substitute [
a biosimilar
] 
an
interchangeable biological
 product for the prescribed biological product only if:
(a) the purchaser specifically requests or consents to the substitute of an
interchangeable [
biosimilar
] 
biological
 product;
[
(b) the biosimilar product has been determined by the United States Food and Drug
Administration to be interchangeable with the prescribed biological product;
]
[
(c)
] 
(b)
 the interchangeable [
biosimilar
] 
biological
 product is permitted to move in
interstate commerce;
[
(d)
] 
(c)
 the pharmacist or pharmacy intern counsels the patient on the use and the
expected response to the prescribed biological product, whether a substitute or not, and the
substitution is not otherwise prohibited by this chapter;
[
(e)
] 
(d)
 the prescribing practitioner has not prohibited the substitution of an
interchangeable [
biosimilar
] 
biological
 product for the prescribed biological product, as
provided in Subsection (6); and
[
(f)
] 
(e)
 the substitution is not otherwise prohibited by law.
(3) [
(a)
] Each out-of-state mail service pharmacy dispensing an interchangeable
[
biosimilar
] 
biological
 product as a substitute for another biological product into this state
shall
:
(a)
 notify the patient of the substitution either by telephone or in writing[
.
]
; and
(b) [
Each out-of-state mail service pharmacy shall
] comply with the requirements of
this chapter with respect to an interchangeable [
biosimilar
] 
biological
 product substituted for
another biological product, including labeling and record keeping.
(4) Pharmacists or pharmacy interns may not substitute without the prescriber's
authorization biological product prescriptions unless the product has been determined by the
United States Food and Drug Administration to be interchangeable with the prescribed
biological product.
(5) A pharmacist or pharmacy intern who dispenses a prescription with an
interchangeable [
biosimilar
] 
biological
 product under this section assumes no greater liability
than would be incurred had the pharmacist or pharmacy intern dispensed the prescription with
the biological product prescribed.
(6) (a) If, in the opinion of the prescribing practitioner, it is in the best interest of the
patient that an interchangeable [
biosimilar
] 
biological
 product not be substituted for a
prescribed biological product, the practitioner may prohibit a substitution either by writing
"dispense as written" or by signing in the appropriate space where two lines have been
preprinted on a prescription order and captioned "dispense as written" or "substitution
permitted."
(b) (i) If the prescription is communicated orally by the prescribing practitioner to the
pharmacist or pharmacy intern, the practitioner shall direct the prohibition or substitution.
(ii) The pharmacist or pharmacy intern shall make a written note of the practioner's
direction by writing the name of the practitioner and the words "orally by" and the initials of
the pharmacist or pharmacy intern written after it.
(7) A pharmacist or pharmacy intern who substitutes an interchangeable [
biosimilar
]
biological
 product for a prescribed biological product shall communicate the substitution to the
purchaser. The interchangeable [
biosimilar
] 
biological
 product container shall be labeled with
the name of the interchangeable [
biosimilar
] 
biological
 product dispensed, and the pharmacist,
pharmacy intern, or pharmacy technician shall indicate on the file copy of the prescription both
the name of the prescribed biological product and the name of the interchangeable [
biosimilar
]
biological
 product dispensed in its place.
[
(8) (a) A pharmacist or pharmacy intern who substitutes an interchangeable biosimilar
product for a prescribed biological product shall:
]
[
(i) notify the prescriber in writing, by fax, telephone, or electronic transmission of the
substitution, as soon as practicable, but not later than three business days after dispensing the
interchangeable biosimilar product in place of the prescribed biological product; and
]
[
(ii) include the name and manufacturer of the interchangeable biosimilar product
substituted.
]
[
(b) This subsection is repealed on May 15, 2015.
]
(8) 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 product
provided to the patient, including the name of the product and the manufacturer. The
communication shall be conveyed by making an entry into an interoperable electronic medical
records system, through an electronic prescribing technology, a pharmacy benefit management
system, or a pharmacy record that is electronically accessible by the prescriber. Entry into an
electronic records system as described in this Subsection (8) is presumed to provide notice to
the prescriber. Otherwise, the pharmacist shall communicate the biological product dispensed
to the prescriber using facsimile, telephone, electronic transmission, or other prevailing means,
provided that communication shall not be required where:
(a) there is no FDA-approved interchangeable biological product for the product
prescribed;
(b) a refill prescription is not changed from the product dispensed on the prior filling of
the prescription; or
(c) the product is paid for using cash or cash equivalent.
Section 2. Section 
63I-2-258
 is amended to read:
63I-2-258.
Repeal dates -- Title 58.
[
(1) Subsection 
58-72-201
(1)(b) is repealed July 1, 2014.
]
[
(2) Subsection 
58-17b-605.5
(8) is repealed on May 15, 2015.
]