Bill Text: IL SB1934 | 2013-2014 | 98th General Assembly | Introduced

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Bill Title: Amends the Pharmacy Practice Act. Provides that a pharmacist may substitute a prescription biosimilar product for a prescribed biological product under certain circumstances. Provides that the Board shall adopt rules for compliance with these provisions. Effective immediately.

Sponsorship: Moderate Partisan Bill (Democrat 6-1)

Status: (Failed) 2015-01-13 - Session Sine Die [SB1934 Detail]

Download: Illinois-2013-SB1934-Introduced.html

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98TH GENERAL ASSEMBLY State of Illinois 2013 and 2014 SB1934 Introduced 2/15/2013, by Sen. Antonio Mu�oz - Iris Y. Martinez - Pamela J. Althoff - Melinda Bush SYNOPSIS AS INTRODUCED:
225 ILCS 85/19.5 new
Amends the Pharmacy Practice Act. Provides that a pharmacist may substitute a prescription biosimilar product for a prescribed biological product under certain circumstances. Provides that the Board shall adopt rules for compliance with these provisions. Effective immediately.
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FISCAL NOTE ACT MAY APPLY
A BILL FOR
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AN ACT concerning regulation.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 5. The Pharmacy Practice Act is amended by adding
Section 19.5 as follows:
(225 ILCS 85/19.5 new)
Sec. 19.5. Biosimilars products.
(a) For the purposes of this Section:
"Biological product", "biosimilar", and "interchangeable"
have the same meanings as under Section 351 of the Public
Health Service Act (42 U.S.C. 262).
"Prescription", with respect to a biological product,
means a product that is subject to Section 503 (b) of the
Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)).
(b) A pharmacist may substitute a prescription biosimilar
product for a prescribed biological product only if:
(1) the biosimilar product has been determined by the
United States Food and Drug Administration to be
interchangeable with the prescribed biological product;
(2) the prescribing physician does not designate
orally, in writing, or electronically that substitution is
prohibited in a manner inconsistent with Section 25 of this
Act;

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(3) the pharmacy informs the patient of the
substitution;
(4) the pharmacist informs the prescriber within 5
business days of the substitution, including the name and
manufacturer of the interchangeable biosimilar dispensed;
(5) the pharmacy retains a written record of the
interchangeable biosimilar substitution for a period of no
less than 5 years.
(c) The Board shall adopt rules for compliance with this
Section.
Section 99. Effective date. This Act takes effect upon
becoming law.