SB1934 98TH GENERAL ASSEMBLY

LRB098 10574 MGM 40827 b

98TH GENERAL ASSEMBLY
State of Illinois
2013 and 2014
SB1934

Introduced 2/15/2013, by Sen. Antonio Muñoz - 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.

FISCAL NOTE ACT MAY APPLY

A BILL FOR

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;

(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.