99TH GENERAL ASSEMBLY
State of Illinois
2015 and 2016
HB3519
 
Introduced , by Rep. David Harris
 
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.
  


LRB099 09712 AMC 29921 b

FISCAL NOTE ACT MAY APPLY
 
 
A BILL FOR
 

  
HB3519LRB099 09712 AMC 29921 b


  
1    AN ACT concerning regulation.
  
 
2    Be it enacted by the People of the State of Illinois,
 
3represented in the General Assembly:
  
 
 
4    Section 5. The Pharmacy Practice Act is amended  by adding 
5Section 19.5 as follows:
 
6    (225 ILCS 85/19.5 new)
7    Sec. 19.5. Biosimilar products. 
8    (a) For the purposes of this Section:
9    "Biological product",  "biosimilar",  and "interchangeable"  
10have the same meanings as under Section 351 of the Public 
11Health Service Act (42 U.S.C. 262).
12    "Prescription", with respect to a biological product, 
13means a product that is subject to Section 503(b) of the 
14Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)).
15    (b) A pharmacist may substitute a prescription biosimilar  
16product for a prescribed biological product only if:
17        (1) the biosimilar product has been determined by the 
18    United States Food and Drug Administration to be 
19    interchangeable with the prescribed  biological  product;
20        (2) the prescribing physician does not designate 
21    orally, in writing, or electronically that substitution is 
22    prohibited in a manner inconsistent with Section 25 of this 
23    Act;
 
 
HB3519- 2 -LRB099 09712 AMC 29921 b

1        (3) the pharmacy informs the patient of the 
2    substitution and the patient agrees to accept the 
3    biosimilar product;
4        (4) the cost of the biosimilar product is less than the 
5    cost of the biological product or, if the cost of the 
6    biosimilar product is more than cost of the biological 
7    product, the patient is informed and has agreed to accept 
8    the higher cost biosimilar product; 
9        (5) the pharmacist informs the prescriber within 3 
10    business days of the substitution, including the name and 
11    manufacturer of the interchangeable biosimilar dispensed; 
12    and
13        (6)  the pharmacy  retains a written record of the 
14    interchangeable biosimilar substitution for a period of no 
15    less than 5 years.
16    (c) The Board shall adopt rules for compliance with this 
17Section.
 
18
 
19    Section 99. Effective date. This Act takes effect upon 
20becoming law.