100TH GENERAL ASSEMBLY
State of Illinois
2017 and 2018
HB2531

 

Introduced , by Rep. Norine K. Hammond

 

SYNOPSIS AS INTRODUCED:
 
410 ILCS 620/3.14  from Ch. 56 1/2, par. 503.14

    Amends the Illinois Food, Drug and Cosmetic Act. Deletes provisions requiring manufacturers to provide the Director of Public Health with a notification containing product technical bioequivalence information no later than 60 days prior to specified generic drug product substitution. Effective immediately.


LRB100 08313 MJP 18420 b

FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

HB2531LRB100 08313 MJP 18420 b

1    AN ACT concerning health.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Illinois Food, Drug and Cosmetic Act is
5amended by changing Section 3.14 as follows:
 
6    (410 ILCS 620/3.14)  (from Ch. 56 1/2, par. 503.14)
7    Sec. 3.14. Dispensing or causing to be dispensed a
8different drug in place of the drug or brand of drug ordered or
9prescribed without the express permission of the person
10ordering or prescribing. Except as set forth in Section 26 of
11the Pharmacy Practice Act, this Section does not prohibit the
12interchange of different brands of the same generically
13equivalent drug product, when the drug products are not
14required to bear the legend "Caution: Federal law prohibits
15dispensing without prescription", provided that the same
16dosage form is dispensed and there is no greater than 1%
17variance in the stated amount of each active ingredient of the
18drug products. A generic drug determined to be therapeutically
19equivalent by the United States Food and Drug Administration
20(FDA) shall be available for substitution in Illinois in
21accordance with this Act and the Pharmacy Practice Act,
22provided that each manufacturer submits to the Director of the
23Department of Public Health a notification containing product

 

 

HB2531- 2 -LRB100 08313 MJP 18420 b

1technical bioequivalence information as a prerequisite to
2product substitution when they have completed all required
3testing to support FDA product approval and, in any event, the
4information shall be submitted no later than 60 days prior to
5product substitution in the State.
6(Source: P.A. 94-936, eff. 6-26-06; 95-689, eff. 10-29-07.)
 
7    Section 99. Effective date. This Act takes effect upon
8becoming law.