Bill Text: IL HB2531 | 2017-2018 | 100th General Assembly | Chaptered


Bill Title: 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.

Spectrum: Partisan Bill (Republican 3-0)

Status: (Passed) 2017-08-11 - Public Act . . . . . . . . . 100-0065 [HB2531 Detail]

Download: Illinois-2017-HB2531-Chaptered.html



Public Act 100-0065
HB2531 EnrolledLRB100 08313 MJP 18420 b
AN ACT concerning health.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 5. The Illinois Food, Drug and Cosmetic Act is
amended by changing Section 3.14 as follows:
(410 ILCS 620/3.14) (from Ch. 56 1/2, par. 503.14)
Sec. 3.14. Dispensing or causing to be dispensed a
different drug in place of the drug or brand of drug ordered or
prescribed without the express permission of the person
ordering or prescribing. Except as set forth in Section 26 of
the Pharmacy Practice Act, this Section does not prohibit the
interchange of different brands of the same generically
equivalent drug product, when the drug products are not
required to bear the legend "Caution: Federal law prohibits
dispensing without prescription", provided that the same
dosage form is dispensed and there is no greater than 1%
variance in the stated amount of each active ingredient of the
drug products. A generic drug determined to be therapeutically
equivalent by the United States Food and Drug Administration
(FDA) shall be available for substitution in Illinois in
accordance with this Act and the Pharmacy Practice Act,
provided that each manufacturer submits to the Director of the
Department of Public Health a notification containing product
technical bioequivalence information as a prerequisite to
product substitution when they have completed all required
testing to support FDA product approval and, in any event, the
information shall be submitted no later than 60 days prior to
product substitution in the State.
(Source: P.A. 94-936, eff. 6-26-06; 95-689, eff. 10-29-07.)
Section 99. Effective date. This Act takes effect upon
becoming law.
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