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
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Public Act 100-0065 | ||||
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AN ACT concerning health.
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Be it enacted by the People of the State of Illinois,
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represented in the General Assembly:
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Section 5. The Illinois Food, Drug and Cosmetic Act is | ||||
amended by changing Section 3.14 as follows:
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(410 ILCS 620/3.14) (from Ch. 56 1/2, par. 503.14)
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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 .
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(Source: P.A. 94-936, eff. 6-26-06; 95-689, eff. 10-29-07.)
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Section 99. Effective date. This Act takes effect upon | ||
becoming law.
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