Bill Text: IL HB2531 | 2017-2018 | 100th General Assembly | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
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-Introduced.html
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-Introduced.html
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1 | AN ACT concerning health.
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2 | Be it enacted by the People of the State of Illinois,
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3 | represented in the General Assembly:
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4 | Section 5. The Illinois Food, Drug and Cosmetic Act is | ||||||||||||||||||||||||
5 | amended by changing Section 3.14 as follows:
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6 | (410 ILCS 620/3.14) (from Ch. 56 1/2, par. 503.14)
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7 | Sec. 3.14. Dispensing or causing to be dispensed a | ||||||||||||||||||||||||
8 | different drug in
place of the drug or brand of drug ordered or | ||||||||||||||||||||||||
9 | prescribed without the
express permission of the person | ||||||||||||||||||||||||
10 | ordering or prescribing.
Except as set forth in Section 26 of | ||||||||||||||||||||||||
11 | the Pharmacy Practice Act, this Section does not prohibit the | ||||||||||||||||||||||||
12 | interchange of different brands
of the same generically | ||||||||||||||||||||||||
13 | equivalent drug product, when the drug
products
are not | ||||||||||||||||||||||||
14 | required to bear the legend "Caution: Federal law prohibits | ||||||||||||||||||||||||
15 | dispensing
without prescription", provided that the same | ||||||||||||||||||||||||
16 | dosage form is dispensed and
there is no greater than 1% | ||||||||||||||||||||||||
17 | variance in the stated amount of each active
ingredient of the | ||||||||||||||||||||||||
18 | drug products.
A generic drug determined to be therapeutically | ||||||||||||||||||||||||
19 | equivalent by the
United States Food and Drug Administration | ||||||||||||||||||||||||
20 | (FDA) shall be available
for substitution in Illinois in | ||||||||||||||||||||||||
21 | accordance with this Act and the
Pharmacy Practice Act , | ||||||||||||||||||||||||
22 | provided that each manufacturer
submits to the Director of the | ||||||||||||||||||||||||
23 | Department of Public Health a notification containing product |
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1 | technical
bioequivalence information as a prerequisite to | ||||||
2 | product
substitution when they have completed all required | ||||||
3 | testing to
support FDA product approval and, in any event, the | ||||||
4 | information
shall be submitted no later than 60 days prior to | ||||||
5 | product
substitution in the State .
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6 | (Source: P.A. 94-936, eff. 6-26-06; 95-689, eff. 10-29-07.)
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7 | Section 99. Effective date. This Act takes effect upon | ||||||
8 | becoming law.
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