Full Text of HB5517 96th General Assembly
HB5517eng 96TH GENERAL ASSEMBLY
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HB5517 Engrossed |
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LRB096 18915 ASK 34303 b |
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| AN ACT concerning professional regulation.
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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 Pharmacy Practice Act is amended by changing | 5 |
| Section 25 as follows:
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| (225 ILCS 85/25) (from Ch. 111, par. 4145)
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| (Section scheduled to be repealed on January 1, 2018)
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| Sec. 25. No person shall compound, or sell or offer for | 9 |
| sale, or
cause to be compounded, sold or offered for sale any | 10 |
| medicine or preparation
under or by a name recognized in the | 11 |
| United States Pharmacopoeia
National Formulary, for internal | 12 |
| or external use, which differs from
the standard of strength, | 13 |
| quality or purity as determined by the test
laid down in the | 14 |
| United States Pharmacopoeia National Formulary official at
the | 15 |
| time
of
such compounding, sale or offering for sale. Nor shall | 16 |
| any person
compound, sell or offer for sale, or cause to be | 17 |
| compounded, sold,
or offered for sale, any drug, medicine, | 18 |
| poison, chemical or pharmaceutical
preparation, the strength | 19 |
| or purity of which shall fall below the professed
standard of | 20 |
| strength or purity under which it is sold. Except as set forth | 21 |
| in Section 26 of this Act, if the physician
or other authorized | 22 |
| prescriber, when transmitting an oral or written
prescription, | 23 |
| does not prohibit drug product selection, a different
brand |
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HB5517 Engrossed |
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LRB096 18915 ASK 34303 b |
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| name or nonbrand name drug product of the same generic name may
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| be dispensed by the pharmacist, provided that the selected drug
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| has
a unit price less than the drug product specified in the | 4 |
| prescription.
A generic drug determined to be therapeutically | 5 |
| equivalent by the
United States Food and Drug Administration | 6 |
| (FDA) shall be
available for substitution in Illinois in | 7 |
| accordance with this
Act and the Illinois Food, Drug and | 8 |
| Cosmetic Act, provided that
each manufacturer submits to the | 9 |
| Director of the Department of Public Health a notification | 10 |
| containing product
technical bioequivalence information as a | 11 |
| prerequisite to product
substitution when they have completed | 12 |
| all required testing to
support FDA product approval and, in | 13 |
| any event, the information
shall be submitted no later than 60 | 14 |
| days prior to product
substitution in the State.
On the | 15 |
| prescription forms of prescribers,
shall be placed a signature | 16 |
| line and the words
"may not substitute". The prescriber, in his | 17 |
| or her own handwriting,
shall place a mark beside "may not | 18 |
| substitute"
to direct
the pharmacist in the dispensing of the | 19 |
| prescription.
Preprinted or rubber stamped marks, or other | 20 |
| deviations from
the above prescription format shall not be | 21 |
| permitted. The prescriber
shall sign the form in his or her own | 22 |
| handwriting to authorize the
issuance of the prescription.
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| If a physician or other authorized prescriber prescribes a | 24 |
| drug and the pharmacy dispenses a generic, then it shall be the | 25 |
| policy of every pharmacy operating in this State to require the | 26 |
| pharmacist to notify the patient, patient's designee, or |
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HB5517 Engrossed |
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LRB096 18915 ASK 34303 b |
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| customer when he or she is dispensing a generic drug with the | 2 |
| same active pharmaceutical ingredient by a different | 3 |
| manufacturer than most recently previously dispensed for the | 4 |
| patient by that pharmacy. This amendatory Act of the 96th | 5 |
| General Assembly shall not be construed to affect the | 6 |
| dispensing of drugs when the prescriber has marked "may not | 7 |
| substitute" on the prescription form. | 8 |
| In every case in which a selection is made as permitted by | 9 |
| the Illinois
Food, Drug and Cosmetic Act, the pharmacist shall | 10 |
| indicate on the pharmacy
record of the filled prescription the | 11 |
| name or other identification
of the manufacturer of the drug | 12 |
| which has been dispensed.
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| The selection of any drug product by a pharmacist shall not | 14 |
| constitute
evidence of negligence if the selected nonlegend | 15 |
| drug product was of
the same dosage form and each of its active | 16 |
| ingredients did not vary
by more than 1 percent from the active | 17 |
| ingredients of the prescribed,
brand name, nonlegend drug | 18 |
| product. Failure of a prescribing
physician to specify that | 19 |
| drug product selection is prohibited does not
constitute | 20 |
| evidence of negligence
unless that practitioner has reasonable | 21 |
| cause to believe that the health
condition of the patient for | 22 |
| whom the physician is prescribing warrants
the use of the brand | 23 |
| name drug product and not another.
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| The Department is authorized to employ an analyst or | 25 |
| chemist of recognized
or approved standing whose duty it shall | 26 |
| be to examine into any claimed
adulteration, illegal |
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HB5517 Engrossed |
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LRB096 18915 ASK 34303 b |
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| substitution, improper selection, alteration,
or other | 2 |
| violation hereof, and report the result of his investigation,
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| and if such report justify such action the Department shall | 4 |
| cause the
offender to be prosecuted.
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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 | 7 |
| becoming law.
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