Full Text of HB0254 97th General Assembly
HB0254 97TH GENERAL ASSEMBLY |
| | 97TH GENERAL ASSEMBLY
State of Illinois
2011 and 2012 HB0254 Introduced 01/25/11, by Rep. Rosemary Mulligan SYNOPSIS AS INTRODUCED: |
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225 ILCS 85/25 | from Ch. 111, par. 4145 |
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Amends the Pharmacy Practice Act. In a provision concerning dispensing prescriptions, provides that if the physician or other authorized prescriber prescribes a drug and the pharmacy dispenses a generic, then the pharmacist must notify the patient or customer when he or she is dispensing a generic drug with the same active pharmaceutical ingredient by a different manufacturer than most recently previously dispensed for the patient by that pharmacy. Effective immediately.
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| | A BILL FOR |
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| 1 | | AN ACT concerning professional regulation.
| 2 | | Be it enacted by the People of the State of Illinois,
| 3 | | represented in the General Assembly:
| 4 | | Section 5. The Pharmacy Practice Act is amended by changing | 5 | | Section 25 as follows:
| 6 | | (225 ILCS 85/25) (from Ch. 111, par. 4145)
| 7 | | (Section scheduled to be repealed on January 1, 2018)
| 8 | | 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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| 1 | | name or nonbrand name drug product of the same generic name may
| 2 | | be dispensed by the pharmacist, provided that the selected drug
| 3 | | 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.
| 23 | | 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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| 1 | | 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 97th | 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.
| 13 | | 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.
| 24 | | 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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| 1 | | substitution, improper selection, alteration,
or other | 2 | | violation hereof, and report the result of his investigation,
| 3 | | and if such report justify such action the Department shall | 4 | | cause the
offender to be prosecuted.
| 5 | | (Source: P.A. 94-936, eff. 6-26-06; 95-689, eff. 10-29-07.)
| 6 | | Section 99. Effective date. This Act takes effect upon | 7 | | becoming law.
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