Rep. Rosemary Mulligan
Filed: 3/23/2010
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1 | AMENDMENT TO HOUSE BILL 5517
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2 | AMENDMENT NO. ______. Amend House Bill 5517, AS AMENDED, by | ||||||
3 | replacing everything after the enacting clause with the | ||||||
4 | following:
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5 | "Section 5. The Pharmacy Practice Act is amended by | ||||||
6 | changing Section 25 as follows:
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7 | (225 ILCS 85/25) (from Ch. 111, par. 4145)
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8 | (Section scheduled to be repealed on January 1, 2018)
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9 | Sec. 25. No person shall compound, or sell or offer for | ||||||
10 | sale, or
cause to be compounded, sold or offered for sale any | ||||||
11 | medicine or preparation
under or by a name recognized in the | ||||||
12 | United States Pharmacopoeia
National Formulary, for internal | ||||||
13 | or external use, which differs from
the standard of strength, | ||||||
14 | quality or purity as determined by the test
laid down in the | ||||||
15 | United States Pharmacopoeia National Formulary official at
the | ||||||
16 | time
of
such compounding, sale or offering for sale. Nor shall |
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1 | any person
compound, sell or offer for sale, or cause to be | ||||||
2 | compounded, sold,
or offered for sale, any drug, medicine, | ||||||
3 | poison, chemical or pharmaceutical
preparation, the strength | ||||||
4 | or purity of which shall fall below the professed
standard of | ||||||
5 | strength or purity under which it is sold. Except as set forth | ||||||
6 | in Section 26 of this Act, if the physician
or other authorized | ||||||
7 | prescriber, when transmitting an oral or written
prescription, | ||||||
8 | does not prohibit drug product selection, a different
brand | ||||||
9 | name or nonbrand name drug product of the same generic name may
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10 | be dispensed by the pharmacist, provided that the selected drug
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11 | has
a unit price less than the drug product specified in the | ||||||
12 | prescription.
A generic drug determined to be therapeutically | ||||||
13 | equivalent by the
United States Food and Drug Administration | ||||||
14 | (FDA) shall be
available for substitution in Illinois in | ||||||
15 | accordance with this
Act and the Illinois Food, Drug and | ||||||
16 | Cosmetic Act, provided that
each manufacturer submits to the | ||||||
17 | Director of the Department of Public Health a notification | ||||||
18 | containing product
technical bioequivalence information as a | ||||||
19 | prerequisite to product
substitution when they have completed | ||||||
20 | all required testing to
support FDA product approval and, in | ||||||
21 | any event, the information
shall be submitted no later than 60 | ||||||
22 | days prior to product
substitution in the State.
On the | ||||||
23 | prescription forms of prescribers,
shall be placed a signature | ||||||
24 | line and the words
"may not substitute". The prescriber, in his | ||||||
25 | or her own handwriting,
shall place a mark beside "may not | ||||||
26 | substitute"
to direct
the pharmacist in the dispensing of the |
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1 | prescription.
Preprinted or rubber stamped marks, or other | ||||||
2 | deviations from
the above prescription format shall not be | ||||||
3 | permitted. The prescriber
shall sign the form in his or her own | ||||||
4 | handwriting to authorize the
issuance of the prescription.
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5 | If a physician or other authorized prescriber prescribes a | ||||||
6 | drug and the pharmacy dispenses a generic, then it shall be the | ||||||
7 | policy of every pharmacy operating in this State to require the | ||||||
8 | pharmacist to notify the patient, patient's designee, or | ||||||
9 | customer when he or she is dispensing a generic drug with the | ||||||
10 | same active pharmaceutical ingredient by a different | ||||||
11 | manufacturer than most recently previously dispensed for the | ||||||
12 | patient by that pharmacy. This amendatory Act of the 96th | ||||||
13 | General Assembly shall not be construed to affect the | ||||||
14 | dispensing of drugs when the prescriber has marked "may not | ||||||
15 | substitute" on the prescription form. | ||||||
16 | In every case in which a selection is made as permitted by | ||||||
17 | the Illinois
Food, Drug and Cosmetic Act, the pharmacist shall | ||||||
18 | indicate on the pharmacy
record of the filled prescription the | ||||||
19 | name or other identification
of the manufacturer of the drug | ||||||
20 | which has been dispensed.
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21 | The selection of any drug product by a pharmacist shall not | ||||||
22 | constitute
evidence of negligence if the selected nonlegend | ||||||
23 | drug product was of
the same dosage form and each of its active | ||||||
24 | ingredients did not vary
by more than 1 percent from the active | ||||||
25 | ingredients of the prescribed,
brand name, nonlegend drug | ||||||
26 | product. Failure of a prescribing
physician to specify that |
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1 | drug product selection is prohibited does not
constitute | ||||||
2 | evidence of negligence
unless that practitioner has reasonable | ||||||
3 | cause to believe that the health
condition of the patient for | ||||||
4 | whom the physician is prescribing warrants
the use of the brand | ||||||
5 | name drug product and not another.
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6 | The Department is authorized to employ an analyst or | ||||||
7 | chemist of recognized
or approved standing whose duty it shall | ||||||
8 | be to examine into any claimed
adulteration, illegal | ||||||
9 | substitution, improper selection, alteration,
or other | ||||||
10 | violation hereof, and report the result of his investigation,
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11 | and if such report justify such action the Department shall | ||||||
12 | cause the
offender to be prosecuted.
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13 | (Source: P.A. 94-936, eff. 6-26-06; 95-689, eff. 10-29-07.)
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14 | Section 99. Effective date. This Act takes effect upon | ||||||
15 | becoming law.".
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