Human Services Committee

Filed: 2/24/2010

 

 


 

 


 
09600HB5517ham001 LRB096 18915 ASK 37234 a

1
AMENDMENT TO HOUSE BILL 5517

2     AMENDMENT NO. ______. Amend House Bill 5517 by replacing
3 everything after the enacting clause with the following:
 
4     "Section 5. The Pharmacy Practice Act is amended by
5 changing 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7     (Section scheduled to be repealed on January 1, 2018)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

 

 

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1 compounded, sold, or offered for sale, any drug, medicine,
2 poison, chemical or pharmaceutical preparation, the strength
3 or purity of which shall fall below the professed standard of
4 strength or purity under which it is sold. Except as set forth
5 in Section 26 of this Act, if the physician or other authorized
6 prescriber, when transmitting an oral or written prescription,
7 does not prohibit drug product selection, a different brand
8 name or nonbrand name drug product of the same generic name may
9 be dispensed by the pharmacist, provided that the selected drug
10 has a unit price less than the drug product specified in the
11 prescription. A generic drug determined to be therapeutically
12 equivalent by the United States Food and Drug Administration
13 (FDA) shall be available for substitution in Illinois in
14 accordance with this Act and the Illinois Food, Drug and
15 Cosmetic Act, provided that each manufacturer submits to the
16 Director of the Department of Public Health a notification
17 containing product technical bioequivalence information as a
18 prerequisite to product substitution when they have completed
19 all required testing to support FDA product approval and, in
20 any event, the information shall be submitted no later than 60
21 days prior to product substitution in the State. On the
22 prescription forms of prescribers, shall be placed a signature
23 line and the words "may not substitute". The prescriber, in his
24 or her own handwriting, shall place a mark beside "may not
25 substitute" to direct the pharmacist in the dispensing of the
26 prescription. Preprinted or rubber stamped marks, or other

 

 

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1 deviations from the above prescription format shall not be
2 permitted. The prescriber shall sign the form in his or her own
3 handwriting to authorize the issuance of the prescription.
4     If the physician or other authorized prescriber prescribes
5 a specific generic drug, then the pharmacist may not dispense a
6 generic drug with a different active pharmaceutical
7 ingredient. If the pharmacist receives verbal approval from the
8 patient, then the pharmacist may dispense another generic drug
9 with the same active pharmaceutical ingredient as the specific
10 generic drug prescribed. If the original physician or other
11 authorized prescriber changes a patient's prescription to a
12 generic drug other than the specific drug that was originally
13 prescribed by that physician or authorized prescriber, then the
14 pharmacist must verbally notify the patient or customer of this
15 change at the time of dispensing that drug and advise the
16 patient or customer of his or her right to refuse the change.
17     In every case in which a selection is made as permitted by
18 the Illinois Food, Drug and Cosmetic Act, the pharmacist shall
19 indicate on the pharmacy record of the filled prescription the
20 name or other identification of the manufacturer of the drug
21 which has been dispensed.
22     The selection of any drug product by a pharmacist shall not
23 constitute evidence of negligence if the selected nonlegend
24 drug product was of the same dosage form and each of its active
25 ingredients did not vary by more than 1 percent from the active
26 ingredients of the prescribed, brand name, nonlegend drug

 

 

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1 product. Failure of a prescribing physician to specify that
2 drug product selection is prohibited does not constitute
3 evidence of negligence unless that practitioner has reasonable
4 cause to believe that the health condition of the patient for
5 whom the physician is prescribing warrants the use of the brand
6 name drug product and not another.
7     The Department is authorized to employ an analyst or
8 chemist of recognized or approved standing whose duty it shall
9 be to examine into any claimed adulteration, illegal
10 substitution, improper selection, alteration, or other
11 violation hereof, and report the result of his investigation,
12 and if such report justify such action the Department shall
13 cause the offender to be prosecuted.
14 (Source: P.A. 94-936, eff. 6-26-06; 95-689, eff. 10-29-07.)
 
15     Section 99. Effective date. This Act takes effect upon
16 becoming law.".