Rep. Rosemary Mulligan

Filed: 3/23/2010

 

 


 

 


 
09600HB5517ham002 LRB096 18915 ASK 39467 a

1
AMENDMENT TO HOUSE BILL 5517

2     AMENDMENT NO. ______. Amend House Bill 5517, AS AMENDED, by
3 replacing everything after the enacting clause with the
4 following:
 
5     "Section 5. The Pharmacy Practice Act is amended by
6 changing Section 25 as follows:
 
7     (225 ILCS 85/25)  (from Ch. 111, par. 4145)
8     (Section scheduled to be repealed on January 1, 2018)
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
10 be dispensed by the pharmacist, provided that the selected drug
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.
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.
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.
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,
11 and if such report justify such action the Department shall
12 cause the offender to be prosecuted.
13 (Source: P.A. 94-936, eff. 6-26-06; 95-689, eff. 10-29-07.)
 
14     Section 99. Effective date. This Act takes effect upon
15 becoming law.".