97TH GENERAL ASSEMBLY
State of Illinois
2011 and 2012
HB0254

 

Introduced 01/25/11, by Rep. Rosemary Mulligan

 

SYNOPSIS AS INTRODUCED:
 
225 ILCS 85/25  from Ch. 111, par. 4145

    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.


LRB097 03038 CEL 43069 b

 

 

A BILL FOR

 

HB0254LRB097 03038 CEL 43069 b

1    AN ACT concerning professional regulation.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Pharmacy Practice Act is amended by changing
5Section 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7    (Section scheduled to be repealed on January 1, 2018)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
9sale, or cause to be compounded, sold or offered for sale any
10medicine or preparation under or by a name recognized in the
11United States Pharmacopoeia National Formulary, for internal
12or external use, which differs from the standard of strength,
13quality or purity as determined by the test laid down in the
14United States Pharmacopoeia National Formulary official at the
15time of such compounding, sale or offering for sale. Nor shall
16any person compound, sell or offer for sale, or cause to be
17compounded, sold, or offered for sale, any drug, medicine,
18poison, chemical or pharmaceutical preparation, the strength
19or purity of which shall fall below the professed standard of
20strength or purity under which it is sold. Except as set forth
21in Section 26 of this Act, if the physician or other authorized
22prescriber, when transmitting an oral or written prescription,
23does not prohibit drug product selection, a different brand

 

 

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1name or nonbrand name drug product of the same generic name may
2be dispensed by the pharmacist, provided that the selected drug
3has a unit price less than the drug product specified in the
4prescription. A generic drug determined to be therapeutically
5equivalent by the United States Food and Drug Administration
6(FDA) shall be available for substitution in Illinois in
7accordance with this Act and the Illinois Food, Drug and
8Cosmetic Act, provided that each manufacturer submits to the
9Director of the Department of Public Health a notification
10containing product technical bioequivalence information as a
11prerequisite to product substitution when they have completed
12all required testing to support FDA product approval and, in
13any event, the information shall be submitted no later than 60
14days prior to product substitution in the State. On the
15prescription forms of prescribers, shall be placed a signature
16line and the words "may not substitute". The prescriber, in his
17or her own handwriting, shall place a mark beside "may not
18substitute" to direct the pharmacist in the dispensing of the
19prescription. Preprinted or rubber stamped marks, or other
20deviations from the above prescription format shall not be
21permitted. The prescriber shall sign the form in his or her own
22handwriting to authorize the issuance of the prescription.
23    If a physician or other authorized prescriber prescribes a
24drug and the pharmacy dispenses a generic, then it shall be the
25policy of every pharmacy operating in this State to require the
26pharmacist to notify the patient, patient's designee, or

 

 

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1customer when he or she is dispensing a generic drug with the
2same active pharmaceutical ingredient by a different
3manufacturer than most recently previously dispensed for the
4patient by that pharmacy. This amendatory Act of the 97th
5General Assembly shall not be construed to affect the
6dispensing of drugs when the prescriber has marked "may not
7substitute" on the prescription form.
8    In every case in which a selection is made as permitted by
9the Illinois Food, Drug and Cosmetic Act, the pharmacist shall
10indicate on the pharmacy record of the filled prescription the
11name or other identification of the manufacturer of the drug
12which has been dispensed.
13    The selection of any drug product by a pharmacist shall not
14constitute evidence of negligence if the selected nonlegend
15drug product was of the same dosage form and each of its active
16ingredients did not vary by more than 1 percent from the active
17ingredients of the prescribed, brand name, nonlegend drug
18product. Failure of a prescribing physician to specify that
19drug product selection is prohibited does not constitute
20evidence of negligence unless that practitioner has reasonable
21cause to believe that the health condition of the patient for
22whom the physician is prescribing warrants the use of the brand
23name drug product and not another.
24    The Department is authorized to employ an analyst or
25chemist of recognized or approved standing whose duty it shall
26be to examine into any claimed adulteration, illegal

 

 

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1substitution, improper selection, alteration, or other
2violation hereof, and report the result of his investigation,
3and if such report justify such action the Department shall
4cause 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
7becoming law.