Illinois General Assembly - Full Text of SB1604
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Full Text of SB1604  100th General Assembly




State of Illinois
2017 and 2018


Introduced 2/9/2017, by Sen. Chris Nybo - Linda Holmes


5 ILCS 80/4.28
5 ILCS 80/4.30
225 ILCS 85/25  from Ch. 111, par. 4145

    Amends the Pharmacy Practice Act. Provides that if a physician or other authorized prescriber does not prohibit drug product substitution, a pharmacist shall dispense a brand name drug product as a substitute for an unavailable nonbrand name drug product specified in the prescription. Provides that if the substitute drug product has a unit price greater than the unavailable drug product specified in the prescription, then the pharmacist shall dispense that substitute drug product at the lesser unit price of the drug product specified in the prescription. Amends the Regulatory Sunset Act to extend the repeal date for the Pharmacy Practice Act to January 1, 2020. Makes conforming changes. Effective immediately.

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1    AN ACT concerning regulation.
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
4    Section 5. The Regulatory Sunset Act is amended by changing
5Sections 4.28 and 4.30 as follows:
6    (5 ILCS 80/4.28)
7    Sec. 4.28. Acts repealed on January 1, 2018. The following
8Acts are repealed on January 1, 2018:
9    The Illinois Petroleum Education and Marketing Act.
10    The Podiatric Medical Practice Act of 1987.
11    The Acupuncture Practice Act.
12    The Illinois Speech-Language Pathology and Audiology
13Practice Act.
14    The Interpreter for the Deaf Licensure Act of 2007.
15    The Nurse Practice Act.
16    The Clinical Social Work and Social Work Practice Act.
17    The Pharmacy Practice Act.
18    The Home Medical Equipment and Services Provider License
20    The Marriage and Family Therapy Licensing Act.
21    The Nursing Home Administrators Licensing and Disciplinary
23    The Physician Assistant Practice Act of 1987.



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1(Source: P.A. 95-187, eff. 8-16-07; 95-235, eff. 8-17-07;
295-450, eff. 8-27-07; 95-465, eff. 8-27-07; 95-617, eff.
39-12-07; 95-639, eff. 10-5-07; 95-687, eff. 10-23-07; 95-689,
4eff. 10-29-07; 95-703, eff. 12-31-07; 95-876, eff. 8-21-08;
596-328, eff. 8-11-09.)
6    (5 ILCS 80/4.30)
7    Sec. 4.30. Acts repealed on January 1, 2020. The following
8Acts are repealed on January 1, 2020:
9    The Auction License Act.
10    The Community Association Manager Licensing and
11Disciplinary Act.
12    The Illinois Architecture Practice Act of 1989.
13    The Illinois Landscape Architecture Act of 1989.
14    The Illinois Professional Land Surveyor Act of 1989.
15    The Land Sales Registration Act of 1999.
16    The Orthotics, Prosthetics, and Pedorthics Practice Act.
17    The Perfusionist Practice Act.
18    The Pharmacy Practice Act.
19    The Professional Engineering Practice Act of 1989.
20    The Real Estate License Act of 2000.
21    The Structural Engineering Practice Act of 1989.
22(Source: P.A. 96-610, eff. 8-24-09; 96-626, eff. 8-24-09;
2396-682, eff. 8-25-09; 96-726, eff. 7-1-10; 96-730, eff.
248-25-09; 96-855, eff. 12-31-09; 96-856, eff. 12-31-09;
2596-1000, eff. 7-2-10.)



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1    Section 10. The Pharmacy Practice Act is amended by
2changing Section 25 as follows:
3    (225 ILCS 85/25)  (from Ch. 111, par. 4145)
4    (Section scheduled to be repealed on January 1, 2018)
5    Sec. 25. No person shall compound, or sell or offer for
6sale, or cause to be compounded, sold or offered for sale any
7medicine or preparation under or by a name recognized in the
8United States Pharmacopoeia National Formulary, for internal
9or external use, which differs from the standard of strength,
10quality or purity as determined by the test laid down in the
11United States Pharmacopoeia National Formulary official at the
12time of such compounding, sale or offering for sale. Nor shall
13any person compound, sell or offer for sale, or cause to be
14compounded, sold, or offered for sale, any drug, medicine,
15poison, chemical or pharmaceutical preparation, the strength
16or purity of which shall fall below the professed standard of
17strength or purity under which it is sold. Except as set forth
18in Section 26 of this Act, if the physician or other authorized
19prescriber, when transmitting an oral or written prescription,
20does not prohibit drug product selection, a different brand
21name or nonbrand name drug product of the same generic name may
22be dispensed by the pharmacist, provided that the selected drug
23has a unit price less than the drug product specified in the
24prescription. If a physician or other authorized prescriber



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



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1authorize the issuance of the prescription.
2    In every case in which a selection is made as permitted by
3the Illinois Food, Drug and Cosmetic Act, the pharmacist shall
4indicate on the pharmacy record of the filled prescription the
5name or other identification of the manufacturer of the drug
6which has been dispensed.
7    The selection of any drug product by a pharmacist shall not
8constitute evidence of negligence if the selected nonlegend
9drug product was of the same dosage form and each of its active
10ingredients did not vary by more than 1 percent from the active
11ingredients of the prescribed, brand name, nonlegend drug
12product. Failure of a prescribing physician to specify that
13drug product selection is prohibited does not constitute
14evidence of negligence unless that practitioner has reasonable
15cause to believe that the health condition of the patient for
16whom the physician is prescribing warrants the use of the brand
17name drug product and not another.
18    The Department is authorized to employ an analyst or
19chemist of recognized or approved standing whose duty it shall
20be to examine into any claimed adulteration, illegal
21substitution, improper selection, alteration, or other
22violation hereof, and report the result of his investigation,
23and if such report justify such action the Department shall
24cause the offender to be prosecuted.
25(Source: P.A. 94-936, eff. 6-26-06; 95-689, eff. 10-29-07.)
26    Section 99. Effective date. This Act takes effect upon



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1becoming law.