Public Act 094-0936
 		





SB2578 Enrolled
LRB094 17772 RAS 53071 b






    AN ACT concerning regulation.

 
    Be it enacted by the People of the State of Illinois,
 
represented in the General Assembly:


 
    Section 5. The Pharmacy Practice Act of 1987 is amended  by 
changing Section 25 and  by adding Section 26 as follows:
 



    (225 ILCS 85/25)  (from Ch. 111, par. 4145)


    (Section scheduled to be repealed on January 1, 2008)

    Sec. 25. No person shall compound, or sell or offer for 
sale, or
cause to be compounded, sold or offered for sale any 
medicine or preparation
under or by a name recognized in the 
United States Pharmacopoeia
National Formulary, for internal 
or external use, which differs from
the standard of strength, 
quality or purity as determined by the test
laid down in the 
United States Pharmacopoeia  National Formulary official at
the 
time
of
such compounding, sale or offering for sale.  Nor shall 
any person
compound, sell or offer for sale, or cause to be 
compounded, sold,
or offered for sale, any drug, medicine, 
poison, chemical or pharmaceutical
preparation, the strength 
or purity of which shall fall below the professed
standard of 
strength or purity under which it is sold.  Except as set forth 
in Section 26 of this Act, if
If the physician
or other 
authorized prescriber, when transmitting an oral or written

prescription, does not prohibit drug product selection, a 
different
brand name or nonbrand name drug product of the same 
generic name may
be dispensed by the pharmacist, provided that 
the selected drug
has
a unit price less than the drug product 
specified in the prescription
.
A generic drug determined to be 
therapeutically equivalent by the
United States Food and Drug 
Administration (FDA) shall be
available for substitution in 
Illinois in accordance with this
Act and the Illinois Food, 
Drug and Cosmetic Act, provided that
each manufacturer submits 
to the Director of the Department of Public Health a 
notification containing product
technical bioequivalence 
information as a prerequisite to product
substitution when they 
have completed all required testing to
support FDA product 
approval and, in any event, the information
shall be submitted 
no later than 60 days prior to product
substitution in the 
State.
On the prescription forms of prescribers,
shall be 
placed a signature line and the words "may substitute" and
"may 
not substitute".  The prescriber, in his or her own handwriting,

shall place a mark beside either the "may substitute" or "may 
not substitute"
alternatives to guide the pharmacist in the 
dispensing of the prescription.
A prescriber placing a mark 
beside the "may substitute" alternative
or failing in his or 
her own handwriting to place a mark beside either
alternative 
authorizes drug product selection in accordance with this
Act.  
Preprinted or rubber stamped marks, or other deviations from

the above prescription format shall not be permitted.  The 
prescriber
shall sign the form in his or her own handwriting to 
authorize the
issuance of the prescription.  When a person 
presents a prescription
to be dispensed, the pharmacist to whom 
it is presented may inform
the person if the pharmacy has 
available a different brand name or
nonbrand name of the same 
generic drug prescribed and the price of
the different brand 
name or nonbrand name of the drug
product.  If
the person 
presenting the prescription is the one to whom the drug
is to 
be administered, the pharmacist may dispense the prescription

with the brand prescribed or a different brand name or nonbrand 
name
product of the same generic name, if the drug is of lesser 
unit cost and the
patient
is informed and agrees to the 
selection and the pharmacist shall enter
such information into 
the pharmacy record.  If the person
presenting
the prescription 
is someone other than the one to whom the drug is
to be 
administered the pharmacist shall not dispense the 
prescription
with a brand other than the one specified in the 
prescription unless
the pharmacist has the written or oral 
authorization to select brands
from the person to whom the drug 
is to be administered or a parent,
legal guardian or spouse of 
that person.

    In every case in which a selection is made as permitted by 
the Illinois
Food, Drug and Cosmetic Act, the pharmacist shall 
indicate on the pharmacy
record of the filled prescription the 
name or other identification
of the manufacturer of the drug 
which has been dispensed.

    The selection of any drug product by a pharmacist shall not 
constitute
evidence of negligence if the selected nonlegend 
drug product was of
the same dosage form and each of its active 
ingredients did not vary
by more than 1 percent from the active 
ingredients of the prescribed,
brand name, nonlegend drug 
product.  Failure of a prescribing
physician to specify that 
drug product selection is prohibited does not
constitute 
evidence of negligence
unless that practitioner has reasonable 
cause to believe that the health
condition of the patient for 
whom the physician is prescribing warrants
the use of the brand 
name drug product and not another.

    The Department is authorized to employ an analyst or 
chemist of recognized
or approved standing whose duty it shall 
be to examine into any claimed
adulteration, illegal 
substitution, improper selection, alteration,
or other 
violation hereof, and report the result of his investigation,

and if such report justify such action the Department shall 
cause the
offender to be prosecuted.

(Source: P.A. 92-112, eff. 7-20-01; 93-841, eff. 7-30-04.)

 
    (225 ILCS 85/26 new)

    (Section scheduled to be repealed on January 1, 2008)
    Sec. 26. Anti-epileptic drug product selection prohibited.

    (a) The General Assembly finds that this Section is 
necessary for the immediate preservation of the public peace, 
health, and safety.
    (b) In this Section:
    "Anti-epileptic drug means (i) any drug prescribed for the 
treatment of epilepsy or (ii) a drug used to treat or prevent 
seizures.
    "Epilepsy" means a neurological condition characterized by 
recurrent seizures.
    "Seizure" means a brief disturbance in the electrical 
activity of the brain.
    (c) When the prescribing physician has indicated on the 
original prescription "dispense as written" or "may not 
substitute", a pharmacist may not interchange an 
anti-epileptic drug or formulation of an anti-epileptic drug 
for the treatment of epilepsy without notification and the 
documented consent of the prescribing physician and the patient 
or the patient's parent, legal guardian, or spouse.

 
    Section 10. The Illinois Food, Drug and Cosmetic Act is 
amended  by changing Section 3.14 as follows:
 



    (410 ILCS 620/3.14)  (from Ch. 56 1/2, par. 503.14)



    Sec. 3.14. Dispensing or causing to be dispensed a 
different drug  in
place of the drug or brand of drug ordered or 
prescribed without the
express permission of the person 
ordering or prescribing.
Except as set forth in Section 26 of 
the Pharmacy Practice Act
However, this Section does not 
prohibit the interchange of different brands
of the same 
generically equivalent drug product, when the drug
products
are 
not required to bear the legend "Caution: Federal law prohibits 
dispensing
without prescription", provided that the same 
dosage form is dispensed and
there is no greater than 1% 
variance in the stated amount of each active
ingredient of the 
drug products.
A generic drug determined to be therapeutically 
equivalent by the
United States Food and Drug Administration 
(FDA) shall be available
for substitution in Illinois in 
accordance with this Act and the
Pharmacy Practice Act of 1987, 
provided that each manufacturer
submits to the Director of the 
Department of Public Health a notification containing product 
technical
bioequivalence information as a prerequisite to 
product
substitution when they have completed all required 
testing to
support FDA product approval and, in any event, the 
information
shall be submitted no later than 60 days prior to 
product
substitution in the State.

(Source: P.A. 92-112, eff. 7-20-01; 93-841, eff. 7-30-04.)

 

    Section 99. Effective date. This Act takes effect upon 
becoming law.