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Public Act 094-0936


 

Public Act 0936 94TH GENERAL ASSEMBLY



 


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    (Section scheduled to be repealed on January 1, 2008)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

Effective Date: 6/26/2006