(225 ILCS 85/25)
(from Ch. 111, par. 4145)
(Section scheduled to be repealed on January 1, 2023)
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
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 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
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 not substitute". The prescriber, in his or her own handwriting,
shall place a mark beside "may not substitute"
the pharmacist in the dispensing of the prescription.
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.
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. 94-936, eff. 6-26-06; 95-689, eff. 10-29-07