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Public Act 91-0766
HB2965 Enrolled LRB9109621ACtm
AN ACT regarding pharmaceuticals.
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 as follows:
(225 ILCS 85/25) (from Ch. 111, par. 4145)
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. 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 such selected
drug has a unit price less than the drug product specified in
the prescription and provided that the selection is
permitted, is not subject to a hearing by the Technical
Advisory Council, or is not specifically prohibited by the
current Drug Product Selection Formulary issued by the
Department of Public Health pursuant to Section 3.14 of the
"Illinois Food, Drug and Cosmetics Act", approved June 29,
1967, as amended. 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 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. If the Technical Advisory
Council finds that a generic drug product may have issues
related to the practice of medicine or the practice of
pharmacy, the Technical Advisory Council shall hold a hearing
at its next regularly scheduled Technical Advisory Council
meeting. Following the Technical Advisory Council's
determination that an issue exists related to the practice of
medicine or the practice of pharmacy, the hearing shall be
conducted in accordance with the rules of the Department of
Public Health and Article 10 of the Illinois Administrative
Procedure Act. The Technical Advisory Council shall make its
recommendation to the Department of Public Health within 20
business days after the public hearing. If the Department of
Public Health, on the recommendation of the Technical
Advisory Council, determines that, based upon a preponderance
of the evidence, the drug is not bioequivalent, not
therapeutically equivalent, or could cause clinically
significant harm to the health or safety of patients
receiving that generic drug, the Department of Public Health
may prohibit the generic drug from substitution in the State.
A decision by the Department of Public Health to prohibit a
drug product from substitution shall constitute a final
administrative decision within the meaning of Section 22.2 of
the Illinois Food, Drug and Cosmetic Act and Section 3-101 of
the Code of Civil Procedure, and shall be subject to judicial
review pursuant to the provisions of Article III of the
Administrative Review Law. A decision to prohibit a generic
drug from substitution must be accompanied by a written
detailed explanation of the basis for the decision. 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
such different brand name or nonbrand name of the such 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 that has been permitted by the Department of
Public Health, if the such 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 or if the selected legend drug product
was included in the Illinois Drug Product Selection Formulary
current at the time the prescription was dispensed. 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. 85-796.)
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. However, this Section does not
prohibit the interchange of different brands of the same
generically equivalent drug product, when the such 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 such drug products. Nothing in this
Section shall prohibit the selection of different brands of
the same generic drug, based upon a positive drug formulary
listing which is developed, maintained, and issued by the
Department of Public Health under which drug product
selection within a generic class, or selection of specific
products for those prescribed, is permitted, is not subject
to the hearing review process by the Technical Advisory
Council, or is not specifically prohibited. 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 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. If the Technical
Advisory Council finds that a generic drug product may have
issues related to the practice of medicine or the practice of
pharmacy, the Technical Advisory Council shall hold a hearing
at its next regularly scheduled Technical Advisory Council
meeting. Following the Technical Advisory Council's
determination that an issue exists related to the practice of
medicine or the practice of pharmacy, the hearing shall be
conducted in accordance with the Department's Rules of
Practice and Procedure in Administrative Hearings (77 Ill.
Admin. Code 100) and Article 10 of the Illinois
Administrative Procedure Act. The Technical Advisory Council
shall make its recommendation to the Department of Public
Health within 20 business days after the public hearing. If
the Department of Public Health, on the recommendation of the
Technical Advisory Council, determines that, based upon a
preponderance of the evidence, the drug is not bioequivalent,
not therapeutically equivalent, or could cause clinically
significant harm to the health or safety of patients
receiving that generic drug, the Department of Public Health
may prohibit the generic drug from substitution in the State.
A decision by the Department to prohibit a drug product from
substitution shall constitute a final administrative decision
within the meaning of Section 22.2 of the Illinois Food, Drug
and Cosmetic Act and Section 3-101 of the Code of Civil
Procedure, and shall be subject to judicial review pursuant
to the provisions of Article III of the Administrative Review
Law. A decision to prohibit a generic drug from substitution
must be accompanied by a written detailed explanation of the
basis for the decision. Determination of products which may
be selected shall be recommended by a Technical Advisory
Council of the Department, selected by the Director of Public
Health, which council shall consist of 7 persons including 2
physicians, 2 pharmacists, 2 pharmacologists and one other
prescriber who have special knowledge of generic drugs and
formulary. Technical Advisory Council members shall serve
without pay, and shall be appointed for a 3 year term and
until their successors are appointed and qualified. The
procedures for operation of the Drug Product Selection
Program shall be promulgated by the Director, however the
actual list of products prohibited or approved for drug
product selection need not be promulgated. The Technical
Advisory Council shall take cognizance of federal studies,
the U.S. Pharmacopoeia - National Formulary, or other
recognized authoritative sources, and shall advise the
Director of any necessary modifications. Drug products
previously approved by the Technical Advisory Council for
generic interchange may be substituted in the State of
Illinois without further review subject to the conditions of
approval in the State of Illinois prior to the effective date
of this amendatory Act of the 91st General Assembly.
Timely notice of revisions to the formulary shall be
furnished at no charge to all pharmacies by the Department.
Single copies of the drug formulary shall be made available
at no charge upon request to licensed prescribers, student
pharmacists, and pharmacists practicing pharmacy in this
State under a reciprocal license. The Department shall offer
subscriptions to the drug formulary and its revisions to
other interested parties at a reasonable charge to be
established by rule. Before the Department makes effective
any additions to or deletions from the procedures for
operation of the Drug Product Selection Program under this
Section, the Department shall file proposed rules to amend
the procedures for operation of the program under Section
5-40 of the Illinois Administrative Procedure Act. The
Department shall issue necessary rules and regulations for
the implementation of this Section.
(Source: P.A. 87-860; 87-1237; 88-45.)
Section 99. Effective date. This Act takes effect upon
becoming law solely for the purpose of allowing the
Department of Public Health to begin rulemaking to effect the
changes made by this Act. In all other respects, this Act
takes effect on September 1, 2000.
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