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Public Act 92-0112
HB3199 Enrolled LRB9206284LBmg
AN ACT concerning 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 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 review at a meeting of a hearing by the
Technical Advisory Council, is not subject to a hearing in
accordance with this Section, 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, 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 review the generic drug product hold a
hearing at its next regularly scheduled Technical Advisory
Council meeting. Following the Technical Advisory Council's
review and initial recommendation that a generic drug product
not be included in the Illinois Formulary, a 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
if requested by the manufacturer. 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
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
that has been permitted by the Department of Public Health,
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 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. 91-766, eff. 9-1-00.)
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 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. Nothing in this Section shall prohibit the
selection of different brands of the same generic drug, based
upon a drug formulary listing which is developed, maintained,
and issued by the Department of Public Health under which
drug product selection is permitted, is not subject to review
at a meeting of the hearing review process by the Technical
Advisory Council, is not subject to a hearing in accordance
with this Section, 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 review the
generic drug product hold a hearing at its next regularly
scheduled Technical Advisory Council meeting. Following the
Technical Advisory Council's review and initial
recommendation that a generic drug product not be included in
the Illinois Formulary, a 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 if requested
by the manufacturer. 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. 91-766, eff. 9-1-00.)
Section 99. Effective date. This Act takes effect upon
becoming law.
Passed in the General Assembly May 01, 2001.
Approved July 20, 2001.
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