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91_HB2965enr
HB2965 Enrolled LRB9109621ACtm
1 AN ACT regarding pharmaceuticals.
2 Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
4 Section 5. The Pharmacy Practice Act of 1987 is amended
5 by changing Section 25 as follows:
6 (225 ILCS 85/25) (from Ch. 111, par. 4145)
7 Sec. 25. No person shall compound, or sell or offer for
8 sale, or cause to be compounded, sold or offered for sale any
9 medicine or preparation under or by a name recognized in the
10 United States Pharmacopoeia National Formulary, for internal
11 or external use, which differs from the standard of strength,
12 quality or purity as determined by the test laid down in the
13 United States Pharmacopoeia National Formulary official at
14 the time of such compounding, sale or offering for sale. Nor
15 shall any person compound, sell or offer for sale, or cause
16 to be compounded, sold, or offered for sale, any drug,
17 medicine, poison, chemical or pharmaceutical preparation, the
18 strength or purity of which shall fall below the professed
19 standard of strength or purity under which it is sold. If
20 the physician or other authorized prescriber, when
21 transmitting an oral or written prescription, does not
22 prohibit drug product selection, a different brand name or
23 nonbrand name drug product of the same generic name may be
24 dispensed by the pharmacist, provided that the such selected
25 drug has a unit price less than the drug product specified in
26 the prescription and provided that the selection is
27 permitted, is not subject to a hearing by the Technical
28 Advisory Council, or is not specifically prohibited by the
29 current Drug Product Selection Formulary issued by the
30 Department of Public Health pursuant to Section 3.14 of the
31 "Illinois Food, Drug and Cosmetics Act", approved June 29,
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1 1967, as amended. A generic drug determined to be
2 therapeutically equivalent by the United States Food and Drug
3 Administration (FDA) shall be available for substitution in
4 Illinois in accordance with this Act and the Illinois Food,
5 Drug and Cosmetic Act, provided that each manufacturer
6 submits a notification containing product technical
7 bioequivalence information as a prerequisite to product
8 substitution when they have completed all required testing to
9 support FDA product approval and, in any event, the
10 information shall be submitted no later than 60 days prior to
11 product substitution in the State. If the Technical Advisory
12 Council finds that a generic drug product may have issues
13 related to the practice of medicine or the practice of
14 pharmacy, the Technical Advisory Council shall hold a hearing
15 at its next regularly scheduled Technical Advisory Council
16 meeting. Following the Technical Advisory Council's
17 determination that an issue exists related to the practice of
18 medicine or the practice of pharmacy, the hearing shall be
19 conducted in accordance with the rules of the Department of
20 Public Health and Article 10 of the Illinois Administrative
21 Procedure Act. The Technical Advisory Council shall make its
22 recommendation to the Department of Public Health within 20
23 business days after the public hearing. If the Department of
24 Public Health, on the recommendation of the Technical
25 Advisory Council, determines that, based upon a preponderance
26 of the evidence, the drug is not bioequivalent, not
27 therapeutically equivalent, or could cause clinically
28 significant harm to the health or safety of patients
29 receiving that generic drug, the Department of Public Health
30 may prohibit the generic drug from substitution in the State.
31 A decision by the Department of Public Health to prohibit a
32 drug product from substitution shall constitute a final
33 administrative decision within the meaning of Section 22.2 of
34 the Illinois Food, Drug and Cosmetic Act and Section 3-101 of
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1 the Code of Civil Procedure, and shall be subject to judicial
2 review pursuant to the provisions of Article III of the
3 Administrative Review Law. A decision to prohibit a generic
4 drug from substitution must be accompanied by a written
5 detailed explanation of the basis for the decision. On the
6 prescription forms of prescribers, shall be placed a
7 signature line and the words "may substitute" and "may not
8 substitute". The prescriber, in his or her own handwriting,
9 shall place a mark beside either the "may substitute" or "may
10 not substitute" alternatives to guide the pharmacist in the
11 dispensing of the prescription. A prescriber placing a mark
12 beside the "may substitute" alternative or failing in his or
13 her own handwriting to place a mark beside either alternative
14 authorizes drug product selection in accordance with this
15 Act. Preprinted or rubber stamped marks, or other deviations
16 from the above prescription format shall not be permitted.
17 The prescriber shall sign the form in his or her own
18 handwriting to authorize the issuance of the prescription.
19 When a person presents a prescription to be dispensed, the
20 pharmacist to whom it is presented may inform the person if
21 the pharmacy has available a different brand name or nonbrand
22 name of the same generic drug prescribed and the price of the
23 such different brand name or nonbrand name of the such drug
24 product. If the person presenting the prescription is the
25 one to whom the drug is to be administered, the pharmacist
26 may dispense the prescription with the brand prescribed or a
27 different brand name or nonbrand name product of the same
28 generic name that has been permitted by the Department of
29 Public Health, if the such drug is of lesser unit cost and
30 the patient is informed and agrees to the selection and the
31 pharmacist shall enter such information into the pharmacy
32 record. If the person presenting the prescription is someone
33 other than the one to whom the drug is to be administered the
34 pharmacist shall not dispense the prescription with a brand
HB2965 Enrolled -4- LRB9109621ACtm
1 other than the one specified in the prescription unless the
2 pharmacist has the written or oral authorization to select
3 brands from the person to whom the drug is to be administered
4 or a parent, legal guardian or spouse of that person.
5 In every case in which a selection is made as permitted
6 by the Illinois Food, Drug and Cosmetic Act, the pharmacist
7 shall indicate on the pharmacy record of the filled
8 prescription the name or other identification of the
9 manufacturer of the drug which has been dispensed.
10 The selection of any drug product by a pharmacist shall
11 not constitute evidence of negligence if the selected
12 nonlegend drug product was of the same dosage form and each
13 of its active ingredients did not vary by more than 1 percent
14 from the active ingredients of the prescribed, brand name,
15 nonlegend drug product or if the selected legend drug product
16 was included in the Illinois Drug Product Selection Formulary
17 current at the time the prescription was dispensed. Failure
18 of a prescribing physician to specify that drug product
19 selection is prohibited does not constitute evidence of
20 negligence unless that practitioner has reasonable cause to
21 believe that the health condition of the patient for whom the
22 physician is prescribing warrants the use of the brand name
23 drug product and not another.
24 The Department is authorized to employ an analyst or
25 chemist of recognized or approved standing whose duty it
26 shall be to examine into any claimed adulteration, illegal
27 substitution, improper selection, alteration, or other
28 violation hereof, and report the result of his investigation,
29 and if such report justify such action the Department shall
30 cause the offender to be prosecuted.
31 (Source: P.A. 85-796.)
32 Section 10. The Illinois Food, Drug and Cosmetic Act is
33 amended by changing Section 3.14 as follows:
HB2965 Enrolled -5- LRB9109621ACtm
1 (410 ILCS 620/3.14) (from Ch. 56 1/2, par. 503.14)
2 Sec. 3.14. Dispensing or causing to be dispensed a
3 different drug in place of the drug or brand of drug ordered
4 or prescribed without the express permission of the person
5 ordering or prescribing. However, this Section does not
6 prohibit the interchange of different brands of the same
7 generically equivalent drug product, when the such drug
8 products are not required to bear the legend "Caution:
9 Federal law prohibits dispensing without prescription",
10 provided that the same dosage form is dispensed and there is
11 no greater than 1% variance in the stated amount of each
12 active ingredient of the such drug products. Nothing in this
13 Section shall prohibit the selection of different brands of
14 the same generic drug, based upon a positive drug formulary
15 listing which is developed, maintained, and issued by the
16 Department of Public Health under which drug product
17 selection within a generic class, or selection of specific
18 products for those prescribed, is permitted, is not subject
19 to the hearing review process by the Technical Advisory
20 Council, or is not specifically prohibited. A generic drug
21 determined to be therapeutically equivalent by the United
22 States Food and Drug Administration (FDA) shall be available
23 for substitution in Illinois in accordance with this Act and
24 the Pharmacy Practice Act of 1987, provided that each
25 manufacturer submits a notification containing product
26 technical bioequivalence information as a prerequisite to
27 product substitution when they have completed all required
28 testing to support FDA product approval and, in any event,
29 the information shall be submitted no later than 60 days
30 prior to product substitution in the State. If the Technical
31 Advisory Council finds that a generic drug product may have
32 issues related to the practice of medicine or the practice of
33 pharmacy, the Technical Advisory Council shall hold a hearing
34 at its next regularly scheduled Technical Advisory Council
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1 meeting. Following the Technical Advisory Council's
2 determination that an issue exists related to the practice of
3 medicine or the practice of pharmacy, the hearing shall be
4 conducted in accordance with the Department's Rules of
5 Practice and Procedure in Administrative Hearings (77 Ill.
6 Admin. Code 100) and Article 10 of the Illinois
7 Administrative Procedure Act. The Technical Advisory Council
8 shall make its recommendation to the Department of Public
9 Health within 20 business days after the public hearing. If
10 the Department of Public Health, on the recommendation of the
11 Technical Advisory Council, determines that, based upon a
12 preponderance of the evidence, the drug is not bioequivalent,
13 not therapeutically equivalent, or could cause clinically
14 significant harm to the health or safety of patients
15 receiving that generic drug, the Department of Public Health
16 may prohibit the generic drug from substitution in the State.
17 A decision by the Department to prohibit a drug product from
18 substitution shall constitute a final administrative decision
19 within the meaning of Section 22.2 of the Illinois Food, Drug
20 and Cosmetic Act and Section 3-101 of the Code of Civil
21 Procedure, and shall be subject to judicial review pursuant
22 to the provisions of Article III of the Administrative Review
23 Law. A decision to prohibit a generic drug from substitution
24 must be accompanied by a written detailed explanation of the
25 basis for the decision. Determination of products which may
26 be selected shall be recommended by a Technical Advisory
27 Council of the Department, selected by the Director of Public
28 Health, which council shall consist of 7 persons including 2
29 physicians, 2 pharmacists, 2 pharmacologists and one other
30 prescriber who have special knowledge of generic drugs and
31 formulary. Technical Advisory Council members shall serve
32 without pay, and shall be appointed for a 3 year term and
33 until their successors are appointed and qualified. The
34 procedures for operation of the Drug Product Selection
HB2965 Enrolled -7- LRB9109621ACtm
1 Program shall be promulgated by the Director, however the
2 actual list of products prohibited or approved for drug
3 product selection need not be promulgated. The Technical
4 Advisory Council shall take cognizance of federal studies,
5 the U.S. Pharmacopoeia - National Formulary, or other
6 recognized authoritative sources, and shall advise the
7 Director of any necessary modifications. Drug products
8 previously approved by the Technical Advisory Council for
9 generic interchange may be substituted in the State of
10 Illinois without further review subject to the conditions of
11 approval in the State of Illinois prior to the effective date
12 of this amendatory Act of the 91st General Assembly.
13 Timely notice of revisions to the formulary shall be
14 furnished at no charge to all pharmacies by the Department.
15 Single copies of the drug formulary shall be made available
16 at no charge upon request to licensed prescribers, student
17 pharmacists, and pharmacists practicing pharmacy in this
18 State under a reciprocal license. The Department shall offer
19 subscriptions to the drug formulary and its revisions to
20 other interested parties at a reasonable charge to be
21 established by rule. Before the Department makes effective
22 any additions to or deletions from the procedures for
23 operation of the Drug Product Selection Program under this
24 Section, the Department shall file proposed rules to amend
25 the procedures for operation of the program under Section
26 5-40 of the Illinois Administrative Procedure Act. The
27 Department shall issue necessary rules and regulations for
28 the implementation of this Section.
29 (Source: P.A. 87-860; 87-1237; 88-45.)
30 Section 99. Effective date. This Act takes effect upon
31 becoming law solely for the purpose of allowing the
32 Department of Public Health to begin rulemaking to effect the
33 changes made by this Act. In all other respects, this Act
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1 takes effect on September 1, 2000.
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