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92_HB3199ham001
LRB9206284ACdvam01
1 AMENDMENT TO HOUSE BILL 3199
2 AMENDMENT NO. . Amend House Bill 3199 by replacing
3 everything after the enacting clause with the following:
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
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1 nonbrand name drug product of the same generic name may be
2 dispensed by the pharmacist, provided that the selected drug
3 has a unit price less than the drug product specified in the
4 prescription and provided that the selection is permitted, is
5 not subject to review at a meeting of a hearing by the
6 Technical Advisory Council, is not subject to a hearing in
7 accordance with this Section, or is not specifically
8 prohibited by the current Drug Product Selection Formulary
9 issued by the Department of Public Health pursuant to Section
10 3.14 of the Illinois Food, Drug and Cosmetics Act, as
11 amended. A generic drug determined to be therapeutically
12 equivalent by the United States Food and Drug Administration
13 (FDA) shall be available for substitution in Illinois in
14 accordance with this Act and the Illinois Food, Drug and
15 Cosmetic Act, provided that each manufacturer submits a
16 notification containing product technical bioequivalence
17 information as a prerequisite to product substitution when
18 they have completed all required testing to support FDA
19 product approval and, in any event, the information shall be
20 submitted no later than 60 days prior to product substitution
21 in the State. If the Technical Advisory Council finds that a
22 generic drug product may have issues related to the practice
23 of medicine or the practice of pharmacy, the Technical
24 Advisory Council shall review the generic drug product hold a
25 hearing at its next regularly scheduled Technical Advisory
26 Council meeting. Following the Technical Advisory Council's
27 review and initial recommendation that a generic drug product
28 not be included in the Illinois Formulary, a determination
29 that an issue exists related to the practice of medicine or
30 the practice of pharmacy, the hearing shall be conducted in
31 accordance with the rules of the Department of Public Health
32 and Article 10 of the Illinois Administrative Procedure Act
33 if requested by the manufacturer. The Technical Advisory
34 Council shall make its recommendation to the Department of
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1 Public Health within 20 business days after the public
2 hearing. If the Department of Public Health, on the
3 recommendation of the Technical Advisory Council, determines
4 that, based upon a preponderance of the evidence, the drug is
5 not bioequivalent, not therapeutically equivalent, or could
6 cause clinically significant harm to the health or safety of
7 patients receiving that generic drug, the Department of
8 Public Health may prohibit the generic drug from substitution
9 in the State. A decision by the Department of Public Health
10 to prohibit a drug product from substitution shall constitute
11 a final administrative decision within the meaning of Section
12 22.2 of the Illinois Food, Drug and Cosmetic Act and Section
13 3-101 of the Code of Civil Procedure, and shall be subject to
14 judicial review pursuant to the provisions of Article III of
15 the Administrative Review Law. A decision to prohibit a
16 generic drug from substitution must be accompanied by a
17 written detailed explanation of the basis for the decision.
18 On the prescription forms of prescribers, shall be placed a
19 signature line and the words "may substitute" and "may not
20 substitute". The prescriber, in his or her own handwriting,
21 shall place a mark beside either the "may substitute" or "may
22 not substitute" alternatives to guide the pharmacist in the
23 dispensing of the prescription. A prescriber placing a mark
24 beside the "may substitute" alternative or failing in his or
25 her own handwriting to place a mark beside either alternative
26 authorizes drug product selection in accordance with this
27 Act. Preprinted or rubber stamped marks, or other deviations
28 from the above prescription format shall not be permitted.
29 The prescriber shall sign the form in his or her own
30 handwriting to authorize the issuance of the prescription.
31 When a person presents a prescription to be dispensed, the
32 pharmacist to whom it is presented may inform the person if
33 the pharmacy has available a different brand name or nonbrand
34 name of the same generic drug prescribed and the price of the
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1 different brand name or nonbrand name of the drug product.
2 If the person presenting the prescription is the one to whom
3 the drug is to be administered, the pharmacist may dispense
4 the prescription with the brand prescribed or a different
5 brand name or nonbrand name product of the same generic name
6 that has been permitted by the Department of Public Health,
7 if the drug is of lesser unit cost and the patient is
8 informed and agrees to the selection and the pharmacist shall
9 enter such information into the pharmacy record. If the
10 person presenting the prescription is someone other than the
11 one to whom the drug is to be administered the pharmacist
12 shall not dispense the prescription with a brand other than
13 the one specified in the prescription unless the pharmacist
14 has the written or oral authorization to select brands from
15 the person to whom the drug is to be administered or a
16 parent, legal guardian or spouse of that person.
17 In every case in which a selection is made as permitted
18 by the Illinois Food, Drug and Cosmetic Act, the pharmacist
19 shall indicate on the pharmacy record of the filled
20 prescription the name or other identification of the
21 manufacturer of the drug which has been dispensed.
22 The selection of any drug product by a pharmacist shall
23 not constitute evidence of negligence if the selected
24 nonlegend drug product was of the same dosage form and each
25 of its active ingredients did not vary by more than 1 percent
26 from the active ingredients of the prescribed, brand name,
27 nonlegend drug product or if the selected legend drug product
28 was included in the Illinois Drug Product Selection Formulary
29 current at the time the prescription was dispensed. Failure
30 of a prescribing physician to specify that drug product
31 selection is prohibited does not constitute evidence of
32 negligence unless that practitioner has reasonable cause to
33 believe that the health condition of the patient for whom the
34 physician is prescribing warrants the use of the brand name
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1 drug product and not another.
2 The Department is authorized to employ an analyst or
3 chemist of recognized or approved standing whose duty it
4 shall be to examine into any claimed adulteration, illegal
5 substitution, improper selection, alteration, or other
6 violation hereof, and report the result of his investigation,
7 and if such report justify such action the Department shall
8 cause the offender to be prosecuted.
9 (Source: P.A. 91-766, eff. 9-1-00.)
10 Section 10. The Illinois Food, Drug and Cosmetic Act is
11 amended by changing Section 3.14 as follows:
12 (410 ILCS 620/3.14) (from Ch. 56 1/2, par. 503.14)
13 Sec. 3.14. Dispensing or causing to be dispensed a
14 different drug in place of the drug or brand of drug ordered
15 or prescribed without the express permission of the person
16 ordering or prescribing. However, this Section does not
17 prohibit the interchange of different brands of the same
18 generically equivalent drug product, when the drug products
19 are not required to bear the legend "Caution: Federal law
20 prohibits dispensing without prescription", provided that the
21 same dosage form is dispensed and there is no greater than 1%
22 variance in the stated amount of each active ingredient of
23 the drug products. Nothing in this Section shall prohibit the
24 selection of different brands of the same generic drug, based
25 upon a drug formulary listing which is developed, maintained,
26 and issued by the Department of Public Health under which
27 drug product selection is permitted, is not subject to review
28 at a meeting of the hearing review process by the Technical
29 Advisory Council, is not subject to a hearing in accordance
30 with this Section, or is not specifically prohibited. A
31 generic drug determined to be therapeutically equivalent by
32 the United States Food and Drug Administration (FDA) shall be
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1 available for substitution in Illinois in accordance with
2 this Act and the Pharmacy Practice Act of 1987, provided that
3 each manufacturer submits a notification containing product
4 technical bioequivalence information as a prerequisite to
5 product substitution when they have completed all required
6 testing to support FDA product approval and, in any event,
7 the information shall be submitted no later than 60 days
8 prior to product substitution in the State. If the Technical
9 Advisory Council finds that a generic drug product may have
10 issues related to the practice of medicine or the practice of
11 pharmacy, the Technical Advisory Council shall review the
12 generic drug product hold a hearing at its next regularly
13 scheduled Technical Advisory Council meeting. Following the
14 Technical Advisory Council's review and initial
15 recommendation that a generic drug product not be included in
16 the Illinois Formulary, a determination that an issue exists
17 related to the practice of medicine or the practice of
18 pharmacy, the hearing shall be conducted in accordance with
19 the Department's Rules of Practice and Procedure in
20 Administrative Hearings (77 Ill. Admin. Code 100) and Article
21 10 of the Illinois Administrative Procedure Act if requested
22 by the manufacturer. The Technical Advisory Council shall
23 make its recommendation to the Department of Public Health
24 within 20 business days after the public hearing. If the
25 Department of Public Health, on the recommendation of the
26 Technical Advisory Council, determines that, based upon a
27 preponderance of the evidence, the drug is not bioequivalent,
28 not therapeutically equivalent, or could cause clinically
29 significant harm to the health or safety of patients
30 receiving that generic drug, the Department of Public Health
31 may prohibit the generic drug from substitution in the State.
32 A decision by the Department to prohibit a drug product from
33 substitution shall constitute a final administrative decision
34 within the meaning of Section 22.2 of the Illinois Food, Drug
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1 and Cosmetic Act and Section 3-101 of the Code of Civil
2 Procedure, and shall be subject to judicial review pursuant
3 to the provisions of Article III of the Administrative Review
4 Law. A decision to prohibit a generic drug from substitution
5 must be accompanied by a written detailed explanation of the
6 basis for the decision. Determination of products which may
7 be selected shall be recommended by a Technical Advisory
8 Council of the Department, selected by the Director of Public
9 Health, which council shall consist of 7 persons including 2
10 physicians, 2 pharmacists, 2 pharmacologists and one other
11 prescriber who have special knowledge of generic drugs and
12 formulary. Technical Advisory Council members shall serve
13 without pay, and shall be appointed for a 3 year term and
14 until their successors are appointed and qualified. The
15 procedures for operation of the Drug Product Selection
16 Program shall be promulgated by the Director, however the
17 actual list of products prohibited or approved for drug
18 product selection need not be promulgated. The Technical
19 Advisory Council shall take cognizance of federal studies,
20 the U.S. Pharmacopoeia - National Formulary, or other
21 recognized authoritative sources, and shall advise the
22 Director of any necessary modifications. Drug products
23 previously approved by the Technical Advisory Council for
24 generic interchange may be substituted in the State of
25 Illinois without further review subject to the conditions of
26 approval in the State of Illinois prior to the effective date
27 of this amendatory Act of the 91st General Assembly.
28 Timely notice of revisions to the formulary shall be
29 furnished at no charge to all pharmacies by the Department.
30 Single copies of the drug formulary shall be made available
31 at no charge upon request to licensed prescribers, student
32 pharmacists, and pharmacists practicing pharmacy in this
33 State under a reciprocal license. The Department shall offer
34 subscriptions to the drug formulary and its revisions to
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1 other interested parties at a reasonable charge to be
2 established by rule. Before the Department makes effective
3 any additions to or deletions from the procedures for
4 operation of the Drug Product Selection Program under this
5 Section, the Department shall file proposed rules to amend
6 the procedures for operation of the program under Section
7 5-40 of the Illinois Administrative Procedure Act. The
8 Department shall issue necessary rules and regulations for
9 the implementation of this Section.
10 (Source: P.A. 91-766, eff. 9-1-00.)
11 Section 99. Effective date. This Act takes effect upon
12 becoming law.".