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91_HB2965ham002
LRB9109621ACmgam04
1 AMENDMENT TO HOUSE BILL 2965
2 AMENDMENT NO. ________. Amend House Bill 2965, AS
3 AMENDED, by replacing everything after the enacting clause
4 with the following:
5 "Section 5. The Pharmacy Practice Act of 1987 is amended
6 by changing Section 25 as follows:
7 (225 ILCS 85/25) (from Ch. 111, par. 4145)
8 Sec. 25. No person shall compound, or sell or offer for
9 sale, or cause to be compounded, sold or offered for sale any
10 medicine or preparation under or by a name recognized in the
11 United States Pharmacopoeia National Formulary, for internal
12 or external use, which differs from the standard of strength,
13 quality or purity as determined by the test laid down in the
14 United States Pharmacopoeia National Formulary official at
15 the time of such compounding, sale or offering for sale. Nor
16 shall any person compound, sell or offer for sale, or cause
17 to be compounded, sold, or offered for sale, any drug,
18 medicine, poison, chemical or pharmaceutical preparation, the
19 strength or purity of which shall fall below the professed
20 standard of strength or purity under which it is sold. If
21 the physician or other authorized prescriber, when
22 transmitting an oral or written prescription, does not
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1 prohibit drug product selection, a different brand name or
2 nonbrand name drug product of the same generic name may be
3 dispensed by the pharmacist, provided that the such selected
4 drug has a unit price less than the drug product specified in
5 the prescription and provided that the selection is
6 permitted, is not subject to a hearing by the Technical
7 Advisory Council, or is not specifically prohibited by the
8 current Drug Product Selection Formulary issued by the
9 Department of Public Health pursuant to Section 3.14 of the
10 "Illinois Food, Drug and Cosmetics Act", approved June 29,
11 1967, as amended. A generic drug determined to be
12 therapeutically equivalent by the United States Food and Drug
13 Administration (FDA) shall be available for substitution in
14 Illinois in accordance with this Act and the Illinois Food,
15 Drug and Cosmetic Act, provided that each manufacturer
16 submits a notification containing product technical
17 bioequivalence information as a prerequisite to product
18 substitution when they have completed all required testing to
19 support FDA product approval and, in any event, the
20 information shall be submitted no later than 60 days prior to
21 product substitution in the State. If the Technical Advisory
22 Council finds that a generic drug product may have issues
23 related to the practice of medicine or the practice of
24 pharmacy, the Technical Advisory Council shall hold a hearing
25 at its next regularly scheduled Technical Advisory Council
26 meeting. Following the Technical Advisory Council's
27 determination that an issue exists related to the practice of
28 medicine or the practice of pharmacy, the hearing shall be
29 conducted in accordance with the rules of the Department of
30 Public Health and Article 10 of the Illinois Administrative
31 Procedure Act. The Technical Advisory Council shall make its
32 recommendation to the Department of Public Health within 20
33 business days after the public hearing. If the Department of
34 Public Health, on the recommendation of the Technical
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1 Advisory Council, determines that, based upon a preponderance
2 of the evidence, the drug is not bioequivalent, not
3 therapeutically equivalent, or could cause clinically
4 significant harm to the health or safety of patients
5 receiving that generic, the Department of Public Health may
6 prohibit the generic drug from substitution in the State. A
7 decision by the Department of Public Health to prohibit a
8 drug product from substitution shall constitute a final
9 administrative decision within the meaning of Section 22.2 of
10 the Illinois Food, Drug and Cosmetic Act and Section 3-101 of
11 the Code of Civil Procedure, and shall be subject to judicial
12 review pursuant to the provisions of Article III of the
13 Administrative Review Law. A decision to prohibit a generic
14 drug from substitution must be accompanied by a written
15 detailed explanation of the basis for the decision. On the
16 prescription forms of prescribers, shall be placed a
17 signature line and the words "may substitute" and "may not
18 substitute". The prescriber, in his or her own handwriting,
19 shall place a mark beside either the "may substitute" or "may
20 not substitute" alternatives to guide the pharmacist in the
21 dispensing of the prescription. A prescriber placing a mark
22 beside the "may substitute" alternative or failing in his or
23 her own handwriting to place a mark beside either alternative
24 authorizes drug product selection in accordance with this
25 Act. Preprinted or rubber stamped marks, or other deviations
26 from the above prescription format shall not be permitted.
27 The prescriber shall sign the form in his or her own
28 handwriting to authorize the issuance of the prescription.
29 When a person presents a prescription to be dispensed, the
30 pharmacist to whom it is presented may inform the person if
31 the pharmacy has available a different brand name or nonbrand
32 name of the same generic drug prescribed and the price of the
33 such different brand name or nonbrand name of the such drug
34 product. If the person presenting the prescription is the
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1 one to whom the drug is to be administered, the pharmacist
2 may dispense the prescription with the brand prescribed or a
3 different brand name or nonbrand name product of the same
4 generic name that has been permitted by the Department of
5 Public Health, if the such drug is of lesser unit cost and
6 the patient is informed and agrees to the selection and the
7 pharmacist shall enter such information into the pharmacy
8 record. If the person presenting the prescription is someone
9 other than the one to whom the drug is to be administered the
10 pharmacist shall not dispense the prescription with a brand
11 other than the one specified in the prescription unless the
12 pharmacist has the written or oral authorization to select
13 brands from the person to whom the drug is to be administered
14 or a parent, legal guardian or spouse of that person.
15 In every case in which a selection is made as permitted
16 by the Illinois Food, Drug and Cosmetic Act, the pharmacist
17 shall indicate on the pharmacy record of the filled
18 prescription the name or other identification of the
19 manufacturer of the drug which has been dispensed.
20 The selection of any drug product by a pharmacist shall
21 not constitute evidence of negligence if the selected
22 nonlegend drug product was of the same dosage form and each
23 of its active ingredients did not vary by more than 1 percent
24 from the active ingredients of the prescribed, brand name,
25 nonlegend drug product or if the selected legend drug product
26 was included in the Illinois Drug Product Selection Formulary
27 current at the time the prescription was dispensed. Failure
28 of a prescribing physician to specify that drug product
29 selection is prohibited does not constitute evidence of
30 negligence unless that practitioner has reasonable cause to
31 believe that the health condition of the patient for whom the
32 physician is prescribing warrants the use of the brand name
33 drug product and not another.
34 The Department is authorized to employ an analyst or
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1 chemist of recognized or approved standing whose duty it
2 shall be to examine into any claimed adulteration, illegal
3 substitution, improper selection, alteration, or other
4 violation hereof, and report the result of his investigation,
5 and if such report justify such action the Department shall
6 cause the offender to be prosecuted.
7 (Source: P.A. 85-796.)
8 Section 10. The Illinois Food, Drug and Cosmetic Act is
9 amended by changing Section 3.14 as follows:
10 (410 ILCS 620/3.14) (from Ch. 56 1/2, par. 503.14)
11 Sec. 3.14. Dispensing or causing to be dispensed a
12 different drug in place of the drug or brand of drug ordered
13 or prescribed without the express permission of the person
14 ordering or prescribing. However, this Section does not
15 prohibit the interchange of different brands of the same
16 generically equivalent drug product, when the such drug
17 products are not required to bear the legend "Caution:
18 Federal law prohibits dispensing without prescription",
19 provided that the same dosage form is dispensed and there is
20 no greater than 1% variance in the stated amount of each
21 active ingredient of the such drug products. Nothing in this
22 Section shall prohibit the selection of different brands of
23 the same generic drug, based upon a positive drug formulary
24 listing which is developed, maintained, and issued by the
25 Department of Public Health under which drug product
26 selection within a generic class, or selection of specific
27 products for those prescribed, is permitted, is not subject
28 to the hearing review process by the Technical Advisory
29 Council, or is not specifically prohibited. A generic drug
30 determined to be therapeutically equivalent by the United
31 States Food and Drug Administration (FDA) shall be available
32 for substitution in Illinois in accordance with this Act and
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1 the Pharmacy Practice Act of 1987, provided that each
2 manufacturer submits a notification containing product
3 technical bioequivalence information as a prerequisite to
4 product substitution when they have completed all required
5 testing to support FDA product approval and, in any event,
6 the information shall be submitted no later than 60 days
7 prior to product substitution in the State. If the Technical
8 Advisory Council finds that a generic drug product may have
9 issues related to the practice of medicine or the practice of
10 pharmacy, the Technical Advisory Council shall hold a hearing
11 at its next regularly scheduled Technical Advisory Council
12 meeting. Following the Technical Advisory Council's
13 determination that an issue exists related to the practice of
14 medicine or the practice of pharmacy, the hearing shall be
15 conducted in accordance with the Department's Rules of
16 Practice and Procedure in Administrative Hearings (77 Ill.
17 Admin. Code 100) and Article 10 of the Illinois
18 Administrative Procedure Act. The Technical Advisory Council
19 shall make its recommendation to the Department of Public
20 Health within 20 business days after the public hearing. If
21 the Department of Public Health, on the recommendation of the
22 Technical Advisory Council, determines that, based upon a
23 preponderance of the evidence, the drug is not bioequivalent,
24 not therapeutically equivalent, or could cause clinically
25 significant harm to the health or safety of patients
26 receiving that generic, the Department of Public Health may
27 prohibit the generic drug from substitution in the State. A
28 decision by the Department to prohibit a drug product from
29 substitution shall constitute a final administrative decision
30 within the meaning of Section 22.2 of the Illinois Food, Drug
31 and Cosmetic Act and Section 3-101 of the Code of Civil
32 Procedure, and shall be subject to judicial review pursuant
33 to the provisions of Article III of the Administrative Review
34 Law. A decision to prohibit a generic drug from substitution
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1 must be accompanied by a written detailed explanation of the
2 basis for the decision. Determination of products which may
3 be selected shall be recommended by a Technical Advisory
4 Council of the Department, selected by the Director of Public
5 Health, which council shall consist of 7 persons including 2
6 physicians, 2 pharmacists, 2 pharmacologists and one other
7 prescriber who have special knowledge of generic drugs and
8 formulary. Technical Advisory Council members shall serve
9 without pay, and shall be appointed for a 3 year term and
10 until their successors are appointed and qualified. The
11 procedures for operation of the Drug Product Selection
12 Program shall be promulgated by the Director, however the
13 actual list of products prohibited or approved for drug
14 product selection need not be promulgated. The Technical
15 Advisory Council shall take cognizance of federal studies,
16 the U.S. Pharmacopoeia - National Formulary, or other
17 recognized authoritative sources, and shall advise the
18 Director of any necessary modifications. Drug products
19 previously approved by the Technical Advisory Council for
20 generic interchange may be substituted in the State of
21 Illinois without further review subject to the conditions of
22 approval in the State of Illinois prior to the effective date
23 of this amendatory Act of the 91st General Assembly.
24 Timely notice of revisions to the formulary shall be
25 furnished at no charge to all pharmacies by the Department.
26 Single copies of the drug formulary shall be made available
27 at no charge upon request to licensed prescribers, student
28 pharmacists, and pharmacists practicing pharmacy in this
29 State under a reciprocal license. The Department shall offer
30 subscriptions to the drug formulary and its revisions to
31 other interested parties at a reasonable charge to be
32 established by rule. Before the Department makes effective
33 any additions to or deletions from the procedures for
34 operation of the Drug Product Selection Program under this
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1 Section, the Department shall file proposed rules to amend
2 the procedures for operation of the program under Section
3 5-40 of the Illinois Administrative Procedure Act. The
4 Department shall issue necessary rules and regulations for
5 the implementation of this Section.
6 (Source: P.A. 87-860; 87-1237; 88-45.)
7 Section 99. Effective date. This Act takes effect upon
8 becoming law solely for the purpose of allowing the
9 Department of Public Health to begin rulemaking to effect the
10 changes made by this Act. In all other respects, this Act
11 takes effect on September 1, 2000.".