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92_HB3199
LRB9206284LBmg
1 AN ACT concerning 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 selected drug
25 has a unit price less than the drug product specified in the
26 prescription and provided that the selection is permitted, is
27 not subject to a hearing by the Technical Advisory Council,
28 or is not specifically prohibited by the current Drug Product
29 Selection Formulary issued by the Illinois Department of
30 Public Health pursuant to Section 3.14 of the Illinois Food,
31 Drug and Cosmetics Act, as amended. A generic drug determined
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1 to be therapeutically equivalent by the United States Food
2 and Drug Administration (FDA) shall be available for
3 substitution in Illinois in accordance with this Act and the
4 Illinois Food, Drug and Cosmetic Act, provided that each
5 manufacturer submits a notification containing product
6 technical bioequivalence information as a prerequisite to
7 product substitution when they have completed all required
8 testing to support FDA product approval and, in any event,
9 the information shall be submitted no later than 60 days
10 prior to product substitution in the State. If the Technical
11 Advisory Council finds that a generic drug product may have
12 issues related to the practice of medicine or the practice of
13 pharmacy, the Technical Advisory Council shall hold a hearing
14 at its next regularly scheduled Technical Advisory Council
15 meeting. Following the Technical Advisory Council's
16 determination that an issue exists related to the practice of
17 medicine or the practice of pharmacy, the hearing shall be
18 conducted in accordance with the rules of the Department of
19 Public Health and Article 10 of the Illinois Administrative
20 Procedure Act. The Technical Advisory Council shall make its
21 recommendation to the Department of Public Health within 20
22 business days after the public hearing. If the Department of
23 Public Health, on the recommendation of the Technical
24 Advisory Council, determines that, based upon a preponderance
25 of the evidence, the drug is not bioequivalent, not
26 therapeutically equivalent, or could cause clinically
27 significant harm to the health or safety of patients
28 receiving that generic drug, the Department of Public Health
29 may prohibit the generic drug from substitution in the State.
30 A decision by the Department of Public Health to prohibit a
31 drug product from substitution shall constitute a final
32 administrative decision within the meaning of Section 22.2 of
33 the Illinois Food, Drug and Cosmetic Act and Section 3-101 of
34 the Code of Civil Procedure, and shall be subject to judicial
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1 review pursuant to the provisions of Article III of the
2 Administrative Review Law. A decision to prohibit a generic
3 drug from substitution must be accompanied by a written
4 detailed explanation of the basis for the decision. On the
5 prescription forms of prescribers, shall be placed a
6 signature line and the words "may substitute" and "may not
7 substitute". The prescriber, in his or her own handwriting,
8 shall place a mark beside either the "may substitute" or "may
9 not substitute" alternatives to guide the pharmacist in the
10 dispensing of the prescription. A prescriber placing a mark
11 beside the "may substitute" alternative or failing in his or
12 her own handwriting to place a mark beside either alternative
13 authorizes drug product selection in accordance with this
14 Act. Preprinted or rubber stamped marks, or other deviations
15 from the above prescription format shall not be permitted.
16 The prescriber shall sign the form in his or her own
17 handwriting to authorize the issuance of the prescription.
18 When a person presents a prescription to be dispensed, the
19 pharmacist to whom it is presented may inform the person if
20 the pharmacy has available a different brand name or nonbrand
21 name of the same generic drug prescribed and the price of the
22 different brand name or nonbrand name of the drug product.
23 If the person presenting the prescription is the one to whom
24 the drug is to be administered, the pharmacist may dispense
25 the prescription with the brand prescribed or a different
26 brand name or nonbrand name product of the same generic name
27 that has been permitted by the Department of Public Health,
28 if the drug is of lesser unit cost and the patient is
29 informed and agrees to the selection and the pharmacist shall
30 enter such information into the pharmacy record. If the
31 person presenting the prescription is someone other than the
32 one to whom the drug is to be administered the pharmacist
33 shall not dispense the prescription with a brand other than
34 the one specified in the prescription unless the pharmacist
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1 has the written or oral authorization to select brands from
2 the person to whom the drug is to be administered or a
3 parent, legal guardian or spouse of that person.
4 In every case in which a selection is made as permitted
5 by the Illinois Food, Drug and Cosmetic Act, the pharmacist
6 shall indicate on the pharmacy record of the filled
7 prescription the name or other identification of the
8 manufacturer of the drug which has been dispensed.
9 The selection of any drug product by a pharmacist shall
10 not constitute evidence of negligence if the selected
11 nonlegend drug product was of the same dosage form and each
12 of its active ingredients did not vary by more than 1 percent
13 from the active ingredients of the prescribed, brand name,
14 nonlegend drug product or if the selected legend drug product
15 was included in the Illinois Drug Product Selection Formulary
16 current at the time the prescription was dispensed. Failure
17 of a prescribing physician to specify that drug product
18 selection is prohibited does not constitute evidence of
19 negligence unless that practitioner has reasonable cause to
20 believe that the health condition of the patient for whom the
21 physician is prescribing warrants the use of the brand name
22 drug product and not another.
23 The Department is authorized to employ an analyst or
24 chemist of recognized or approved standing whose duty it
25 shall be to examine into any claimed adulteration, illegal
26 substitution, improper selection, alteration, or other
27 violation hereof, and report the result of his investigation,
28 and if such report justify such action the Department shall
29 cause the offender to be prosecuted.
30 (Source: P.A. 91-766, eff. 9-1-00.)
31 Section 10. The Illinois Food, Drug and Cosmetic Act is
32 amended by changing Section 3.14 as follows:
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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 drug products
8 are not required to bear the legend "Caution: Federal law
9 prohibits dispensing without prescription", provided that the
10 same dosage form is dispensed and there is no greater than 1%
11 variance in the stated amount of each active ingredient of
12 the drug products. Nothing in this Section shall prohibit the
13 selection of different brands of the same generic drug, based
14 upon a drug formulary listing which is developed, maintained,
15 and issued by the Illinois Department of Public Health under
16 which drug product selection is permitted, is not subject to
17 the hearing review process by the Technical Advisory Council,
18 or is not specifically prohibited. A generic drug determined
19 to be therapeutically equivalent by the United States Food
20 and Drug Administration (FDA) shall be available for
21 substitution in Illinois in accordance with this Act and the
22 Pharmacy Practice Act of 1987, provided that each
23 manufacturer submits a notification containing product
24 technical bioequivalence information as a prerequisite to
25 product substitution when they have completed all required
26 testing to support FDA product approval and, in any event,
27 the information shall be submitted no later than 60 days
28 prior to product substitution in the State. If the Technical
29 Advisory Council finds that a generic drug product may have
30 issues related to the practice of medicine or the practice of
31 pharmacy, the Technical Advisory Council shall hold a hearing
32 at its next regularly scheduled Technical Advisory Council
33 meeting. Following the Technical Advisory Council's
34 determination that an issue exists related to the practice of
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1 medicine or the practice of pharmacy, the hearing shall be
2 conducted in accordance with the Department's Rules of
3 Practice and Procedure in Administrative Hearings (77 Ill.
4 Admin. Code 100) and Article 10 of the Illinois
5 Administrative Procedure Act. The Technical Advisory Council
6 shall make its recommendation to the Department of Public
7 Health within 20 business days after the public hearing. If
8 the Department of Public Health, on the recommendation of the
9 Technical Advisory Council, determines that, based upon a
10 preponderance of the evidence, the drug is not bioequivalent,
11 not therapeutically equivalent, or could cause clinically
12 significant harm to the health or safety of patients
13 receiving that generic drug, the Department of Public Health
14 may prohibit the generic drug from substitution in the State.
15 A decision by the Department to prohibit a drug product from
16 substitution shall constitute a final administrative decision
17 within the meaning of Section 22.2 of the Illinois Food, Drug
18 and Cosmetic Act and Section 3-101 of the Code of Civil
19 Procedure, and shall be subject to judicial review pursuant
20 to the provisions of Article III of the Administrative Review
21 Law. A decision to prohibit a generic drug from substitution
22 must be accompanied by a written detailed explanation of the
23 basis for the decision. Determination of products which may
24 be selected shall be recommended by a Technical Advisory
25 Council of the Department, selected by the Director of Public
26 Health, which council shall consist of 7 persons including 2
27 physicians, 2 pharmacists, 2 pharmacologists and one other
28 prescriber who have special knowledge of generic drugs and
29 formulary. Technical Advisory Council members shall serve
30 without pay, and shall be appointed for a 3 year term and
31 until their successors are appointed and qualified. The
32 procedures for operation of the Drug Product Selection
33 Program shall be promulgated by the Director, however the
34 actual list of products prohibited or approved for drug
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1 product selection need not be promulgated. The Technical
2 Advisory Council shall take cognizance of federal studies,
3 the U.S. Pharmacopoeia - National Formulary, or other
4 recognized authoritative sources, and shall advise the
5 Director of any necessary modifications. Drug products
6 previously approved by the Technical Advisory Council for
7 generic interchange may be substituted in the State of
8 Illinois without further review subject to the conditions of
9 approval in the State of Illinois prior to the effective date
10 of this amendatory Act of the 91st General Assembly.
11 Timely notice of revisions to the formulary shall be
12 furnished at no charge to all pharmacies by the Department.
13 Single copies of the drug formulary shall be made available
14 at no charge upon request to licensed prescribers, student
15 pharmacists, and pharmacists practicing pharmacy in this
16 State under a reciprocal license. The Department shall offer
17 subscriptions to the drug formulary and its revisions to
18 other interested parties at a reasonable charge to be
19 established by rule. Before the Department makes effective
20 any additions to or deletions from the procedures for
21 operation of the Drug Product Selection Program under this
22 Section, the Department shall file proposed rules to amend
23 the procedures for operation of the program under Section
24 5-40 of the Illinois Administrative Procedure Act. The
25 Department shall issue necessary rules and regulations for
26 the implementation of this Section.
27 (Source: P.A. 91-766, eff. 9-1-00.)