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91_HB3052
LRB9109876ACtm
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 either (i) the selected
27 drug has been rated therapeutically equivalent to the
28 prescribed drug in Approved Drug Products with Therapeutic
29 Equivalence Evaluations (Orange Book) published by the
30 federal Food and Drug Administration and the product is not a
31 "critical dose drug" as defined by Section 3.14 of the
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1 Illinois Food, Drug and Cosmetic Act or (ii) the selection is
2 permitted by the current Drug Product Selection Formulary
3 issued by the Department of Public Health pursuant to Section
4 3.14 of the "Illinois Food, Drug and Cosmetics Act", approved
5 June 29, 1967, as amended. On the prescription forms of
6 prescribers, shall be placed a signature line and the words
7 "may substitute" and "may not substitute". The prescriber,
8 in his or her own handwriting, shall place a mark beside
9 either the "may substitute" or "may not substitute"
10 alternatives to guide the pharmacist in the dispensing of the
11 prescription. A prescriber placing a mark beside the "may
12 substitute" alternative or failing in his or her own
13 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
23 such different brand name or nonbrand name of 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 such drug is of lesser unit cost and the
30 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
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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 approved in accordance with Section 3.14 of the Illinois
17 Food, Drug and Cosmetic Act or was included in the Illinois
18 Drug Product Selection Formulary current at the time the
19 prescription was dispensed. Failure of a prescribing
20 physician to specify that drug product selection is
21 prohibited does not constitute evidence of negligence unless
22 that practitioner has reasonable cause to believe that the
23 health condition of the patient for whom the physician is
24 prescribing warrants the use of the brand name drug product
25 and not another.
26 The Department is authorized to employ an analyst or
27 chemist of recognized or approved standing whose duty it
28 shall be to examine into any claimed adulteration, illegal
29 substitution, improper selection, alteration, or other
30 violation hereof, and report the result of his investigation,
31 and if such report justify such action the Department shall
32 cause the offender to be prosecuted.
33 (Source: P.A. 85-796.)
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1 Section 10. The Illinois Food, Drug and Cosmetic Act is
2 amended by changing Section 3.14 as follows:
3 (410 ILCS 620/3.14) (from Ch. 56 1/2, par. 503.14)
4 Sec. 3.14. Dispensing or causing to be dispensed a
5 different drug in place of the drug or brand of drug ordered
6 or prescribed without the express permission of the person
7 ordering or prescribing. However, this Section does not
8 prohibit the interchange of different brands of the same
9 generically equivalent drug product, when such drug products
10 are not required to bear the legend "Caution: Federal law
11 prohibits dispensing without prescription", provided that the
12 same dosage form is dispensed and there is no greater than 1%
13 variance in the stated amount of each active ingredient of
14 such drug products. Nothing in this Section shall prohibit
15 the selection of different brands of the same generic drug,
16 provided that either (i) the selected drug has been rated
17 therapeutically equivalent to the prescribed drug in Approved
18 Drug Products with Therapeutic Equivalence Evaluations
19 (Orange Book) published by the federal Food and Drug
20 Administration, except that drug products named by the
21 Technical Advisory Council to be "critical dose drugs" must
22 be approved by the Technical Advisory Council prior to being
23 selected, or (ii) the selected drug is listed in based upon a
24 positive drug formulary that listing which is developed,
25 maintained, and issued by the Department of Public Health
26 under which drug product selection within a generic class, or
27 selection of specific products for those prescribed, is
28 permitted. A "critical dose drug" is a drug that, for its
29 safe and effective use, requires medically-supervised dosage
30 titration, requires routine monitoring of the patient through
31 laboratory or other means, and exhibits a narrow therapeutic
32 ratio, meaning there is less than a 2-fold difference in the
33 median lethal dose (LD50) and the median effective dose
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1 (ED50) values, or there is less than a 2-fold difference in
2 the minimum toxic concentrations and minimum effective
3 concentrations in the blood. Determination of products that
4 which may be selected shall be recommended by a Technical
5 Advisory Council of the Department, selected by the Director
6 of Public Health, which council shall consist of 7 persons
7 including 2 physicians, 2 pharmacists, 2 pharmacologists and
8 one other prescriber who have special knowledge of generic
9 drugs and formulary. The Technical Advisory Council may
10 consider drugs which require a prescription and are legally
11 marketed in the United States according to FDA regulations.
12 Technical Advisory Council members shall serve without pay,
13 and shall be appointed for a 3 year term and until their
14 successors are appointed and qualified. The procedures for
15 operation of the Drug Product Selection Program shall be
16 promulgated by the Director, however the actual list of
17 products approved for drug product selection need not be
18 promulgated. The Technical Advisory Council shall take
19 cognizance of federal studies, the U.S. Pharmacopoeia -
20 National Formulary, or other recognized authoritative
21 sources, and shall advise the Director of any necessary
22 modifications.
23 Timely notice of revisions to the formulary shall be
24 furnished at no charge to all pharmacies by the Department.
25 Single copies of the drug formulary shall be made available
26 at no charge upon request to licensed prescribers, student
27 pharmacists, and pharmacists practicing pharmacy in this
28 State under a reciprocal license. The Department shall offer
29 subscriptions to the drug formulary and its revisions to
30 other interested parties at a reasonable charge to be
31 established by rule. Before the Department makes effective
32 any additions to or deletions from the procedures for
33 operation of the Drug Product Selection Program under this
34 Section, the Department shall file proposed rules to amend
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1 the procedures for operation of the program under Section
2 5-40 of the Illinois Administrative Procedure Act. The
3 Department shall issue necessary rules and regulations for
4 the implementation of this Section.
5 (Source: P.A. 87-860; 87-1237; 88-45.)
6 Section 99. Effective date. This Act takes effect upon
7 becoming law.