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91_HB2965ham001
LRB9109621ACmgam03
1 AMENDMENT TO HOUSE BILL 2965
2 AMENDMENT NO. . Amend House Bill 2965 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 such selected drug
3 has a unit price less than the drug product specified in the
4 prescription and provided that the selection is permitted by
5 the current Drug Product Selection Formulary issued by the
6 Department of Public Health pursuant to Section 3.14 of the
7 "Illinois Food, Drug and Cosmetics Act", approved June 29,
8 1967, as amended. On the prescription forms of prescribers,
9 shall be placed a signature line and the words "may
10 substitute" and "may not substitute". The prescriber, in his
11 or her own handwriting, shall place a mark beside either the
12 "may substitute" or "may not substitute" alternatives to
13 guide the pharmacist in the dispensing of the prescription. A
14 prescriber placing a mark beside the "may substitute"
15 alternative or failing in his or her own handwriting to place
16 a mark beside either alternative authorizes drug product
17 selection in accordance with this Act. Preprinted or rubber
18 stamped marks, or other deviations from the above
19 prescription format shall not be permitted. The prescriber
20 shall sign the form in his or her own handwriting to
21 authorize the issuance of the prescription. When a person
22 presents a prescription to be dispensed, the pharmacist to
23 whom it is presented may inform the person if the pharmacy
24 has available a different brand name or nonbrand name of the
25 same generic drug prescribed and the price of such different
26 brand name or nonbrand name of such drug product. If the
27 person presenting the prescription is the one to whom the
28 drug is to be administered, the pharmacist may dispense the
29 prescription with the brand prescribed or a different brand
30 name or nonbrand name product of the same generic name that
31 has been permitted by the Department of Public Health, if
32 such drug is of lesser unit cost and the patient is informed
33 and agrees to the selection and the pharmacist shall enter
34 such information into the pharmacy record. If the person
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1 presenting the prescription is someone other than the one to
2 whom the drug is to be administered the pharmacist shall not
3 dispense the prescription with a brand other than the one
4 specified in the prescription unless the pharmacist has the
5 written or oral authorization to select brands from the
6 person to whom the drug is to be administered or a parent,
7 legal guardian or spouse of that person.
8 In every case in which a selection is made as permitted
9 by the Illinois Food, Drug and Cosmetic Act, the pharmacist
10 shall indicate on the pharmacy record of the filled
11 prescription the name or other identification of the
12 manufacturer of the drug which has been dispensed.
13 The selection of any drug product by a pharmacist shall
14 not constitute evidence of negligence if the selected
15 nonlegend drug product was of the same dosage form and each
16 of its active ingredients did not vary by more than 1 percent
17 from the active ingredients of the prescribed, brand name,
18 nonlegend drug product or if the selected legend drug product
19 was included in the Illinois Drug Product Selection Formulary
20 current at the time the prescription was dispensed. Failure
21 of a prescribing physician to specify that drug product
22 selection is prohibited does not constitute evidence of
23 negligence unless that practitioner has reasonable cause to
24 believe that the health condition of the patient for whom the
25 physician is prescribing warrants the use of the brand name
26 drug product and not another.
27 The Department is authorized to employ an analyst or
28 chemist of recognized or approved standing whose duty it
29 shall be to examine into any claimed adulteration, illegal
30 substitution, improper selection, alteration, or other
31 violation hereof, and report the result of his investigation,
32 and if such report justify such action the Department shall
33 cause the offender to be prosecuted.
34 (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 based upon a positive drug formulary listing which is
17 developed, maintained, and issued by the Department of Public
18 Health under which drug product selection within a generic
19 class, or selection of specific products for those
20 prescribed, is permitted. Determination of products that
21 which may be selected shall be recommended by a Technical
22 Advisory Council of the Department, selected by the Director
23 of Public Health, which council shall consist of 7 persons
24 including 2 physicians, 2 pharmacists, 2 pharmacologists and
25 one other prescriber who have special knowledge of generic
26 drugs and formulary. Technical Advisory Council members
27 shall serve without pay, and shall be appointed for a 3 year
28 term and until their successors are appointed and qualified.
29 The procedures for operation of the Drug Product Selection
30 Program shall be promulgated by the Director, however the
31 actual list of products approved for drug product selection
32 need not be promulgated. The Technical Advisory Council shall
33 take cognizance of federal studies, the U.S. Pharmacopoeia -
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1 National Formulary, or other recognized authoritative
2 sources, and shall advise the Director of any necessary
3 modifications.
4 Timely notice of revisions to the formulary shall be
5 furnished at no charge to all pharmacies by the Department.
6 Single copies of the drug formulary shall be made available
7 at no charge upon request to licensed prescribers, student
8 pharmacists, and pharmacists practicing pharmacy in this
9 State under a reciprocal license. The Department shall offer
10 subscriptions to the drug formulary and its revisions to
11 other interested parties at a reasonable charge to be
12 established by rule. Before the Department makes effective
13 any additions to or deletions from the procedures for
14 operation of the Drug Product Selection Program under this
15 Section, the Department shall file proposed rules to amend
16 the procedures for operation of the program under Section
17 5-40 of the Illinois Administrative Procedure Act. The
18 Department shall issue necessary rules and regulations for
19 the implementation of this Section.
20 (Source: P.A. 87-860; 87-1237; 88-45.)".