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91_HB2965
LRB9109621ACtm
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 or (ii) the selection is
31 permitted by the current Drug Product Selection Formulary
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1 issued by the Department of Public Health pursuant to Section
2 3.14 of the "Illinois Food, Drug and Cosmetics Act" ,
3 approved June 29, 1967, as amended. On the prescription
4 forms of prescribers, shall be placed a signature line and
5 the words "may substitute" and "may not substitute". The
6 prescriber, in his or her own handwriting, shall place a mark
7 beside either the "may substitute" or "may not substitute"
8 alternatives to guide the pharmacist in the dispensing of the
9 prescription. A prescriber placing a mark beside the "may
10 substitute" alternative or failing in his or her own
11 handwriting to place a mark beside either alternative
12 authorizes drug product selection in accordance with this
13 Act. Preprinted or rubber stamped marks, or other deviations
14 from the above prescription format shall not be permitted.
15 The prescriber shall sign the form in his or her own
16 handwriting to authorize the issuance of the prescription.
17 When a person presents a prescription to be dispensed, the
18 pharmacist to whom it is presented may inform the person if
19 the pharmacy has available a different brand name or nonbrand
20 name of the same generic drug prescribed and the price of
21 such different brand name or nonbrand name of such drug
22 product. If the person presenting the prescription is the
23 one to whom the drug is to be administered, the pharmacist
24 may dispense the prescription with the brand prescribed or a
25 different brand name or nonbrand name product of the same
26 generic name that has been permitted by the Department of
27 Public Health, if such drug is of lesser unit cost and the
28 patient is informed and agrees to the selection and the
29 pharmacist shall enter such information into the pharmacy
30 record. If the person presenting the prescription is someone
31 other than the one to whom the drug is to be administered the
32 pharmacist shall not dispense the prescription with a brand
33 other than the one specified in the prescription unless the
34 pharmacist has the written or oral authorization to select
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1 brands from the person to whom the drug is to be administered
2 or a parent, legal guardian or spouse of that person.
3 In every case in which a selection is made as permitted
4 by the Illinois Food, Drug and Cosmetic Act, the pharmacist
5 shall indicate on the pharmacy record of the filled
6 prescription the name or other identification of the
7 manufacturer of the drug which has been dispensed.
8 The selection of any drug product by a pharmacist shall
9 not constitute evidence of negligence if the selected
10 nonlegend drug product was of the same dosage form and each
11 of its active ingredients did not vary by more than 1 percent
12 from the active ingredients of the prescribed, brand name,
13 nonlegend drug product or if the selected legend drug product
14 was rated therapeutically equivalent in the Orange Book or
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. 85-796.)
31 Section 10. The Illinois Food, Drug and Cosmetic Act is
32 amended by changing Section 3.14 as follows:
-4- LRB9109621ACtm
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 such 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 such drug products. Nothing in this Section shall prohibit
13 the selection of different brands of the same generic drug,
14 provided that either (i) the selected drug has been rated
15 therapeutically equivalent to the prescribed drug in Approved
16 Drug Products with Therapeutic Equivalence Evaluations
17 (Orange Book) published by the federal Food and Drug
18 Administration or (ii) the selected drug is listed in based
19 upon a positive drug formulary listing that which is
20 developed, maintained, and issued by the Department of Public
21 Health under which drug product selection within a generic
22 class, or selection of specific products for those
23 prescribed, is permitted. Determination of products that
24 which may be selected shall be recommended by a Technical
25 Advisory Council of the Department, selected by the Director
26 of Public Health, which council shall consist of 7 persons
27 including 2 physicians, 2 pharmacists, 2 pharmacologists and
28 one other prescriber who have special knowledge of generic
29 drugs and formulary. Technical Advisory Council members
30 shall serve without pay, and shall be appointed for a 3 year
31 term and until their successors are appointed and qualified.
32 The procedures for operation of the Drug Product Selection
33 Program shall be promulgated by the Director, however the
34 actual list of products approved for drug product selection
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1 need not be promulgated. The Technical Advisory Council shall
2 take cognizance of federal studies, the U.S. Pharmacopoeia -
3 National Formulary, or other recognized authoritative
4 sources, and shall advise the Director of any necessary
5 modifications.
6 Timely notice of revisions to the formulary shall be
7 furnished at no charge to all pharmacies by the Department.
8 Single copies of the drug formulary shall be made available
9 at no charge upon request to licensed prescribers, student
10 pharmacists, and pharmacists practicing pharmacy in this
11 State under a reciprocal license. The Department shall offer
12 subscriptions to the drug formulary and its revisions to
13 other interested parties at a reasonable charge to be
14 established by rule. Before the Department makes effective
15 any additions to or deletions from the procedures for
16 operation of the Drug Product Selection Program under this
17 Section, the Department shall file proposed rules to amend
18 the procedures for operation of the program under Section
19 5-40 of the Illinois Administrative Procedure Act. The
20 Department shall issue necessary rules and regulations for
21 the implementation of this Section.
22 (Source: P.A. 87-860; 87-1237; 88-45.)
23 Section 99. Effective date. This Act takes effect upon
24 becoming law.