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| [ Introduced ] | [ Engrossed ] | [ House Amendment 001 ] |
92_HB3199enr HB3199 Enrolled 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 review at a meeting ofa hearing bythe 28 Technical Advisory Council, is not subject to a hearing in 29 accordance with this Section, or is not specifically 30 prohibited by the current Drug Product Selection Formulary 31 issued by the Department of Public Health pursuant to Section HB3199 Enrolled -2- LRB9206284LBmg 1 3.14 of the Illinois Food, Drug and Cosmetics Act, as 2 amended. A generic drug determined to be therapeutically 3 equivalent by the United States Food and Drug Administration 4 (FDA) shall be available for substitution in Illinois in 5 accordance with this Act and the Illinois Food, Drug and 6 Cosmetic Act, provided that each manufacturer submits a 7 notification containing product technical bioequivalence 8 information as a prerequisite to product substitution when 9 they have completed all required testing to support FDA 10 product approval and, in any event, the information shall be 11 submitted no later than 60 days prior to product substitution 12 in the State. If the Technical Advisory Council finds that a 13 generic drug product may have issues related to the practice 14 of medicine or the practice of pharmacy, the Technical 15 Advisory Council shall review the generic drug producthold a16hearingat its next regularly scheduled Technical Advisory 17 Council meeting. Following the Technical Advisory Council's 18 review and initial recommendation that a generic drug product 19 not be included in the Illinois Formulary, adetermination20that an issue exists related to the practice of medicine or21the practice of pharmacy, thehearing shall be conducted in 22 accordance with the rules of the Department of Public Health 23 and Article 10 of the Illinois Administrative Procedure Act 24 if requested by the manufacturer. The Technical Advisory 25 Council shall make its recommendation to the Department of 26 Public Health within 20 business days after the public 27 hearing. If the Department of Public Health, on the 28 recommendation of the Technical Advisory Council, determines 29 that, based upon a preponderance of the evidence, the drug is 30 not bioequivalent, not therapeutically equivalent, or could 31 cause clinically significant harm to the health or safety of 32 patients receiving that generic drug, the Department of 33 Public Health may prohibit the generic drug from substitution 34 in the State. A decision by the Department of Public Health HB3199 Enrolled -3- LRB9206284LBmg 1 to prohibit a drug product from substitution shall constitute 2 a final administrative decision within the meaning of Section 3 22.2 of the Illinois Food, Drug and Cosmetic Act and Section 4 3-101 of the Code of Civil Procedure, and shall be subject to 5 judicial review pursuant to the provisions of Article III of 6 the Administrative Review Law. A decision to prohibit a 7 generic drug from substitution must be accompanied by a 8 written detailed explanation of the basis for the decision. 9 On the prescription forms of prescribers, shall be placed a 10 signature line and the words "may substitute" and "may not 11 substitute". The prescriber, in his or her own handwriting, 12 shall place a mark beside either the "may substitute" or "may 13 not substitute" alternatives to guide the pharmacist in the 14 dispensing of the prescription. A prescriber placing a mark 15 beside the "may substitute" alternative or failing in his or 16 her own handwriting to place a mark beside either alternative 17 authorizes drug product selection in accordance with this 18 Act. Preprinted or rubber stamped marks, or other deviations 19 from the above prescription format shall not be permitted. 20 The prescriber shall sign the form in his or her own 21 handwriting to authorize the issuance of the prescription. 22 When a person presents a prescription to be dispensed, the 23 pharmacist to whom it is presented may inform the person if 24 the pharmacy has available a different brand name or nonbrand 25 name of the same generic drug prescribed and the price of the 26 different brand name or nonbrand name of the drug product. 27 If the person presenting the prescription is the one to whom 28 the drug is to be administered, the pharmacist may dispense 29 the prescription with the brand prescribed or a different 30 brand name or nonbrand name product of the same generic name 31 that has been permitted by the Department of Public Health, 32 if the drug is of lesser unit cost and the patient is 33 informed and agrees to the selection and the pharmacist shall 34 enter such information into the pharmacy record. If the HB3199 Enrolled -4- LRB9206284LBmg 1 person presenting the prescription is someone other than the 2 one to whom the drug is to be administered the pharmacist 3 shall not dispense the prescription with a brand other than 4 the one specified in the prescription unless the pharmacist 5 has the written or oral authorization to select brands from 6 the person to whom the drug is to be administered or a 7 parent, 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. 91-766, eff. 9-1-00.) HB3199 Enrolled -5- LRB9206284LBmg 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 the 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 the drug products. Nothing in this Section shall prohibit the 15 selection of different brands of the same generic drug, based 16 upon a drug formulary listing which is developed, maintained, 17 and issued by the Department of Public Health under which 18 drug product selection is permitted, is not subject to review 19 at a meeting ofthe hearing review process bythe Technical 20 Advisory Council, is not subject to a hearing in accordance 21 with this Section, or is not specifically prohibited. A 22 generic drug determined to be therapeutically equivalent by 23 the United States Food and Drug Administration (FDA) shall be 24 available for substitution in Illinois in accordance with 25 this Act and the Pharmacy Practice Act of 1987, provided that 26 each manufacturer submits a notification containing product 27 technical bioequivalence information as a prerequisite to 28 product substitution when they have completed all required 29 testing to support FDA product approval and, in any event, 30 the information shall be submitted no later than 60 days 31 prior to product substitution in the State. If the Technical 32 Advisory Council finds that a generic drug product may have 33 issues related to the practice of medicine or the practice of HB3199 Enrolled -6- LRB9206284LBmg 1 pharmacy, the Technical Advisory Council shall review the 2 generic drug producthold a hearingat its next regularly 3 scheduled Technical Advisory Council meeting. Following the 4 Technical Advisory Council's review and initial 5 recommendation that a generic drug product not be included in 6 the Illinois Formulary, adetermination that an issue exists7related to the practice of medicine or the practice of8pharmacy, thehearing shall be conducted in accordance with 9 the Department's Rules of Practice and Procedure in 10 Administrative Hearings (77 Ill. Admin. Code 100) and Article 11 10 of the Illinois Administrative Procedure Act if requested 12 by the manufacturer. The Technical Advisory Council shall 13 make its recommendation to the Department of Public Health 14 within 20 business days after the public hearing. If the 15 Department of Public Health, on the recommendation of the 16 Technical Advisory Council, determines that, based upon a 17 preponderance of the evidence, the drug is not bioequivalent, 18 not therapeutically equivalent, or could cause clinically 19 significant harm to the health or safety of patients 20 receiving that generic drug, the Department of Public Health 21 may prohibit the generic drug from substitution in the State. 22 A decision by the Department to prohibit a drug product from 23 substitution shall constitute a final administrative decision 24 within the meaning of Section 22.2 of the Illinois Food, Drug 25 and Cosmetic Act and Section 3-101 of the Code of Civil 26 Procedure, and shall be subject to judicial review pursuant 27 to the provisions of Article III of the Administrative Review 28 Law. A decision to prohibit a generic drug from substitution 29 must be accompanied by a written detailed explanation of the 30 basis for the decision. Determination of products which may 31 be selected shall be recommended by a Technical Advisory 32 Council of the Department, selected by the Director of Public 33 Health, which council shall consist of 7 persons including 2 34 physicians, 2 pharmacists, 2 pharmacologists and one other HB3199 Enrolled -7- LRB9206284LBmg 1 prescriber who have special knowledge of generic drugs and 2 formulary. Technical Advisory Council members shall serve 3 without pay, and shall be appointed for a 3 year term and 4 until their successors are appointed and qualified. The 5 procedures for operation of the Drug Product Selection 6 Program shall be promulgated by the Director, however the 7 actual list of products prohibited or approved for drug 8 product selection need not be promulgated. The Technical 9 Advisory Council shall take cognizance of federal studies, 10 the U.S. Pharmacopoeia - National Formulary, or other 11 recognized authoritative sources, and shall advise the 12 Director of any necessary modifications. Drug products 13 previously approved by the Technical Advisory Council for 14 generic interchange may be substituted in the State of 15 Illinois without further review subject to the conditions of 16 approval in the State of Illinois prior to the effective date 17 of this amendatory Act of the 91st General Assembly. 18 Timely notice of revisions to the formulary shall be 19 furnished at no charge to all pharmacies by the Department. 20 Single copies of the drug formulary shall be made available 21 at no charge upon request to licensed prescribers, student 22 pharmacists, and pharmacists practicing pharmacy in this 23 State under a reciprocal license. The Department shall offer 24 subscriptions to the drug formulary and its revisions to 25 other interested parties at a reasonable charge to be 26 established by rule. Before the Department makes effective 27 any additions to or deletions from the procedures for 28 operation of the Drug Product Selection Program under this 29 Section, the Department shall file proposed rules to amend 30 the procedures for operation of the program under Section 31 5-40 of the Illinois Administrative Procedure Act. The 32 Department shall issue necessary rules and regulations for 33 the implementation of this Section. 34 (Source: P.A. 91-766, eff. 9-1-00.) HB3199 Enrolled -8- LRB9206284LBmg 1 Section 99. Effective date. This Act takes effect upon 2 becoming law.