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| [ Introduced ] | [ Engrossed ] | [ House Amendment 001 ] |
| [ House Amendment 002 ] |
91_HB2965enr HB2965 Enrolled 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 thesuchselected 25 drug has a unit price less than the drug product specified in 26 the prescription and provided that the selection is 27 permitted, is not subject to a hearing by the Technical 28 Advisory Council, or is not specifically prohibited by the 29 current Drug Product Selection Formulary issued by the 30 Department of Public Health pursuant to Section 3.14 of the 31"Illinois Food, Drug and Cosmetics Act", approved June 29,HB2965 Enrolled -2- LRB9109621ACtm 11967, as amended. A generic drug determined to be 2 therapeutically equivalent by the United States Food and Drug 3 Administration (FDA) shall be available for substitution in 4 Illinois in accordance with this Act and the Illinois Food, 5 Drug and Cosmetic Act, provided that each manufacturer 6 submits a notification containing product technical 7 bioequivalence information as a prerequisite to product 8 substitution when they have completed all required testing to 9 support FDA product approval and, in any event, the 10 information shall be submitted no later than 60 days prior to 11 product substitution in the State. If the Technical Advisory 12 Council finds that a generic drug product may have issues 13 related to the practice of medicine or the practice of 14 pharmacy, the Technical Advisory Council shall hold a hearing 15 at its next regularly scheduled Technical Advisory Council 16 meeting. Following the Technical Advisory Council's 17 determination that an issue exists related to the practice of 18 medicine or the practice of pharmacy, the hearing shall be 19 conducted in accordance with the rules of the Department of 20 Public Health and Article 10 of the Illinois Administrative 21 Procedure Act. The Technical Advisory Council shall make its 22 recommendation to the Department of Public Health within 20 23 business days after the public hearing. If the Department of 24 Public Health, on the recommendation of the Technical 25 Advisory Council, determines that, based upon a preponderance 26 of the evidence, the drug is not bioequivalent, not 27 therapeutically equivalent, or could cause clinically 28 significant harm to the health or safety of patients 29 receiving that generic drug, the Department of Public Health 30 may prohibit the generic drug from substitution in the State. 31 A decision by the Department of Public Health to prohibit a 32 drug product from substitution shall constitute a final 33 administrative decision within the meaning of Section 22.2 of 34 the Illinois Food, Drug and Cosmetic Act and Section 3-101 of HB2965 Enrolled -3- LRB9109621ACtm 1 the Code of Civil Procedure, and shall be subject to judicial 2 review pursuant to the provisions of Article III of the 3 Administrative Review Law. A decision to prohibit a generic 4 drug from substitution must be accompanied by a written 5 detailed explanation of the basis for the decision. On the 6 prescription forms of prescribers, shall be placed a 7 signature line and the words "may substitute" and "may not 8 substitute". The prescriber, in his or her own handwriting, 9 shall place a mark beside either the "may substitute" or "may 10 not substitute" alternatives to guide the pharmacist in the 11 dispensing of the prescription. A prescriber placing a mark 12 beside the "may substitute" alternative or failing in his or 13 her own 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 the 23suchdifferent brand name or nonbrand name of thesuchdrug 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 thesuchdrug is of lesser unit cost and 30 the 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 HB2965 Enrolled -4- LRB9109621ACtm 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 included in the Illinois Drug Product Selection Formulary 17 current at the time the prescription was dispensed. Failure 18 of a prescribing physician to specify that drug product 19 selection is prohibited does not constitute evidence of 20 negligence unless that practitioner has reasonable cause to 21 believe that the health condition of the patient for whom the 22 physician is prescribing warrants the use of the brand name 23 drug product and not another. 24 The Department is authorized to employ an analyst or 25 chemist of recognized or approved standing whose duty it 26 shall be to examine into any claimed adulteration, illegal 27 substitution, improper selection, alteration, or other 28 violation hereof, and report the result of his investigation, 29 and if such report justify such action the Department shall 30 cause the offender to be prosecuted. 31 (Source: P.A. 85-796.) 32 Section 10. The Illinois Food, Drug and Cosmetic Act is 33 amended by changing Section 3.14 as follows: HB2965 Enrolled -5- 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 thesuchdrug 8 products are not required to bear the legend "Caution: 9 Federal law prohibits dispensing without prescription", 10 provided that the same dosage form is dispensed and there is 11 no greater than 1% variance in the stated amount of each 12 active ingredient of thesuchdrug products. Nothing in this 13 Section shall prohibit the selection of different brands of 14 the same generic drug, based upon apositivedrug formulary 15 listing which is developed, maintained, and issued by the 16 Department of Public Health under which drug product 17 selectionwithin a generic class, or selection of specific18products for those prescribed,is permitted, is not subject 19 to the hearing review process by the Technical Advisory 20 Council, or is not specifically prohibited. A generic drug 21 determined to be therapeutically equivalent by the United 22 States Food and Drug Administration (FDA) shall be available 23 for substitution in Illinois in accordance with this Act and 24 the Pharmacy Practice Act of 1987, provided that each 25 manufacturer submits a notification containing product 26 technical bioequivalence information as a prerequisite to 27 product substitution when they have completed all required 28 testing to support FDA product approval and, in any event, 29 the information shall be submitted no later than 60 days 30 prior to product substitution in the State. If the Technical 31 Advisory Council finds that a generic drug product may have 32 issues related to the practice of medicine or the practice of 33 pharmacy, the Technical Advisory Council shall hold a hearing 34 at its next regularly scheduled Technical Advisory Council HB2965 Enrolled -6- LRB9109621ACtm 1 meeting. Following the Technical Advisory Council's 2 determination that an issue exists related to the practice of 3 medicine or the practice of pharmacy, the hearing shall be 4 conducted in accordance with the Department's Rules of 5 Practice and Procedure in Administrative Hearings (77 Ill. 6 Admin. Code 100) and Article 10 of the Illinois 7 Administrative Procedure Act. The Technical Advisory Council 8 shall make its recommendation to the Department of Public 9 Health within 20 business days after the public hearing. If 10 the Department of Public Health, on the recommendation of the 11 Technical Advisory Council, determines that, based upon a 12 preponderance of the evidence, the drug is not bioequivalent, 13 not therapeutically equivalent, or could cause clinically 14 significant harm to the health or safety of patients 15 receiving that generic drug, the Department of Public Health 16 may prohibit the generic drug from substitution in the State. 17 A decision by the Department to prohibit a drug product from 18 substitution shall constitute a final administrative decision 19 within the meaning of Section 22.2 of the Illinois Food, Drug 20 and Cosmetic Act and Section 3-101 of the Code of Civil 21 Procedure, and shall be subject to judicial review pursuant 22 to the provisions of Article III of the Administrative Review 23 Law. A decision to prohibit a generic drug from substitution 24 must be accompanied by a written detailed explanation of the 25 basis for the decision. Determination of products which may 26 be selected shall be recommended by a Technical Advisory 27 Council of the Department, selected by the Director of Public 28 Health, which council shall consist of 7 persons including 2 29 physicians, 2 pharmacists, 2 pharmacologists and one other 30 prescriber who have special knowledge of generic drugs and 31 formulary. Technical Advisory Council members shall serve 32 without pay, and shall be appointed for a 3 year term and 33 until their successors are appointed and qualified. The 34 procedures for operation of the Drug Product Selection HB2965 Enrolled -7- LRB9109621ACtm 1 Program shall be promulgated by the Director, however the 2 actual list of products prohibited or approved for drug 3 product selection need not be promulgated. The Technical 4 Advisory Council shall take cognizance of federal studies, 5 the U.S. Pharmacopoeia - National Formulary, or other 6 recognized authoritative sources, and shall advise the 7 Director of any necessary modifications. Drug products 8 previously approved by the Technical Advisory Council for 9 generic interchange may be substituted in the State of 10 Illinois without further review subject to the conditions of 11 approval in the State of Illinois prior to the effective date 12 of this amendatory Act of the 91st General Assembly. 13 Timely notice of revisions to the formulary shall be 14 furnished at no charge to all pharmacies by the Department. 15 Single copies of the drug formulary shall be made available 16 at no charge upon request to licensed prescribers, student 17 pharmacists, and pharmacists practicing pharmacy in this 18 State under a reciprocal license. The Department shall offer 19 subscriptions to the drug formulary and its revisions to 20 other interested parties at a reasonable charge to be 21 established by rule. Before the Department makes effective 22 any additions to or deletions from the procedures for 23 operation of the Drug Product Selection Program under this 24 Section, the Department shall file proposed rules to amend 25 the procedures for operation of the program under Section 26 5-40 of the Illinois Administrative Procedure Act. The 27 Department shall issue necessary rules and regulations for 28 the implementation of this Section. 29 (Source: P.A. 87-860; 87-1237; 88-45.) 30 Section 99. Effective date. This Act takes effect upon 31 becoming law solely for the purpose of allowing the 32 Department of Public Health to begin rulemaking to effect the 33 changes made by this Act. In all other respects, this Act HB2965 Enrolled -8- LRB9109621ACtm 1 takes effect on September 1, 2000.