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91_HB2256enr HB2256 Enrolled LRB9105244ACtm 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 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 HB2256 Enrolled -2- LRB9105244ACtm 1 issued by the Department of Public Health pursuant to Section 2 3.14 of the"Illinois Food, Drug and Cosmetics Act", approved3June 29, 1967, as amended. On the prescription forms of 4 prescribers, shall be placed a signature line and the words 5 "may substitute" and "may not substitute". The prescriber, 6 in his or her own handwriting, shall place a mark beside 7 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 HB2256 Enrolled -3- LRB9105244ACtm 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: HB2256 Enrolled -4- LRB9105244ACtm 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 inbased19upona positive drug formulary listing thatwhichis 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 24whichmay 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 HB2256 Enrolled -5- LRB9105244ACtm 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.