Sen. Dan Kotowski

Filed: 4/28/2010

 

 


 

 


 
09600HB5890sam001 LRB096 18739 ASK 40836 a

1
AMENDMENT TO HOUSE BILL 5890

2     AMENDMENT NO. ______. Amend House Bill 5890 on page 1, by
3 replacing line 5 with "Sections 3 and 25 as follows:"; and
 
4 on page 3, by replacing line 10 with "age or and older or, in
5 the case of influenza vaccination, 9 years of age or older
6 pursuant to a valid prescription or standing"; and
 
7 on page 14, by replacing line 25 with "age or and older or, in
8 the case of influenza vaccination, 9 years of age or older
9 pursuant to a valid prescription or standing"; and
 
10 on page 24, immediately below line 13, by inserting the
11 following:
 
12     "(225 ILCS 85/25)  (from Ch. 111, par. 4145)
13     (Section scheduled to be repealed on January 1, 2018)
14     Sec. 25. No person shall compound, or sell or offer for

 

 

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1 sale, or cause to be compounded, sold or offered for sale any
2 medicine or preparation under or by a name recognized in the
3 United States Pharmacopoeia National Formulary, for internal
4 or external use, which differs from the standard of strength,
5 quality or purity as determined by the test laid down in the
6 United States Pharmacopoeia National Formulary official at the
7 time of such compounding, sale or offering for sale. Nor shall
8 any person compound, sell or offer for sale, or cause to be
9 compounded, sold, or offered for sale, any drug, medicine,
10 poison, chemical or pharmaceutical preparation, the strength
11 or purity of which shall fall below the professed standard of
12 strength or purity under which it is sold. Except as set forth
13 in Section 26 of this Act, if the physician or other authorized
14 prescriber, when transmitting an oral or written prescription,
15 does not prohibit drug product selection, a different brand
16 name or nonbrand name drug product of the same generic name may
17 be dispensed by the pharmacist, provided that the selected drug
18 has a unit price less than the drug product specified in the
19 prescription. A generic drug determined to be therapeutically
20 equivalent by the United States Food and Drug Administration
21 (FDA) shall be available for substitution in Illinois in
22 accordance with this Act and the Illinois Food, Drug and
23 Cosmetic Act, provided that each manufacturer submits to the
24 Director of the Department of Public Health a notification
25 containing product technical bioequivalence information as a
26 prerequisite to product substitution when they have completed

 

 

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1 all required testing to support FDA product approval and, in
2 any event, the information shall be submitted no later than 60
3 days prior to product substitution in the State. On the
4 prescription forms of prescribers, shall be placed a signature
5 line and the words "may not substitute". The prescriber, in his
6 or her own handwriting, shall place a mark beside "may not
7 substitute" to direct the pharmacist in the dispensing of the
8 prescription. Preprinted or rubber stamped marks, or other
9 deviations from the above prescription format shall not be
10 permitted. The prescriber shall sign the form in his or her own
11 handwriting to authorize the issuance of the prescription. If a
12 prescription has been substituted from a brand name drug to a
13 generic, then it shall be the policy of the pharmacy to provide
14 written notice of this substitution to the patient. If the
15 Department finds a pattern and practice of not following its
16 policy, then it shall be considered a violation of this Act.
17     In every case in which a selection is made as permitted by
18 the Illinois Food, Drug and Cosmetic Act, the pharmacist shall
19 indicate on the pharmacy record of the filled prescription the
20 name or other identification of the manufacturer of the drug
21 which has been dispensed.
22     The selection of any drug product by a pharmacist shall not
23 constitute evidence of negligence if the selected nonlegend
24 drug product was of the same dosage form and each of its active
25 ingredients did not vary by more than 1 percent from the active
26 ingredients of the prescribed, brand name, nonlegend drug

 

 

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1 product. Failure of a prescribing physician to specify that
2 drug product selection is prohibited does not constitute
3 evidence of negligence unless that practitioner has reasonable
4 cause to believe that the health condition of the patient for
5 whom the physician is prescribing warrants the use of the brand
6 name drug product and not another.
7     The Department is authorized to employ an analyst or
8 chemist of recognized or approved standing whose duty it shall
9 be to examine into any claimed adulteration, illegal
10 substitution, improper selection, alteration, or other
11 violation hereof, and report the result of his investigation,
12 and if such report justify such action the Department shall
13 cause the offender to be prosecuted.
14 (Source: P.A. 94-936, eff. 6-26-06; 95-689, eff. 10-29-07.)".