Sen. Dan Kotowski

Filed: 3/15/2010

 

 


 

 


 
09600SB2060sam002 LRB096 11300 ASK 38943 a

1
AMENDMENT TO SENATE BILL 2060

2     AMENDMENT NO. ______. Amend Senate Bill 2060 by replacing
3 everything after the enacting clause with the following:
 
4     "Section 5. The Pharmacy Practice Act is amended by
5 changing Section 25 as follows:
 
6     (225 ILCS 85/25)  (from Ch. 111, par. 4145)
7     (Section scheduled to be repealed on January 1, 2018)
8     Sec. 25. No person shall compound, or sell or offer for
9 sale, or cause to be compounded, sold or offered for sale any
10 medicine or preparation under or by a name recognized in the
11 United States Pharmacopoeia National Formulary, for internal
12 or external use, which differs from the standard of strength,
13 quality or purity as determined by the test laid down in the
14 United States Pharmacopoeia National Formulary official at the
15 time of such compounding, sale or offering for sale. Nor shall
16 any person compound, sell or offer for sale, or cause to be

 

 

09600SB2060sam002 - 2 - LRB096 11300 ASK 38943 a

1 compounded, sold, or offered for sale, any drug, medicine,
2 poison, chemical or pharmaceutical preparation, the strength
3 or purity of which shall fall below the professed standard of
4 strength or purity under which it is sold. Except as set forth
5 in Section 26 of this Act, if the physician or other authorized
6 prescriber, when transmitting an oral or written prescription,
7 does not prohibit drug product selection, a different brand
8 name or nonbrand name drug product of the same generic name may
9 be dispensed by the pharmacist, provided that the selected drug
10 has a unit price less than the drug product specified in the
11 prescription. A generic drug determined to be therapeutically
12 equivalent by the United States Food and Drug Administration
13 (FDA) shall be available for substitution in Illinois in
14 accordance with this Act and the Illinois Food, Drug and
15 Cosmetic Act, provided that each manufacturer submits to the
16 Director of the Department of Public Health a notification
17 containing product technical bioequivalence information as a
18 prerequisite to product substitution when they have completed
19 all required testing to support FDA product approval and, in
20 any event, the information shall be submitted no later than 60
21 days prior to product substitution in the State. On the
22 prescription forms of prescribers, shall be placed a signature
23 line and the words "may not substitute". The prescriber, in his
24 or her own handwriting, shall place a mark beside "may not
25 substitute" to direct the pharmacist in the dispensing of the
26 prescription. Preprinted or rubber stamped marks, or other

 

 

09600SB2060sam002 - 3 - LRB096 11300 ASK 38943 a

1 deviations from the above prescription format shall not be
2 permitted. The prescriber shall sign the form in his or her own
3 handwriting to authorize the issuance of the prescription. If a
4 pharmacist substitutes any prescription, then the pharmacist
5 shall provide written notice to the patient.
6     In every case in which a selection is made as permitted by
7 the Illinois Food, Drug and Cosmetic Act, the pharmacist shall
8 indicate on the pharmacy record of the filled prescription the
9 name or other identification of the manufacturer of the drug
10 which has been dispensed.
11     The selection of any drug product by a pharmacist shall not
12 constitute evidence of negligence if the selected nonlegend
13 drug product was of the same dosage form and each of its active
14 ingredients did not vary by more than 1 percent from the active
15 ingredients of the prescribed, brand name, nonlegend drug
16 product. Failure of a prescribing physician to specify that
17 drug product selection is prohibited does not constitute
18 evidence of negligence unless that practitioner has reasonable
19 cause to believe that the health condition of the patient for
20 whom the physician is prescribing warrants the use of the brand
21 name drug product and not another.
22     The Department is authorized to employ an analyst or
23 chemist of recognized or approved standing whose duty it shall
24 be to examine into any claimed adulteration, illegal
25 substitution, improper selection, alteration, or other
26 violation hereof, and report the result of his investigation,

 

 

09600SB2060sam002 - 4 - LRB096 11300 ASK 38943 a

1 and if such report justify such action the Department shall
2 cause the offender to be prosecuted.
3 (Source: P.A. 94-936, eff. 6-26-06; 95-689, eff. 10-29-07.)".