Rep. Sara Feigenholtz
Filed: 3/26/2014
 
 

 

 

 
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1
AMENDMENT TO HOUSE BILL 3956




2    AMENDMENT NO. ______. Amend House Bill 3956 by replacing 
3everything after the enacting clause with the following:

 
4    "Section 5. The Pharmacy Practice Act is amended  by adding 
5Section 25.25 as follows:
 
6    (225 ILCS 85/25.25 new)
7    Sec. 25.25. Opioid analgesic drugs. 
8    (a) For the purposes of this Section:
9    "Interchange or substitution of an opioid analgesic drug" 
10means the substitution of any brand name or generic opioid 
11analgesic drug for a prescribed opioid analgesic drug 
12incorporating a tamper-resistance technology, whether or not 
13the substituted drug is rated as pharmaceutically and 
14therapeutically equivalent by the United States Food and Drug 
15Administration or the Board or whether the opioid analgesic 
16drug with tamper-resistance technology bears a labeling claim 
 
 
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1with respect to reduction of tampering, abuse, or abuse 
2potential. 
3    "Opioid analgesic drug" means a drug in the opioid drug 
4class prescribed to treat moderate to severe pain or other 
5conditions, including opioid dependence, whether in immediate 
6release or extended release form and whether or not combined 
7with other drug substances to form a single tablet or other 
8dosage form.
9    "Opioid analgesic drug incorporating a tamper-resistance 
10technology" means an opioid analgesic drug listed as such by 
11the Board under subsection (b).
12    (b) The Board shall establish a list of the opioid 
13analgesic drugs for which it has received evidence from the 
14drug manufacturer or distributor that the drug incorporates a 
15tamper-resistance technology.
16    The list shall also include a determination by the Board as 
17to which of the opioid analgesic drugs incorporating 
18tamper-resistance technologies on the list provide 
19substantially similar tamper-resistance properties. Such a 
20determination by the Board shall be based solely on any studies 
21submitted to the United States Food and Drug Administration 
22with the drug manufacturer's application for approval.
23    (c) The Board shall not exclude an opioid analgesic drug 
24from the list established under subsection (b) on the basis 
25that the drug does not bear a labeling claim with respect to 
26reduction of tampering, abuse, or abuse potential at the time 
 
 
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1the drug is being considered for placement on the list or any 
2time after the drug's placement on the list.
3    (d) A pharmacist shall not interchange or substitute a 
4brand name or generic opioid analgesic drug otherwise eligible 
5for interchange or substitution under this Section without 
6doing one of the following:
7        (1)  verifying that the Board has determined under 
8    subsection (b) that the opioid analgesic drug provides 
9    tamper-resistance properties substantially similar to the 
10    prescribed opioid analgesic drug incorporating a 
11    tamper-resistance technology; or
12        (2) obtaining written, signed consent from the 
13    prescriber for the interchange or substitution.
 

14    Section 99. Effective date. This Act takes effect January 
151, 2015.".