97TH GENERAL ASSEMBLY
State of Illinois
2011 and 2012
HB5529
 
Introduced , by Rep. Randy Ramey, Jr.
 
SYNOPSIS AS INTRODUCED:
 

 
225 ILCS 120/57.5 new

     Amends the Wholesale Drug Distribution Licensing Act. Creates a provision concerning general pedigree requirements. Provides that each prescription drug manufactured in each stage shall have a drug identification number that is assigned by the manufacturer to initiate pedigree tracking. Sets forth the general requirements of assigning, labeling,  and transferring documents containing a drug identification number with each prescription drug manufactured. Effective immediately.
  


LRB097 20442 CEL 65941 b

 
 
A BILL FOR
 

  
HB5529LRB097 20442 CEL 65941 b


  
1    AN ACT concerning regulation.
  
 
2    Be it enacted by the People of the State of Illinois,
 
3represented in the General Assembly:
  
 
 
4    Section 5. The Wholesale Drug Distribution Licensing Act is 
5amended  by adding Section 57.5 as follows:
 
6    (225 ILCS 120/57.5 new)
7    Sec. 57.5. General pedigree requirements.
8    (a) For the purposes of this Section:
9        "Drug identification number" or "DIN" means a series of 
10    Arabic numbers and Roman letters that is assigned to a 
11    prescription drug for pedigree transaction identification 
12    purposes. 
13    (b) Each prescription drug manufactured in each stage shall 
14have a DIN that is assigned by the manufacturer to initiate 
15pedigree tracking. Each drug manufactured in more than one 
16stage shall have a DIN assigned by the incomplete drug 
17manufacturer. Drug ingredient manufacturers, manufacturers, 
18wholesalers retailers, and providers shall maintain  an 
19original assigned DIN with the documentation as specified in 
20subsection (c) of Section 57 of this Act and shall utilize the 
21DIN assigned by the original manufacturer of the drug.
22    (c) Each DIN shall consist of the components of the 
23National Directory Code number as defined by the FDA, such as 
 
 
HB5529- 2 -LRB097 20442 CEL 65941 b

1an identification of the drug, strength, size of package, and 
2manufacturer, followed by an Employer Identification Number 
3(EIN), the date of receipt, and a transfer to each party 
4handling the inventory. 
5    (d) The DIN shall be appended and modified with the EIN and 
6data in progression on the drug packaging or record of movement 
7and on any transfer documents containing the updated DIN 
8prepared by the manufacturer and documented by each party as it 
9is given from one party to the next. 
10    (e) The DINs of any 2 drug lots manufactured within a 
1130-year period shall not be identical. 
12    (f) The DIN of each drug package shall appear clearly and 
13indelibly upon either a part of the drug packaging or container 
14that is not designed to be removed except for repair or upon a 
15separate plate or label that is permanently affixed to such a 
16part. 
 
 
17    Section 99. Effective date. This Act takes effect upon 
18becoming law.