101ST GENERAL ASSEMBLY
State of Illinois
2019 and 2020
HB4771
 
Introduced 2/18/2020, by Rep. Deanne M. Mazzochi
 
SYNOPSIS AS INTRODUCED:
 

 
410 ILCS 620/3.24 new

     Amends the Illinois Food, Drug and Cosmetic Act. Requires a manufacturer of a prescription drug that is sold, offered for sale, or distributed in this State, or placed on a formulary to be eligible for payment,  co-payment, or reimbursement in this State, to notify the Department of Public Health of specified information concerning active pharmaceutical ingredients.
  


LRB101 17711 CPF 69458 b

 
 
A BILL FOR
 

  
HB4771LRB101 17711 CPF 69458 b


  
1    AN ACT concerning health.
  
 
2    Be it enacted by the People of the State of Illinois,
 
3represented in the General Assembly:
  
 
 
4    Section 5. The Illinois Food, Drug and Cosmetic Act is 
5amended  by adding Section 3.24 as follows:
 
6    (410 ILCS 620/3.24 new)
7    Sec. 3.24. Active pharmaceutical ingredients. A 
8manufacturer of a prescription drug that is sold, offered for 
9sale, or distributed in this State, or placed on a formulary to 
10be eligible for payment,  co-payment, or reimbursement in this 
11State, must notify the Department of Public Health of the 
12following:
13        (1) the country of origin for the active pharmaceutical 
14    ingredient, in a searchable form by proprietary name, such 
15    as a brand name, if one is associated with the drug 
16    product, and ingredient name, such as a generic chemical 
17    name; if the country of origin for a manufacturer varies 
18    based on dosage or route of administration, each country of 
19    origin shall be specified for each such dosage or route of 
20    administration;
21        (2) the Drug Master File number for any angiotensin II 
22    receptor blocker and certification that the active 
23    ingredient specification contains a nitrosamine 
 
 
HB4771- 2 -LRB101 17711 CPF 69458 b

1    specification of "Not Detected"; and
2        (3) the Drug Master File number and drug name for any 
3    active pharmaceutical ingredient that contains a 
4    nitrosamine specification control because the process of 
5    manufacture for the active pharmaceutical ingredient makes 
6    use of recycled solvents or catalysts.